Exhibit 10.26

Portions of this exhibit marked [*] are requested to be treated confidentially.

 

 

 

CONFIDENTIAL

LICENSE AND ASSET TRANSFER AGREEMENT

BY AND BETWEEN

ALZA CORPORATION AND JANSSEN PHARMACEUTICA, NV

AND

FURIEX PHARMACEUTICALS, INC., AND GENUPRO, INC.

(A WHOLLY-OWNED SUBSIDIARY OF FURIEX PHARMACEUTICALS, INC.)

 

 

 

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Table of Contents

 

         Page  

SECTION 1 DEFINITIONS

     2   

    1.1

  Definitions      2   

    1.2

  Miscellaneous Interpretation Aids      13   

SECTION 2 EFFECTIVE DATE

     14   

SECTION 3 TERMINATION OF LICENSE AGREEMENT

     16   

    3.1

  Termination of Rights and Obligations      16   

    3.2

  Final Accounting      16   

    3.3

  Release and Covenant Not to Sue      17   

    3.4

  Interpretation of the License Agreement Under the New Lilly License      18   

SECTON 4 TRANSFER OF CERTAIN INTELLECTUAL PROPERTY

     18   

    4.1

  License of Alza Intellectual Property to Genupro      18   

    4.2

  Assignment of Trademarks, Domain Names      20   

    4.3

  Rights Retained by Alza      21   

SECTION 5 TRANSFER OF PRODUCT RIGHTS IN THE TERRITORY

     21   

    5.1

  Completion of Transfer of Product Rights      22   

    5.2

  Country Designation as a Group A Market, Group B Market, Group C Market, or
Group E Market      23   

    5.3

  Rights and Obligations of the Parties Based on Country Designation      25   

    5.4

  Designated Sub-distributors      32   

    5.5

  Delays in Transfer of ALZA Marketing Authorizations, ALZA Regulatory
Submissions, and Product Rights      32   

    5.6

  Reporting During Transition Period      33   

    5.7

  Disposition of Product Contracts      33   

    5.8

  Responsibility for Transitional Development      34   

SECTION 6 DILIGENCE AND COORDINATION OF EFFORTS

     36   

    6.1

  Diligence and Cooperation      36   

    6.2

  Transition Manager      40   

    6.3

  Transition Team      41   

    6.4

  Regulatory Transition Plan      41   

    6.5

  Pharmacovigilance Responsibilities and Product Inquiries      43   

    6.6

  Other External Communications Related to Agreement Product      44   

    6.7

  No Warranties      44   

SECTION 7 PAYMENT AND FINANCIAL MATTERS

     44   

    7.1

  Document Transfer Payments      44   

 

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    7.2

  Transition Services Payments      44   

    7.3

  Service Fees      45   

    7.4

  Taxes      45   

    7.5

  Regulatory Fees and Other Costs and Expenses      46   

    7.6

  Accounts Receivable on Pre-Transfer Sales      46   

SECTION 8 MANUFACTURING AND SUPPLY MATTERS

     47   

    8.1

  Manufacturing and Supply Agreement(s)      47   

SECTION 9 ANCILLARY AGREEMENTS

     47   

SECTION 10 CERTAIN PROVISIONS REGARDING DISTRIBUTION, SALE AND SUPPLIES OF
AGREEMENT PRODUCT

     48   

    10.1

  Orders for Agreement Product      48   

    10.2

  Labelling and Packaging      48   

    10.3

  Recalls      49   

SECTION 11 REPRESENTATIONS AND WARRANTIES

     50   

    11.1

  Mutual Representations      50   

    11.2

  By Alza      50   

    11.3

  Alza Covenants      60   

SECTION 12 LIABILITY AND INDEMNIFICATION

     63   

    12.1

  By Genupro      63   

    12.2

  By Alza      64   

    12.3

  Procedures      65   

    12.4

  Settlements      65   

    12.5

  No Consequential Damages      66   

    12.6

  Insurance      66   

SECTION 13 CONFIDENTIALITY

     66   

    13.1

  Confidential Information      66   

    13.2

  Non-Disclosure and Non-Use      67   

    13.3

  Permitted Disclosures      67   

    13.4

  Disclosure of Financial and Other Terms      68   

    13.5

  No Use of Name      69   

    13.6

  Publicity      69   

SECTION 14 FAILURE OF EFFECTIVE DATE UNDER SECTION 2.1 TO OCCUR

     69   

SECTION 15 TERMINATION AND SURVIVAL

     70   

SECTION 16 GENERAL

     70   

    16.1

  Entire Agreement/Integration      70   

    16.2

  Notice      71   

 

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    16.3

  No Third Party Beneficiaries      71   

    16.4

  Assignment      72   

    16.5

  Compliance      72   

    16.6

  Governing Law and Dispute Resolution      72   

    16.7

  Execution in Counterparts; Facsimile Signatures      73   

    16.8

  Schedules      73   

Schedules

 

Schedule 4.2A

   Domain Names

Schedule 4.2B1

   Trademarks to be Assigned to GENUPRO

Schedule 4.2B2

   Trademarks to be Assigned to Menarini

Schedule 5.1.1

   Third Party MAHs

Schedule 5.2A

   Group A Markets

Schedule 5.2B

   Group B Markets

Schedule 5.2C

   Group C Markets

Schedule 5.4

   Distribution Agreements

Schedule 5.7

   Product Contracts

Schedule 5.8.1

   Ongoing Clinical Studies

Schedule 5.8.2A

   ALZA Universal Calendar

Schedule 5.8.2B

   Example Invoice

Schedule 5.8.7

   Post-marketing clinical study reporting obligations

Schedule 6.1.1

   Documents to be Included in Development Records

Schedule 6.1.1.1

   Listing of Record Categories in Index of Transferred Development Records

Schedule 6.1.2

   Third Party Software

Schedule 6.1.5

   Additional Information to be Included in Electronic Media and Provided to
GENUPRO

Schedule 6.2

   Initial Transition Managers

Schedule 11

   Exceptions to Representations and Warranties

Schedule 11.2.15.1A

   ALZA Marketing Authorizations

Schedule 11.2.15.1B

   ALZA Regulatory Submissions

Schedule 11.2.15.1C

   Pricing Approvals

Schedule 11.2.18

   ALZA Sublicenses

Schedule 11.3.11

   Required Consents

 

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LICENSE AND ASSET TRANSFER AGREEMENT

This License and Asset Transfer Agreement (the “Agreement”), by and between ALZA
CORPORATION, a company incorporated in the State of Delaware and having offices
at 700 Eubanks Drive, Vacaville, California 95688 and JANSSEN PHARMACEUTICA NV,
a corporation organised under the laws of the Kingdom of Belgium and having its
principal place of business at Turnhoutseweg 30, B-2340 Beerse, Belgium
(“JANSSEN”) (collectively “ALZA”), and FURIEX PHARMACEUTICALS, INC., a company
incorporated in the State of Delaware and having its registered office at 3900
Paramount Parkway, Suite 150, Morrisville, NC 27560 (“FURIEX”) and GenuPro, Inc.
(“GENUPRO”), a wholly-owned subsidiary of FURIEX organized under the laws of the
State of North Carolina and having its registered office at 3900 Paramount
Parkway, Suite 150, Morrisville, NC 27560, is entered into as of the date of
signature by the last Party to sign below and is effective upon the satisfaction
of the conditions set forth in Section 2 below (the “Effective Date”). ALZA,
FURIEX and GENUPRO are each referred to from time to time herein either
individually as a “Party” or collectively as the “Parties”.

WHEREAS, ALZA, FURIEX, as successor-in-interest to Pharmaceutical Product
Development, Inc. (“PPD”), and GENUPRO, entered into a License Agreement having
an effective date of January 2, 2001, and which was amended on December 26, 2003
by Amendment No. 1 to License Agreement, and which was further amended on
October 16, 2009 by Amendment No. 2 to License Agreement (such License Agreement
between FURIEX, GENUPRO, and ALZA, hereinafter referred to as the “License
Agreement”), and which the Parties have further taken in context with the
Termination and License Agreement, having an effective date of December 18,
2003, amongst Eli Lilly and Company (“Lilly”) and PPD, GENUPRO and APBI
Holdings, LLC, a wholly-owned subsidiary of PPD (such Termination and License
Agreement between Lilly, PPD, GENUPRO, and APBI Holdings, LLC, the “New Lilly
License”) relating to the licensing by GENUPRO to ALZA of certain rights
pertaining to the development and commercialization of Dapoxetine; and

WHEREAS, FURIEX, GENUPRO and ALZA desire to terminate the License Agreement, at
which time ALZA’s rights and responsibilities thereunder will terminate and
revert to GENUPRO, subject to the survival of certain rights and obligations as
described therein and in this Agreement; and

WHEREAS, ALZA desires to transfer ownership of Product Rights (as defined below)
to GENUPRO and achieve an orderly and efficient transition of manufacturing and
marketing capabilities to GENUPRO or its designee; and

WHEREAS, the Parties therefore desire to state their respective rights and
responsibilities in connection with the termination of the License Agreement and
the reversion and transfer of rights and responsibilities for Dapoxetine-based
products to GENUPRO, all on the terms and conditions set forth in this
Agreement.

 

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NOW, THEREFORE, in consideration of the mutual covenants and agreements set
forth herein and intending to be legally bound, the Parties hereby agree as
follows:

Section 1 Definitions

1.1 Definitions. The capitalized terms used in this Agreement shall have the
defined meanings set forth below or elsewhere in this Agreement. Capitalized
singular, plural, and other variant forms of the defined terms shall have the
corresponding meanings.

“Affiliate” means a person or entity that directly or indirectly through one or
more intermediates, controls, is controlled by, or is under common control with
the person or entity specified. For the purpose of this definition, “control”
shall mean with respect to an entity, (a) the direct or indirect ownership of:
(x) at least fifty percent (50%) or more of the capital stock or share capital
entitled to vote for the election of directors of the entity (or such lesser
percentage which is the maximum allowed to be owned by a foreign corporation in
a particular jurisdiction); or (y) at least fifty percent (50%) of equity or
voting interest of the entity (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular jurisdiction) or
(b) the power to direct or cause the direction of the management and policies of
the corporation or other entity.

“Agreement Product” means a drug product in its final dosage form(s) containing
Dapoxetine described in any ALZA Regulatory Submissions made by or on behalf of
ALZA or any Affiliate thereof prior to the Effective Date or in ALZA Marketing
Authorizations of ALZA or any Affiliate thereof.

“ALZA Derivative” means a Derivative of Dapoxetine that (a) is not a
Product-Related Improvement (as defined in the License Agreement), (b) is not
incorporated in any Agreement Product, and (c) was first developed or conceived
by or on behalf of ALZA, or any Affiliate thereof, independently of ALZA’s, its
Affiliates, or their sublicensees’ (i) exercise of any rights granted under the
License Agreement or (ii) access to, or knowledge or use of, any Confidential
Information (as defined under the Licensed Agreement or this Agreement)
disclosed by or on behalf of GENUPRO.

“ALZA Distribution Termination Date” shall have the meaning set forth in
Section 5.3.1.2.1 of this Agreement.

“ALZA Know-How” means the Know-How disclosed in the documents and Electronic
Media identified in the Index, Controlled by ALZA as of the Effective Date, or
coming under the Control of ALZA prior to the Final Transfer Date, that
specifically relates to Agreement Product and was used or generated in ALZA’s
and its Affiliates’ and Sublicensees’ development, use, manufacture,
importation, sale, offering for sale, distribution, or commercialization of,
Dapoxetine or the Agreement Product, including any Know-How resulting from any
On-Going Clinical Studies, but excluding any Know-How to the extent specifically
relating to any ALZA Derivative.

 

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“ALZA Marketing Authorizations” means all health registrations, marketing
authorizations, centralized registrations, labelling approvals, Regulatory
Approvals, any other technical, medical and scientific licenses, authorizations
or approvals in the Territory for any Agreement Product (together with any
amendments or supplements to any of the foregoing) filed with or granted by any
Regulatory Authority, that, in each case, are Controlled by ALZA or any
Affiliate thereof (and which shall include those held or controlled by a Third
Party MAH on behalf of ALZA or an Affiliate thereof pursuant to a Distribution
Agreement), as of the Effective Date, or come under the Control of ALZA or any
Affiliate thereof (or any Third Party MAH) prior to the end of the Transition
Completion Date.

“ALZA Patents” means all Patents (if any) Controlled by ALZA (directly or
through any Affiliate) thereof as of the Effective Date, or coming under the
Control of ALZA (directly or through any Affiliate thereof) through issuance
after the Effective Date and prior to the end of the Transition Completion Date,
including any claim Covering Dapoxetine or the Agreement Product.

“ALZA Permitted Liens” means a Permitted Lien arising, directly or indirectly,
from the acts or omissions of ALZA, any Affiliate thereof, or any Third Party
contractor or licensee of either of the foregoing with respect to Agreement
Product, any Product Rights, or any Distribution Agreement or Product Contract.

“ALZA Regulatory Submissions” means all Regulatory Submissions, together with
any amendments or supplements thereto, that, in each case, are Controlled by
ALZA or an Affiliate thereof as of the Effective Date, or come under the Control
of ALZA or an Affiliate thereof prior to the Transition Completion Date (and
which shall include those held or controlled by a Third Party MAH on behalf of
ALZA or an Affiliate thereof pursuant to a Distribution Agreement).

“Ancillary Agreements” means the following:

(a) In the event of a Section 2.1 Closing: Non-Group E Markets Manufacturing
Agreement, Group E Markets Manufacturing Agreement, Non-Group E Markets Quality
Agreement, Group E Markets Quality Agreement, GENUPRO Trademark Assignment
Agreement, Menarini Trademark Assignment Agreement, Domain Name Assignment
Agreement, PV Agreement, Delegations of Authority (if any), Transition Services
Agreement, and Sales Service Agreement; or

(b) In the event of a Section 2.2 Closing: GENUPRO Manufacturing Agreement,
GENUPRO Quality Agreement, GENUPRO Trademark Assignment Agreement, Domain Name
Assignment Agreement, GENUPRO PV Agreement, Delegations of Authority (if any),
Transition Services Agreement, and Sales Service Agreement.

“Calendar Quarter” shall mean a calendar quarter based on the ALZA Universal
Calendar for that year, a copy of which, for 2012 is attached as Schedule
5.8.2A, and which shall be updated by ALZA for each Calendar Year of the Term
consistent with the ALZA Universal Calendar used for ALZA’s internal business
purposes; provided, however that the first calendar quarter for the first
Calendar Year shall extend from the Effective Date to the end of the
then-current Calendar Quarter and the last Quarter shall extend from the first
day of such Calendar Quarter until the effective date of the termination or
expiration of the Agreement.

 

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“Calendar Year” means a calendar year during the term of this Agreement based on
the ALZA Universal Calendar for that year.

“Clinical Trial Application” means an application submitted to a Regulatory
Authority to obtain the right to perform human clinical trials, including an
IND.

“Commercially Reasonable Efforts” means the carrying out by a Party of
obligations or activities as specified herein exerting overall a level of effort
no less than consistent with the level of effort that such Party customarily
devotes to corresponding activities, with respect to a pharmaceutical product or
products of similar market potential, profit potential or strategic value, based
on conditions then prevailing. Without limiting the foregoing, Commercially
Reasonable Efforts requires that a Party: (i) timely assign responsibility for
such activities to specific employees, contractors, agents, Affiliates or
Sublicensees, as applicable, who are held accountable for progress with respect
to such activities, (ii) monitor such progress on an on-going basis, (iii) set
and seek to achieve objectives and timelines for carrying out such activities,
and (iv) allocate resources reasonably designed to advance progress with respect
to such objectives and timelines.

“Copyrights” means any and all copyrights or other rights in any works of
authorship specifically relating to any Agreement Product, Controlled by ALZA
(directly or through any Affiliate thereof) as of the Effective Date or coming
under the Control of ALZA at any time prior to the Final Transition Date,
including any such rights in works for any websites, package inserts, package
layups, pill photographs, templates, artwork, development, advertising,
marketing, promotional, or sales-related materials developed or used by or on
behalf of ALZA for any Agreement Product but excluding for the avoidance of
doubt any rights or interests in any trademarks, logos or trade dress owned or
licensed by ALZA not specifically relating to Agreement Product that may be
incorporated in such materials (including the corporate names and logos
representing ALZA and its Affiliates).

“Confidential Information” shall have the meaning set forth in Section 13.1 of
this Agreement.

“Control” means possession of the right to grant a license or sublicense or
other rights as provided for herein by the applicable Party, whether through
ownership or license from any Affiliate or Third Party, without violating the
terms of any agreement with any Third Party.

“Cover” means, with respect to a claim of any Patent in reference to specified
subject matter (such as a composition of matter or method of use or
manufacture), reading on or literally encompassing such subject matter, whether
generically or specifically.

“Country Transfer Date” means, on a country-by-country basis, the date on which
all of the Product Rights (other than any ALZA Regulatory Submissions and
Governmental Permits that cannot be transferred by such date, as contemplated by
Section 5.5) in a country are to be transferred, assigned, and delivered to
GENUPRO, directly or to GENUPRO’s designated Affiliate or Sublicensee, in
accordance with the terms of Section 5 of this Agreement pursuant to the
Transition Plan.

 

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“Country Transfer Transition Period” shall have the meaning set forth in
Section 5.3.6.1 of this Agreement.

“Damages” means any and all damages, liabilities, claims, costs, charges,
judgments, injuries, awards, fines, penalties, fees and expenses (including,
without limitation, reasonable attorneys’ fees) suffered or incurred.

“Dapoxetine” means (a) (+/-)-N,N-dimethyl-l
-phenyl-3-(1-naphthalenyloxy)-propanamine,
(b) (S)-(+)-N,N-dimethyl-l-phenyl-3-(1-naphthalenyloxy)-propanamine,
(c) (R)-(-)-N,N-dimethyl-l-phenyl-3-(1-naphthalenyloxy)-propanamine,
(d) (+/-)-N,N-dimethyl-a-[2-(1-naphthalenyloxy) ethyl-benzenemethanamine,
(e) (S)-(+)-N,N-dimethyl-a-[2-(1-naphthalenyloxy) ethyl-benzenemethanamine,
(f) (R)-(-)-N,N-dimethyl-a-[2-(1-naphthalenyloxy) ethyl-benzenemethanamine,
(g) any pharmaceutically acceptable salt of any of the foregoing, or (h) any
active metabolite of any of the foregoing, including without limitation
mono-desmethyl dapoxetine and di-desmethyl dapoxetine.

“Data Room” means that certain electronic data room created by or on behalf of
ALZA to which GENUPRO was provided access by ALZA in connection with GENUPRO’s
due diligence activities related to the transactions contemplated by this
Agreement.

“Delegation of Authority” means a written agreement between ALZA or its
Affiliate and GENUPRO and/or its Affiliate and/or Sublicensee delegating
authority from ALZA or its Affiliate to GENUPRO and/or its Affiliate and/or
Sublicensee to distribute Agreement Product in a country or countries under ALZA
Market Authorization(s) in such country/countries, such authority terminating
country-by-country on the Regulatory Transfer Date in the applicable country.

“Derivative” means, with respect to any referenced chemical compound, any
analog, isomer, tautomer, enantiomer, diastereomer, prodrug, metabolite, ester,
salt, hydrate, solvate, racemate, or polymorph thereof.

“Development Costs” shall mean FTE Costs and Out-of-Pocket Costs incurred by the
Parties and their Affiliates in accordance with this Agreement in support of
Ongoing Clinical Studies, including but not limited to:

(a) all Out-of-Pocket Costs and FTE Costs incurred for activities in the Ongoing
Clinical Studies;

(b) the FTE Costs of scientific, medical, technical and other personnel directly
engaged in performing clinical study activities; and

(c) the Out-of-Pocket Costs and FTE Costs of clinical supplies for the Ongoing
Clinical Studies, including (i) the supply cost of clinical supply of the
Agreement Product; (ii) costs and expenses incurred to purchase or package Third
Party comparator or Third Party combination drugs or devices; and (iii) costs
and expenses of disposal of clinical samples.

 

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“Development Records” means all regulatory filings, records, and other documents
(whether in hardcopy or electronic form) in the Control of ALZA (directly or
through any Affiliate thereof) at any time prior to the Transition Completion
Date, material to the development of the Agreement Product, including any
Governmental Permits, ALZA Regulatory Submissions, or Manufacturing Records
anywhere in the Territory, including such portions of any documents bearing ALZA
Know-How relating to Dapoxetine or the Agreement Product and any Governmental
Permits or ALZA Regulatory Submissions for the Agreement Product and all
material written communications with Regulatory Authorities with respect
thereto. For the avoidance of doubt, Development Records include such records
used to obtain and maintain Governmental Permits or ALZA Regulatory Submissions,
and such records needed to support clinical development.

“Distribution Agreements” means all agreements between ALZA (and/or its
Affiliates) and any Third Party, including Third Party MAHs (as defined in
Section 5.1.1), granting such Third Party rights to market, promote, distribute
and commercialize Agreement Product.

“DMF” means a drug master file, as provided for in 21 CFR § 314.420, device
master file, as defined in 21 CFR § 814.3, or similar submission to or file
maintained with the FDA or any other Regulatory Authority or governmental agency
(including any supranational agency) that may be used to provide confidential
detailed information about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of one or more Agreement
Products.

“Domain Names” mean all registrations for, and pending applications for
registration of, the domain names associated with Agreement Product or the
marketing and sale thereof in any countries of the Territory, as set forth in
Schedule 4.2A.

“Electronic Media” means those encrypted hard drives, identified by serial
number in the Index, provided by ALZA to GENUPRO in connection with the
transactions contemplated by this Agreement.

“EMA” means European Medicines Agency, or any successor agency.

“Execution Date” means the date on which this Agreement has been executed by the
last Party to sign this Agreement.

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

“Field” means the development, manufacture, distribution, marketing,
advertising, promotion, and commercialization of Dapoxetine, Agreement Product,
and any Related Products for any and all uses or applications.

“Final Transfer Date” means, for a particular country, the later of the [*] or
[*].

“FTE” means a full time equivalent person year of professional scientific and/or
technical work or managerial work to the extent working on or directly involved
in Ongoing Clinical Studies.

[*] Confidential treatment requested.

 

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“FTE Cost” means [*] ($[*]) per FTE, which amount shall be adjusted [*], as
published by the [*], upon each [*] of the Effective Date during the Term.

“GENUPRO Know-How” means all Know-How Controlled by GENUPRO as of the Effective
Date, or coming under the Control of GENUPRO prior to the Transition Completion
Date, that, in either case, specifically relates to Agreement Product and was
used or generated by GENUPRO’s and its Affiliates’ and Sublicensees’
development, use, manufacture, sale, import, sale, offering for sale,
distribution, or commercialization of, Dapoxetine or Agreement Product.

“GENUPRO Patents” mean any and all Patents Controlled by GENUPRO that include
any claim that Covers Dapoxetine or the Agreement Product or any process or
material for making or method of using Dapoxetine or Agreement Product,
including any Lilly Patents (as defined in the License Agreement) and GenuPro
Patents (as defined in the License Agreement) only, in each case, to the extent
licensed by GENUPRO to ALZA under Article 2 of the License Agreement.

“GENUPRO PV Agreement” shall have the meaning set forth in Section 6.5 of this
Agreement.

“Good Clinical Practice” or “GCP” means the then current standards for clinical
trials for pharmaceuticals, as set forth in the ICH guidelines and applicable
regulations promulgated thereunder, as amended from time to time, and such
standards of good clinical practice as are required by the European Union and
other organizations and governmental agencies in countries in which a Agreement
Product is intended to be sold to the extent such standards are not less
stringent than the ICH guidelines.

“Good Laboratory Practices” or “GLP” means, with respect to the United States,
the then-current requirements for non-clinical (animal or laboratory) trials
that will be submitted to a Regulatory Authority to support a marketing
application, specified in 21 C.F.R. § 58, as may be amended, and, with respect
to any other country or jurisdiction, the equivalent regulations in such other
country or jurisdiction, including any such standards or guidelines set forth by
ICH.

“Good Manufacturing Practice” or “GMP” means: 1) the regulatory requirements for
current good manufacturing practices promulgated by the FDA under the U.S. Food,
Drug and Cosmetic Act (as set forth at 21 C.F.R. § 210 et seq.) and under the
Public Health Service Act, Biological Products (as set forth at 21 C.F.R. §§
600-610), as the same may be amended from time to time; and 2) such standards of
good manufacturing practice as are required by the European Union and other
organizations and governmental agencies in countries in which a Agreement
Product is intended to be manufactured or sold, to the extent such standards are
not less stringent than the FDA regulatory requirements stated above.

“Governmental Permits” means (i) the ALZA Marketing Authorizations and (ii) any
and all pricing or pricing reimbursement approvals for any Agreement Product
granted, in either case, by any Regulatory Authorities anywhere in the
Territory.

“Group A Market” shall have the meaning set forth in Section 5.2.1 of this
Agreement.

[*] Confidential treatment requested.

 

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“Group B Market” shall have the meaning set forth in Section 5.2.2 of this
Agreement.

“Group C Market” shall have the meaning set forth in Section 5.2.3 of this
Agreement.

“Group E Market” shall have the meaning set forth in Section 5.2.4 of this
Agreement.

“ICH” means the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceutical for Human Use.

“Identified ALZA Patents” shall have the meaning set forth in Section 4.1.5.

“Implementation Date” shall have the meaning set forth in Section 10.2 of this
Agreement.

“IND” means an Investigational New Drug Application filed with the FDA as more
fully defined in 21 C.F.R. §312.3 necessary to commence human clinical trials of
a drug in conformance with applicable laws and regulations or any foreign
equivalent thereof.

“Index” shall have the meaning set forth in Section 6.1.1.1.

“Indirect Taxes” shall have the meaning set forth in Section 7.4.3 of this
Agreement.

“Know-How” means all proprietary information (including data and results, and
information relating to practices, protocols, devices, technology, trade
secrets, inventions, compositions, designs, formulae, know-how, show-how,
processes and analytical methodologies used in research, development, testing,
analysis and manufacture, and medical, pre-clinical, clinical and toxicological
testing, including such information resulting from clinical trials),
specifically related to Dapoxetine or Agreement Product.

“Legal Requirements” mean any applicable federal, state, local or foreign
constitution, law, statute, rule or regulation, including, as applicable, GCP,
GLP, and GMP.

“License Agreement” shall have the meaning set forth for such term in the
introductory clauses above.

“Licensed Product” shall mean any “Licensed Product” as defined in Section 1.22
of the License Agreement.

“Lien” means any lien, pledge, claim, charge, mortgage, encumbrance or other
security interest of any kind, including any restriction on the use, voting,
transfer, receipt of income or other exercise of any attributes of ownership,
whether arising by contract or by operation of law.

“MA Delegate” means an entity to which ALZA (directly or through an Affiliate
thereof) delegates authority under a Delegation of Authority to distribute
Agreement Product in a country under the ALZA Market Authorization in such
country.

“Maintain” shall have the meaning assigned to such term based on its applicable
context as set forth in Section 5.2.5.

 

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“Manufacturing Agreements” means collectively in the event of a Section 2.1
Closing (a) the supply agreement upon execution by ALZA and Menarini for the
manufacture by ALZA of bulk Dapoxetine and finished Agreement Product for supply
to Menarini for use or commercial sale in the Group A Markets, Group B Markets
and Group C Markets (the “Non-Group E Markets Manufacturing Agreement”) and
(b) the supply agreement upon execution by ALZA and GENUPRO for the manufacture
by ALZA of bulk Dapoxetine and finished Agreement Product for supply to GENUPRO
or its designated Affiliates and/or Sublicensees for use or commercial sale in
the Group E Markets (the “Group E Markets Manufacturing Agreement”). In the
event of a Section 2.2 Closing, “Manufacturing Agreements” shall mean the supply
agreement upon execution by ALZA and GENUPRO for the manufacture by ALZA of bulk
Dapoxetine and finished Agreement Product for supply to GENUPRO or its
designated Affiliates and/or Sublicensees for use or commercial sale in the
Group A Markets, Group B Markets, Group C Markets and Group E Market countries
(the “GENUPRO Manufacturing Agreement”).

“Manufacturing Records” means all filings, records, and other documents (whether
in hardcopy or electronic form) Controlled by ALZA (directly or through its
Affiliates) pertaining to the manufacture of Dapoxetine or any Agreement
Product, including the portions of any such documents bearing Know-How relating
to the manufacture of Dapoxetine or any Agreement Product, the CMC portion of
all ALZA Regulatory Submissions and ALZA Marketing Authorizations for Dapoxetine
or any Agreement Product, all DMFs for Dapoxetine or any Agreement Product,
together with all amendments and supplements, in support thereof, records used
to obtain and maintain ALZA Marketing Authorizations or ALZA Regulatory
Submissions, and records needed to support clinical development of Dapoxetine or
any Agreement Product.

“Marketing Applications” means all applications for Regulatory Approval.

“Material Product Contract” shall have the meaning set forth in Section 5.7.

“Menarini” means Berlin Chemie AG (Menarini Group).

“Menarini Priligy License Agreement” shall mean a written agreement between
GENUPRO and Menarini licensing to Menarini any Product Rights anywhere in the
Territory or sublicensing any rights granted to GENUPRO by ALZA under
Section 4.1, such as without limitation wherein Menarini would become a
Sublicensee of GENUPRO under this Agreement.

“Menarini Trademark Assignment Agreement” means the agreement between ALZA or an
Affiliate thereof and Menarini that assigns all Trademarks outside the Group E
Markets from ALZA or any Affiliate thereof to Menarini, as contemplated by
Section 4.2.1.

“NDA” means any new drug application filed with the FDA pursuant to 21 U.S.C.
Section 505(b)(1), as amended from time to time, which is necessary for approval
to use, market, import, sell and offer for sale Agreement Products in the US.

“Ongoing Clinical Studies” shall have the meaning set forth in Section 5.8.1.

 

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“Out of Pocket Expenses” means all Third Party invoiced expenses incurred by
ALZA or its Affiliates for their conduct of Ongoing Clinical Studies or
activities under Section 6.1.1, respectively, to the extent reimburseable under
Section 5.8.2 or 7.1, respectively.

“Patents” means, with respect to a given invention: (i) any and all original
(priority-establishing) patents and patent applications claiming the invention
filed anywhere in the world, including provisional and nonprovisional
applications, (ii) all patent applications related to the foregoing thereafter
filed including a common priority right, including any continuations,
continuations-in-part, divisional and substitute applications, (iii) any patents
issued or granted from any of the patent applications referenced in (i) and
(ii) above, (iv) any reissues, renewals, reexaminations, limitations, extensions
(including by virtue of any Supplementary Protection Certificates and Patent
Term Extensions) of any of the patents referenced in (i) or (iii) above, (v) any
confirmation patents, inventor’s certificates or registration patents or patents
of addition based on any such patents, and (vi) all foreign counterparts or
equivalents in any country or jurisdiction of any of the foregoing.

“Permitted Liens” means the following: (i) statutory Liens for Taxes not yet due
or payable and (ii) Liens for assessments and other governmental charges or
Liens of landlords, carriers, warehousemen, mechanics and repairmen incurred in
the ordinary course of business, in each case for sums not yet due and payable
or due but not delinquent or being contested in good faith by appropriate
proceedings.

“Proceedings” means any action, suit, litigation, claim, administrative action
or proceeding by a Regulatory Authority or any other person or entity or
investigation, audit, or inspection by a Regulatory Authority or other
governmental authority.

“Product Contract(s)” means any contract(s) between ALZA, or any Affiliate
thereof, and any Third Party(ies) related to the development, manufacture,
distribution, marketing, promotion, or sale of Agreement Product in the
Territory, but not including the Distribution Agreements. Product Contracts
include, but are not limited to, agreements with local distributors, carriers,
wholesalers, purchasers, clinical study agreements and consulting agreements.

“Product Rights” means all rights, title and interest of, or controlled by, ALZA
or its Affiliates, including such right, title, and interest held on behalf of
ALZA or its Affiliates by a Third Party MAH with respect to any Governmental
Permits or ALZA Regulatory Submissions under, and subject to, a Distribution
Agreement, in and to the Trademarks, Domain Names, Governmental Permits, ALZA
Regulatory Submissions, Development Records, and Manufacturing Records,
including all rights to package, distribute, offer for sale, advertise, market,
promote, import, export and sell the Agreement Product in a country, but not
including the rights licensed to ALZA under the License Agreement (which shall
revert to GENUPRO upon termination thereof except as otherwise provided in this
Agreement)

“PV Agreement” shall have the meaning set forth in Section 6.5 of this
Agreement.

 

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“Quality Agreement(s)” means an agreement appended to a Manufacturing Agreement
setting forth quality standards for manufacture of Agreement Product. The
Non-Group E Markets Quality Agreement shall be appended to the Non-Group E
Markets Manufacturing Agreement and the Group E Markets Quality Agreement shall
be appended to the Group E Market Manufacturing Agreement. In the event of a
Section 2.2 Closing, “Quality Agreement(s)” shall mean an agreement (“the
GENUPRO Quality Agreement”) appended to the GENUPRO Manufacturing Agreement
setting forth quality standards for manufacture of Agreement Product.

“Regulatory Approval” means, for any Agreement Product, all permissions,
approvals, licenses, registrations, authorizations, or clearances of any
Regulatory Authority that are necessary for the sale of such Agreement Product
as a human pharmaceutical in any country in the Territory (excluding pricing and
reimbursement approvals)

“Regulatory Authority” means any regulatory agency, ministry, department,
commission, council or other governmental body having authority in any country
to authorize or control development, manufacture, marketing and sale of human
pharmaceutical products, and including among others the FDA and the EMA.

“Regulatory Proceeding” means any action, administrative action or proceeding by
or before a Regulatory Authority or other governmental authority occurring in
the ordinary and due course of a Party’s (i) filing or maintaining a Regulatory
Submission, (ii) maintaining or obtaining a Regulatory Approval, or (iii) filing
or maintaining an application for, or obtaining approval of and maintaining, any
other Governmental Permits.

“Regulatory Submissions” means, with respect to the Territory, all applications,
filings, dossiers and other documents submitted to a Regulatory Authority for
the purpose of seeking or obtaining Regulatory Approval (or engaging in clinical
trials with respect to any human pharmaceutical) for Agreement Product or
pricing and reimbursement approval from that Regulatory Authority for Agreement
Product, including, without limitation, Clinical Trial Applications (including
INDs), and Marketing Applications (including ANDAs, NDAs, and sNDAs), and any
equivalents of any of the foregoing.

“Regulatory Transfer Date” means the date on which the assignment and transfer
to GENUPRO or its designated Affiliates or Sublicensees of all ALZA Regulatory
Submissions and Governmental Permits in a given country are effective, except
with respect to any Governmental Permits or ALZA Regulatory Submissions that
cannot be transferred and assigned under this Agreement due to limitations
imposed by Legal Requirements, as contemplated by Section 5.1.2, which
limitations shall be addressed as described in Section 5.1.2, in which event the
Regulatory Transfer Date in such country shall be the date on which a substitute
action taken by ALZA (directly or through its Affiliates), or caused by ALZA to
be taken by a Third Party MAH, as set forth in Section 5.1.2 becomes effective.

“Regulatory Transfer Transition Period” shall have the meaning set forth in
Section 5.3.6.2 of this Agreement.

“Regulatory Transition Plan” shall have the meaning set forth in Section 6.4 of
this Agreement.

 

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“Related Product” means a drug product, other than Agreement Product, in final
dosage form incorporating as its active ingredient Dapoxetine or another
compound that was Covered by a claim of U.S. Patent No. 5,135,947 during its
patent term, for use in treatment of humans for therapeutic indications within
the urogenital area including premature ejaculation, primary urinary
incontinence, urge, stress and mixed incontinence, urinary urgency, interstitial
cystitis, neurogenic bladder, bladder sphincter dyssynergia and irritative
symptoms of benign prostate hypertrophy (“BPH”), hypoactive sexual desire,
impotence, retarded ejaculation, delayed orgasm, and anorgasmia, but not
including diseases of the kidney.

“Responsible Party” shall have the meaning set forth in Section 10.4.1 of this
Agreement.

“Safety Database” shall have the meaning set forth in the PV Agreement attached
hereto.

“Sales Services Agreement” shall have the meaning set forth in Section 5.3.1.2.

“Split Lot” shall have the meaning set forth in Section 10.3.1 of this
Agreement.

“Sublicensees” means, with respect to GENUPRO, Menarini or any Affiliate of
either, a Third Party granted a sublicense to any of the rights granted to
GENUPRO under Section 4.1 or a license under any GENUPRO Patents or Product
Rights transferred to GENUPRO under this Agreement (each such Third Party, a
“GENUPRO Sublicensee”), and, with respect to ALZA, any Affiliate or Third Party
granted a sublicense to: (i) any of the rights granted to ALZA under the License
Agreement; or (ii) any of the Transitional Rights granted to ALZA under this
Agreement.

“Taxes” means all taxes of any kind, and all charges, fees, customs, levies,
duties, imposts, required deposits or other assessments, including all federal,
state, local or foreign net income, capital gains, gross income, gross receipt,
property, franchise, sales, use, excise, withholding, payroll, employment,
social security, worker’s compensation, unemployment, occupation, capital stock,
transfer, gains, windfall profits, net worth, asset, transaction, and other
taxes, and any interest, penalties or additions to tax with respect thereto,
imposed upon any person by any taxing authority or other Regulatory Authority
under applicable law.

“Territory” shall mean all the countries of the world.

“Third Party” shall mean any individual, corporation or entity, or any
government, or any agency or political subdivisions thereof, other than ALZA,
GENUPRO or their respective Affiliates.

“Third Party MAH” shall have the meaning set forth in Section 5.1.1.

“Trade Dress” means any product packaging, pill design, graphics, color, color
combinations, or any other designs used to create a visual impression used to
identify the Agreement Product (and not any other product of ALZA or any
Affiliate thereof).

 

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“Trademarks” shall mean all rights, title and interest Controlled by ALZA to any
trademarks, trade names, and logos used or held for use by ALZA or any Affiliate
thereof that are specific to the Agreement Product, including the trademarks
listed on Schedule 4.2B1 and on Schedule 4.2B2, including registrations for, and
pending applications for registration, of any of the foregoing, and the goodwill
related to any of the foregoing. Schedule 4.2B1 lists the Trademarks to be
assigned to GENUPRO in the event of a Section 2.1 Closing; Schedule 4.2B2 lists
the Trademarks to be assigned to Menarini in the event of a Section 2.1 Closing;
and, in the event of a Section 2.2 Closing, all Trademarks listed in Schedules
4.2B1 and 4.2B2 shall be assigned to GENUPRO.

“Transition Completion Date” means the later of: (i) the date of [*] or (ii) the
date [*]

“Transition Period” means, on a country-by-country basis, the Country Transfer
Transition Period and/or Regulatory Transfer Transition Period, if applicable.

“Transitional Rights” means, on a country-by-country basis, the rights retained
by ALZA under Section 4.3 to develop, have developed, manufacture, have
manufactured, distribute, have distributed, sell, offer for sale, import and
export Agreement Product during the Country Transfer Transition Period, and if
applicable, the Regulatory Transfer Transition Period in such country.

“Transition Services Agreement” means a written agreement between ALZA and
GENUPRO for the provision of certain transitional services by ALZA and its
Affiliates to GENUPRO or its designated Affiliates and/or Sublicensees.

“Transition Team” shall have the meaning set forth in Section 6.3 of this
Agreement.

“US” means the United States of America, including its territories,
commonwealths and possessions.

1.2 Miscellaneous Interpretation Aids.

(a) Each use in this Agreement of the term “including”, “comprising”, or
“containing” (or a variant form thereof) shall be understood to have an open,
non-limiting meaning. Thus, e.g., “including” shall be interpreted as meaning
“including without limitation” or “including but not limited to”, regardless of
whether the words “without limitation” or “but not limited to” actually follow
the term “including”. Similarly, the terms “such as”, “for example”, and “e.g.”
shall be understood as referring to non-limiting illustrations or examples.

(b) “Herein,” “hereby,” “hereunder,” “hereof,” and other equivalent words shall
be understood as referring to this Agreement in its entirety, and not solely to
the particular provision or portion of this Agreement in which any such word is
used.

(c) Wherever used herein, any pronoun or pronouns shall be understood to cover
all genders.

[*] Confidential treatment requested.

 

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(d) All references to days, months, quarters, or years shall be understood to
refer, respectively, to calendar days, calendar months, calendar quarters, or
calendar years, unless otherwise indicated.

(e) Any reference to a supranational, national, federal, state, local, or
foreign statute or law shall be understood to refer to the applicable version of
the law or statute then in force (as it may have been amended or superseded) as
well as all rules and regulations promulgated thereunder, unless the context
requires otherwise.

(f) All references to “dollars” or “$” shall mean United States dollars.

Section 2 Effective Date

2.1 This Agreement, and the Parties’ rights and obligations hereunder shall not
become effective until all of the agreements and terminations of agreements set
forth in clauses a. through (and including) j. below are fully executed by duly
authorized representatives of each party to each such agreement and the other
conditions set forth in clauses k. and l. below have been satisfied:

 

  a. The Menarini Priligy License Agreement (including execution of all
ancillary agreements contemplated thereby, including but not limited to a
reasonable form of pharmacovigilance agreement and any other agreements to be
negotiated following the execution of the sublicense agreement itself);

 

  b. The Non-Group E Markets Manufacturing Agreement;

 

  c. The Non-Group E Markets Quality Agreement;

 

  d. The GENUPRO Trademark Assignment Agreement;

 

  e. The Menarini Trademark Assignment Agreement;

 

  f. The Domain Name Assignment Agreement;

 

  g. The PV Agreement;

 

  h. The written agreement(s) terminating the sublicense agreements set forth in
Schedule 11.2.18;

 

  i. The Transition Services Agreement;

 

  j. The Sales Services Agreement;

 

  k.

ALZA shall not have suspended or terminated any Ongoing Clinical Studies prior
to the Effective Date, other than a suspension or termination resulting from
ALZA’s reasonable determination, after consulting with GENUPRO and providing
GENUPRO a reasonable opportunity to comment, that such suspension or termination
is necessary to protect subject or patient health or safety or to

 

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  comply with a Legal Requirement (in which case ALZA shall promptly notify
GENUPRO in writing of such suspension or termination and the circumstances
related thereto supporting such suspension or termination). In the event that
ALZA suspends or terminates any Ongoing Clinical Studies prior to the Effective
Date for reasons other than those necessary to protect subject or patient health
or safety or to comply with a Legal Requirement, GENUPRO may, if and as
determined in its sole discretion, elect to waive this clause k. as a condition
for this Agreement to become effective. In the event that ALZA suspends or
terminates any Ongoing Clinical Studies prior to the Effective Date for reasons
necessary to protect subject or patient health or safety or to comply with a
Legal Requirement, GENUPRO agrees to waive this clause k. as a condition for
this Agreement to become effective; and

 

  l. Delivery by ALZA of the following Schedules, subject to Section 16.8:
Schedules 5.1.1, 5.7 and 11.3.11.

In the event that the Effective Date under this Section 2.1 has not occurred by
the date set forth in Section 14.1, this Section 2.1 shall be of no further
effect and the Effective Date shall be determined according to
Section 2.2.[*]2.2 In the event the Effective Date under Section 2.1 has not
occurred by the date set forth in Section 14.1, this Agreement, and the Parties’
rights and obligations hereunder, shall not become effective until all of the
agreements and terminations of agreements set forth in clauses a. through (and
including) f. below are fully executed by duly authorized representatives of
each Party to each such agreement and the other conditions set forth in clauses
g. and h. below have been satisfied:

a. The GENUPRO Trademark Assignment Agreement as amended or modified under
Section 14.2.2;

b. The GENUPRO PV Agreement under Section 14.2.2;

c. The written agreement(s) terminating the sublicense agreements set forth in
Schedule 11.2.18;

d. The Transition Services Agreement;

e. The Sales Services Agreement;

f. Domain Name Assignment Agreement;

g. ALZA shall not have suspended or terminated any Ongoing Clinical Studies
prior to the Effective Date, other than a suspension or termination resulting
from ALZA’s reasonable determination, after consulting with GENUPRO and
providing GENUPRO a reasonable opportunity to comment, that such suspension or
termination is necessary to protect subject or patient health or safety or to
comply with a Legal Requirement (in which case ALZA shall promptly notify
GENUPRO in writing of such suspension or termination and the circumstances
related thereto supporting such suspension or termination). In the event that
ALZA suspends or

 

[*] Confidential treatment requested.

 

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terminates any Ongoing Clinical Studies prior to the Effective Date for reasons
other than those necessary to protect subject or patient health or safety or to
comply with a Legal Requirement, GENUPRO may, if and as determined in its sole
discretion, elect to waive this clause g. as a condition for this Agreement to
become effective. In the event that ALZA suspends or terminates any Ongoing
Clinical Studies prior to the Effective Date for reasons necessary to protect
subject or patient health or safety or to comply with a Legal Requirement,
GENUPRO agrees to waive this clause g. as a condition for this Agreement to
become effective.; and

h. Delivery by ALZA of the following Schedules, subject to Section 16.8:
Schedules 5.1.1, 5.7 and 11.3.11.

2.3 The Effective Date of this Agreement shall be the last date of signature of
the last to be executed of the agreements, and terminations of agreements:
(a) as set forth in Section 2.1 in the event of a Section 2.1 Closing as defined
in Section 14.1; or (b) as set forth in Section 2.2 in the event of a
Section 2.2 Closing as defined in Section 14.2.

Section 3 Termination of License Agreement

3.1 Termination of Rights and Obligations. ALZA, FURIEX and GENUPRO hereby
terminate the License Agreement effective as of the Effective Date. As of the
Effective Date, the License Agreement is hereby superseded by this Agreement
and, notwithstanding anything to the contrary in the License Agreement, except
for ALZA’s Transitional Rights under Section 4.3 of this Agreement, neither
ALZA, FURIEX, nor GENUPRO shall have any surviving rights or obligations
thereunder, except that:

3.1.1 Termination of the License Agreement shall not release or discharge any
Party from the performance of any payment obligation under the License Agreement
that accrued prior to the Effective Date and that remains to be paid as of the
Effective Date, including in accordance with Section 3.2 below.

3.1.2 The confidentiality and other rights and obligations set forth in Sections
6.01, 6.02, 8.01(a), 8.04(a), and 10.01 of the License Agreement shall continue
in effect.

3.1.3 The obligations with respect to adverse event reporting under Section 4.06
of the License Agreement will continue for each Party until transition of
pharmacovigilance responsibility as provided in Section 6.5 below.

3.1.4 ALZA shall, on a country-by-country basis, remain obligated to pay
royalties due under the License Agreement on ALZA’s or its Affiliates’ or Third
Party licensees’ sales of Agreement Product in Group A Market countries prior to
the Effective Date in a manner substantially consistent with the terms of the
License Agreement (including Sections 5.03, 5.04, 5.05, 5.06, and 5.08 thereof
(as if the License Agreement had not been terminated)).

3.2 Final Accounting. ALZA will make a final accounting and payment to GENUPRO
of royalties due for Net Sales (as defined in the License Agreement) of the
Agreement Product accrued under the License Agreement with respect to each Group
A Market country as of the Effective Date in accordance with the provisions of
the License Agreement.

 

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3.3 Release; Covenant Not to Sue; Termination Right.

3.3.1 Waiver and Release by FURIEX and GENUPRO. Notwithstanding anything to the
contrary herein, upon the Effective Date, FURIEX and GENUPRO, each on behalf of
it and all of its predecessors and successors and their respective subsidiaries
and assigns and their respective agents, directors, officers, and employees
(each a “GENUPRO Entity”), hereby irrevocably and unconditionally releases ALZA
and all of its predecessors and successors, and their respective Affiliates and
each of its assigns, and their respective agents, directors, officers, and
employees, as well as their respective shareholders, distributors, and customers
thereof (each an “Alza Entity”), from any and all claims, demands, damages,
rights of action, debts, liabilities, or controversies of any kind whatsoever,
in any jurisdiction, whether at law or in equity, whether before a local, state,
national, or federal court, or state, national, regional, or federal
administrative agency, commission, or other tribunal, and whether now known or
unknown, liquidated or unliquidated, which any GENUPRO Entity has, or may have,
based on, arising out of, or in any way related to the License Agreement,
including all claims known or which reasonably could have been known for breach
of contract or tortious injury but excluding only any such claims for failure to
make any payment remaining due by ALZA under the License Agreement, up to and as
of the Effective Date (collectively, “Waived Contract Claims”), and hereby
waives all Waived Contract Claims, provided that this Section 3.3.1 shall be
subject to, and shall not in any event be construed as limiting, ALZA’s
indemnification obligations under Section 12 or otherwise under this Agreement
or any Ancillary Agreement or GENUPRO’s or any GENUPRO Indemnitee’s rights under
any of the foregoing.

3.3.2 Covenant Not to Sue by GENUPRO. On the Effective Date, each of FURIEX and
GENUPRO hereby covenants and agrees with ALZA that neither FURIEX or GENUPRO nor
any other GENUPRO Entity or other person directly or indirectly controlled by
FURIEX or GENUPRO or claiming through FURIEX or GENUPRO, will bring suit based
on a Waived Contract Claim or otherwise assert a Waived Contract Claim against
ALZA or any other Alza Entity, whether before a local, state, national or
federal court, or state, national, regional or federal administrative agency,
commission, or other tribunal, and whether such Waived Contract Claim is now
known or unknown, liquidated or unliquidated, or arises before or after the
Effective Date, or is based on events which occurred before or after the
Effective Date (“Covenant Not to Sue”). This Covenant Not to Sue shall run with
any assignment by FURIEX or GENUPRO of its interest in this Agreement or
transfer of GENUPRO’s Product Rights (as may remain subject to any Transitional
Rights retained by ALZA hereunder), and shall bind any assignee or other person
or entity to which FURIEX or GENUPRO, jointly or severally, may convey an
interest hereunder. For the avoidance of doubt, this Covenant Not to Sue shall
not extend to any cause of action that may be brought by FURIEX or GENUPRO
alleging ALZA’s breach of the terms of this Agreement, or to any patent
infringement claim that may be brought by FURIEX or GENUPRO after termination of
the license rights and Transitional Rights of ALZA hereunder alleging ALZA’s
infringement of any

 

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GENUPRO Patents occurring after any such termination. Notwithstanding anything
to the contrary, this Section 3.3.2 shall be subject to, and shall not in any
event be construed as limiting, ALZA’s indemnification obligations under
Section 12 or otherwise under this Agreement or any Ancillary Agreement or
FURIEX’s, GENUPRO’s, or any GENUPRO Indemnitee’s rights under any of the
foregoing.

3.3.3 Termination Right for Breach Claim. In the event, prior to the Effective
Date, GENUPRO files a lawsuit in any court or other governmental or judicial
forum against ALZA or any Affiliate thereof in which GENUPRO claims or seeks any
remedies or damages with respect to ALZA’s or any of its Affiliate’s actual or
alleged breach of the License Agreement, ALZA shall be entitled, upon written
notice to GENUPRO given prior to the Effective Date, to terminate this Agreement
and all of ALZA’s obligations, and GENUPRO’s rights, hereunder.

3.4 Interpretation of the License Agreement Under the New Lilly License. The
Parties hereby agree that the License Agreement is amended to the extent
necessary to cause (a) it to be consistent with the New Lilly License and
(b) the terms and conditions of the License Agreement to not themselves
constitute or directly result in a breach of the New Lilly License, with such
amendment to be effective as of the date of the New Lilly Agreement.

Section 4 Transfer of Certain Intellectual Property

4.1 License of ALZA Intellectual Property to GENUPRO.

4.1.1 Subject to the terms and conditions of this Agreement and the Ancillary
Agreements (and effective as of the Effective Date), ALZA hereby grants to
GENUPRO an exclusive (even as to ALZA and its Affiliates, subject to any
Transitional Rights), perpetual, royalty-free, transferable, worldwide license,
with right to sublicense to Affiliates and Third Parties, under the ALZA
Know-How to develop, make, have made, use, offer for sale, sell, import, export,
and commercialize Dapoxetine and Agreement Product solely for purposes in the
Field.

4.1.2 Subject to the terms and conditions of this Agreement and the Ancillary
Agreements (and effective as of the Effective Date), ALZA hereby grants to
GENUPRO a non-exclusive, perpetual, royalty-free, transferable, worldwide
license, with right to sublicense to Affiliates and Third Parties, under the
ALZA Know-How to develop, make, have made, use, offer for sale, sell, import,
export, and commercialize Related Products solely for purposes in the Field.

4.1.3 Transfer of ALZA Know-How.

4.1.3.1 ALZA shall, at [*] expense, provide GENUPRO with a copy of the ALZA
Know-How in documentary or Electronic Media form during each country’s
Transition Period according to Section 6. Each Party shall treat the ALZA
Know-How as the other Party’s Confidential Information, whether or not marked or
labeled as being confidential, pursuant to the terms and conditions of this
Agreement, GENUPRO (and its Affiliates and Sublicensees) shall use it

 

[*] Confidential treatment requested.

 

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solely for the purposes expressly permitted hereunder, and ALZA shall retain
ownership of all ALZA Know-How. During the Country Transfer Transition Period
and for the period running [*] ([*]) [*] thereafter, ALZA shall promptly answer
any reasonable requests from GENUPRO to decipher or explain any notation within
the ALZA Know-How documentation provided to GENUPRO under this Section 4.1.3.1
and Section 6.1.1.

4.1.3.2 In providing the ALZA Know-How to GENUPRO in documentary or Electronic
Media form, ALZA will use reasonable efforts to redact from copies of the
original records listed in the Index all extraneous Know-How contained therein
that is not ALZA Know-How or GENUPRO Know-How. GENUPRO acknowledges that,
despite such reasonable efforts, in an effort to expedite the provision of the
ALZA Know-How documentation, some extraneous Know-How may be inadvertently
included, and that ALZA reserves the right, exercisable on notice to GENUPRO, to
correct any documentary form of the ALZA Know-How as promptly as possible, but
in any event within [*] ([*]) [*] after its original provision to GENUPRO,
provided that GENUPRO shall not be liable for any internal use of any such
extraneous Know-How as permitted hereunder with respect to the ALZA Know-How
prior to receiving notice of such correction.

4.1.4 Subject to the terms and conditions of this Agreement and the Ancillary
Agreements (and effective as of the Effective Date), ALZA hereby grants to
GENUPRO a perpetual, royalty-free, transferable, exclusive (even as to ALZA and
its Affiliates, subject to any Transitional Rights) right and license, with
right to sublicense to Affiliates and Third Parties (including rights of further
sublicense by any Affiliates of GENUPRO or Sublicensees), under the Copyrights,
to (i) use, copy, modify, reproduce, display, perform or distribute the contents
of ALZA’s or its Affiliates advertising, marketing, promotional and sales
materials specific to Dapoxetine or any Agreement Product (such content, the
“Licensed Materials”) solely for purposes in the Field (such license excluding,
for the avoidance of doubt, the corporate names and logos of ALZA and its
Affiliates and any other content that is not specific to Dapoxetine or any
Agreement Product)), (ii) prepare derivative works incorporating all or any
portion of the Licensed Materials (excluding, for the avoidance of doubt, the
corporate names and logos of ALZA and its Affiliates), and (iii) to use such
derivative works solely for purposes in the Field. For the avoidance of doubt,
except as expressly set forth in this Agreement, nothing in this Section 4.1.4
shall be construed as granting or conveying (whether expressly or by
implication) to GENUPRO or its Affiliates any rights to use the names of ALZA or
any of its Affiliates or any of their logos or trademarks owned, licensed, or
controlled by ALZA and that are not specific to any Agreement Product but are
incorporated in any such advertising, marketing, promotional or sales materials
containing content being licensed to GENUPRO pursuant to this Agreement.

4.1.5 ALZA hereby represents and warrants to its knowledge (including upon
reasonable inquiry of its Affiliates) that, as of the Effective Date, except for
expired or abandoned ALZA Patents, no ALZA Patents have issued or are pending.
In the event, at any time before the Transition Completion Date, ALZA identifies
any ALZA Patents

 

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claiming Dapoxetine or Agreement Product, for which Regulatory Approval has been
obtained or is being sought by or on behalf of ALZA (directly or through an
Affiliate) (“Identified ALZA Patents”), it shall promptly notify GENUPRO in
writing (for the purposes of this section the date of such notice being the
“Notification Date”). ALZA shall and hereby does, subject to any pre-existing
obligations and other terms of any Third Party agreements as of the Notification
Date, grant to GENUPRO an exclusive (even as to ALZA, except as to any
Transitional Rights), royalty-free, transferable worldwide license, with right
to sublicense to Affiliates and Third Parties, under the Identified ALZA Patents
during the term thereof, to develop, make, have made, use, offer for sale, sell,
import, export, and commercialize Dapoxetine and Agreement Product solely for
purposes in the Field subject to the terms and conditions of this Agreement and
the Ancillary Agreements.

4.1.6 GENUPRO shall have the right to sublicense or license any of its rights
under Section 4.1 or under any Product Rights licensed or transferred to it
under this Agreement to any Affiliate or Third Party without ALZA’s prior
written consent, provided that the licensing of any manufacturing, distribution,
or commercial rights relating to any Agreement Product, Related Product, or any
Product Rights to any Third Party shall be by written agreement, except that
GENUPRO shall notify ALZA of any sublicensing of GENUPRO’s rights to ALZA
Know-How or Identified ALZA Patents (if any) to GENUPRO’s Affiliates or
Sublicensees and any further sublicensing of ALZA Know-How or Identified ALZA
Patents (if any) by its Affiliates or Sublicensees.

4.1.7 The license rights granted by ALZA under Section 4.1 shall become:
(i) fully paid-up upon satisfaction of all of GENUPRO’s, and its Affiliates’ and
Sublicensees’, payment obligations to ALZA under Sections 7.1 and 7.2; and
(ii) irrevocable upon expiry of [*] ([*]) [*] after the Effective Date, provided
that GENUPRO or its Affiliates or Sublicensees have not breached any material
obligation, warranty or covenant during the period starting on the Effective
Date and ending [*] ([*]) [*] after the Effective Date.

4.2 Assignment of Trademarks, Domain Names.

4.2.1 As of the Effective Date, ALZA shall assign, and cause its applicable
Affiliates to assign, to GENUPRO the Trademarks with respect to the Group E
Market Countries and Domain Names. As of the Effective Date, subject to Menarini
having become a Sublicensee of GENUPRO, ALZA shall assign, and cause its
applicable Affiliates to assign, to Menarini the Trademarks with respect to all
countries other than the Group E Countries. The Parties shall separately
document the assignment to GENUPRO of ownership of the Trademarks with respect
to the Group E Market Countries and Domain Names using commercially reasonable
and customary forms of assignments to be negotiated in good faith promptly
following the Execution Date (the “GENUPRO Trademark Assignment Agreement” and
“Domain Name Assignment Agreement”, respectively), which shall be executed on or
prior to the Effective Date. Subject to Menarini having become a Sublicensee of
GENUPRO, the Trademarks concerning such countries other than the Group E Market
countries shall be assigned to Menarini pursuant to, and Menarini’s ownership of
such Trademarks, shall be separately documented by

 

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commercially reasonable and customary forms of assignments to be negotiated in
good faith by ALZA promptly following the Execution Date (the “Menarini
Trademark Assignment Agreement”), which shall be executed on or prior to the
Effective Date. Notwithstanding the preceding sentence, the Trademarks in Group
A Market countries shall be assigned to Menarini on a country-by-country basis
on the [*] as defined in Section 5.3.1.2 in each such country. In the event of a
Section 2.2 Closing, the Menarini Trademark Assignment Agreement shall be of no
effect and the assignments that would have been made thereunder in accordance
with this Section 4.2.1 shall be made to GENUPRO in the GENUPRO Trademark
Assignment Agreement.

4.2.2 Notwithstanding the foregoing, GENUPRO and its Affiliates and Sublicensees
shall have no rights to Trade Dress under the GENUPRO Trademark Assignment
Agreement or the Menarini Trademark Assignment Agreement.

4.3 Rights Retained by ALZA.

4.3.1 ALZA acknowledges that, by virtue of termination of the License Agreement,
as of the Effective Date, ALZA’s rights thereunder to develop, have developed,
manufacture, have manufactured, distribute, have distributed, sell, offer for
sale, import, and export Licensed Products (as defined in Section 1.22 of the
License Agreement) have been terminated or reverted to GENUPRO, except for
ALZA’s retention of Transitional Rights as provided hereunder until the
Transition Completion Date.

4.3.2 Effective as of the Effective Date, GENUPRO hereby grants to ALZA a
non-exclusive, royalty-free (except for amounts due GENUPRO under the Sales
Services Agreement with respect to the sale of Agreement Product by ALZA or its
designated Affiliates or Sublicensees), worldwide license, with right to
sublicense to Affiliates and/or Sublicensees, under the GENUPRO Patents, GENUPRO
Know-How, Product Rights, ALZA Know-How, and Identified ALZA Patents (if any)
transferred or licensed to GENUPRO hereunder, to develop, have developed, make,
have made, use, have used, offer for sale, sell, and import Dapoxetine and the
Agreement Product solely for purposes of practicing its Transitional Rights in
the Non-Group E Market Countries as provided hereunder until the Transition
Completion Date and performing its obligations under the this Agreement and the
Ancillary Agreements. The rights granted hereunder with respect to any GENUPRO
Know-How constituting Lilly Know-How, Lilly Manufacturing Know-How, and Lilly
Improvements (as defined in the New Lilly License) shall be subject to the
applicable terms of the New Lilly License. Notwithstanding the foregoing, the
scope of such rights shall not in any event be broader than such rights
previously granted under the License Agreement.

Section 5 Transfer of Product Rights in the Territory

The provisions of this Section 5 are intended to govern the orderly transfer and
delivery of Product Rights and the transition of the business specifically
related to manufacturing, packaging and commercialization of the Agreement
Product in the applicable countries in the Territory from ALZA to GENUPRO or, if
and as requested by GENUPRO, any of its Affiliates

 

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or Sublicensees. To the extent that any Affiliates of ALZA or Third Party MAH as
defined in Section 5.1.1 hold or maintain, or are responsible for holding and
maintaining, Governmental Permits and/or ALZA Regulatory Submissions, and/or are
otherwise responsible for the manufacturing, packaging and/or commercialization
of Agreement Product in one or more countries in the Territory, ALZA shall
(i) cause such Affiliates or Third Party MAH to undertake and complete such
actions as are necessary to enable ALZA to fulfil its obligations under this
Agreement and (ii) be liable for the acts and omissions of such Affiliates or
Third Party MAH as if such acts or omissions were those of ALZA hereunder.

5.1 Completion of Transfer of Product Rights. Except as expressly provided for
in this Agreement and any Ancillary Agreements, the Transition Team shall decide
in writing upon a mutually acceptable date for each applicable country in the
Territory that will be the target Country Transfer Date for the completion of
the assignment and transfer of all Product Rights to GENUPRO or its designated
Affiliate(s), or Third Party Sublicensee(s), in such country. ALZA shall,
subject to the Legal Requirements in such country, assign, transfer, and
deliver, or cause to be assigned, transferred, and delivered, to GENUPRO or its
designee(s) the Product Rights on a country-by-country basis in accordance with
the terms and conditions of this Agreement and any Ancillary Agreement and,
except as otherwise provided below in Sections 5.3, 5.4, or 5.5, the transfer
and delivery of the Product Rights in a country shall be completed and made
effective as of [*]. On and after the Effective Date of this Agreement, the
Parties shall use good faith efforts to expedite the transfer and delivery of
Product Rights in each of the countries of the Territory. For purposes of
clarification but not limitation, GENUPRO may request in writing that any
portion of the Product Rights be directly assigned, transferred, and delivered
to a particular Affiliate or other Third Party designee (or any other
Sublicensee), and ALZA shall comply with such request, provided that, to the
extent any Product Rights are not transferred or assigned to one or more
Affiliates or Third Party designees of GENUPRO pursuant to the foregoing, all
remaining Product Rights shall be assigned and transferred, or caused to be
assigned and transferred, to GENUPRO.

5.1.1 Third Party Marketing Authorization Holders. Those Third Parties
identified on Schedule 5.1.1 are under contractual obligations, as set forth in
the Distribution Agreements therewith, to ALZA or its Affiliates with respect to
the distribution, sale, and promotion of Agreement Product in the corresponding
countries noted on Schedule 5.1.1, and have filed or maintained, respectively,
Marketing Applications or ALZA Marketing Authorizations, respectively, on behalf
of ALZA or its Affiliates in such countries (each such Third Party, a “Third
Party MAH”). In each country that a Third Party MAH has filed and maintains a
Marketing Application, or maintains an ALZA Marketing Authorization, on behalf
of ALZA or its designated Affiliate as of the Effective Date, ALZA’s obligations
(directly or through its Affiliates) under this Section 5 to (a) Maintain
Marketing Applications and obtain Regulatory Approval therefor, (b) Maintain
ALZA Marketing Authorizations, (c) transfer and/or assign such ALZA Marketing
Authorizations to GENUPRO or its designated Affiliate or Sublicensee, and
(d) execute such documents as are necessary to give effect to such transfer
and/or assignment in such country, shall, subject to Section 5.1.2, be
understood to be obligations of ALZA (directly or through its Affiliates) to
cause such Third Party MAH to do the same in such country.

 

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5.1.2 ALZA’s Obligations Subject to Legal Requirements. The Parties understand
and agree that in this Section 5 and throughout this Agreement, ALZA’s
obligations to take an action (directly or through its Affiliates), or cause a
Third Party MAH to take an action (e.g., transfer an ALZA Marketing
Authorization to GENUPRO or its Affiliate or Sublicensee; or Maintain a
Marketing Application), are subject to the Legal Requirements of each particular
country or jurisdiction of the Territory. In the event that an obligation of
ALZA under this Agreement to take an action (directly or through its
Affiliates), or cause a Third Party MAH to take an action, is not permitted by
Legal Requirements in a country, ALZA shall not be in breach of any its
obligations, representations and warranties, or covenants under this Agreement
or any Ancillary Agreement so long as ALZA (directly or through its Affiliates)
takes, or causes a Third Party MAH to take, a substitute action in compliance
with Legal Requirements of such country reasonably intended to achieve the
purpose of ALZA’s corresponding obligation under this Agreement. By way of an
illustrative, but not limiting, example: in the event that transfer of an ALZA
Marketing Authorization from an ALZA Affiliate or Third Party MAH to GENUPRO or
its designated Affiliate or Sublicensee is not permitted by Legal Requirements
in a country or jurisdiction, ALZA’s obligation shall be deemed fulfilled if
ALZA (directly or through its Affiliates) withdraws such ALZA Marketing
Authorization and/or takes such other steps reasonably intended to permit and
enable GENUPRO or its designated Affiliate or Sublicensee to file a Marketing
Application and obtain a corresponding Regulatory Approval in such country or
jurisdiction.

5.2 Country Designation as a Group A Market, Group B Market, Group C Market, or
Group E Market. The Parties have used good faith efforts based upon available
information to identify countries and designate them in the Regulatory
Transition Plan in the applicable group as of the Effective Date according to
the following criteria:

5.2.1 “Group A Market” means countries of the Territory, excluding [*], [*], and
[*] (countries other than [*], collectively, “Non-Group E Market Countries”),
where, as of the Effective Date, Agreement Product is [*]. The Group A Markets
are set forth on Schedule 5.2A;

5.2.2 “Group B Market” means Non-Group E Market Countries where there is [*].
The Group B Markets are set forth on Schedule 5.2B;

5.2.3 “Group C Market” means Non-Group E Market Countries where [*]. Group C
Markets are set forth on Schedule 5.2C; and

5.2.4 “Group E Market” means the [*].

5.2.5 Certain Limitations with Respect to ALZA’s Transition Obligations. The
following capitalized terms as used in this Agreement shall have the meanings
set forth below in this Section 5.2.5:

5.2.5.1. “Maintain”, in reference to any ALZA Marketing Authorization and/or any
other existing Governmental Permits obtained by or on behalf of ALZA or any of
its Affiliates for Agreement Product as of the Effective

 

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Date in a particular country, or ALZA Regulatory Submissions in a particular
country following receipt of Regulatory Approval therein, means to use
Commercially Reasonable Efforts to undertake the following, as may be
applicable, during the Regulatory Transfer Transition Period: (a) making
safety-related labelling changes required by a Regulatory Authority; (b) sending
Dear Doctor letters required by a Regulatory Authority; (c) collecting adverse
event reports and filing such reports, and development safety update reports
(DSUR), until transfer of pharmacovigilance responsibilities to GENUPRO and/or
its designated Affiliates and/or Sublicensees; (d) filing periodic safety update
reports (PSUR) until transfer of pharmacovigilance responsibilities to GENUPRO
and/or its designated Affiliates and/or Sublicensees; (e) making renewals of an
ALZA Market Authorization and/or any other existing Governmental Permits or ALZA
Regulatory Submissions upon reasonable written request from GENUPRO;
(f) responding to Regulatory Authority requests for information; and (g) taking
any other actions with respect to any Governmental Permit(s) in such country as
required by any Legal Requirement. The Parties acknowledge and agree that (i) in
order for GENUPRO and/or its Affiliates and/or Sublicensees to receive
Regulatory Approval in [*] according to the Legal Requirements of that country,
ALZA or its Affiliate shall withdraw its ALZA Marketing Authorization and
GENUPRO and/or its Affiliates and/or Sublicensees shall concurrently file a
Marketing Application on a date that will be agreed to by ALZA and GENUPRO (“[*]
Date”), and (ii) ALZA’s and its Affiliate’s obligation to Maintain the ALZA
Marketing Authorization in [*] shall cease on the [*] Date, which date shall be
deemed the Regulatory Transfer Date in [*].

5.2.5.2 “Maintain”, in reference to a Marketing Application filed by or on
behalf of ALZA or any of its Affiliates for Agreement Product pending as of the
Effective Date in a particular country, means to use Commercially Reasonable
Efforts during the Regulatory Transfer Transition Period to seek Regulatory
Approval based on such Marketing Application by (a) timely responding to any
Regulatory Authority’s inquiries regarding such Marketing Application or
(b) making such filings or submissions, or taking such other actions, including
attending meetings requested by Regulatory Authorities, as reasonably required
to obtain such Regulatory Approval, provided that actions shall not, in any
event, include the conducting of any clinical trials or other in vivo or in
vitro research or development activities.

For the avoidance of doubt, ALZA shall not be obligated during the Transition
Period in any country to: (a) file any Marketing Application in any country
where no such Marketing Application exists as of the Effective Date; (b) make
resubmission filings of any Marketing Application, including in [*];
(c) initiate or conduct any new clinical studies on or after the Effective Date;
or (d) initiate or conduct any post-marketing clinical trials that may be
required by a Regulatory Authority on or after the Effective Date.

 

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5.3 Rights and Obligations of the Parties Based on Country Designation.

5.3.1 Group A Market.

5.3.1.1 GENUPRO (directly or through its Affiliates and/or Sublicensees) will,
subject to any legal obligations ALZA or its Affiliates may have as holder of
ALZA Marketing Authorizations or ALZA Regulatory Submissions prior to [*] or
contractual obligations ALZA or its Affiliates may have under any Ancillary
Agreement or with respect to a Third Party’s rights to market, promote,
distribute and commercialize Agreement Product under a Distribution Agreement
and subject to ALZA’s obligations with respect to the Ongoing Clinical Trials as
set forth in Section 5.8.1, assume full responsibility and control over all
aspects of the distribution and commercialization of the Agreement Product in
the Group A Market countries as of [*], and the development and manufacture of
Agreement Product anywhere for such purposes in each Group A Market country, [*]

5.3.1.2 ALZA will continue to distribute or have distributed (such as through
its Affiliates or Third Parties) Agreement Product on GENUPRO’s (or its
designated Affiliates’ or Third Party Sublicensees’) behalf in each Group A
Market country on or after [*] until the ALZA Distribution Termination Date (as
defined below) in accordance with and under the terms of a commercially
reasonable and customary form of written agreement to be negotiated in good
faith by the Parties (hereinafter “Sales Services Agreement”).

5.3.1.2.1 ALZA’s obligations under the Sales Services Agreement shall terminate
on a country-by-country basis the earlier of: (i) [*] ([*]) [*] from [*]; or
(ii) the [*] in such country (such earlier date, the “ALZA Distribution
Termination Date”).

5.3.1.2.2 ALZA’s distribution activities under the Sales Services Agreement
shall be limited to the services specifically set forth therein. For avoidance
of doubt, ALZA shall not be obligated to engage in sales (except as set forth in
the Sales Services Agreement), marketing, promotional, advertising, detailing
or, except as set forth in the Sales Services Agreement, any other
commercialization activities under such Sales Services Agreement.

5.3.1.3 The Parties will coordinate through the Transition Team (directly or
through their applicable Affiliate or Sublicensees) and make, or cause to be
made, the necessary inquiries and file the necessary documents with the
Regulatory Authority in each Group A Market country in accordance with Legal
Requirements of each such country to transfer ownership and pharmacovigilance
responsibility and, subject to the filing of any such necessary documents for a
particular Group A Market country and subject to Legal Requirements in such
country, ALZA hereby assigns (or shall cause its Affiliates or Third Party MAHs
to hereby assign) to GENUPRO (or its designated Affiliate or Sublicensee) all

 

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right, title, and interest in all ALZA Marketing Authorizations and any other
existing Governmental Permits and ALZA Regulatory Submissions in such country.
ALZA shall execute or cause to be executed all documents necessary to effect
such assignment. Such assignment is subject to approval or acknowledgement by
the Regulatory Authority of each country to the extent required in accordance
with the Legal Requirements of such country. ALZA shall (or shall cause its
applicable Affiliate or Third Party MAH to) use Commercially Reasonable Efforts
to file, and obtain approval of, any variations of any Governmental Permits or
ALZA Regulatory Submissions needed to effect such transfer of the ALZA Marketing
Authorization and any other Governmental Permits and ALZA Regulatory Submissions
to GENUPRO and/or its Affiliates and/or Sublicensees.

5.3.1.4 ALZA’s only other obligations in each Group A Market country will be as
follows:

(a) beginning on [*], ALZA shall (or shall cause its applicable Affiliate or
Third Party MAH to) make inquiries and file such documents as set forth in
Section 5.3.1.3, and Maintain the ALZA Marketing Authorization and any other
existing Governmental Permits and ALZA Regulatory Submissions, which obligations
shall cease on [*] in each Group A Market country;

(b) beginning on [*], if requested in writing by GENUPRO or its designated
Affiliate and/or Sublicensee, ALZA shall, subject to Legal Requirements, appoint
(or cause its applicable Affiliate or Third Party MAH to appoint) GENUPRO or its
designated Affiliate and/or Sublicensee as its MA Delegate in each requested
Group A Market country under a Delegation of Authority, which shall expire on a
country-by-country basis on [*] in each country, to allow GENUPRO or its
designated Affiliate and/or Sublicensee to distribute and commercialize
Agreement Product prior to [*]. In such case, ALZA’s obligations under the Sales
Services Agreement under Section 5.3.1.2 in each such Group A Market country
shall terminate on [*];

(c) beginning on [*], ALZA shall (or cause its applicable Affiliate to) proceed
with the transfer of other Product Rights in each Group A Market country as set
forth in this Agreement;

(d) ALZA shall (or shall cause its applicable Affiliate or Third Party MAH to)
comply with any legal obligations ALZA or its Affiliates or Third Party MAH may
have as holder of ALZA Marketing Authorizations or ALZA Regulatory Submissions
prior to [*]; and

(e) ALZA shall comply with its obligations as set forth in any Ancillary
Agreement.

 

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The obligations in clauses (a), (b) and (d) of this Section 5.3.1.4 shall cease
on [*] in each Group A Market country.

5.3.2 Group B Market.

5.3.2.1 GENUPRO (directly or through its Affiliates and/or Sublicensees) will,
subject to any legal obligations ALZA or its Affiliates or Third Party MAHs may
have as holder of ALZA Marketing Authorizations or ALZA Regulatory Submissions
prior to [*] or contractual obligations ALZA or its Affiliates may have under
any Ancillary Agreement or with respect to a Third Party’s rights to market,
promote, distribute and commercialize Agreement Product under a Distribution
Agreement and subject to ALZA’s obligations with respect to the Ongoing Clinical
Trials as set forth in Section 5.8.1, assume full responsibility and control
over all aspects of the distribution and commercialization of the Agreement
Product as of [*] in each Group B Market country, and the development and
manufacture of Agreement Product anywhere for such purposes in each Group B
Market country, [*]

5.3.2.2 The Parties will coordinate through the Transition Team (directly or
through their applicable Affiliate or Sublicensee) and make the necessary
inquiries and file the necessary documents with the Regulatory Authority in each
Group B Market country in accordance with the Legal Requirements of such country
to transfer ownership and pharmacovigilance responsibility and, subject to the
filing of any such necessary documents for a particular Group B Market country
and subject to Legal Requirements in such country, ALZA hereby assigns (or shall
cause its Affiliates or Third Party MAHs to hereby assign) to GENUPRO (or its
designated Affiliate or Sublicensee) all right, title, and interest in all ALZA
Marketing Authorizations and any other existing Governmental Permits and ALZA
Regulatory Submissions in such country. ALZA shall execute or cause to be
executed all documents necessary to effect such assignment. Such assignment is
subject to approval or acknowledgement by the Regulatory Authority of each
country to the extent required in accordance with the Legal Requirements of such
country. ALZA shall (or shall cause its applicable Affiliate or Third Party MAH
to) use Commercially Reasonable Efforts to file, and obtain approval of, any
variations needed of any Governmental Permits or ALZA Regulatory Submissions to
effect such transfer, of the ALZA Market Authorization and any other existing
Governmental Permits and ALZA Regulatory Submissions to GENUPRO and/or its
Affiliates and/or Sublicensees.

5.3.2.3 ALZA’s only other obligations in each Group B Market country will be as
follows:

(a) beginning on [*], ALZA shall (or shall cause its applicable Affiliate or
Third Party MAH to) make inquiries and file such documents as set forth in
Section 5.3.2.2, and Maintain the ALZA Market Authorization and any other
existing Governmental Permits and ALZA Regulatory Submissions;

 

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(b) beginning on [*], if requested in writing by GENUPRO or its designated
Affiliate and/or Sublicensee, ALZA shall, subject to Legal Requirements, appoint
(or cause its applicable Affiliate or Third Party MAH to appoint) GENUPRO or its
designated Affiliate and/or Sublicensee as its MA Delegate in each requested
Group B Market country under a Delegation of Authority, which shall expire on a
country-by-country basis on [*] in each country, to allow GENUPRO or its
designated Affiliate and/or Sublicensee to distribute and commercialize
Agreement Product prior to [*];

(c) beginning on [*], ALZA shall (or cause its applicable Affiliate to) proceed
with the transfer of other Product Rights in each Group B Market country as set
forth in this Agreement;

(d) ALZA shall (or shall cause its applicable Affiliate or Third Party MAH to)
comply with any legal obligations ALZA or its Affiliates or Third Party MAH may
have as holder of ALZA Marketing Authorizations or ALZA Regulatory Submissions
prior to [*]; and

(e) ALZA shall comply with its obligations as set forth in any Ancillary
Agreement.

The obligations in clauses (a), (b), and (d) of this Section 5.3.2.3 shall cease
on [*] in each Group B Market country.

5.3.3 Group C Market.

5.3.3.1 GENUPRO (directly or through its Affiliates and/or Sublicensees) will,
subject to any legal obligations ALZA or its Affiliates or Third Party MAHs may
have as holder of ALZA Marketing Authorizations or ALZA Regulatory Submissions
prior to [*] or contractual obligations ALZA or its Affiliates may have under
any Ancillary Agreement or with respect to a Third Party’s rights to market,
promote, distribute and commercialize Agreement Product under a Distribution
Agreement and subject to ALZA’s obligations with respect to the Ongoing Clinical
Trials as set forth in Section 5.8.1, assume full responsibility and control
over all aspects of the distribution and commercialization of the Agreement
Product as of [*] in each Group C Market country, and the development and
manufacture of Agreement Product anywhere for such purposes in each Group C
Market country, [*]

5.3.3.2 ALZA will (or will cause its applicable Affiliate or Third Party MAH to)
Maintain the Marketing Application in each Group C Market country. Upon ALZA’s
or its Affiliates’ or Third Party MAHs’ receipt of Regulatory Approval in a
Group C Market Country, the Parties will coordinate

 

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through the Transition Team (directly or through their applicable Affiliate or
Sublicensee) and make the necessary inquiries and file the necessary documents
with the Regulatory Authority in each Group C Market country in accordance with
the Legal Requirements of such country to transfer ownership and
pharmacovigilance responsibility and, subject to the filing of any such
necessary documents for a particular Group C Market country and subject to Legal
Requirements in such country, ALZA hereby assigns (and shall cause its
Affiliates or Third Party MAHs to hereby assign) to GENUPRO (or its designated
Affiliate or Sublicensee) all right, title, and interest in all ALZA Marketing
Authorizations and any other existing Governmental Permits and ALZA Regulatory
Submissions in such country. ALZA shall (or shall cause its applicable Affiliate
or Third Party MAH to) execute all documents necessary to effect such
assignment. Such assignment is subject to approval or acknowledgement by the
Regulatory Authority of each country to the extent required in accordance with
the Legal Requirements of such country. ALZA shall (or shall cause its
applicable Affiliate or Third Party MAH to) use Commercially Reasonable Efforts
to obtain approval of any variations of any ALZA Regulatory Submissions or
resulting Governmental Permits needed to effect such transfer of the ALZA
Marketing Authorization and any other existing Governmental Permits and ALZA
Regulatory Submissions to GENUPRO and/or its Affiliates and/or Sublicensees as
soon as reasonably possible following receipt of Regulatory Approval in such
country or on such earlier date as may be requested in writing by GENUPRO
following [*].

5.3.3.3 ALZA’s only other obligations in each Group C Market country will be as
follows:

(a) ALZA shall (or cause its applicable Affiliate or Third Party MAH to)
Maintain the Marketing Application in such country;

(b) ALZA shall (or cause its applicable Affiliate or Third Party MAH to) make
the inquiries and file such documents as set forth in Section 5.3.3.2, Maintain
the Marketing Application, and Maintain any resulting ALZA Marketing
Authorization and any other existing Governmental Permits and ALZA Regulatory
Submissions, which obligations shall cease on [*] in each Group C Market
country;

(b) beginning on [*], ALZA shall (or cause its applicable Affiliate to) proceed
with the transfer of other Product Rights in each Group C Market country as set
forth in this Agreement; and

(c) ALZA shall comply with its obligations as set forth in any Ancillary
Agreement.

The obligations in clauses (a) and (b) of this Section 5.3.3.3 shall cease on
[*] in each Group C Market country.

 

[*] Confidential treatment requested.

 

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5.3.4 Group E Market.

5.3.4.1 GENUPRO (directly or through its Affiliates and/or Sublicensees) will,
subject to any legal obligations ALZA or its Affiliates may have as holder of
ALZA Marketing Authorizations or ALZA Regulatory Submissions prior to [*] or
contractual obligations ALZA or its Affiliates may have under any Ancillary
Agreement and subject to ALZA’s obligations with respect to the Ongoing Clinical
Trials as set forth in Section 5.8.1, assume full responsibility and control
over all aspects of the distribution and commercialization of the Agreement
Product as [*] in each Group E Market country, and the development and
manufacture of Agreement Product anywhere for such purposes in such Group E
Market country, [*].

5.3.4.2 The Parties will coordinate through the Transition Team and file (or
shall cause their applicable Affiliate or Sublicensee to file) with the [*] all
documents necessary to transfer ownership of the [*] to GENUPRO such that the
[*] and [*] in [*] shall be no later than [*] and subject to the filing of any
such necessary documents with the [*], ALZA hereby assigns (and shall cause its
Affiliates to hereby assign) to GENUPRO (or its designated Affiliate or
Sublicensee) all right, title, and interest in all ALZA Regulatory Submissions
in [*]. ALZA shall execute all documents necessary to effect such assignment.
Such assignment is subject to acknowledgement by the [*] to the extent required
in accordance with [*] Legal Requirements. ALZA’s only other obligations with
respect to the [*] prior [*] shall be to take any actions necessary to comply
with all Legal Requirements applicable to ALZA (or any Affiliate thereof) as the
owner of any ALZA Regulatory Submissions or sponsor of any clinical studies and
submit safety reports, including any DSUR. ALZA shall not be obligated to
initiate or take any actions, or make any responses, related to any resubmission
or supplementation of the [*] by GENUPRO.

5.3.4.3 ALZA’s only other obligations in each Group E Market country will be:

(a) the filing of such applications as set forth in Section 5.3.4.2 and
Maintaining the [*] and any other ALZA Regulatory Submissions, which obligations
shall cease on [*] in each Group E Market country;

(b) beginning on [*], ALZA shall (or shall cause its applicable Affiliate or
Third Party MAH to) transfer the other Product Rights in each Group E Market
country as set forth in this Agreement; and

(c) ALZA’s obligations as set forth in any Ancillary Agreement.

The obligations in clause (a) of this Section 5.3.4.3 shall cease on [*] in [*].

 

[*] Confidential treatment requested.

 

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5.3.5 No Further ALZA Rights or Obligations in Other Countries. As of [*], ALZA
will have no further rights or obligations with respect to Agreement Product in
any country of the Territory other than ALZA’s rights and obligations in the
Group A Market, Group B Market, Group C Market, and Group E Market countries as
set forth in this Agreement and the Ancillary Agreements. For all countries that
are not in the Group A Market, Group B Market, Group C Market, or Group E
Market, the [*] shall be [*].

5.3.6 Transition Periods.

5.3.6.1 Country Transfer Transition Period. For each Group A Market, Group B
Market, Group C Market, and Group E Market country, the Parties shall take
Commercially Reasonable Efforts to cause the Country Transfer Date to occur no
later than the expiration of the period ending [*] ([*]) [*] from the Effective
Date (“Country Transfer Transition Period”).

5.3.6.2 Regulatory Transfer Transition Period. In the event of Governmental
Transfer Delay as defined in Section 5.5 as of expiry of the Country Transfer
Transition Period, then the transfer of Governmental Permits and ALZA Regulatory
Submissions shall not be subject to the expiry of the Country Transfer
Transition Period, but for each Group A Market, Group B Market, Group C Market,
and Group E Market country, the Parties shall take Commercially Reasonable
Efforts to cause the Regulatory Transfer Date to occur no later than the
expiration of the period ending [*] ([*]) [*] from the [*] (“Regulatory Transfer
Transition Period”). For avoidance of doubt, when the term “Regulatory Transfer
Transition Period” is used herein in reference to a particular country, the
Regulatory Transfer Transition Period in such country shall end on the
Regulatory Transfer Date in that country. The Parties expect that all transfers
of Governmental Permits and ALZA Regulatory Submissions subject to this
Agreement will be approved by the relevant Regulatory Authorities no later than
expiry of the Regulatory Transfer Transition Period. Except as set forth in
Section 5.3.7, Section 4.1.3.1 and Section 5.3.8, ALZA shall have no obligation
to Maintain, transfer, or assist GENUPRO and its Affiliates and/or Sublicensees
to maintain or transfer Governmental Permits and ALZA Regulatory Submissions
after the expiry of the Regulatory Transfer Transition Period.

5.3.7 Transfer of Regulatory Responsibility. Except as expressly set forth in
any Ancillary Agreement (and subject to the Parties’ compliance with, and the
terms of, the PV Agreements), ALZA shall be responsible for regulatory matters
in each Group A Market, Group B Market, Group C Market, and Group E Market
country during the Regulatory Transfer Transition Period in that country and
GENUPRO (directly or through its Affiliates and/or Sublicensees) shall assume
regulatory responsibility on the [*] in each country. In the event that action
or inaction by a Regulatory Authority in a country prevents completion of such
transfer prior to expiry of the Regulatory Transfer Transition Period, the
Parties agree to negotiate in good faith an extension of the Regulatory Transfer
Transition Period for that country to effectuate such regulatory transfer,
including compensation for ALZA. Notwithstanding the foregoing, in the event
ALZA has performed substantially all activities necessary to effect such
regulatory transfer such that only minimal activity is needed by ALZA, ALZA
shall complete the transfer at no cost to GENUPRO.

 

[*] Confidential treatment requested.

 

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5.3.8 Regulatory Support. In addition to (and without limitation of) ALZA’s
obligations under the Ancillary Agreements, ALZA will provide to GENUPRO and/or
its Affiliates and/or Sublicensees with regulatory support as follows:

(a) for a period beginning on [*] and ending [*] ([*]) [*] after [*] in each
country in the Group A Market, Group B Market, Group C Market or Group E Market,
upon reasonable request from GENUPRO, ALZA will assist GENUPRO and/or its
Affiliates and/or Sublicensees with the development of regulatory documents,
including the drafting and submission of responses to Regulatory Authorities.
Notwithstanding the foregoing, ALZA shall not be obligated to prepare, or to
assist GENUPRO in the preparation of, any U.S. NDA documents; and

(b) for a period beginning [*] ([*]) [*] from the [*] in each country in the
Group A Market, Group B Market, Group C Market, and Group E Market and ending
[*] ([*]) [*] after such [*], ALZA will provide consulting services [*] to
GENUPRO and/or its Affiliates and/or Sublicensees regarding regulatory matters.
Such consulting services shall be limited to responding to reasonable requests
for information from GENUPRO and/or its Affiliates and/or Sublicensees
concerning specific regulatory matters, but shall not include the development of
regulatory documents, including the drafting and submission of responses to
Regulatory Authorities.

5.4 Disposition of Distribution Agreements. ALZA shall identify and list all
Distribution Agreements in Schedule 5.4 on or before the Effective Date. ALZA
shall, or shall cause its Affiliates to, terminate all rights and obligations as
to Agreement Product in the Distribution Agreements, subject to ALZA’s
obligations under this Agreement and any Ancillary Agreement, and subject to
Legal Requirements, on or before the date [*] ([*]) [*] after [*], except for
those Distribution Agreements where the Third Parties to such Distribution
Agreements are Third Party MAHs, ALZA shall, or shall cause its Affiliates to,
terminate all rights and obligations as to Agreement Product in such
Distribution Agreements subject to Legal Requirements, on a country-by-country
basis, on or before [*] ([*]) [*] after [*].

5.5 Delays in Transfer of ALZA Marketing Authorizations, ALZA Regulatory
Submissions, and Product Rights. The Parties acknowledge that, notwithstanding
their good faith diligent efforts to complete the transfer and delivery of all
of the Product Rights in each country in the Territory to GENUPRO and/or its
designated Affiliates and/or Sublicensees by or on the applicable [*], there
will be some countries in which the transfer of ownership and control of
Governmental Permits or ALZA Regulatory Submissions (and possibly certain other
Product Rights) to GENUPRO and/or its Affiliates and/or Sublicensees cannot be
completed on or before [*] as a result of (a) processes or conditions imposed by
Regulatory Authorities or other governmental authorities and that are outside
the reasonable control of the Parties or (b) the requirements or limitations of
any Legal Requirements applicable to such country (all such circumstances in
(a) or (b) referred to as “Governmental Transfer Delay”). It is the intention

 

[*] Confidential treatment requested.

 

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of the Parties that, to the fullest extent possible under Legal Requirements,
such delays in transferring ALZA Marketing Authorizations, other existing
Governmental Permits, or ALZA Regulatory Submissions (and/or other Product
Rights, if any) in a country should not result in a delay in the transfer of
those Product Rights that can be transferred on or before [*], so that GENUPRO
(directly or through its Affiliates and/or Sublicensees) can assume, to the
greatest extent possible pursuant to Legal Requirements, full control and
responsibility for the Agreement Product (and become entitled to the benefit of
all sales of and other activities with respect to, Agreement Product) in such
country as of [*]. Accordingly, the Parties agree that in the event of any
Governmental Transfer Delay:

5.5.1.1 the Parties will undertake to complete the transfer and delivery of all
of the Product Rights that are not the subject of such Governmental Transfer
Delay on or before [*];

5.5.1.2 Subject to Section 5.3.6.2 and Section 5.3.7, ALZA (directly or through
its Affiliates) may continue to hold and maintain the Governmental Permits and
ALZA Regulatory Submissions (and such other Product Rights, if any, that cannot
be transferred on or before [*]) for the Agreement Product on behalf of and for
the sole benefit of GENUPRO and its designated Affiliates and/or Sublicensees
only until such time as the transfer of Governmental Permits and ALZA Regulatory
Submissions (and any other affected Product Rights) to GENUPRO or its designated
Affiliates and/or its Sublicensees can be completed in such country;

5.5.1.3 ALZA (directly or through its Affiliates) will perform certain
manufacturing activities (as further described in Section 8 of this Agreement)
for GENUPRO and/or its designated Affiliates and/or Sublicensees in accordance
with and under the terms of the Manufacturing Agreements, as applicable; and

5.5.1.4 Subject to Section 5.3.6.2 and Section 5.3.7, the Parties will enter
into such other agreements or undertake such additional actions as are
reasonably necessary to grant GENUPRO or its designated Affiliates and/or its
Sublicensees control and responsibility over the disposition of all such
Governmental Permits, ALZA Regulatory Submissions, and other Product Rights in
the country that do not transfer on or before the expiry of [*] as soon as
reasonably possible.

For the avoidance of doubt, nothing herein shall be construed as obligating ALZA
to undertake or perform any advertising, marketing or promotional services for
or on behalf of GENUPRO or its designated Affiliates and/or Sublicensees with
respect to the Agreement Product in a country in the Territory on or after [*].

5.6 Reporting During Transition Period. Until the end of the Transition Period
in each country, ALZA shall keep GENUPRO reasonably informed regarding the
material ongoing activities by ALZA (directly or through its Affiliates or Third
Party MAHs) for the Agreement Product in the country.

5.7 Disposition of Product Contracts. ALZA shall use Commercially Reasonable
Efforts to identify and list Product Contracts in Schedule 5.7 on or before [*].
ALZA shall have

 

[*] Confidential treatment requested.

 

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the right to supplement Schedule 5.7 until the expiry of [*] ([*]) [*] after
[*]. Any member of the Transition Team shall have the right, in its discretion
and promptly following its reasonable written request with respect thereto, to
review any Product Contract(s) listed on Schedule 5.7 during the Transition
Period, subject to the applicable confidentiality and consent provisions of such
Product Contract(s) that any member of the Transition Team desires to review. If
the Transition Team decides, by [*] according to Section 6.3.2, that a Product
Contract is material to GENUPRO’s and/or its designated Affiliate’s and/or
Sublicensee’s rights to manufacture, use, sell, market, develop, distribute or
commercialize Agreement Product (“Material Product Contract”), ALZA shall, or
shall cause its Affiliates to, use Commercially Reasonable Efforts to terminate
with respect to Agreement Product, or allow to expire, such Material Product
Contract, such termination subject to ALZA’s pre-existing obligations and other
terms of such Material Product Contract and subject to ALZA’s obligations under
this Agreement and any Ancillary Agreement, on or before [*] ([*]) [*] after the
decision date documented in writing according to Section 6.3.2, except in the
[*], where ALZA shall, or shall cause its Affiliates to, use Commercially
Reasonable Efforts to terminate with respect to Agreement Product, or allow to
expire, such Material Product Contract on a country-by-country basis no later
than the later of: (i) [*] ([*]) [*] after [*] or (ii) [*] ([*]) [*] after [*]
for each such country. Without limitation of any more stringent requirements
with respect to any particular Product Contract(s) explicitly provided in this
Agreement, ALZA shall, or shall cause its Affiliates to, use Commercially
Reasonable Efforts to terminate with respect to Agreement Product, or allow to
expire, all other Product Contracts material to GENUPRO’s and/or its designated
Affiliate’s and/or Sublicensee’s rights to manufacture, use, sell, market,
distribute or commercialize Agreement Product no later than [*] ([*]) [*] after
[*]. If, after review of the Product Contracts listed in Schedule 5.7, GENUPRO
identifies in writing to ALZA such a material Product Contract concerning solely
Agreement Product (and not concerning any unrelated products) that GENUPRO
reasonably requests to have assigned to it, its Affiliate, or a designated
Sublicensee or indicates whether or not GENUPRO wishes such material Product
Contract to be terminated, allowed to expire, or to remain in effect, ALZA
shall, or shall cause its Affiliates to, use Commercially Reasonable Efforts to
assign such Product Contract to GENUPRO, and/or its designated Affiliates and/or
Sublicensee, subject to the assignment provision of such Product Contract or
comply with GENUPRO’s reasonable request with respect to termination,
expiration, or survival thereof.

5.8 Responsibility for Transitional Development.

5.8.1 Ongoing Clinical Studies. The Parties acknowledge that, as of the
Effective Date, ALZA (directly or through its Affiliates) is supporting,
conducting or otherwise responsible for the ongoing clinical studies listed in
Schedule 5.8.1 (“Ongoing Clinical Studies”). Beginning on [*], ALZA (directly or
through its Affiliates) shall use Commercially Reasonable Efforts to complete
all Ongoing Clinical Studies by [*] (the “Study Transition Date”), where
completion of a study means closing out the study, analyzing the study results,
and generating a study report (if any) required for submission to the relevant
Regulatory Authorities, which shall be provided to GENUPRO (or its designated
Affiliate or Sublicensee). In the event that, on or after the Effective Date,
either Party reasonably determines in good faith that any Ongoing Clinical Study
cannot or will not be completed by the Study Transition Date or should be
suspended or terminated prior to such date, it shall promptly notify the other
Party in writing to that

 

[*] Confidential treatment requested.

 

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effect. Promptly after such notice, the Transition Team will meet and review the
status of the relevant Ongoing Clinical Study and attempt to decide, by mutual
agreement of the Parties, whether (i) ALZA will terminate/discontinue such
Ongoing Clinical Study (effective no later than [*]) or (ii) the responsibility
for (and control over) such Ongoing Clinical Study will be transferred to
GENUPRO or its designated Affiliate or Sublicensee, provided that if the Parties
cannot mutually agree on the disposition of such Ongoing Clinical Study, [*]
shall have the final decision with respect to such matter, in its sole
discretion. If it is decided pursuant to the foregoing that such uncompleted
Ongoing Clinical Study will be terminated/discontinued, ALZA will be responsible
for arranging for termination of such Ongoing Clinical Study on or prior to [*]
in a manner consistent with Legal Requirements. If it is decided that
responsibility for such Ongoing Clinical Study will be transferred to GENUPRO or
its designated Affiliate or Sublicensee, then the Parties shall use Commercially
Reasonable Efforts, and collaborate in good faith, to transfer responsibility
for the study to GENUPRO (or its designated Affiliate or Sublicensee) as soon as
reasonably practicable in a manner consistent with Legal Requirements.
Notwithstanding anything to the contrary, nothing shall prohibit ALZA from
suspending or terminating any Ongoing Clinical Study due to reasonable concerns
regarding patient/subject safety or where required by the applicable Regulatory
Authority. ALZA shall not be obligated to submit to any Regulatory Authority any
report regarding Ongoing Clinical Studies except as required to be submitted by
such Regulatory Authority.

5.8.2 [*] shall be responsible for [*] costs and expenses related to the conduct
of the Ongoing Clinical Studies prior to [*]. In the event of a [*] then, as of
[*], GENUPRO shall be responsible for [*] Development Costs incurred with
respect to the conduct of the Ongoing Clinical Studies following [*] including
any and all reasonable, documented costs and expenses incurred by ALZA and its
Affiliates in the event that an Ongoing Clinical Study is terminated,
discontinued or transferred to GENUPRO according to Section 5.8.1, up to a total
of Nineteen Million Dollars (US $19,000,000), and [*] shall be responsible for
[*] costs and expenses incurred with respect to the Ongoing Clinical Studies in
which [*]is still participating. ALZA shall invoice the Development Costs, in
U.S. dollars (USD), [*], due under this Section 5.8.2 within [*] ([*]) [*] after
the end of each [*]. Payments must be sent within [*] ([*]) [*] following
GENUPRO’s receipt of invoice. By way of example, an illustrative invoice is
shown in Schedule 5.8.2B. GENUPRO shall not have any payment or reimbursement
obligations with respect to the Ongoing Clinical Studies unless [*].

5.8.3 Manner of Payment. All sums due to ALZA shall be payable by bank wire
transfer in immediately available funds to such bank account as ALZA shall
designate in writing to GENUPRO. GENUPRO shall notify ALZA’s Finance designee as
to the date and amount of any such wire transfer two (2) business days prior to
such transfer. All payments shall be made in USD.

5.8.4 Currency Conversion. If any payments to be made in USD under this
Agreement are earned in a currency other than USD, such payments, and the
expenses used to calculate such payments, shall be converted to USD using the
receiving Party’s standard conversion methodology determined in accordance with
standard internal policies and procedures and accounting standards consistently
applied throughout ALZA and its Affiliates.

 

[*] Confidential treatment requested.

 

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5.8.5 Interest on Late Payments. If GENUPRO shall fail to make a timely payment,
any such payment that is not paid on or before the date such payment is due
under this Agreement shall bear interest [*] but in no event higher than the
highest rate permissible under Legal Requirements, effective for the first date
on which payment was delinquent and calculated on the number of days such
payment is overdue.

5.8.6 Records; Inspection. ALZA shall keep complete, true and accurate books of
accounts and records for the purpose of determining the basis and accuracy of
the payments to be made for the On-Going Clinical Trials. Such records shall be
kept in accordance with ALZA’s standard internal policies and procedures and
accounting standards consistently applied throughout ALZA and its Affiliates
(which shall be commercially reasonable). Such books and records shall be kept
for at least [*] ([*]) [*] following the end of the [*] to which they pertain.
Such records will be open for inspection by GENUPRO during such [*] ([*]) [*]
period by independent accountants reasonably acceptable to ALZA, solely for the
purpose of verifying the basis and accuracy of amounts in the payment statements
hereunder. Such inspections shall be made no more than [*] each [*], at
reasonable time and on reasonable notice and shall be limited to information
related to On-Going Clinical Trials. Results of any such inspection shall be
deemed to be Confidential Information of ALZA. If any errors in favor of ALZA
are discovered in the course of such inspection, then within [*] ([*]) [*] of
written request by GENUPRO, ALZA shall pay GENUPRO those amounts that GENUPRO
should not have paid in the absence of such errors, plus interest pursuant to
and in accordance with Section 5.8.5. Inspections conducted under this
Section 5.8.6 shall be at the expense of [*], unless a variation or error in
favor of [*] exceeding [*] percent ([*]%) of the amount due for the period
covered by the inspection is established in the course of such inspection,
whereupon [*] costs relating to the inspection for such period will be paid
promptly by [*].

5.8.7 Data Collection. The Parties acknowledge that, as of the Effective Date,
ALZA (directly or through its Affiliates) is supporting, conducting or otherwise
responsible for the medical affairs activities listed in Schedule 5.8.7, the
responsibility for which shall be transferred to GENUPRO and/or its designated
Affiliates or Sublicensees effective when [*] has occurred for all countries in
the Territory.

5.8.8 For the avoidance of doubt, nothing herein shall be construed as
authorizing a Party or its Affiliates to make any commitments or representations
to Third Parties on behalf of the other Party or its Affiliates regarding any
clinical studies or registries without the prior written consent of the other
Party.

Section 6     Diligence and Coordination of Efforts

6.1 Diligence and Cooperation. On and after the Effective Date, the Parties
shall cooperate diligently in coordinated efforts to timely complete the various
transfers and delivery of Product Rights provided for in Section 5 of this
Agreement. Each of ALZA and GENUPRO

 

[*] Confidential treatment requested.

 

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shall undertake, and shall cause their respective Affiliates and/or
Sublicensees, as applicable, to undertake any actions reasonably necessary to
timely complete the various transfers and delivery of Product Rights to GENUPRO
and/or its designated Affiliates and/or Sublicensees as provided in Section 5 of
this Agreement, including by causing the execution of any documents necessary to
transfer and/or assign the ALZA Regulatory Submissions and Governmental Permits
for Agreement Product to GENUPRO or its designated Affiliates or Sublicensees.

6.1.1 Disposition of Development Records. Without limitation of any of ALZA’s
representations, warranties, or covenants regarding the Electronic Media, and
their contents under Section 11, in connection with the transfer and delivery of
Product Rights to GENUPRO or its designated Affiliates or Sublicensees, ALZA
agrees that during each country’s Transition Period it shall, and shall cause
its applicable Affiliates to, transfer and deliver to GENUPRO or its designated
Affiliates or Sublicensees all material Development Records in ALZA’s or its
Affiliates’ possession or control that may be relevant to such country. The
Parties will coordinate the timing and prioritization of Development Records to
be transferred and delivered to GENUPRO or its designated Affiliates or
Sublicensees pursuant to this Section 6.1.1. The Parties will use Commercially
Reasonable Efforts to complete the transfer and delivery of Development Records
as soon as reasonably possible following the Effective Date. For the avoidance
of doubt, copies of Development Records to be provided in Electronic Media or
documentary form shall include, without limitation, the documents identified in
Schedule 6.1.1. ALZA shall also provide GENUPRO (or any designated Affiliate or
Sublicensee thereof) with all records and information related to or resulting
from the conduct of the Ongoing Trial Studies by or on behalf of ALZA, all of
which shall be deemed included in and a part of the Product Rights to be
assigned to GENUPRO (or any designated Affiliate or Sublicensee thereof)
hereunder, in a manner reasonably acceptable to GENUPRO.

6.1.1.1 Index of Transferred Development Records. ALZA shall list all material
Development Records transferred to GENUPRO or its designated Affiliates or
Sublicensees in an Index of Transferred Development Records (“Index”). Schedule
6.1.1.1 lists the categories of documents to be listed in the Index. ALZA shall
first provide the Index to GENUPRO by means of Electronic Media on [*] and
thereafter shall provide to GENUPRO an update to the Index by means of
Electronic Media on each succeeding [*], each [*] and on [*].

6.1.2 Development Records in Electronic Form. For the avoidance of doubt, to the
extent that data and information included within the Development Records to be
transferred and delivered to GENUPRO or its designated Affiliates or
Sublicensees pursuant to this Agreement are maintained by ALZA or its Affiliates
in electronic form, the obligation of ALZA to transfer and deliver such
Development Records to GENUPRO or its designated Affiliates or Sublicensees
shall be limited to providing GENUPRO or its designated Affiliates or
Sublicensees with such Development Records as part of the Electronic Media in a
mutually agreed format that permits GENUPRO or its designated Affiliates or
Sublicensees to access the data and information and is reasonably acceptable to
both Parties. Nothing herein shall be construed as obligating ALZA to transfer
to GENUPRO or its designated Affiliates or Sublicensees or to otherwise provide
GENUPRO or its designated Affiliates or Sublicensees with access to or rights to
use any

 

[*] Confidential treatment requested.

 

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proprietary software (including Third Party or licensed software and/or software
that is owned by ALZA or its Affiliates) that may be utilized by ALZA or its
Affiliates from time to time in connection with such electronic data and
information included within Development Records. ALZA represents that, to its
knowledge, any and all Third Party software platforms or tools (including the
relevant version number and Third Party vendors/licensors from which such
software was obtained) utilized by or on behalf of ALZA or any Affiliate thereof
in connection with such electronic data and information are identified on
Schedule 6.1.2, other than those platforms or tools for which the failure to
include in Schedule 6.1.2 or otherwise provide to GENUPRO would not be
reasonably anticipated to have a material adverse effect on GENUPRO’s, any
GENUPRO Affiliate’s, or any Sublicensee’s ability to utilize and/or access the
Development Records or otherwise make, have made, use, sell, offer for sale,
develop, commercialize, or seek or obtain Regulatory Approval for any Agreement
Product or Related Product.

6.1.3 ALZA Quality Assurance Records. Notwithstanding anything to the contrary
herein, documentation related to quality assurance (QA) audit activities related
to Agreement Product (including with respect to clinical trials thereof)
conducted by or on behalf of ALZA will not be transferred as part of the
Agreement, except to the extent contained or referenced in, or supporting, any
ALZA Regulatory Submissions or Governmental Permits prior to the Effective Date,
previously made public, required to be provided to any Regulatory Authority, or
required by Legal Requirement to be disclosed. At GENUPRO’s prior written
request, ALZA shall permit individuals employed by GENUPRO’s or its Affiliates’
or Sublicensee’s quality assurance department to review, by appointment during
normal business hours, at a facility identified by ALZA, the quality assurance
audit reports for the Ongoing Clinical Studies (see Section 5.8.1), however, no
copies in full or in part will be provided except as set forth herein above. In
addition, GENUPRO agrees that, except to the extent contained or referenced in,
or supporting, any ALZA Regulatory Submissions or Governmental Permits existing
as of the Effective Date, previously made public, required to be provided to any
Regulatory Authority, or required by Legal Requirement to be disclosed, these
quality assurance audits will not be referenced within any Regulatory Authority
filing and will be held in strict confidence. Notwithstanding the foregoing,
this Section 6.1.3 shall not be construed to limit ALZA’s liability for any
breach of the representations, warranties, or covenants made under Section 11.

6.1.4 ALZA Retained Rights to Development Records. The Parties acknowledge and
agree that ALZA and its Affiliates shall be permitted to retain copies of
Development Records being transferred and delivered to GENUPRO or its designated
Affiliates or Sublicensees pursuant to this Section 6.1 solely to the extent
necessary, and for the limited purposes of: (i) complying with all Legal
Requirements with respect thereto (including without limitation compliance with
GMP, generally accepted accounting principles, external financial reporting
obligations, and Sarbanes-Oxley); (ii) compliance with internal corporate
policies and standard operating procedures regarding the creation and retention
of books and records; (iii) performing its obligations under this Agreement,
and/or the Ancillary Agreements; and (iv) maintaining an archival copy for legal
purposes. If and to the extent ALZA or its Affiliates do retain copies of any

 

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Development Records on and after the relevant [*], ALZA and its Affiliates shall
only use such Development Records for the specific purposes identified in the
preceding sentence and not for any other purpose.

6.1.5 Additional Information.

6.1.5.1 In addition to the Development Records to be provided pursuant to
Section 6.1.1, GENUPRO has requested and ALZA is willing to provide GENUPRO or
its designated Affiliates or Sublicensees with certain additional types of
information material to the Agreement Product as listed on Schedule 6.1.5.
Without limitation of the representations, warranties, and covenants of ALZA
under Section 11, to the extent all such information has not as of the Effective
Date or already been provided to GENUPRO or its designated Affiliates or
Sublicensees and included in Electronic Media, ALZA agrees that during each
country’s Transition Period, ALZA shall, and shall cause its Affiliates to,
collect and provide this additional information as identified in the Index to
GENUPRO or its designated Affiliates or Sublicensees as soon as reasonably
possible.

6.1.5.2 In addition to the foregoing, the Parties acknowledge that at any time
prior to [*], GENUPRO or its Affiliates and/or Sublicensees may request by
notice to ALZA that ALZA provide additional data or information material to the
development, packaging, marketing, promotion, distribution or sale of Agreement
Product in one or more countries in the Territory. Except as otherwise provided
in Section 6.1.6, all such requests shall be copied and coordinated through the
Transition Team. ALZA will use Commercially Reasonable Efforts to (x) promptly
satisfy any such requests by GENUPRO or its Affiliates and/or Sublicensees for
additional data or information and (y) notify GENUPRO in writing of any such
material information of which ALZA becomes aware at any time after the Effective
Date and provide GENUPRO such information; provided, however, nothing herein
shall be construed as obligating ALZA or its Affiliates to (i) generate or
procure any data or information that is not in its or their possession or
control, (ii) provide GENUPRO or its Affiliates and/or Sublicensees with data or
information to the extent that it is owned or controlled by a Third Party and
was made available to ALZA or its Affiliates under terms and conditions that do
not permit its disclosure or transfer to others, (iii) provide GENUPRO or its
Affiliates and/or Sublicensees with any data or information related to any
products other than Agreement Product, or (iv) provide GENUPRO or its designated
Affiliates and/or Sublicensees with any data or information to the extent
precluded by Legal Requirements (including without limitation, antitrust or
competition law).

6.1.6 Communication with ALZA Affiliates. Promptly after the Effective Date, the
Transition Team shall exchange relevant contact information and permit direct
communications between their respective global regulatory personnel, and upon
Transition Team agreement the Transition Team shall exchange relevant contact
information and permit direct communications between their respective regional
and

 

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local regulatory personnel with copy of all such communications to the relevant
global regulatory personnel, as each Party may designate in those regions and/or
countries in the Territory in order to facilitate planning and implementation of
certain aspects of the Regulatory Transition Plan. The Transition Team will also
agree in writing upon the specific subject matter for such direct interactions.
As of the Effective Date, no other direct interactions with Affiliates of ALZA
have been authorized and GENUPRO shall not, and shall use Commercially
Reasonable Efforts to cause its Affiliates and/or Sublicensees to not,
communicate requests for data, information or materials directly to any of
ALZA’s Affiliates in any country in the Territory unless and solely to the
extent (i) expressly authorized in advance by ALZA in writing or (ii) required
by Legal Requirement, provided that GENUPRO shall provide ALZA with prompt
notice of such Legal Requirement. Any request or proposal for direct
interactions between GENUPRO or its Affiliates and/or Sublicensees and any of
ALZA’s applicable Affiliates not permitted by clause (i) or (ii) above shall be
communicated through the Transition Team, and ALZA will reasonably consider any
such requests; provided, however, that nothing herein shall be construed as
obligating ALZA to agree to any such request or proposal, provided, however,
that (a) any failure by ALZA to satisfy any such request or proposal shall not
limit any other obligations of ALZA and its Affiliates hereunder and (b) ALZA
shall, notwithstanding anything to the contrary herein, provide any information
or documentation in its or any of its Affiliates’ possession or control to the
extent requested of it (directly or through any of its Affiliates, GENUPRO, or
any of GENUPRO’s Affiliates, Sublicensees, or independent contractors of any of
the foregoing) by any Regulatory Authority or as necessary to comply with any
Legal Requirement or enable the transfer of Product Rights to GENUPRO in a
timely fashion. If ALZA does agree to permit its applicable Affiliates in one or
more regions or countries in the Territory to engage in direct interactions with
GENUPRO and its Affiliates and/or Sublicensees, the Parties shall agree in
advance and in writing on the specific subject matter and scope of those
permitted interactions, shall communicate that information to their respective
Affiliates and/or Sublicensees, as applicable, and shall exchange relevant
contact information identifying their respective representatives who will
participate in those interactions.

6.2 Transition Manager. Each Party shall appoint a senior representative (each,
a “Transition Manager”) who possesses a basic understanding of the relevant
operational, regulatory and commercial issues to manage the transfer obligations
to GENUPRO envisioned under this Agreement (the “Transition”). The initial
Transition Manager for each Party is set forth in Schedule 6.2, and either Party
may later replace such Transition Manager by providing written notice thereof to
the other Party (which notice shall identify the new Transition Manager and
provide contact information therefor), provided that any replacement Transition
Manager shall possess reasonably sufficient expertise to reasonably satisfy the
intended role of the Transition Manager under this Agreement and leadership
responsibilities within the relevant Party that are substantially similar to or
more senior than those of the preceding Transition Manager. Each Party’s
Transition Manager shall be the primary contact with the other Party in
connection with the on-going implementation, communication and voting on matters
within the Transition Team’s authority concerning the Transition and shall lead
his/her Party’s Transition Team (as defined below).

 

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6.3 Transition Team.

6.3.1 The Parties will establish a joint committee (the “Transition Team”) to
facilitate and oversee the planning and implementation of strategic and tactical
plans to effect the transfer and delivery of Product Rights in each applicable
country in the Territory in accordance with the terms of this Agreement and to
make decisions pursuant to Section 6.3.2 expressly authorized by this Agreement,
and to discuss transitional issues and to facilitate communications between the
Parties with respect to such matters. The Transition Team shall also serve as a
forum to address supply chain and inventory management matters during all
Transition Periods and to discuss transitional issues and to facilitate
communications between the Parties with respect to such matters. Each Party
shall appoint reasonably appropriate representatives to the Transition Team,
which may include personnel involved with clinical development, regulatory,
manufacturing, packaging, distribution, marketing and/or sales of Agreement
Product. The Transition Team shall meet (whether by teleconference, in person or
by video-conference) (i) at least weekly until specific, written strategic and
tactical plans are in place, with detailed timelines for specific actions, to
transfer and deliver Product Rights from ALZA to GENUPRO and/or GENUPRO’s
designated Affiliates and/or Sublicensees, and (ii) at least monthly until the
transfer of all Product Rights has occurred hereunder (i.e., until the Final
Transfer Date has occurred for all countries), provided that the Transition Team
may elect to meet with less frequency during the period described in (ii) based
on the obligations of each Party, and the progress of the Parties’ efforts, to
implement such transfers. The specific times and places of all meetings shall be
determined by the Transition Managers in a manner consistent with the foregoing
obligations and reasonably acceptable to the Parties. The Transition Team may
also establish sub-teams or working groups to address specific areas or topics
related to the process for transferring the Product Rights in the Territory.

6.3.2 The Transition Team may make decisions expressly within its authority
under this Agreement, and such decisions shall be binding on the Parties, [*],
and the Transition Team shall document such decisions in a writing signed by
authorized team representatives of both Parties. For the avoidance of doubt, the
Transition Team shall have no authority to modify any term in the body of this
Agreement. If the Transition Team is unable to reach consensus regarding any
matter within its decision-making authority before it (including any matter that
was unable to be resolved by any subcommittee), the matter shall be presented to
[*] and [*] or his designee (the “Applicable Senior Officers”) for decision.
Once a matter has been presented to the Applicable Senior Officers, they shall
have [*] ([*]) [*] to make a decision on the matter. In the event that the
Applicable Senior Officers are unable to reach a mutual decision within such [*]
([*]) [*] period, then the matter shall be considered a Dispute under
Section 16.6 and shall be resolved in accordance therewith.

6.4 Regulatory Transition Plan. The Transition Team will agree on a regulatory
transition plan (the “Regulatory Transition Plan”) setting forth the timelines
and activities to be performed by the Parties and/or their Affiliates and/or
Sublicensees pursuant to this Agreement to effect the transfer and delivery of
all Governmental Permits, ALZA Regulatory Submissions, and certain other Product
Rights to GENUPRO. The Parties shall use

 

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Commercially Reasonable Efforts to complete the activities by the various dates
set forth in the Regulatory Transition Plan. Each Party shall promptly notify
the other Party in the event that it determines that the activities and/or
timelines set forth in the Regulatory Transition Plan require modification. The
Transition Team shall be responsible for periodically reviewing and approving
any changes to the Regulatory Transition Plan that are proposed by a Party
and/or that are necessary to address any requests or requirements that may be
imposed by Regulatory Authorities in the Territory with respect to the transfer
to GENUPRO or its Affiliates and/or Sublicensees of any Governmental Permits or
ALZA Regulatory Submissions. In such event, the Transition Team shall use good
faith efforts to agree upon a mutually acceptable means to address the relevant
issues.

6.4.1 Cooperation by the Parties. At all times prior to [*] in a particular
country, ALZA shall, and shall cause its applicable Affiliates to, reasonably
cooperate with GENUPRO and/or its designated Affiliates and/or Sublicensees to
facilitate communications or other interactions with Regulatory Authorities
and/or other governmental authorities in any country that are reasonably
necessary in connection with ALZA’s performance of its obligations under
Section 5.3 or GENUPRO’s and/or its Affiliates’ and/or Sublicensees’ planning
and preparations for the transfer of Governmental Permits or ALZA Regulatory
Submissions, including, without limitation, by providing GENUPRO and/or its
Affiliates and/or Sublicensees with copies of any material communications with
or from Regulatory Authorities (including meeting minutes). ALZA shall consider
and grant any reasonable requests by GENUPRO and/or its designated Affiliates
and/or Sublicensees for any consent or authorizations necessary to enable
GENUPRO and/or its designated Affiliates and/or Sublicensees to engage in direct
communications with Regulatory Authorities in connection with the maintenance,
filing, seeking, or transfer of ALZA Regulatory Submissions and Governmental
Permits for Agreement Product. GENUPRO shall not, and shall cause its Affiliates
and/or Sublicensees to not, knowingly and intentionally take any actions in the
course of any such direct communications with any Regulatory Authorities in
connection with any such transfer which (i) may reasonably be expected to
materially damage or impair the goodwill or reputation of ALZA or its Affiliates
and/or (ii) would, without the prior written consent of ALZA, impose any new
obligations or commitments (financial or otherwise) upon ALZA or its Affiliates
related to or in connection with the development, registration or
commercialization of Agreement Product in such country (except such obligations
as ALZA has expressly agreed to under this Agreement or any Ancillary
Agreement). Prior to the Final Transfer Date for a particular country, ALZA
shall keep GENUPRO and/or its designated Affiliates and/or Sublicensees
reasonably informed, and provide GENUPRO and/or its designated Affiliates and/or
Sublicensees a reasonable opportunity to comment, as to any of ALZA’s or its
Affiliates’ communications with Regulatory Authorities, filing or amendment of
any Marketing Applications, pursuit of Regulatory Approvals, and/or other
developments related to the transition of Governmental Permits, ALZA Regulatory
Submissions, or any other Product Rights, including but not limited to those
actions contemplated by Section 5.3, and in particular shall promptly notify
GENUPRO and/or its designated Affiliates and/or Sublicensees with respect to any
new developments related to such activities, including but not limited to those
that may materially and adversely affect (x) the development, manufacture, or

 

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commercialization of Agreement Product in a country by GENUPRO and/or its
designated Affiliates or Sublicensees and/or (y) the rights and responsibilities
of the Parties with respect to, and/or the timing of, the transfer and delivery
of the Product Rights in a country to GENUPRO and/or its Affiliates and/or
Sublicensees. Prior to the Final Transfer Date in a particular country, ALZA
shall provide GENUPRO and/or its designated Affiliates and/or Sublicensees with
reasonable advance notice of any scheduled meeting or conference call between
ALZA or its Affiliate and any Regulatory Authority relating to any Governmental
Permits or ALZA Regulatory Submissions, and GENUPRO and/or its Affiliates and/or
Sublicensees shall have a right to have up to [*] ([*]) representatives of
GENUPRO, [*], [*], and, if and as reasonably requested by GENUPRO and/or [*],
participate in, any such meeting. Prior to [*] in a particular country, GENUPRO
and/or its designated Affiliates and/or Sublicensees shall keep ALZA reasonably
informed as to any of GENUPRO’s and/or its designated Affiliates’ and/or
Sublicensees’ communications with Regulatory Authorities and/or other
developments related to the transition of Governmental Permits, ALZA Regulatory
Submissions, or any other Product Rights, and in particular shall promptly
notify ALZA with respect to any new developments related to such activities that
may materially and adversely affect (x) the sale of Agreement Product in a
country by ALZA and/or its Affiliates under the Sales Services Agreement and/or
(y) the rights and responsibilities of the Parties with respect to, and/or the
timing of, the transfer and delivery of the Product Rights in a country to
GENUPRO and/or its Affiliates and/or Sublicensees. The rights and obligations of
the Parties under this Section 6 are in addition to, and without limitation of,
the Parties’ rights and obligations under the PV Agreements or any other
Ancillary Agreement with respect to the matters addressed in this Section 6.

6.5 Pharmacovigilance Responsibilities and Product Inquiries. In the event of a
Section 2.1 Closing, the responsibilities of the Parties and Menarini for
pharmacovigilance activities respecting Agreement Product following the
Effective Date, and the transfer of such responsibilities from ALZA to Menarini
(with respect to the Non-Group E Market countries and the global safety
database), shall be set forth in a commercially reasonable and customary form of
pharmacovigilance agreement to be negotiated in good faith by the Parties; (the
“PV Agreement”). In the event of a Section 2.2 Closing, the Parties shall
negotiate in good faith a pharmacovigilance agreement between ALZA and GENUPRO
(“GENUPRO PV Agreement”) setting forth the responsibilities of the Parties for
pharmacovigilance activities respecting Agreement Product following the
Effective Date under Section 2.2, and the transfer of such responsibilities from
ALZA to GENUPRO with respect to the Group A Market, Group B Market, Group C
Market and Group E Market countries and the global safety database.

6.6 Other External Communications Related to Agreement Product. As soon as
practicable after the Effective Date, the Transition Team shall develop in
writing, and from time to time thereafter during the applicable Transition
Period in each country update as necessary, one or more external communications
plans related to the transfer of Product Rights with respect thereto, which the
Parties shall then implement in accordance with this Section 6.6. Until the
Final Transfer Date for a particular country, the Transition Managers from
GENUPRO and ALZA will coordinate review of any Party’s proposed press releases,
public statements or similar communications with Third Parties with respect to
the transfer of the

 

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Product Rights in such country, the contents of which shall be limited to
publicly available information unless approved in advance by both Parties, such
approval not to be unreasonably withheld, or required by any Legal Requirement
or rule of any securities exchange. To the extent reasonably practicable, each
Party will provide the other Party a reasonable opportunity to review and
comment on any such planned communication concerning a country prior to such
country’s Final Transfer Date, at least [*] ([*]) [*] prior to its planned
release or implementation and use good faith efforts to address any comments or
concerns raised by the other Party with respect to the timing and/or content of
the planned communication. Neither Party shall have the right to use the names,
logos or trademarks of the other Party (or any of such other Party’s Affiliates
or Sublicensees) in any such communications in a particular country prior to
such country’s Final Transfer Date without the prior written consent of such
Party, such approval not to be unreasonably withheld, except to the extent
required by Legal Requirement. For the avoidance of doubt, the Parties
acknowledge that GENUPRO and/or its designated Affiliates and/or Sublicensees
will have the right to use the Trademarks and Domain Names in any communications
issued pursuant to this Section 6.6.

6.7 NO WARRANTIES. EXCEPT AS MAY OTHERWISE BE EXPRESSLY SET FORTH IN THIS
AGREEMENT, AND WITHOUT LIMITATION OF ANY REPRESENTATIONS AND WARRANTIES
EXPRESSLY SET FORTH IN THIS AGREEMENT, NOTHING HEREIN SHALL BE CONSTRUED AS A
REPRESENTATION OR WARRANTY (WHETHER EXPRESS OR IMPLIED) BY ALZA OR ITS
AFFILIATES WITH RESPECT TO ANY MATERIAL, DATA OR INFORMATION PROVIDED OR
OTHERWISE MADE AVAILABLE TO GENUPRO AND/OR ITS AFFILIATES AND/OR SUBLICENSEES
PURSUANT TO THIS SECTION 6, ALL OF WHICH ARE BEING PROVIDED TO GENUPRO AND/OR
ITS AFFILIATES AND/OR SUBLICENSEES “AS IS, WHERE IS”, EXCEPT AS EXPRESSLY SET
FORTH IN THIS AGREEMENT, AND ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY DISAVOWED.

Section 7 Payment and Financial Matters

7.1 Document Transfer Payments. GENUPRO shall reimburse ALZA or its designated
Affiliates for all reasonable, documented Out of Pocket Expenses incurred by
ALZA and its Affiliates with respect to the collection from its Affiliates or
Third Party record-keeping or archiving vendors, and delivery to GENUPRO or its
designated Affiliate(s) or Sublicensee(s), of clinical trial data (in accordance
with Legal Requirements, including those respecting privacy) and documents as
set forth in Section 6.1 and elsewhere in this Agreement as such expenses are
incurred by ALZA, up to a maximum of one million US dollars ($1,000,000).
Payments must be received by ALZA within [*] ([*]) [*] after GENUPRO’s receipt
of each detailed invoice from ALZA with respect thereto and shall be paid in the
manner set forth in Sections 5.8.3-5.8.5.

7.2 Transition Services Payments. In the event that a Section 2.1 Closing occurs
by the Final Section 2.1 Closing Date, then, in consideration of the services to
be provided by ALZA and its Affiliates under the Transition Services Agreement,
GENUPRO shall pay to ALZA or its designated Affiliate fifteen million US Dollars
($15,000,000.00) as follows: the first payment of [*] ($[*]), shall be paid
within [*], and a payment of [*] ($[*]) shall be paid within [*] ([*]) [*] of
the [*] of the [*] that begin following [*]. Payment shall be made in the manner

 

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set forth in Sections 5.8.3-5.8.5. In the event that a Section 2.2 Closing
occurs and GENUPRO or its Affiliates license, assign or otherwise convey rights
to Dapoxetine or Agreement Product to Menarini within [*] ([*]) [*] of the Final
Section 2.1 Closing Date, then, in consideration of the services to be provided
by ALZA and its Affiliates under the Transition Services Agreement, GENUPRO
shall pay to ALZA or its designated Affiliate fifteen million US Dollars
($15,000,000.00) [*] of the execution of such license, assignment or otherwise
conveyance. Payment shall be made in the manner set forth in Sections
5.8.3-5.8.5.

7.3 Service Fees. In consideration of the distribution activities to be
performed by ALZA (directly or through its Affiliates) in any countries pursuant
to Section 5.3.1.2 of this Agreement, GENUPRO shall compensate ALZA or its
designated Affiliate as provided by the financial terms set forth in the Sales
Services Agreement.

7.4 Taxes.

7.4.1 Income Tax. Subject to Section 7.4.2.1 below, [*] (or its designated
Affiliate) shall be responsible for the collection, remittance and payments of
any or all Taxes (including income taxes, charges, duties, levies, assessments
or other fees) of any kind imposed by governmental or other authority in respect
of the amounts received by ALZA (or its designated Affiliate) from GENUPRO
pursuant to this Agreement.

7.4.2 Withholding.

7.4.2.1 GENUPRO will make all payments to ALZA (or its designated Affiliate)
under this Agreement without deduction or withholding for Taxes except to the
extent that any such deduction or withholding is required by Legal Requirements
in effect at the time of payment, in which case GENUPRO shall be entitled to
withhold such amount from the amount due ALZA (or its designated Affiliate)
under this Agreement and pay such amount in accordance with Section 7.4.2.2.

7.4.2.2 Any Tax required to be withheld on amounts payable under this Agreement
will promptly be paid by [*] on behalf of [*] (or its designated Affiliate) to
the appropriate governmental authority, and [*] will furnish [*] (or its
designated Affiliate) with proof of payment of such Tax. Any such Tax required
to be withheld will be an expense of and borne by [*] (or its designated
Affiliate).

7.4.2.3 GENUPRO and ALZA (or its designated Affiliate) will reasonably cooperate
with respect to all documentation required by any taxing authority or reasonably
requested by GENUPRO to secure a reduction in the rate or amount of applicable
withholding taxes.

7.4.2.4 If GENUPRO had a duty to withhold Taxes in connection with any payment
it made to ALZA (or its designated Affiliate) under this Agreement but GENUPRO
failed to withhold, and such Taxes were assessed against and paid by GENUPRO,
then ALZA (or its designated Affiliate) will indemnify and hold harmless GENUPRO
from and against such Taxes (including interest).

 

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If GENUPRO makes a claim under this Section 7.4.2.4, it will comply with the
obligations imposed by Section 7.4.2.2 as if GENUPRO had withheld Taxes from a
payment to ALZA (or its designated Affiliate).

7.4.3 Indirect Taxes. The Parties acknowledge that all payment amounts specified
in this Agreement, if any, are exclusive of any sales, use, value added taxes,
excise taxes or other similar taxes, duties, or charges (but excluding taxes on
income or similar taxes) that may be imposed by governmental authorities in the
relevant jurisdictions with respect to the transactions contemplated hereby
(collectively, “Indirect Taxes”). In the event that any Indirect Taxes will be
due pursuant to Legal Requirements with respect to any payments to be made
pursuant to this Agreement, if any, [*] (directly or through its designated
Affiliate or its Sublicensee) shall pay these Indirect Taxes to [*] (or its
designated Affiliate, as applicable) upon receipt of a fully compliant invoice
as defined by the relevant jurisdictions applying the applicable and correct
rates.

7.5 Regulatory Fees and Other Costs and Expenses. The Parties agree that the
Party (or its designated Affiliate or Sublicensee) required by Legal
Requirements in a particular country of the Territory to make application in
such country for transfer of ownership of Governmental Permits or ALZA
Regulatory Submissions shall be responsible for any fees imposed by Regulatory
Authorities and other governmental agencies in connection with such application.
[*] (or its designated Affiliate) shall also be solely responsible for all other
direct and indirect costs and expenses (including all internal FTE costs,
administrative and overhead costs, and out-of-pocket costs and expenses) that
are incurred by [*] (directly or through its Affiliates) in connection with the
transfer and delivery of the Product Rights in the Territory as contemplated in
accordance with Section 5 of this Agreement.

7.5.1 For the avoidance of doubt, nothing in this Agreement shall be construed
(whether expressly or by implication) as obligating [*] or its Affiliates to
undertake or share in the conduct or costs of any additional clinical studies or
other additional development work to generate any additional data related to
Agreement Product that may be requested or required by Regulatory Authorities
following the Effective Date in support of or in connection with the transfer of
any Governmental Permits for the Agreement Product in the Territory as
contemplated hereunder, provided that the foregoing shall not be construed as
limiting [*] and its Affiliates’ obligations under Section 5.8 or 6.5.

7.5.2 FDA User Fee. GENUPRO hereby accepts responsibility for any FDA user fees
incurred after the [*] in connection with any Agreement Product, and ALZA (or
its designated Affiliate) will transfer to GENUPRO, and GENUPRO will accept,
ALZA’s FDA user fee under Sec. 736 of the Federal Food, Drug and Cosmetic Act,
codified at 21 USC § 379(h) (Authority to Assess and Use Drug Fees).

7.6 Accounts Receivable on Pre-Transfer Sales. The Parties acknowledge that all
sales of Agreement Product by ALZA and/or its designated Affiliates in a given
country in the Territory prior to the [*] shall be [*] the calculation of Net
Sales, [*]. The Parties further acknowledge and agree that all accounts
receivable arising from such sales of Agreement Product in a country in the
Territory ([*]) [*]. [*] (directly or through its Affiliates) shall remain

 

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solely responsible for the collection of, and shall use Commercially Reasonable
Efforts to collect, such accounts receivable at all times as may be outstanding
during, on and after expiry of the Transition Period with respect to [*] sales
of Agreement Product, and, subject to [*], nothing herein shall be construed as
granting or conveying to [*] or its [*] any rights or interest in or to such
accounts receivable.

Section 8 Manufacturing and Supply Matters

8.1 Manufacturing and Supply Agreement(s). On or prior to the Effective Date,
ALZA and Menarini will, except in the event a Section 2.1 Closing does not occur
by the Final Section 2.1 Closing Date, execute a mutually acceptable Non-Group E
Market Manufacturing Agreement. Except in the event a Section 2.1 Closing does
not occur by the Final Section 2.1 Closing Date, ALZA and GENUPRO agree to
negotiate in good faith and execute a mutually acceptable Group E Market
Manufacturing Agreement which shall provide for the supply of Agreement Product
to GENUPRO for at least one year following Regulatory Approval in the US. In the
event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing
Date, the Non-Group E Market Manufacturing Agreement and the Group E Market
Manufacturing Agreement shall be of no effect and, subject to Section 14.2.2.2,
ALZA and GENUPRO shall negotiate in good faith a GENUPRO Manufacturing Agreement
and GENUPRO Quality Agreement under which ALZA will supply Agreement Product to
GENUPRO for a limited time in those Group A Market, Group B Market, Group C
Market and Group E Market countries where GENUPRO intends to use or sell
Agreement Product.

Section 9 Ancillary Agreements

The Parties acknowledge that, in connection with the transfer and delivery of
Product Rights to GENUPRO (and/or its designated Affiliates or Sublicensees)
and/or the continued operation of the business related to Agreement Product
thereafter, ALZA has agreed to perform certain transitional services and enter
into certain agreements, including but not limited to those related to:
(i) distribution and sale of Agreement Product, on a country-by-country basis in
the Group A Market countries, as described in Section 5.3.1.2 and/or (ii) the
manufacturing of Agreement Product for use or sale in one or more countries in
the Territory as described in Section 8, and including, in any case:

(a) In the event of a Section 2.1 Closing: Non-Group E Markets Manufacturing
Agreement, Group E Markets Manufacturing Agreement, Non-Group E Markets Quality
Agreement, Group E Markets Quality Agreement, GENUPRO Trademark Assignment
Agreement, Menarini Trademark Assignment Agreement, Domain Name Assignment
Agreement, PV Agreement, Delegations of Authority (if any), Transition Services
Agreement, and Sales Services Agreement; or

(b) In the event of a Section 2.2 Closing: GENUPRO Manufacturing Agreement,
GENUPRO Quality Agreement, GENUPRO Trademark Assignment Agreement, Domain Name
Assignment Agreement, GENUPRO PV Agreement, Delegations of Authority (if any),
Transition Services Agreement, and Sales Services Agreement.

 

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On or as soon as reasonably practicable after the Execution Date, the Parties
shall negotiate in good faith and, to the extent each Party is intended to be a
party thereto (e.g. GENUPRO is not a party to the Menarini Trademark Assignment
Agreement), enter into commercially reasonable, customary, and mutually
acceptable written forms of all of the foregoing consistent with the terms
hereof, including but not limited to agreements specifying customary and
commercially reasonable terms governing the distribution and sale of Agreement
Product, the manufacturing services, and the Parties’ related rights and
obligations. The specific manufacturing activities to be performed by ALZA and
its Affiliates shall be set forth in the Manufacturing Agreements. For the
avoidance of doubt, the PV Agreement or GENUPRO PV Agreement, as applicable,
shall be considered Ancillary Agreements.

Section 10 Certain Provisions Regarding Distribution, Sale and Supplies of
Agreement Product

10.1 Orders for Agreement Product. On and after the Effective Date, ALZA shall
not, and shall cause its Affiliates to not, (i) solicit orders for Agreement
Product from any prospective Third Party purchasers for the relevant country,
(ii) accept or fulfill any orders for Agreement Product for such country, or
(iii) deliver or tender (or cause to be delivered or tendered) any Agreement
Product to any purchaser in such country, except as, in each case, specifically
provided for in the Sales Services Agreement under Section 5.3.1.2 or any other
Ancillary Agreement.

10.2 Labelling and Packaging. The Parties agree to use their respective
Commercially Reasonable Efforts and to cooperate to obtain, pursuant to Legal
Requirement, in an expeditious manner Regulatory Authority approval in each
applicable country in the Territory for Agreement Product labelling bearing
GENUPRO’s or its designated Affiliate’s and/or Sublicensee’s name, trademark,
and/or trade dress for use after the transfer of Regulatory Approval in each
country in the Group A Market and Group B Market or after the obtaining of
Regulatory Approval in each country in the Group C Market, provided that, if and
as requested by GENUPRO or any Sublicensee thereof for a particular Group C
Market country, ALZA and its Affiliates shall use Commercially Reasonable
Efforts to obtain approval of such labelling as part of its efforts to obtain
Regulatory Approval in any such countries under Section 5.3. Except as otherwise
expressly set forth in this Agreement or the Manufacturing Agreements
contemplated by Section 8, ALZA shall have no obligation to assist GENUPRO with
respect to any labelling changes for the Agreement Product. Where it is
permissible under Legal Requirements to continue on and after the ALZA
Distribution Termination Date for a particular Group A Market country to package
Agreement Product for distribution and sale by GENUPRO or its designated
Affiliates and/or Sublicensees in such Group A Market country with trademarks,
logos and/or trade dress (other than Trademarks) Controlled by ALZA, then, upon
written request from GENUPRO or its designated Affiliates and/or Sublicensees,
ALZA shall package and supply such Agreement Product in accordance with the
terms and conditions of the Manufacturing Agreements on a country-by-country,
product-by-product basis until no later than the applicable Implementation Date
or such earlier date as the Parties mutually agree. As used herein the term
“Implementation Date” means, on a country-by-country basis, the earlier of
(i) the date that on which [*] or (ii) the date which is [*] ([*]) [*] after the
date on which the applicable Governmental Permits for the Agreement Product in
such country are legally transferred, in accordance with all Legal Requirements,
to GENUPRO or its designated Affiliate or Sublicensee.

 

[*] Confidential treatment requested.

 

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10.3 Recalls.

10.3.1 [*] (directly or through its designated Affiliates or Sublicensees) shall
have responsibility and control over any recalls, withdrawals, or field
corrections of Agreement Product or its, its Affiliates’, or any GENUPRO
Sublicensee’s Related Product (collectively, “Recalls”) in a country that occurs
on or after the [*]. However, if such a Recall involves one or more lots of
Agreement Product that were distributed and sold both (i) by ALZA or its
Affiliates in one or more countries and (ii) by or on behalf of GENUPRO or its
Affiliates and/or Sublicensees in one or more countries in the Territory (each,
a “Split Lot”), then the Parties shall notify each other immediately upon
becoming aware of any possible Recall (or any circumstances reasonably
justifying a Recall) that may affect such Split Lot. The Parties shall, to the
extent reasonably possible, meet prior to instituting any such Recall with
respect to Agreement Product in an attempt to come to a mutually acceptable
decision regarding such Recall; provided, however, that [*] in a country at the
time of Recall (the “Responsible Party”) shall [*] in such case as to whether to
institute a Recall (regardless of whether such Recall is mandated by a
Regulatory Authority or voluntarily instituted by the Responsible Party) in such
country. [*] shall have the right, solely [*], to contact any Regulatory
Authority with respect to Agreement Product if [*] has a reasonable good faith
belief that such Agreement Product may not meet the representations and
warranties set forth with respect thereto in this Agreement or any of the
Manufacturing Agreements in a manner that may reasonably justify a Recall.
Except as may otherwise be provided for in this Agreement or any of the
Manufacturing Agreements, [*] shall, subject to Sections 12.3 and 12.4,
indemnify [*] and its Affiliates against all reasonable, documented costs and
expenses incurred in connection with any Recall of Agreement Product that is
distributed and/or sold on or after [*] or otherwise by [*] or any of its
Affiliates or Sublicensees.

10.3.2 [*] shall have responsibility and control over any Recalls of Agreement
Product in a country that occur following [*] and prior to the [*] for such
country, provided that (i) [*] shall, to the extent reasonably practicable,
provide written notice of any such proposed Recall as promptly as reasonably
possible, with such notice to include detailed information concerning the amount
of Agreement Product to be Recalled, the circumstances justifying or supporting
such Recall, and copies of any correspondence with Regulatory Authorities or
other government agencies concerning such Recall, and [*] shall provide [*] a
reasonable opportunity to comment on the proposed scope of such Recall or the
manner in which such Recall shall be conducted. Further, in the event of any
such Recall in any country that may have a material adverse impact on the
development, marketing, sale, or distribution of Agreement Product in such
country, [*] shall, if and as requested by [*] in writing and in addition to any
Recall, immediately suspend all further distribution of Agreement Product in
such country under any Sales Services Agreement.

 

[*] Confidential treatment requested.

 

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Section 11 Representations, Warranties, and Covenants

11.1 Mutual Representations. Each Party hereby represents, warrants and
undertakes to the other that:

11.1.1 it has the requisite power and authority to execute, deliver and perform
its obligations under this Agreement and each Ancillary Agreement, and the
execution, delivery and performance by each Party of this Agreement and the
Ancillary Agreements have been duly and validly authorized by all necessary
corporate action on the part of such Party, and each constitutes (or in the case
of Ancillary Agreements to be entered into at or by the Effective Date, will
constitute), or, with respect to the agreements set forth herein to be executed
following the Execution Date, when executed and delivered will constitute, a
valid and binding obligation of each Party, enforceable against each Party in
accordance with its terms, except that enforceability thereof may be limited by
applicable bankruptcy, insolvency, reorganization or other similar laws
affecting creditors’ rights, generally and by principles of equity regarding the
availability of remedies;

11.1.2 the execution, delivery and performance by it of its obligations under
this Agreement will not result in a breach of, or constitute a default under,
any instrument or agreement to which it is a party or by which it is bound or
result in a violation of any law or regulation in any jurisdiction or of any
order, judgement or decree of any court or governmental agency by which it is
bound, except as would not, individually or in the aggregate, materially
adversely affect the ability of either Party to perform its obligations
hereunder or under any Ancillary Agreement or GENUPRO’s, its Affiliates’, or its
Sublicensees’ ability to exploit the Product Rights or Agreement Product; and

11.1.3 it is duly organized, validly existing and in good standing under the
laws of the state or country of its organization.

11.2 By ALZA. GENUPRO acknowledges and agrees that, except as otherwise set
forth in this Agreement, and without limitation of the representations and
warranties set forth above or below, the Product Rights are conveyed by ALZA to
GENUPRO hereunder “as is, where is”. GENUPRO agrees to accept, subject to the
terms and conditions set forth in this Agreement, the Product Rights on the
Country Transfer Date or Regulatory Transfer Date as defined herein in the
condition they are in at the place(s) where they are located on the Country
Transfer Date or Regulatory Transfer Date based on its own inspection,
examination and determination with respect to all matters, and without reliance
upon any express or implied representations or warranties of any nature made by,
or on behalf of, or imputed to ALZA other than the representations and
warranties expressly set forth in this Agreement. Without limiting the
generality of the foregoing, GENUPRO acknowledges that (x) ALZA makes no
representation or warranty, express or implied, with respect to (i) any
forecasts, projections, estimates or budgets provided or made available to
GENUPRO of future revenues, future results of operations, future cash flows or
future financial condition relating to Agreement Product (“Forward-Looking
Statements”); or (ii) any other information made available to GENUPRO with
respect to Agreement Product, except as expressly set forth in this Agreement
and the Schedules hereto; and (y) GENUPRO is taking full responsibility for
making its own evaluation of the adequacy and accuracy of all Forward-Looking
Statements and is not relying on any Forward-Looking Statements in any manner
whatsoever.

 

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Except as set forth on Schedule 11 (the parts of which are numbered to
correspond to the individual section numbers of this Section 11, provided that
any information set forth in one section or subsection of Schedule 11 will be
deemed to apply to each other section or subsection of Schedule 11 and this
Section 11 to which a cross-reference is expressly made) or otherwise disclosed
in this Agreement, ALZA hereby represents and warrants to GENUPRO that, as of
the Effective Date, each Country Transfer Date, Regulatory Transfer Date, and
each Final Transfer Date (except such representation and warranty that are of a
specific date shall only be given as of such date):

11.2.1 Qualification. ALZA, directly and/or through its Affiliates, has all
requisite corporate power and authority to own, operate, lease, license,
transfer, assign, practice, develop, commercialize, and exploit the Product
Rights as exploited as of the Effective Date, except to the extent, in each
case, as would not, individually or in the aggregate, materially and adversely
affect the ability of either Party to perform its obligations hereunder or under
any Ancillary Agreement or GENUPRO’s, its Affiliates’, or its Sublicensees’
exploitation of the Product Rights or Agreement Product. Each of ALZA and its
designated Affiliates is duly qualified to do business in, and are in good
standing in, all jurisdictions in which the ownership or control of the Product
Rights makes such qualification necessary. ALZA has all requisite corporate
power and authority to execute and deliver this Agreement and the Ancillary
Agreements, to perform and consummate the transactions contemplated hereby and
thereby, and to cause its Affiliates to comply with all applicable obligations
hereunder.

11.2.2 Title to Assets.

11.2.2.1 ALZA, directly or through its Affiliates or Third Party MAHs, has good
and transferable title, or the right to assign and transfer (or cause to be
assigned and transferred) hereunder such title, to each of the Product Rights to
be transferred hereunder:

(a) Development Records as identified in the Index;

(b) Manufacturing Records as identified in the Index;

(c) Trademarks as identified in Schedules 4.2B1 and 4.2B2;

(d) Domain Names as identified in Schedule 4.2A; and

(e) All ALZA Marketing Authorizations, ALZA Regulatory Submissions and pricing
and reimbursement approvals as identified on Schedule 11.2.15.1A, Schedule
11.2.15.1B, and Schedule 11.2.15.1C, respectively, all ALZA Regulatory
Submissions made and Governmental Permits obtained following

 

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the Effective Date, and, with respect to any ALZA Regulatory Submissions
referenced above, all Governmental Permits resulting from the Maintenance
thereof as contemplated by this Agreement.

11.2.2.2 ALZA, directly or through its Affiliates or Third Party MAH, has the
right to transfer and assign, or cause to be transferred and assigned, to
GENUPRO (or its designated Affiliate(s) or Sublicensee(s)) such Product Rights
as set forth in (a) to (e) above, free and clear of all liens, claims, and
encumbrances, except Permitted Liens, and upon the consummation of the
transactions contemplated by this Agreement and the Ancillary Agreements, or the
relevant date set forth herein therefor, GENUPRO shall acquire good and
marketable title to, and all right, title and interest of ALZA and its
Affiliates in and to such Product Rights as set forth in (a) to (e) above, free
and clear of all liens, claims, and encumbrances except Permitted Liens. ALZA,
directly or through its Affiliates, owns sufficient right, title, and interest
in the ALZA Know-How and Licensed Materials material to the development,
manufacture, use, and commercialization of Agreement Product to grant the rights
granted thereto under this Agreement without material breach or conflict of any
existing contract, agreement, or arrangement ALZA or any of its Affiliates may
have with any Third Party.

11.2.3 Sufficiency. Except with respect to any Governmental Permits or ALZA
Regulatory Submissions that cannot be transferred and assigned under this
Agreement due to limitations imposed by Legal Requirement, as contemplated by
Section 5.1.2, which limitations shall be addressed as described in
Section 5.1.2, as of the Effective Date, the Product Rights, Copyrights, and
ALZA Know-How identified in the Index or the Schedules constitute all material
intellectual property and contractual rights, other than (i) the rights licensed
to ALZA under the License Agreement and, solely to the extent providing for the
manufacture, use, sale, marketing, distribution, development, commercialization,
import, or export of Agreement Product by the relevant Third Party on behalf of
ALZA or an Affiliate thereof (and not required for the manufacture, use, sale,
marketing, distribution, development, commercialization, import, or export of
Agreement Product generally), (ii) Distribution Agreements and Product
Contracts, owned or controlled by ALZA, its Affiliates, and Third Party MAHs
necessary for manufacture, use, sale, marketing, distribution, development,
commercialization, import, or export of Agreement Product as approved in the
Territory prior to the Effective Date.

11.2.4 Exercise of Rights under License Agreement Limited to Agreement Product.
Prior to the Effective Date, the only product clinically developed,
manufactured, used and commercialized by ALZA (directly or through its
Affiliates and Sublicensees) under the License Agreement was Agreement Product.
ALZA makes no further representation or warranty regarding whether or not ALZA
(or its Affiliates or Sublicensees) engaged in the development, manufacture,
use, or commercialization of any Licensed Product other than the Agreement
Product in the course of its exercise of rights under the License Agreement.

 

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11.2.5 Proceedings.

11.2.5.1 Other than Regulatory Proceedings, there are no actions, suits, or
other Proceedings instituted, pending, or, to the knowledge of ALZA (including
upon reasonable inquiry of its Affiliates), threatened in writing against ALZA
or any Affiliate thereof with respect to any Trademarks, Copyrights, Domain
Names, Identified ALZA Patents (if any), ALZA Know-How, Product Rights, ALZA
Regulatory Submissions, Regulatory Approvals, Governmental Permits, or Agreement
Product.

11.2.5.2 There are no actions, suits or other Proceedings instituted, pending,
or, to the knowledge of ALZA (including upon reasonable inquiry of its
Affiliates), threatened in writing against ALZA or any Affiliate thereof which
present a claim that would materially restrain, materially prohibit, or
materially and adversely affect the transactions contemplated in this Agreement
or any Ancillary Agreement or that would otherwise materially and adversely
affect any Product Rights or GENUPRO’s (or any Affiliate’s or Sublicensee’s)
ability to exploit Product Rights or develop or commercialize Agreement Product
following the Effective Date.

11.2.6 Ownership. ALZA (directly or through its Affiliates or Third Party MAHs)
exclusively owns (or, in the case of any of the following owned by Third Party
MAHs) controls) all right, title, and interest in the Trademarks listed in
Schedules 4.2B1 and 4.2B2, Domain Names listed in Schedule 4.2A, and Product
Rights listed in the Index or the Schedules, free and clear of all liens,
claims, and encumbrances, except Permitted Liens.

11.2.7 Infringement/Misappropriation of Third Party Rights. ALZA has no
knowledge (including upon reasonable inquiry of its Affiliates) that the use of
ALZA Know-How as contemplated and permitted under this Agreement with respect to
the use, manufacture, sale, offering for sale, import, export, development, or
commercialization of Agreement Product as carried on by or on behalf of ALZA or
its applicable Affiliates prior to and as of the Effective Date, would
constitute a misappropriation of a Third Party’s trade secrets or infringement
of any Third Party’s Patents. Neither ALZA nor, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates), any Affiliate thereof has received any
written notice from any Third Party alleging any infringement of any Third
Party’s Patents or misappropriation of any Third Party’s trade secrets, with
respect to the Agreement Product in the Territory due to the manufacture, use,
sale, marketing, or import thereof.

11.2.8 Infringement/Misappropriation by Third Parties. ALZA has no knowledge
(including upon reasonable inquiry of its Affiliates) that any Third Party
(i) is misappropriating, has misappropriated, or has threatened to
misappropriate any trade secret ALZA Know-How material to Agreement Product or
(ii) is infringing, has infringed, or has threatened to infringe any of the
Lilly Patents, or GenuPro Patents, and neither ALZA nor any Affiliate thereof
has made any written claims or threats, or engaged in any legal action or
Proceeding of any kind, involving any claim or allegation

 

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that a Third Party misappropriated any trade secret ALZA Know-How or GENUPRO
Know-How material to any Agreement Product, or infringed any Lilly Patents, or
GenuPro Patents. ALZA hereby expressly makes no representations or warranties
under Section 11.2.8(ii) relating to Internet Offers, as defined in that portion
of Schedule 11 referring to this Section 11.2.8, prior to, or after, the
Effective Date.

11.2.9 Agreement Product Trademarks.

11.2.9.1 No Agreement Product is being commercialized, sold or offered for sale
anywhere in the Territory by or on behalf of ALZA, or its Affiliates under any
proprietary brand name, trademark, trade name, or logo for the Agreement Product
other than the Trademarks. The Trademarks are valid, enforceable, and
subsisting, and all necessary registration, maintenance, and renewal fees have
been made as of the Effective Date and all necessary documentation,
recordations, and certifications have been filed with relevant authorities for
purposes of maintaining such registrations.

11.2.9.2 ALZA has no knowledge (including upon reasonable inquiry of its
Affiliates) that the use of Trademarks as contemplated and permitted under this
Agreement with respect to the use, manufacture, sale, offering for sale, import,
export, development, or commercialization of Agreement Product as carried on by
or on behalf of ALZA or its applicable Affiliates prior to and as of the
Effective Date, would constitute an infringement of any Third Party’s
trademarks. Neither ALZA nor, to ALZA’s knowledge (including reasonable inquiry
of its Affiliates), any Affiliate thereof has received any written notice from
any Third Party alleging any infringement of any Third Party’s trademarks with
respect to the Agreement Product in the Territory due to the manufacture, use,
sale, marketing, or import thereof.

11.2.9.3 ALZA has no knowledge (including upon reasonable inquiry of its
Affiliates) that any Third Party is infringing, has infringed, or has threatened
to infringe any of the Trademark rights, and neither ALZA nor any Affiliate
thereof has made any written claims or threats, or engaged in any legal action
or Proceeding of any kind, involving any claim or allegation that a Third Party
infringed any Trademark rights.

11.2.10 Domain Names. The Domain Names constitute all the domain names, and
registrations and applications therefor, used in connection with the supply,
development, marketing, sale, offering for sale, and distribution of Agreement
Product in the Territory prior to and as of the Effective Date. ALZA has
registered each of the Domain Names with an accredited domain name registrar and
is up to date and paid in full as of the Effective Date with respect to the
payment of all fees due to such registrar(s) in connection with the Domain
Names.

11.2.11 Distribution Agreements. All Distribution Agreements are listed, with
the corresponding Third Party MAH (if applicable) and country clearly identified
with respect thereto, on Schedule 5.1.1. To the knowledge of ALZA (including
reasonable

 

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inquiry of its Affiliates), ALZA (or the relevant Affiliate thereof) is, and at
all times since its execution has been, in compliance with all material
applicable terms of each Distribution Agreement, and to the knowledge of ALZA
(including reasonable inquiry of its Affiliates), each Third Party that has any
rights or obligations under any Distribution Agreement is, and at all times has
been, in compliance with all material applicable terms of such Distribution
Agreement, except as would not reasonably be expected, individually or in the
aggregate, to have a material adverse effect on either Party’s ability to
perform its obligations under this Agreement or any Ancillary Agreement, the
exploitation of the Product Rights, or the use, development, manufacture, sale,
marketing, import, export, or commercialization of Agreement Product.

11.2.12 Product Contracts. ALZA and, to its knowledge (including reasonable
inquiry of its Affiliates), its Affiliates are, and at all times have been, in
compliance with all material applicable terms of each Product Contract, and to
the knowledge of ALZA (including reasonable inquiry of its Affiliates), each
Third Party that has any obligation to ALZA or any Affiliate thereof under any
Product Contract is, and at all times has been, in compliance with all material
applicable terms of such Product Contract, except as would, in either case, not
reasonably be expected, individually or in the aggregate, to have a material
adverse effect on either Party’s ability to perform its obligations under this
Agreement or any Ancillary Agreement, the exploitation of the Product Rights, or
the use, development, manufacture, sale, marketing, import, export, or
commercialization of Agreement Product.

11.2.13 License Agreement. As of the Effective Date, to ALZA’s knowledge
(including reasonable inquiry of its Affiliates), there are no Product-Related
Improvements (as defined in the License Agreement) or Product-Related
Improvement Patents (as defined in the License Agreement) that are incorporated
in or utilized by (or, in the case of Product-Related Improvement Patents, that
cover the composition, manufacture, or use of) any products in, or that have
previously been the subject of, preclinical or clinical development or are
being, or have previously been, commercialized by ALZA or its Affiliates.

11.2.14 Compliance With Legal Requirements; Regulatory Authorizations.

(a) Except as expressly set forth in this Agreement, ALZA and its Affiliates
are, and at all times have been, in compliance with all Legal Requirements
applicable to the Product Rights, Copyrights, Trademarks, ALZA Know-How,
Agreement Product, or the use, development, manufacture, sale, marketing,
import, export, or commercialization of Agreement Product, except as would not
reasonably be expected, individually or in the aggregate, to have a material
adverse effect on either Party’s performance of its obligations under this
Agreement or any Ancillary Agreement, the exploitation of the Product Rights, or
the use, development, manufacture, sale, marketing, import, export, or
commercialization of Agreement Product.

 

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(b) ALZA and its Affiliates have all authorizations of Regulatory Authorities
necessary for the conduct of its and their business (solely as it relates to the
Agreement Product or Product Rights) as conducted as of the Effective Date,
except as would not reasonably be expected, individually or in the aggregate, to
have a material adverse effect on either Party’s performance of its obligations
under this Agreement or any Ancillary Agreement, the exploitation of the Product
Rights, or the use, development, manufacture, sale, marketing, import, export,
or commercialization of Agreement Product.

(c) The Development Records, Manufacturing Records, Governmental Permits, and
ALZA Regulatory Submissions as identified in the Index have been maintained in
accordance with all Legal Requirements.

11.2.15 Regulatory Matters.

11.2.15.1 The ALZA Marketing Authorizations set forth in Schedule 11.2.15.1A,
ALZA Regulatory Submissions set forth in Schedule 11.2.15.1B and pricing and
reimbursement approvals set forth in Schedule 11.2.15.1C are the only ALZA
Regulatory Submissions or Governmental Permits obtained, filed, submitted, or in
effect as of the Effective Date with respect to Agreement Product;

11.2.15.2 The Governmental Permits and ALZA Regulatory Submissions have at all
times been filed and maintained in material compliance with all Legal
Requirements, and ALZA’s normal and customary business practices. The ALZA
Marketing Authorizations are in full force and effect. There are no Proceedings
pending or, to the knowledge of ALZA (including upon reasonable inquiry of its
Affiliates), threatened by written notice seeking, or that would reasonably be
anticipated to lead to, the revocation or suspension of, or have any other
material adverse effect on, any ALZA Marketing Authorization or ALZA Regulatory
Submission. All maintenance and other fees related to the ALZA Marketing
Authorizations or ALZA Regulatory Submissions occurring or coming due prior to
the Effective Date have been paid. Neither ALZA nor any Affiliate thereof has
received since the effective date of the License Agreement: (i) any FDA Form
483’s or foreign equivalents thereof concerning Agreement Product or
(ii) warning letters from any Regulatory Authority concerning the Agreement
Product in which it is asserted that the operations of ALZA, any Affiliate
thereof, or any Third Party manufacturer or contractor of any of the foregoing
(to the extent they relate to the Agreement Product or Product Rights) or the
Agreement Product were not in compliance with any Legal Requirements in any
material respect. There are no outstanding consent decrees entered into by ALZA
or any of its Affiliates or sublicensees with respect to Agreement Product.

11.2.16 Electronic Media. As of each Country Transfer Date (on a
country-by-country basis with respect to that portion of the items below
relevant to the applicable country), each Regulatory Transfer Date (on a
country-by-country basis with

 

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respect to that portion of the items below relevant to the applicable country)
and the Transition Completion Date, the Electronic Media collectively contain
copies, which in all material respects are complete and accurate, of the
following records as identified in the Index:

(a) the Development Records;

(b) the Manufacturing Records;

(c) Governmental Permits;

(d) ALZA Regulatory Submissions;

(e) all material information referenced on Schedule 6.1.5; and

(f) any other material information, document, or correspondence material to
Agreement Product or Product Rights.

The Electronic Media contain all serious adverse event reports received by ALZA,
any Affiliate thereof, any Third Party MAH, or any contractor, agent, or
representative of any of the foregoing that relate to the Agreement Product. All
of the records and information in items (a) to (f) referenced above and as
identified in the Index have been in material compliance with Legal Requirements
and ALZA’s normal and customary business practices. To ALZA’s knowledge, the
Index identifies and contains an index of all documents and records that are, on
a country-by country basis as of the relevant Country Transfer Date or
Regulatory Transfer Date, material to or necessary for the development, use,
manufacture, sale, offering for sale, import, export, or commercialization of
the Agreement Product in such country, except, as of a particular Country
Transfer Date or Regulatory Transfer Date, those records and information to be
transferred for such country following, or resulting from activities of ALZA and
its Affiliates taking place following, such Country Transfer Date or Regulatory
Transfer Date and prior to the Transition Completion Date as contemplated by
this Agreement.

11.2.17 Governmental Reports, Proceedings, Notices.

(a) As of the Effective Date, ALZA and, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates and Third Party MAHs), its Affiliates and
Third Party MAHs have completed and filed, in a timely and professional manner,
all reports required by Regulatory Authorities and Legal Requirements in order
to maintain Governmental Permits for Agreement Product that is the subject of a
Regulatory Approval (including all Agreement Product marketed by or on behalf of
ALZA and its Affiliates and Third Party MAHs prior to the Effective Date),
except for those reports not due within the six (6) months following the
Effective Date.

 

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(b) As of the Effective Date, neither ALZA nor, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates or Third Party MAH), any Affiliate thereof
or Third Party MAH has received any written notice of any actions or Proceedings
(including those from a Regulatory Authority) alleging that the Agreement
Product or the manufacture, storage, warehousing, packaging, handling, use,
testing, sale, offering for sale, marketing, distribution, import, or export
thereof is in violation of any Legal Requirements, except as would not
reasonably be expected, individually or in the aggregate, to have a material
adverse effect on either Party’s performance of its obligations under this
Agreement or any Ancillary Agreement, the exploitation of the Product Rights, or
the use, development, manufacture, sale, marketing, import, export, or
commercialization of Agreement Product.

(c) As of the Effective Date, neither ALZA nor, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates), any Affiliate thereof, has received any
written notice that any Regulatory Authority or other government agency has
initiated, or threatened to initiate, any action to recall, suspend or otherwise
restrict or adversely affect the manufacture, use, development, sale, marketing,
distribution, commercialization, import, or export of Agreement Product. To the
knowledge of ALZA (including upon reasonable inquiry of its Affiliates), as of
the Effective Date, there are no pending proceedings or requests for
information, voluntary or involuntary market withdrawals, field corrective
actions (including recalls), safety alerts, or notices of other regulatory or
governmental enforcement actions from any Regulatory Authority related to the
Agreement Product.

(d) In the course of clinically developing, manufacturing, using and
commercializing Agreement Product prior to the Effective Date, and for the
purposes of providing services under this Agreement from the Effective Date
until the Transition Completion Date, neither ALZA nor, to ALZA’s knowledge
(including reasonable inquiry of its Affiliates) any Affiliate thereof (i) has
been debarred, or is subject to a pending debarment, or has used or is using in
any capacity any person who has been debarred pursuant to section 306 of the
FDCA, 21 U.S.C. § 335a, (ii) has been listed by any federal and/or state
agencies, excluded, debarred, suspended or otherwise been made ineligible to
participate in United States federal or state healthcare programs or federal
procurement or non-procurement programs (as that term is defined in 42 U.S.C.
1320a-7b(f), (iii) has been convicted of a criminal offense related to the
provision of healthcare items or services or (iv) is subject to any such pending
action, or is the subject of a conviction or pending action described in such
sections. ALZA agrees to notify GENUPRO in writing as soon as reasonably
possible if, in performing services under this Agreement, ALZA, or to ALZA’s
knowledge (including reasonable inquiry of its

 

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Affiliates) any Affiliate thereof, or any person used by ALZA, or to ALZA’s
knowledge (including reasonable inquiry of its Affiliates) any Affiliate
thereof, is subject to any of the foregoing, or if any action, suit, claim,
investigation, or proceeding relating to the foregoing is pending.

11.2.18 Sublicenses. All material sublicenses (excluding Distribution
Agreements) granted by ALZA or any Affiliate thereof with respect to Agreement
Product, the rights licensed to ALZA under the License Agreement, or the Product
Rights are set forth in Schedule 11.2.18. Unless otherwise agreed by the Parties
in writing, ALZA shall, subject to the terms of such agreements, terminate such
agreements on or before the Effective Date.

11.2.19 Taxes. ALZA and its Affiliates have completed and duly and timely filed
in correct form with the appropriate government, regulatory, or taxing
authority, all material returns, reports and declarations of estimated tax for
Taxes related to the Agreement Product and Product Rights that were required to
be filed by it (the “Tax Returns”). All such Tax Returns are correct and
complete in all material respects. ALZA and its Affiliates have paid in full or
made adequate provision for all amounts shown to be due and owing on its Tax
Returns. There are no tax liens upon the Agreement Product or Product Rights. No
action for the assessment or collection of Taxes of ALZA or any Affiliate
thereof with respect to the Agreement Product or Product Rights is pending or
has been threatened in writing and no written claim or deficiency against ALZA
or any Affiliate thereof for the assessment or collection of any Taxes with
respect to the Agreement Product or Product Rights has been asserted or proposed
which written claim or deficiency has not been settled with all amounts
determined to have been due and payable having been timely paid (taking into
account any granted extension of the due date for payment of such Taxes).

11.2.20 Brokers. ALZA, and to ALZA’s knowledge (including reasonable inquiry of
its Affiliates and Third Party MAHs) its Affiliates and Third Party MAHs have
not incurred any obligation or liability, contingent or otherwise, for brokerage
or finders’ fees or agents’ commissions or other similar payment (including
those of or to any Third Party MAH) in connection with this Agreement or the
transfer of Agreement Product and Product Rights pursuant hereto.

11.2.21 Product Distribution Practices. ALZA and, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates and Third Party MAHs), its Affiliates and
Third Party MAHs have shipped and sold the Agreement Product, at all times since
(and including) January 1, 2011 until the Effective Date in quantities and at
prices consistent with past Agreement Product demand and shipment and sales
practices in all material respects (and not in quantities in excess of the
historical demand for the Agreement Product) and, in particular, neither ALZA
nor, to ALZA’s knowledge (including reasonable inquiry of its Affiliates and
Third Party MAHs), any Affiliate thereof nor Third Party MAHs has engaged in
(a) stop or slow shipping of any Agreement Product; (b) sales practices for any
Agreement Product unreasonably requiring any customer thereof to purchase a
specific or larger-than-desired amount of Agreement Product solely for purposes,
or with the primary effect, of bringing forward future sales or maximizing

 

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short-term sales (i.e. not tied to batch sizes or reasonable or customary
minimum purchase obligations); (c) encouraging or requiring customers of
Agreement Product, in a manner inconsistent with generally-accepted customary
sales practices, to, as a condition or requirement to gain access to the
Agreement Product in any amount, to purchase a specific or larger-than-desired
amount of Agreement Product solely for purposes, or with the primary effect, of
bringing forward future sales or maximizing short-term sales (i.e., not tied to
batch sizes or reasonable or reasonable or customary minimum purchase
obligations).

11.2.22 Government Sponsored Research and Development. No governmental agency or
authority has any material right, title or interest in or to any of the ALZA
Know-How, Identified ALZA Patents, Trademarks, Domain Names, Governmental
Permits, ALZA Regulatory Submissions, Development Records, Manufacturing
Records, or any other Product Rights, except as would not reasonably be
expected, individually or in the aggregate, to have a material adverse effect on
either Party’s performance of their obligations under this Agreement or any
Ancillary Agreement, the exploitation of the Product Rights, or the use,
development, manufacture, sale, marketing, import, export, or commercialization
of Agreement Product. Neither ALZA nor, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates), any Affiliate thereof received or
currently receives funds or other resources provided by a governmental agency or
authority with respect to any research or development of the Agreement Product.

11.2.23 Clinical Trials. As of the Effective Date, there are no clinical trials
being conducted by or on behalf of ALZA or, to ALZA’s knowledge (including
reasonable inquiry of its Affiliates), its Affiliates with respect to the
Agreement Product other than the Ongoing Clinical Studies.

11.2.24 Market Definitions. As of the Effective Date, the countries set forth on
Schedules 5.2A, 5.2B and 5.2C, respectively, accurately reflect the descriptions
thereof set forth in Sections 5.2.1, 5.2.2 and 5.2.3, respectively.

11.3 ALZA Covenants.

11.3.1 To the extent any circumstances arise after the Effective Date and on or
before the Transition Completion Date that, to ALZA’s knowledge, would render
any of the representations and warranties set forth in Section 11.2 no longer
true or accurate, ALZA shall provide detailed written notice thereof to GENUPRO
and the Transition Team shall discuss and recommend in good faith the reasonable
actions to be taken by the Parties to mitigate the effects of any such
circumstances (and the Parties shall use Commercially Reasonable Efforts to
agree in writing to any such reasonable recommendation).

11.3.2 At all times following the Effective Date, ALZA shall, and shall cause
its Affiliates to, complete and duly and timely file in correct, complete, and
accurate form with the appropriate government, regulatory, or taxing authority,
all material Tax Returns (as defined in Section 11.2.19) and pay in full or make
adequate provision for all amounts due and owing on such Tax Returns.

 

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11.3.3 ALZA shall not, and shall cause its Affiliates to not, enter into any
licenses or sublicenses or other contracts with respect to any Product Rights or
other rights to Licensed Products (including any rights under the License
Agreement) following the Effective Date without GENUPRO’s prior written consent,
except for any contracts (i) reasonably necessary for ALZA to fulfil its
obligations hereunder or under any Ancillary Agreements and (ii) of which
GENUPRO is informed of by ALZA in writing and reasonably in advance of the
execution thereof by ALZA.

11.3.4 ALZA shall use Commercially Reasonable Efforts (and shall use
Commercially Reasonable Efforts to cause its Affiliates to use Commercially
Reasonable Efforts) to comply with all Legal Requirements with respect to all
Governmental Permits, ALZA Regulatory Submissions, and all of its (and its
Affiliates’) activities and other obligations with respect to Agreement Product
following the Effective Date.

11.3.5 ALZA shall pay (directly or through its Affiliates) all necessary
registration, maintenance, and renewal fees that come due or may arise with
respect to any Trademark in any particular country prior to the assignment
thereof to GENUPRO under this Agreement, and ALZA shall use Commercially
Reasonable Efforts to file (directly or through its Affiliates) all necessary
documentation, recordations, and certifications with relevant authorities for
purposes of maintaining trademark registrations therefor until such assignment.

11.3.6 ALZA shall use Commercially Reasonable Efforts to cause all Domain Name
registrations and related fees to be maintained up to date and paid in full with
respect to all Domain Names prior to the assignment thereof to GENUPRO under
this Agreement.

11.3.7 ALZA shall pay, or cause to be paid, all maintenance and other fees
imposed by Regulatory Authorities and other governmental agencies related to the
ALZA Marketing Authorizations or ALZA Regulatory Submissions incurred or coming
due prior to the Regulatory Transfer Date (even if payable after the Regulatory
Transfer Date). Notwithstanding the preceding sentence, the Party (or its
designated Affiliate or Sublicensee) required by Legal Requirements in a
particular country of the Territory to make application in such country for
transfer of ownership of Governmental Permits or ALZA Regulatory Submissions
shall be responsible for any fees imposed by Regulatory Authorities and other
governmental agencies in connection with such application as set forth in
Section 7.5.

11.3.8 ALZA shall, beginning on the Effective Date and during the Transition
Period, transfer to GENUPRO by means of the Electronic Media all ALZA Regulatory
Submissions, Governmental Permits, Development Records, Manufacturing Records,
or other information, materials, or documentation material to the Product Rights
set forth in the Schedules appended hereto or in the Index or development,
manufacture, or commercialization of Agreement Product, in accordance with
Section 6.1.1. ALZA shall

 

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update the Electronic Media until the Transition Completion Date with such of
the foregoing not initially included in the Electronic Media as soon as
reasonably possible upon ALZA becoming aware thereof (whether pursuant to notice
or request by GENUPRO or otherwise), and provide written notice to GENUPRO upon
any update thereof (which notice shall identify with reasonable detail the
material being added to the Electronic Media). ALZA shall deliver to GENUPRO
copies of the contents of the Data Room, which ALZA may do electronically in a
form reasonably acceptable to GENUPRO, within five (5) business days of the
Effective Date (which copies shall represent the contents of the Data Room as of
the Effective Date) and, from and after the Effective Date until the later of
(a) such time as ALZA delivers the final contents of the Data Room in electronic
form to GENUPRO as set forth above or (b) the date ninety (90) days following
the Effective Date, ALZA shall continue to permit GENUPRO to access the Data
Room, including the ability to print documents therefrom.

11.3.9 Without limitation of ALZA’s rights and obligations with respect to
Ongoing Clinical Studies, ALZA shall not (and shall cause its Affiliates,
sublicensees, and subcontractors to not) initiate any clinical trials of any
Licensed Product following the Effective Date without GENUPRO’s written consent
(which may be granted or withheld in GENUPRO’s sole discretion).

11.3.10 On or after the Effective Date, neither ALZA nor any Affiliate thereof,
nor any Third Party acting on behalf of ALZA or any Affiliate thereof (under a
Distribution Agreement or otherwise), shall sell, market, or commercially
distribute any Agreement Product in any country other than in a Group A Market
country under the Sales Services Agreement in accordance with Section 5.3.1.2
without GENUPRO’s prior written consent.

11.3.11 Consents and Approvals. ALZA shall, or shall cause its Affiliates or
Third Party MAH to, obtain the following: (a) each consent, approval,
authorization, registration or filing with any Governmental Authority and
(b) each consent, approval, authorization of or notice to any other Third Party,
which, in each case, is required in connection with the consummation by ALZA of
the transactions contemplated by this Agreement and the Ancillary Agreements,
including the consents described in Schedule 11.3.11; except to the extent as,
in each case, would not, individually or in the aggregate, materially and
adversely affect the ability of either Party to perform its obligations
hereunder or under any Ancillary Agreement or GENUPRO’s, its Affiliates’, or its
Sublicensees’ ability to exploit the Product Rights or Agreement Product.

11.3.12 ALZA Permitted Liens. ALZA shall, and shall cause its Affiliates to,
promptly take all actions and make all payments reasonably necessary to avoid
the existence, imposition, maintenance, survival, or creation of any ALZA
Permitted Liens or, to the extent ALZA and its Affiliates are unable to avoid
the existence, imposition, maintenance, survival, or creation of any ALZA
Permitted Liens or otherwise fail to prevent the existence, imposition,
maintenance, survival, or creation thereof, ALZA shall, and shall cause its
Affiliates, to promptly take all such actions and make all payments necessary to
avoid, extinguish, terminate, or remove any ALZA Permitted Liens.

 

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11.4 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT OR MANDATED BY
APPLICABLE LAW WITHOUT THE RIGHT TO WAIVE OR DISCLAIM, NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY WITH RESPECT TO ANY AGREEMENT PRODUCT, PRODUCT
RIGHTS, KNOW-HOW, PATENTS, ONGOING CLINICAL STUDIES, DATA, RECORDS, GOODS,
RESULTS, OR OTHER RIGHTS, MATERIALS, OR SUBJECT MATTER UNDER THIS AGREEMENT, AND
EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES, CONDITIONS AND REPRESENTATIONS OF
ANY KIND, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF PERFORMANCE,
MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE AND
NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

11.5 Each Party agrees that, in the event that of a breach by the other Party of
both a representation and warranty under this Agreement and the same or a
substantially similar representation and warranty in one or more Ancillary
Agreements, such Party shall only be entitled to make a single claim against the
other Party with respect to such breach, under either this Agreement or one of
the Ancillary Agreements.

Section 12 Liability and Indemnification

12.1 By GENUPRO.

12.1.1 Subject to Sections 12.3 and 12.4, and except as otherwise expressly
provided for in the Ancillary Agreements, GENUPRO shall indemnify, defend and
hold harmless ALZA and its Affiliates, and their respective directors, officers,
employees, agents and representatives (and each of their respective successors
and permitted assigns) (collectively, the “ALZA Indemnitees”) from and against
(a) any and all Third Party claims and resulting Damages which any ALZA
Indemnitee may sustain, incur or suffer arising out of, or directly or
indirectly resulting from, the ownership, possession, manufacture, research,
development, use, distribution, marketing, promotion, offering for sale, sale,
import, export or commercialization of Agreement Product or any other Licensed
Product (if any) by (or by any Third Party on behalf of) GENUPRO or any of its
Affiliates or Sublicensees anywhere in the Territory (including, but not limited
to, any product liability or personal injury claims as a result of the
manufacture, sale, distribution or use of any end-product sold by GENUPRO or any
of its Affiliates or Sublicensees that incorporates any Agreement Product or any
other Licensed Product (if any), or any claims made with respect to any
intellectual property or materials used by GENUPRO or any of its Affiliates or
Sublicensees in connection with any Agreement Product or any other Licensed
Product (if any)), and (b) any and all Third Party claims and resulting Damages
which any ALZA Indemnitee may sustain, incur or suffer arising out of, or
directly or indirectly resulting from, the infringement or misappropriation of
such Third Party’s intellectual property rights (including Patents) by GENUPRO
or any of its Affiliates or Sublicensees (or by any Third Party on any of their
behalf) with respect to any of the activities described in clause (a), except in
each case to the extent resulting from (x) any ALZA Indemnitee’s breach of this
Agreement (including any representation, warranty, or covenant of ALZA contained
herein) or any Ancillary Agreement, failure to comply with any Legal
Requirement, negligence, or intentional misconduct or (y) any matter subject to
indemnification by ALZA pursuant to Section 12.2 or any Ancillary Agreement.

 

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12.1.2 Furthermore, subject to Sections 12.3 and 12.4, and except as otherwise
expressly provided for in the Ancillary Agreements, GENUPRO shall indemnify,
defend and hold harmless the ALZA Indemnitees from and against any Third Party
claims and resulting Damages that any ALZA Indemnitee may sustain, suffer or
incur arising out of, or directly or indirectly resulting from: (i) the
negligence or intentional misconduct of GENUPRO or any of its Affiliates or
Sublicensees in connection with the performance of GENUPRO’s, its Affiliates’ or
Sublicensees’ obligations or exercise of GENUPRO’s rights under this Agreement,
(ii) the breach of one or more of GENUPRO’s covenants, agreements or obligations
under this Agreement (including any breach by GENUPRO of its representations and
warranties set forth in Section 11) or any Ancillary Agreement, (iii) any
failure by GENUPRO or any of its Affiliates or Sublicensees to comply with any
Legal Requirement with respect to Licensed Products (as defined in Section 1.22
of the License Agreement), or (iv) any of GENUPRO’s, its Affiliates’, or
GENUPRO’s or its Affiliates’ licensees’, distributors’, or contractors’
exploitation, use, or practice of any Product Rights or rights under the ALZA
Know-How, except in each case to the extent resulting from (x) any ALZA
Indemnitee’s breach of this Agreement (including any representation, warranty,
or covenant contained herein) or any Ancillary Agreement, failure to comply with
any Legal Requirement, negligence, or intentional misconduct or (y) any matter
subject to indemnification by ALZA pursuant to Section 12.2 or any Ancillary
Agreement.

12.2 By ALZA.

12.2.1 Subject to Sections 12.3 and 12.4, and except as otherwise expressly
provided for in the Ancillary Agreements, ALZA shall indemnify, defend and hold
harmless GENUPRO and its Affiliates, and all of the foregoing’s respective
directors, officers, employees, agents, and representatives (and each of their
respective successors and permitted assigns) (collectively, the “GENUPRO
Indemnitees”) from and against any and all Third Party claims and resulting
Damages which any GENUPRO Indemnitee may sustain, incur or suffer arising out
of, or directly or indirectly resulting from, (a) the ownership, possession,
manufacture, research, development, use, distribution, marketing, promotion,
offering for sale, sale, import, export or commercialization of Agreement
Product or any other Licensed Product (if any) by or on behalf of ALZA or any
Affiliate thereof anywhere in the Territory prior to the Effective Date, or
(b) any claim by a Third Party with respect to any infringement or
misappropriation of such Third Party’s intellectual property rights (including
Patents) with respect to any of the activities prior to the Effective Date
described in clause (a), except in each case to the extent resulting from
(x) any GENUPRO Indemnitee’s breach of this Agreement (including any
representation, warranty, or covenant contained herein) or any Ancillary
Agreement, failure to comply with any Legal Requirement, negligence, or
intentional misconduct or (y) any matter subject to indemnification by GENUPRO
pursuant to Section 12.1 or any Ancillary Agreement.

 

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12.2.2 Furthermore, subject to Sections 12.3 and 12.4, and except as otherwise
expressly provided for in the Ancillary Agreements, ALZA shall indemnify, defend
and hold harmless the GENUPRO Indemnitees from and against any and all Third
Party claims and resulting Damages which any GENUPRO Indemnitee may sustain,
incur or suffer arising out of, or directly or indirectly resulting from:
(i) the negligence or intentional misconduct of ALZA or any Affiliate thereof in
connection with this Agreement or the performance of ALZA’s or its Affiliates’
obligations or exercise of ALZA’s rights under this Agreement, (ii) the breach
of one or more of ALZA’s covenants, agreements or obligations under this
Agreement (including any breach by ALZA of its representations and warranties
set forth in Section 11) or any Ancillary Agreement, or (iii) ALZA’s or any
Affiliate’s failure to comply with any Legal Requirement related to Agreement
Product or any other Licensed Product (or the use, development, manufacture,
sale, distribution, promotion, marketing, import, or export thereof), except in
each case to the extent resulting from (x) any GENUPRO Indemnitee’s breach of
this Agreement (including breach of any representation, warranty, or covenant
contained herein) or any Ancillary Agreement, failure to comply with any Legal
Requirement, negligence, or intentional misconduct or (y) any matter subject to
indemnification by GENUPRO pursuant to Section 12.1 or any Ancillary Agreement.

12.3 Procedures. Each Party shall promptly give the other Party written notice
of any claim for which indemnification may be sought under this Agreement.
However, failure of a Party with a right to be indemnified hereunder (an
“Indemnified Party”) to provide notice of a claim shall only affect the
Indemnified Party’s right to indemnification if and to the extent that such
failure has a material adverse effect on the ability of the other Party (the
“Indemnifying Party”) to defend the claim and/or the nature or amount of such
claim The Indemnifying Party shall have the right to assume control of the
defense of the suit or claim, and the Indemnified Party shall cooperate as
reasonably requested by the Indemnifying Party (at the expense of the
Indemnifying Party) in the defense of any claim subject to indemnification
hereunder; provided, however, that if, in the reasonable judgment of the
Indemnified Party, such suit or claim involves an issue or matter which could
have a materially adverse effect on the business operations or assets of the
Indemnified Party, the Indemnified Party may, by written notice to the
Indemnifying Party, waive its rights to indemnity under this Agreement and
control the defense or settlement thereof, but in no event shall any such waiver
be construed as a waiver of any rights which such Party may have at law or in
equity. If the Indemnifying Party controls the defense of the suit or claim, the
Indemnified Party may fully participate in (but not control) the defense thereof
and be represented by counsel at its sole cost and expense.

12.4 Settlements. Notwithstanding the foregoing, neither Party may settle a
claim or action that is subject to the terms of this Section 12 without the
prior written consent of the other Party if such settlement would (i) impose any
non-indemnified monetary obligation on the other Party, (ii) admit fault or
wrongdoing on the part of the other Party, (iii) require the other Party to
submit to an injunction, (iv) limit the other Party’s rights under this
Agreement or any Ancillary Agreement, or surviving rights under the License
Agreement, or (v) limit or otherwise adversely affect either Party’s (or its
Affiliates’ or Sublicensees’) rights or ability to make, have made, use, sell,
offer for sale, import, export, market, distribute, develop, or commercialize
Agreement Product or any other Licensed Product (if any) to the extent it
retains or otherwise has such rights

 

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hereunder or under the Product Rights. Any payment required pursuant to any
settlement agreement entered into in violation of this Section 12.4 shall be at
the settling Party’s own cost and expense.

12.5 NO CONSEQUENTIAL DAMAGES. THE PARTIES EXPRESSLY AGREE THAT IN NO EVENT
SHALL EITHER PARTY OR ITS AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY
INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY, LOSS OF PROFITS OR
CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT,
WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT
OF THIS AGREEMENT, PROVIDED THAT, NOTWITHSTANDING ANYTHING TO THE CONTRARY
HEREIN, THE FOREGOING SHALL NOT BE CONSTRUED TO LIMIT: (i) THE INDEMNITY
OBLIGATIONS SET FORTH ABOVE OR IN ANY ANCILLARY AGREEMENT; OR (ii) EITHER
PARTY’S LIABILITY FOR FRAUD, GROSS NEGLIGENCE, OR PATENT INFRINGEMENT.

12.6 Insurance. During the term of and for a period of not less than five years
after a Party’s and/or its Affiliates’ and/or its Sublicensees’ ownership,
possession, manufacture, research, development, use, distribution, marketing,
promotion and/or sale of Agreement Product (or by any Third Party on behalf of
that Party and/or its Affiliates and/or its Sublicensees) such Party and/or its
Affiliates and/or its Sublicensees shall maintain commercial general liability
insurance and product liability insurance covering the Agreement Product in
amounts not less than $[*] per occurrence and $[*] annual aggregate. Such
insurance shall include worldwide coverage. In addition, during each Party’s
and/or its Affiliates’ and/or its Sublicensees’ conduct of clinical trials such
Party and/or its Affiliates and/or its Sublicensees conducting clinical trials
shall maintain clinical trial insurance where required by and compliant with
regulations in those territories where clinical trials are conducted. Upon
written request, each Party and/or its Affiliates and/or its Sublicensees shall
provide the other Party and/or its Affiliates and/or its Sublicensees with
written evidence of the required insurance. The amounts of insurance required
herein shall not be construed to create a limit of liability with respect to
each Party’s indemnification rights and obligations under this Agreement.

Section 13 Confidentiality

13.1 “Confidential Information” means any proprietary and confidential
information that is disclosed orally, visually or in writing, by one Party
(directly or through its Affiliates and/or Sublicensees, as applicable)
(“Disclosing Party”) to the other Party (directly or through its Affiliates
and/or Sublicensees, as applicable) (“Receiving Party”) pursuant to this
Agreement, provided that, notwithstanding the foregoing, all such information
related to Product Rights, Agreement Product, and Related Products shall,
following the Effective Date, be treated as the Confidential Information of each
Party, and each Party shall be deemed the Disclosing Party (and the Receiving
Party) with respect thereto, regardless of whether any information may have been
first disclosed hereunder by or on behalf of ALZA to GENUPRO or any Affiliate
thereof; for the avoidance of doubt, however, any such information that is ALZA
Know-How shall remain the property of ALZA unless expressly provided otherwise
hereunder.

 

[*] Confidential treatment requested.

 

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13.2 Non-Disclosure and Non-Use. The Receiving Party shall keep confidential and
shall not disclose to any Third Parties and shall not use for any purpose, other
than as, in either case, provided for in this Agreement, the Transition Services
Agreement, Sales Services Agreement, the Manufacturing Agreements, or any other
Ancillary Agreement, any Confidential Information of the Disclosing Party for a
period of [*] ([*]) [*] from disclosure, except for any identified as trade
secrets, for which the obligation shall continue. The obligations with respect
to confidentiality and non-use shall no longer apply, however, to a Disclosing
Party’s Confidential Information to the extent that such information:

(a) is or becomes published or generally known to the public through no fault or
omission on the part of the Receiving Party; or

(b) was known or used by the Receiving Party prior to its disclosure by the
Disclosing Party to the Receiving Party as evidenced by its written records,
provided that this clause (b) shall not apply to Confidential Information that
is confidential to both parties as set forth in Section 13.1; or

(c) is provided to the Receiving Party without obligation of confidentiality or
limitation on use by a Third Party having the right to do so; provided that such
Third Party was not bound by any agreement to keep such information confidential
or otherwise prohibited from transmitting the information by a contractual,
legal or fiduciary obligation; or

(d) was independently developed by the Receiving Party as evidenced by its
contemporaneous written records without reference to or the aid, application or
use of Confidential Information of the Disclosing Party.

For the avoidance of doubt, Confidential Information pertaining to a combination
of published elements shall not be deemed to be in the public domain because the
individual elements of such confidential combination are in the public domain,
unless the specific combination of those elements is also in the public domain.
Furthermore, upon the transfer of ownership of any Product Rights from ALZA to
GENUPRO, Confidential Information disclosed by or on behalf of ALZA to GENUPRO
pertaining to such Product Rights shall be deemed confidential to GENUPRO as
well, as set forth in Section 13.1 above. Additionally, notwithstanding anything
to the contrary herein, the duration of the confidentiality obligation will
continue indefinitely as to any unpublished Confidential Information pertaining
to the manufacture of Agreement Product that by its nature is commonly
recognized in the industry as constituting valuable trade secret information,
including any such information that is not accessible by the public in the
Chemistry, Manufacturing and Controls (CMC) section of drug applications
submitted to Regulatory Authorities or other Regulatory Submissions, except as
provided in Section 13.3 below.

13.3 Permitted Disclosures. The confidentiality and non-disclosure obligations
contained in Sections 13.1 and 13.2 above with respect to a Disclosing Party’s
Confidential Information shall not apply to the extent that the Receiving Party
is required:

 

[*] Confidential treatment requested.

 

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(a) to disclose information by Legal Requirements or order of a governmental
agency or a court of competent jurisdiction, provided that the Receiving Party
shall, to the extent reasonably possible, (i) give reasonable prior written
notice thereof to the Disclosing Party, (ii) provide the Disclosing Party with
reasonably sufficient opportunity to prevent or limit any such disclosure or to
request confidential or protective treatment thereof, and (iii) give reasonable
assistance to the Disclosing Party, as reasonably requested thereby, to protect
the information as confidential;

(b) to, in the case of either Party in exercise of its rights hereunder or under
the Ancillary Agreements, disclose information to any Regulatory Authority for
purposes of obtaining approval to test, develop, manufacture, use, sell, offer
for sale, import, export, market, or otherwise commercialize any Agreement
Product or Related Product;

(c) to satisfy either Party’s duty of disclosure in the prosecution of any
Patents concerning Dapoxetine or any Agreement Product or Related Product before
governmental patent agencies, provided that a Receiving Party shall, to the
extent reasonably possible, take Commercially Reasonable Efforts to protect the
confidentiality of the other Party’s Confidential Information; or

(d) to disclose to its Affiliates and its and its Affiliates’ employees,
directors, contractors, or licensees who have a need to know for purposes of
this Agreement or, in the case of either Party in exercise of its rights
hereunder or under the Ancillary Agreements, the practice of the Product Rights
or manufacture, use, sale, offering for sale, import, development, or
commercialization of Agreement Product or Related Products and are under an
obligation of confidentiality with respect thereto substantially equivalent to
that of the Receiving Party.

13.4 Disclosure of Financial and Other Terms. Except as required by Legal
Requirement, the Parties agree that the terms and existence of this Agreement
will be considered Confidential Information of both Parties. Notwithstanding the
foregoing, either Party may disclose: (a) such terms as are required to be
disclosed in its publicly-filed financial statements or other public statements
pursuant to Legal Requirements and stock market or exchange rules or regulations
(e.g., the U.S. Securities and Exchange Commission, NASDAQ, NYSE, London Stock
Exchange, or any other securities exchange on which securities issued by a Party
or its Affiliates are, or may be, issued); provided that the disclosing Party
shall, to the extent reasonably practicable, provide the other Party with a
draft of the proposed text of such statement or disclosure (including any
Schedules containing this Agreement) sufficiently in advance of the scheduled
release or publication thereof to afford the other Party a reasonable
opportunity to review and comment upon the proposed text (including redacted
versions of this Agreement), which comments shall be reasonably considered by
the disclosing Party; and (b) the material terms of this Agreement under
confidentiality undertakings to any potential or actual acquirer, acquisition or
merger target, or merger partner, licensee, licensor, manufacturer, or other
strategic partner with respect to any Agreement Product, Related Product, or the
Product Rights or in exercise of the Party’s rights hereunder or under the
Ancillary Agreements, or potential providers of financing (whether equity, debt,
or otherwise) and their advisors. Neither Party

 

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shall make any other statement to the public regarding the execution and/or any
other aspect of the subject matter of this Agreement, except: (i) where a Party
reasonably believes disclosure is required under Legal Requirements or
applicable stock market rules; and (ii) either Party may use the text of a
statement previously disclosed in accordance with this Agreement; and
(iii) GENUPRO shall be free, as it may determine in its reasonable discretion,
to make public statements and/or public disclosures regarding GENUPRO’s or its
Affiliates’ or Sublicensees’ manufacture, commercialization or development of
Agreement Product or Related Products following the Effective Date, subject to
the terms and conditions of this Agreement.

13.5 No Use of Name. Except as otherwise provided herein or required by Legal
Requirement, government authority, or the rule of any applicable securities
exchange, neither Party shall use the name, mark or logo of the other Party or
any of its Affiliates, or the name of any of their respective employees or
agents, in any sales, promotion, advertising or other forms of publicity,
without the prior written approval of the other Party.

13.6 Publicity. Each of GENUPRO and ALZA agrees not to issue any press releases
or public announcements concerning this Agreement (and to cause their respective
Affiliates to not do so) without the prior written consent (which may be sent by
e-mail from an authorized representative) of the other Party as to the form,
timing and content of any such release or announcement, except as required by a
governmental authority, Legal Requirement, or rule of any applicable securities
exchange. The Parties may agree on an initial form of press release in relation
to the transfer to GENUPRO of the Product Rights to be issued by one or both of
the Parties.

Section 14 Failure of Effective Date under Section 2.1 to Occur

14.1 In the event that the Effective Date under Section 2.1 has not occurred on
or before [*] (such date, the “Final Section 2.1 Closing Date”), then beginning
on the Final Section 2.1 Closing Date the Effective Date shall be determined
under Section 2.2, and Section 2.1 shall have no further effect. The occurrence
of the Effective Date by the Final Section 2.1 Closing Date under Section 2.1
shall be referred to herein as a “Section 2.1 Closing”.

14.2 In the event that a Section 2.1 Closing does not occur by the Final
Section 2.1 Closing Date, the Parties agree that the terms of this Agreement
shall become effective, and the Effective Date shall occur, only upon the
satisfaction of the conditions as expressly set forth in Sections 2.2, 14.2.1,
and 14.2.2 and elsewhere in this Agreement. The occurrence of the Effective Date
following the Final Section 2.1 Closing Date pursuant to Section 2.2 and this
Section 14 shall be referred to herein as a “Section 2.2 Closing”.

14.2.1 Payments. In the event that a Section 2.1 Closing does not occur by the
Final Section 2.1 Closing Date, [*]. Notwithstanding anything to the contrary,
GENUPRO shall be obligated to make the payments to ALZA set forth in Section 7.1
and in Section 7.3.

 

[*] Confidential treatment requested.

 

69

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

14.2.2 Ancillary Agreements. In the event that a Section 2.1 Closing does not
occur by the Final Section 2.1 Closing Date, the Parties shall negotiate in good
faith the following Ancillary Agreements:

14.2.2.1 The GENUPRO PV Agreement;

14.2.2.2 The GENUPRO Manufacturing Agreement, and the GENUPRO Quality Agreement
appended thereto, under which ALZA will supply Agreement Product to GENUPRO for
a limited time in those Group A Market, Group B Market, Group C Market and Group
E Market countries where GENUPRO intends to use or sell Agreement Product. In
the event that the GENUPRO Manufacturing Agreement and the GENUPRO Quality
Agreement are not both effective on or before the date that is [*] ([*]) [*]
from the Effective Date under Section 2.2, ALZA shall have no further obligation
to negotiate such agreements;

14.2.2.3 The GENUPRO Trademark Assignment Agreement to assign Trademarks to
GENUPRO in the Group A Market, Group B Market, Group C Market and Group E Market
countries; and

14.2.2.4 The Domain Name Assignment Agreement.

Section 15 Termination and Survival

15.1 The term of this Agreement shall commence on the Effective Date as
determined under Section 2.1 or under Section 2.2 and expire on the latest of:
(i) Transition Completion Date; (ii) expiration of the last payment obligation
under Section 5.8.2, 7.1, 7.2, or 7.3, as applicable according to
Section 14.2.1; or (iii) expiration of the last-to-expire Ancillary Agreement.

15.2 Termination or expiration of this Agreement for any reason will be without
prejudice to any rights or obligations that will have accrued to the benefit of
any Party prior to such termination or expiration. The following shall survive
termination or expiration of this Agreement: [*] For avoidance of doubt,
reference in the above list to a Section number shall not include subsections
thereof unless specifically indicated to include subsections thereof.

Section 16 General

16.1 Entire Agreement/Integration. This Agreement and the Ancillary Agreements
constitute the entire understanding of the Parties, and supersedes any and all
prior agreements, understandings and arrangements whether oral or written,
between the Parties relating to the subject matter hereof. No amendments to this
Agreement shall be effective unless agreed in writing signed by the Parties
hereto. The Parties agree that in the event of any conflict between the terms of
this Agreement and the terms of any Manufacturing Agreement, the Transition
Services Agreement, the Sales Services Agreement, or other Ancillary Agreements
that may be entered into by the Parties or their Affiliates in furtherance of
this Agreement, the terms of this Agreement shall control.

 

[*] Confidential treatment requested.

 

70

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

16.2 Notice. All notices required hereunder shall be in writing and shall be
deemed given when delivered personally or by facsimile transmission (receipt
verified), five (5) days after mailed by registered or certified mail (return
receipt requested), postage prepaid, or two (2) days after sent by express
courier service or Express Mail, to the other Party at the following addresses
(as may be updated by notice hereunder):

 

 

To GENUPRO:

   GenuPro, Inc.     

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

Fax Number: [*]

Attention: [*]

 

Copy to:

   GenuPro, Inc.     

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

Fax Number: [*]                 Attention: [*]

 

To ALZA:

   Janssen Pharmaceutica NV     

Turnhoutseweg 30

B-2340 Beerse

Belgium

Attention: CEO and President

 

and

 

ALZA Corporation

700 Eubanks Drive

Vacaville, CA 95688

USA

Fax Number: [*]

Attention: [*]

 

Copy to:

   Johnson & Johnson     

Office of General Counsel

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Fax Number: [*]

Attention: [*]

16.3 No Third Party Beneficiaries. Nothing in this Agreement shall be construed
as giving any person or entity, other than the Parties hereto and their
successors and permitted assigns, any right, remedy or claim under or in respect
of this Agreement or any provision hereof, provided that the foregoing shall not
be construed as limiting the rights of any Sublicensee or other Third Party
under any Product Rights that may be granted thereto by GENUPRO or any Affiliate
thereof.

 

[*] Confidential treatment requested.

 

71

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

16.4 Assignment. Neither Party may assign or transfer this Agreement, in whole
or in part, nor any rights or obligations hereunder, by merger, operation of law
or otherwise, without the prior written consent of the other, except that (i) a
Party may make such an assignment without the other Party’s consent to any of
its Affiliates and (ii) either Party may make such an assignment without the
other’s consent in connection with the transfer or sale of all or substantially
all of the assigning Party’s assets or business (or that portion thereof
related, in either case, to this Agreement and the Ancillary Agreements), or in
the event of a Party’s merger, consolidation, change in control, reorganization,
or similar transaction; provided that, in either case, the assigning Party
provides the other Party with written notice of such assignment and the assignee
agrees to be bound to all of the terms and conditions of this Agreement
applicable to such assigned or transferred rights and obligations. Any permitted
assignment shall be binding on the successors of the assigning Party. In the
event a Party assigns this Agreement to an Affiliate other than a successor to
such Party, the assigning Party shall remain liable to the other Party for the
performance of the assignee Affiliate for so long as such assignee remains an
Affiliate of the assigning Party. Any assignment or attempted assignment by
either Party in violation of the terms of this Section 16.4 shall be null and
void and of no legal effect.

16.5 Compliance. Each Party hereby agrees that it shall comply, and shall
procure that its Affiliates and Sublicensees (as applicable) comply, with all
Legal Requirements in connection with the performance of, and compliance with,
its obligations and exercise of its rights under this Agreement.

16.6 Governing Law and Dispute Resolution.

16.6.1 The Parties recognize that a bona fide dispute as to certain matters
arising out of this Agreement or relating to the interpretation of this
Agreement or performance hereunder, including any such controversy or claim
involving a Party (a “Dispute”) may from time to time arise. In the event of the
occurrence of any Dispute, including any question regarding the Agreement’s
existence, validity or termination, or performance of a Party’s obligations
(directly or through any Affiliates), such Dispute shall be resolved in
accordance with this Section 16.6. Either Party may initiate Dispute resolution
by written notice to the other, in which event such Dispute shall be referred to
the Parties’ respective executives designated below or the executive’s
successor, for attempted resolution by good faith negotiations within [*] ([*])
[*] after such notice is received. The Parties’ designated executives for this
purpose are as follows: (a) for GENUPRO: June Almenoff, President and Chief
Medical Officer; and (b) for ALZA: Managing Director of Janssen Pharmaceutica NV
or his designee. No statements made during executive mediation under this
Section 16.6.1, which shall be held in confidence, shall be admissible in any
arbitration under Section 16.6.2.

16.6.2 In the event that the respective executives are unable to resolve a
Dispute by executive mediation within thirty (30) days of the disputing Party’s
notice (unless the Parties agree in writing to extend that period), the Dispute
shall be resolved by binding arbitration in accordance with the Commercial
Arbitration Rules of the AAA (“AAA Rules”; see www.adr.org) and the Federal
Arbitration Act, 9 U.S.C. §1 et seq. The arbitration shall be conducted in New
York, New York by three (3) independent, neutral arbitrators reasonably
experienced in the pharmaceutical industry appointed as follows.

 

[*] Confidential treatment requested.

 

72

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

GENUPRO and ALZA shall each be entitled to select one (1) such arbitrator, with
the two (2) such arbitrators so selected selecting the third (3rd) such
arbitrator. In the event either Party fails to select its arbitrator within ten
(10) business days of notice from either Party initiating arbitration hereunder,
the arbitrator selected by the other Party within such ten (10) business day
period shall be entitled to select such arbitrator. The arbitration shall be
conducted in English. The decision of the arbitrators will be final and binding
on the Parties, and any decision of the arbitrators may be enforced in any court
of competent jurisdiction. Each Party shall bear its own expenses and an equal
share of the reasonable, documented expenses of the arbitration panel and any
fees required by AAA to submit such matter to arbitration, unless the panel
determines that any such fees or expenses are to be paid by the non-prevailing
Party.

16.6.3 The arbitrators shall follow the ICDR Guidelines for Arbitrators
Concerning Exchanges of Information in managing and ruling on requests for
discovery. Each arbitrator, by accepting appointment, undertakes to exert her or
his best efforts to conduct the process so as to issue an award as soon as
reasonably possible, but in any event within three (3) months of her or his
appointment, provided that failure to meet that timetable shall not affect the
validity of the award.

16.6.4 The arbitrators shall decide the Dispute in accordance with the
substantive law of the State of New York, U.S.A., without regard to the choice
of law provisions thereof, which law shall govern the interpretation of this
Agreement. The arbitrators may not award punitive or consequential damages, nor
may the arbitrators apply any multiplier to any award of actual damages, except
as may be required by statute or permitted by this Agreement (i.e. to the extent
such damages are not precluded by Section 12.5). The award of the arbitrators
may be entered in any court of competent jurisdiction. The award of arbitration
shall be final and binding upon both Parties. The Parties waive all rights to
seek review of the award for errors of law or fact in any court.

16.6.5 The Parties hereby irrevocably and unconditionally submit to the
jurisdiction of the AAA for the purposes of the arbitration proceedings, and any
counterclaims that relate in any respect to the Agreement.

16.6.6 Notwithstanding the foregoing, either Party may seek injunctive,
equitable, or similar relief from a court of competent jurisdiction as necessary
to enforce its rights or protect its interests hereunder without the requirement
of arbitration.

16.7 Execution in Counterparts; Facsimile Signatures. This Agreement may be
executed in counterparts, each of which, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument even if both Parties have not
executed the same counterpart. Signatures for this Agreement (and the Transition
Services Agreement, Sales Services Agreement, Manufacturing Agreements, and
other Ancillary Agreements entered into in connection herewith) that are
provided by facsimile transmission or PDF file shall be deemed to be original
signatures.

 

73

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

16.8 Schedules. Alza shall have the right from time to time prior to the
Effective Date, except as expressly set forth elsewhere in this Agreement, to
supplement those Schedules to the Agreement delivered on the Execution Date. Any
such supplemental or amended disclosure delivered to the other Party shall be
deemed to modify any provision made in this Agreement for all purposes.

[Signature page to follow.]

 

74

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

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their authorized representatives as set forth below.

 

ALZA CORPORATION   GENUPRO, INC.   

By:

        By:       

Name:

        Name:       

Title:

        Title:       

Date:

        Date:        JANSSEN PHARMACEUTICA N.V.   FURIEX PHARMACEUTICALS, INC.
  

By:

        By:       

Name:

        Name:       

Title:

        Title:       

Date:

        Date:       

JANSSEN PHARMACEUTICA N.V.

      

By:

            

Name:

            

Title:

            

Date:

            

SIGNATURE PAGE OF LICENSE AND ASSET TRANSFER AGREEMENT BY AND BETWEEN ALZA
CORPORATION AND JANSSEN PHARMACEUTICA, NV AND FURIEX PHARMACEUTICALS, INC., AND
GENUPRO, INC. (A WHOLLY-OWNED SUBSIDIARY OF FURIEX PHARMACEUTICALS, INC.)

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

Portions of this exhibit marked [*] are requested to be treated confidentially.

Schedule 4.2A

Domain Names

 

Domain Name

 

registry

 

Domain Translation

 

Registrant

 

Registration Date

aboutpe.co.nz   New Zealand   About Premature Ejaculation   Johnson & Johnson  
June 19, 2009 aboutpe.com.au   Australia   about premature ejaculation   Johnson
& Johnson Pacific Pty. Ltd   April 16, 2009 aboutpe.com.my   Malaysia   about
premature ejaculation   Johnson & Johnson SDN BHD   July 8, 2009
aboutpriligy.com   Global   None   Johnson & Johnson   September 29, 2005
accademiaep.it   Italy   pe -> premature eiaculation accedemy   Johnson &
Johnson SPA   August 5, 2009 aitopriligy.com   Global   genuine priligy  
Johnson & Johnson   January 29, 2009 aitopriligy.fi   Finland   genuine priligy
  Janssen-Cilag Oy   February 3, 2009 aktapriligy.com   Global   genuine priligy
  Johnson & Johnson   January 29, 2009 äktapriligy.com   Global   Genuine
Priligy   Johnson & Johnson   February 12, 2009 aktapriligy.se   Sweden  
genuine priligy   Johnson & Johnson   January 31, 2009 äktapriligy.se   Sweden  
genuinepriligy   Johnson & Johnson   February 12, 2009 beatpe.com.my   Malaysia
  beat Premature Ejaculation   Johnson & Johnson SDN BHD   April 2, 2010
beatpe.net   Global   beat Premature Ejaculation   Johnson & Johnson   March 24,
2010 buydapoxetinepriligy.com   Global   buy dapoxetine priligy   Johnson &
Johnson   August 28, 2010 buypriligy.com   Global   buy priligy   Johnson &
Johnson   March 10, 2009 buy-priligy.com   Global   buy priligy   Johnson &
Johnson   February 10, 2009 buypriligy.info   Global   buy priligy   Johnson &
Johnson   July 1, 2009 buy-priligy.net   Global   buy priligy   Johnson &
Johnson   March 2, 2010 buy-priligy-dapoxetine.com   Global   buy priligy
dapoxetine   Johnson & Johnson   May 19, 2010 buypriligyonline.com   Global  
buy priligy online   Johnson & Johnson   February 3, 2009 buy-priligy-online.com
  Global   buy priligy online   Johnson & Johnson   February 3, 2009

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

cheappriligy.com   Global   None   Johnson & Johnson   September 29, 2005
checkpriligy.co.kr   Korea   n/a   Johnson & Johnson Korea Ltd.   November 11,
2009 comprarpriligy.com   Global   compare priligy   Johnson & Johnson   July 8,
2009 comprar-priligy.com   Global   compare priligy   Johnson & Johnson   August
16, 2010 comprarpriligy.es   Spain   compare Priligy   Johnson & Johnson   March
16, 2010 comprarpriligy.org   Global   compare Priligy   Johnson & Johnson  
August 3, 2010 contralaeyaculacionprecoz.com   Global  
againstprematureeyaculation   Johnson & Johnson   June 2, 2009
controlatueyaculacion.com   Global   control your eyaculation   Johnson &
Johnson   February 24, 2009 controlep.com.ar   Argentina   premature eyaculation
control   Johnson & Johnson de Argentina SACel   November 19, 2009
controleyaculacion.cl   Chile   ejaculation control   Johnson & Johnson  
December 17, 2009 controlpe.com   Global   None   Johnson & Johnson   September
29, 2005 controlpe.com.my   Malaysia   control premature ejaculation   Johnson &
Johnson SDN BHD   April 19, 2010 controlpe.com.sg   Singapore   control
premature ejaculation   Johnson & Johnson PTE. LTD.   July 7, 2010 controlpe.my
  Malaysia   control premature ejaculation   Johnson & Johnson SDN BHD   April
19, 2010 dapaxatine.biz   Global   None   Johnson & Johnson   June 28, 2005
dapaxatine.com   Global   None   Johnson & Johnson   June 20, 2005
dapaxatine.info   Global   None   Johnson & Johnson   June 27, 2005
dapaxatine.net   Global   None   Johnson & Johnson   June 20, 2005
dapaxatine.org   Global   None   Johnson & Johnson   June 20, 2005
dapoxeteen.biz   Global   None   Johnson & Johnson   June 28, 2005
dapoxeteen.com   Global   None   Johnson & Johnson   June 20, 2005
dapoxeteen.info   Global   None   Johnson & Johnson   June 27, 2005
dapoxeteen.net   Global   None   Johnson & Johnson   June 20, 2005
dapoxeteen.org   Global   None   Johnson & Johnson   June 20, 2005 dapoxetin.at
  Austria   None   Johnson & Johnson   August 26, 2005 dapoxetina.cl   Chile  
dapoxetine   Johnson & Johnson   August 20, 2009 dapoxetina.com.bo   Bolivia  
dapoxetine   Johnson & Johnson   August 25, 2009 dapoxetina.com.br   Brazil  
n/a   Janssen-Cilag Farmacêutica Ltda   April 11, 2008

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

dapoxetina.com.ec   Ecuador   dapoxetine   Johnson & Johnson   August 28, 2009
dapoxetina.com.pe   Peru   dapoxetine   Johnson & Johnson   August 19, 2009
dapoxetina.com.py   Paraguay   dapoxetine   Johnson & Johnson   August 24, 2009
dapoxetina.com.uy   Uruguay   dapoxetine   Johnson & Johnson   September 15,
2009 dapoxetina.com.ve   Venezuela   dapoxetina   Johnson & Johnson   September
9, 2009 dapoxetina.es   Spain   None   Johnson & Johnson   November 11, 2005
dapoxetinapriligy.com   Global   dapoxetine priligy   Johnson & Johnson  
December 20, 2010 dapoxetine.at   Austria   dapoxetine   Johnson & Johnson  
September 26, 2008 dapoxetine.biz   Global   None   Johnson & Johnson   June 27,
2005 dapoxetine.ca   Canada   dapoxetine   Johnson & Johnson   September 26,
2008 dapoxetine.com   Global   None   Johnson & Johnson   July 9, 2002
dapoxetine.com.au   Australia   dapoxetine   Johnson & Johnson Pacific Pty. Ltd
  September 29, 2008 dapoxetine.com.tw   Taiwan   n/a   Johnson & Johnson Taiwan
Ltd.   January 20, 2009 dapoxetine.dk   Denmark   None   Johnson & Johnson  
March 31, 2006 dapoxetine.es   Spain   dapoxetine   Johnson & Johnson  
September 26, 2008 dapoxetine.eu   European Union   None   Janssen Pharmaceutica
N.V.   April 7, 2006 dapoxetine.fi   Finland   dapoxetine.fi   Janssen-Cilag Oy
  January 10, 2009 dapoxetine.fr   France   dapoxetine   Johnson & Johnson
Consumer France SAS   September 26, 2008 dapoxetine.info   Global   None  
Johnson & Johnson   June 27, 2005 dapoxetine.md   Moldova   None   Johnson &
Johnson   May 10, 2004 dapoxetine.net   Global   None   Johnson & Johnson   June
20, 2005 dapoxetine.org   Global   None   Johnson & Johnson   June 20, 2005
dapoxetine.se   Sweden   dapoxetine   Johnson & Johnson   September 26, 2008
dapoxetinekills.biz   Global   None   Johnson & Johnson   June 27, 2005
dapoxetinekills.com   Global   None   Johnson & Johnson   June 20, 2005
dapoxetinekills.info   Global   None   Johnson & Johnson   June 27, 2005
dapoxetinekills.net   Global   None   Johnson & Johnson   June 20, 2005

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dapoxetinekills.org   Global   None   Johnson & Johnson   June 21, 2005
dapoxetine-priligy.com   Global   priligy dapoxetine   Johnson & Johnson   March
25, 2010 dapoxetine-priligy.info   Global   priligy dapoxetine   Johnson &
Johnson   November 29, 2009 dapoxetinesucks.biz   Global   None   Johnson &
Johnson   June 27, 2005 dapoxetinesucks.com   Global   None   Johnson & Johnson
  June 20, 2005 dapoxetinesucks.info   Global   None   Johnson & Johnson   June
20, 2005 dapoxetinesucks.net   Global   None   Johnson & Johnson   June 20, 2005
dapoxetinesucks.org   Global   None   Johnson & Johnson   June 20, 2005
dapoxetinetruth.biz   Global   None   Johnson & Johnson   June 27, 2005
dapoxetinetruth.com   Global   None   Johnson & Johnson   June 20, 2005
dapoxetinetruth.info   Global   None   Johnson & Johnson   June 27, 2005
dapoxetinetruth.net   Global   None   Johnson & Johnson   June 20, 2005
dapoxetinetruth.org   Global   None   Johnson & Johnson   June 21, 2005
depoxetine.biz   Global   None   Johnson & Johnson   June 27, 2005
depoxetine.com   Global   None   Johnson & Johnson   June 20, 2005
depoxetine.info   Global   None   Johnson & Johnson   June 27, 2005
depoxetine.net   Global   None   Johnson & Johnson   June 20, 2005
depoxetine.org   Global   None   Johnson & Johnson   June 20, 2005
discountpriligy.com   Global   None   Johnson & Johnson   September 29, 2005
dupoxetine.biz   Global   None   Johnson & Johnson   June 28, 2005
dupoxetine.com   Global   None   Johnson & Johnson   June 20, 2005
dupoxetine.info   Global   None   Johnson & Johnson   June 20, 2005
dupoxetine.net   Global   None   Johnson & Johnson   June 20, 2005
dupoxetine.org   Global   None   Johnson & Johnson   June 20, 2005
early-male-climax.biz   Global   None   Johnson & Johnson   June 27, 2005
early-male-climax.com   Global   None   Johnson & Johnson   June 20, 2005
early-male-climax.info   Global   None   Johnson & Johnson   June 20, 2005
early-male-climax.net   Global   None   Johnson & Johnson   June 20, 2005
edorpe.com   Global   Erectile Dysfunction or Premature Ejaculation   Johnson &
Johnson   March 9, 2005 ejaculacaoprecoce.com   Global   None   Johnson &
Johnson   February 8, 2005

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ejaculacao-precoce.com   Global   None   Johnson & Johnson   June 20, 2005
ejaculacaoprecoce.com.pt   Portugal   precoce ejaculation   Johnson & Johnson  
May 1, 2009 ejaculacaoprecoce.info   Global   None   Johnson & Johnson   June
27, 2005 ejaculacaoprecoce.mobi   Global   portuguese   Johnson & Johnson  
August 14, 2009 ejaculacaoprecoceonline.com.br   Brazil   premature ejaculation
online   Janssen-Cilag Farmacêutica Ltda   August 15, 2009
ejaculacaoprematura.com.pt   Portugal   premature ejaculation   Johnson &
Johnson   May 1, 2009 ejaculacaorapidaonline.com.br   Brazil   rapid ejaculation
online   Janssen-Cilag Farmacêutica Ltda   August 15, 2009 ejacularapido.com.br
  Brazil   rapid ejaculation   Janssen-Cilag Farmacêutica Ltda   August 15, 2009
ejaculationprematurée.com   Global   Premature Ejaculation   Johnson & Johnson  
December 2, 2009 ejaculationprematuree.fr   France   Premature Ejaculation  
Johnson & Johnson Consumer France SAS   October 26, 2009 ejaculatiopracox.de  
Germany   None   Johnson & Johnson   August 29, 2011 ejaculatiopracox.info  
Global   None   Johnson & Johnson   December 8, 2005 ejaculatiopraecox.at  
Austria   None   Johnson & Johnson   August 26, 2005 ejaculatio-praecox.at  
Austria   None   Johnson & Johnson   August 26, 2005 ejaculorapidinho.com.br  
Brazil   portuguese   Janssen-Cilag Farmacêutica Ltda   August 15, 2009
ejakulatioskontroll.se   Sweden   ejaculation control   Johnson & Johnson  
March 14, 2009 ejeculacaoprecoce.com.pt   Portugal   precoce ejaculation  
Johnson & Johnson   April 22, 2009 ejeculacaoprematura.com.pt   Portugal  
premature ejaculation   Johnson & Johnson   April 22, 2009 ellosyalohanhecho.com
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ellosyalohanhecho.es   Spain   theyhavealreadydoneit   Johnson & Johnson  
October 6, 2009 ennenaikainensiemensyoksy.fi   Finland   premature ejaculation .
fi   Janssen-Cilag Oy   March 5, 2009 ennenaikainensiemensyöksy.fi   Finland  
premature-ejaculation.fi   Janssen-Cilag Oy   March 6, 2009 everymaleclimax.biz
  Global   None   Johnson & Johnson   June 27, 2005 everymaleclimax.com   Global
  None   Johnson & Johnson   June 20, 2005 everymaleclimax.info   Global   None
  Johnson & Johnson   June 27, 2005 everymaleclimax.net   Global   None  
Johnson & Johnson   June 20, 2005 everymaleclimax.org   Global   None   Johnson
& Johnson   June 20, 2005

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exyaculacionprecoz.com   Global   exprematureeyaculation.com   Johnson & Johnson
  June 2, 2009 eyaculacion-precoz.com.mx   Mexico   None   Johnson & Johnson  
August 31, 2005 eyaculacionprecoz.com.ve   Venezuela   Premature Ejaculation  
Johnson & Johnson   September 9, 2009 eyaculacionycontrol.com.ar   Australia  
eyaculation and control   Johnson & Johnson de Argentina SACel   November 19,
2009 fakedapoxetine.com   Global   None   Johnson & Johnson   September 29, 2005
fakepriligy.com   Global   None   Johnson & Johnson   September 29, 2005
foldingthelaundry.com   Global   Dapoxetine   Johnson & Johnson   June 8, 2005
foldingthelaundry.net   Global   Dapoxetine   Johnson & Johnson   June 8, 2005
foldingthelaundry.org   Global   Dapoxetine   Johnson & Johnson   June 8, 2005
fortidigutlosning.se   Sweden   premature ejaculation   Johnson & Johnson  
February 27, 2009 freepriligy.com   Global   None   Johnson & Johnson  
September 29, 2005 fruehersamenerguss.de   Germany   rapid ejaculatio   Johnson
& Johnson   August 29, 2011 frueher-samenerguss.de   Germany   zu schneller
samenerguss - too quick ejaculation   Johnson & Johnson   August 29, 2011
fruehzeitiger-samenerguss.at   Austria   fruehzeitiger samenerguss - too quick
ejaculation   Johnson & Johnson   August 26, 2005 garforfort.se   Sweden   goes
too fast   Johnson & Johnson   March 14, 2009 garforsnabbt.se   Sweden   goes
too soon   Johnson & Johnson   February 27, 2009 garfortidigt.se   Sweden   goes
too soon   Johnson & Johnson   February 27, 2009 genericpriligy.com   Global  
None   Johnson & Johnson   September 29, 2005 genericpriligy.info   Global  
generic priligy   Johnson & Johnson   July 1, 2009 genericpriligy.org   Global  
generic priligy   Johnson & Johnson   April 27, 2010 generic-priligy.org  
Global   generic priligy   Johnson & Johnson   November 13, 2010
genuinepriligy.ca   Canada   genuine priligy   Johnson & Johnson   April 17,
2009 genuinepriligy.cn   China   Genuine PRILIGY   Johnson & Johnson HK Ltd.  
December 2, 2010 genuinepriligy.co.nz   New Zealand   n/a   Johnson & Johnson  
October 2, 2009 genuinepriligy.com   Global   genuine priligy   Johnson &
Johnson   January 29, 2009 genuinepriligy.com.au   Australia   genuine priligy  
Johnson & Johnson   February 2, 2009 genuinepriligy.com.cn   China   Genuine
PRILIGY   Johnson & Johnson HK Ltd.   December 2, 2010

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

genuinepriligy.com.hk   Hong Kong   genuine priligy   Johnson & Johnson (HK) Ltd
  May 19, 2009 genuinepriligy.com.my   Malaysia   n/a   Johnson & Johnson SDN
BHD   October 7, 2009 genuinepriligy.com.ph   Philippines   n/a   Johnson &
Johnson   October 5, 2009 genuinepriligy.com.sg   Singapore   n/a   Johnson &
Johnson   September 24, 2009 genuinepriligy.eu   European Union   genuine
priligy   Janssen Pharmaceutica N.V.   January 30, 2009 genuinepriligy.hk   Hong
Kong   genuine priligy   Johnson & Johnson (HK) Ltd   May 19, 2009
gercekpriligy.com   Global   real(genuine) priligy   Johnson & Johnson  
February 17, 2010 gercekpriligy.info   Global   real(genuine) priligy   Johnson
& Johnson   February 17, 2010 getpriligy.com   Global   get priligy   Johnson &
Johnson   May 20, 2009 ilmoittaudu-priligy.fi   Finland   register-priligy  
Janssen-Cilag Oy   March 5, 2009 kommaforfort.se   Sweden   comes too fast  
Johnson & Johnson   March 14, 2009 kommaforsnabbt.se   Sweden   comes too fast  
Johnson & Johnson   March 14, 2009 kontrolli.info   Global   control.info in
finnish   Johnson & Johnson   February 24, 2009 laengergeniessen.de   Germany  
Enjoy longer   Johnson & Johnson   August 29, 2011 laenger-geniessen.de  
Germany   enjoy longer   Johnson & Johnson   August 29, 2011
laeyaculacionprecoz.bo   Bolivia   premature eyaculation   Johnson & Johnson  
November 19, 2009 laeyaculacionprecoz.com.py   Paraguay   premature eyaculation
  Johnson & Johnson   January 22, 2010 laeyaculacionprecoz.com.uy   Uruguay  
premature eyaculation   Johnson & Johnson   November 16, 2009
laeyaculacionprecoz.ec   Ecuador   premature eyaculation   Johnson & Johnson  
November 13, 2009 laeyaculacionprecoz.es   Spain   theprematureeyaluculation.es
  Johnson & Johnson   June 4, 2009 laeyaculacionprecoz.info   Global  
theprematureeyaculation.com / info   Johnson & Johnson   June 1, 2009
laeyaculacionprecoz.pe   Peru   premature eyaculation   Johnson & Johnson  
November 13, 2009 maleclimax.biz   Global   None   Johnson & Johnson   October
14, 2003 maleclimax.com   Global   None   Johnson & Johnson   October 14, 2003
maleclimax.info   Global   None   Johnson & Johnson   October 14, 2003
maleclimax.net   Global   None   Johnson & Johnson   October 14, 2003
maleclimax.org   Global   None   Johnson & Johnson   October 14, 2003
managepe.com   Global   None   Johnson & Johnson   September 29, 2005

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

mannkannlänger.at   Austria   man is able longer   Johnson & Johnson   April 5,
2010 mascontrol-mastiempo.com   Global   morecontrol-moretime   Johnson &
Johnson   October 9, 2009 mascontrolmastiempo.com.mx   Mexico  
morecontrolmoretime   Johnson & Johnson   October 12, 2009
mascontrol-mastiempo.com.mx   Mexico   morecontrol-moretime   Johnson & Johnson
  October 12, 2009 mascontrolmastiempo.mx   Mexico   morecontrolmoretime  
Johnson & Johnson   October 23, 2009 mascontrol-mastiempo.mx   Mexico  
morecontrol-moretime   Johnson & Johnson   October 23, 2009 mehrzeitzuzweit.de  
Germany   more time twosome   Johnson & Johnson   August 29, 2011
mehr-zeit-zu-zweit.de   Germany   more time twosome   Johnson & Johnson   August
29, 2011 mejorcontrol.com   Global   bettercontrol   Johnson & Johnson   April
5, 2010 onlinepriligy.com   Global   priligy online   Johnson & Johnson  
February 3, 2009 pe.co.at   Austria   None   Johnson & Johnson   September 7,
2005 pedebate.com   Global   Premature Ejaculation Debates   Johnson & Johnson  
March 1, 2010 pedebate.info   Global   Premature Ejaculation Debates   Johnson &
Johnson   March 1, 2010 pedebates.com   Global   Premature Ejaculation Debates  
Johnson & Johnson   March 1, 2010 pedebates.info   Global   Premature
Ejaculation Debates   Johnson & Johnson   March 1, 2010 pediscussion.com  
Global   Premature Ejaculation discussion   Johnson & Johnson   March 10, 2010
pediscussion.info   Global   Premature Ejaculation discussion   Johnson &
Johnson   March 10, 2010 pediscussions.com   Global   Premature Ejaculation
discussions   Johnson & Johnson   March 10, 2010 pediscussions.info   Global  
Premature Ejaculation discussions   Johnson & Johnson   March 10, 2010
pefacts.com   Global   None   Johnson & Johnson   January 27, 2005
pe-kontrolle.at   Austria   None   Johnson & Johnson   August 30, 2005
pemedia.biz   Global   pe = Pre-ejaculation   Johnson & Johnson   November 4,
2004 pemedia.info   Global   pe = Pre-ejaculation   Johnson & Johnson   November
4, 2004 pemedia.org   Global   pe = Pre-ejaculation   Johnson & Johnson  
November 4, 2004 pemedication.com   Global   None   Johnson & Johnson  
September 29, 2005 peored.com   Global   Premature Ejaculation or Erectile
Dysfunction   Johnson & Johnson   March 9, 2005

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

pesupportcompany.com   Global   None   Johnson & Johnson   September 29, 2005
pirligy.com   Global   None   Johnson & Johnson   September 29, 2005
prematureejaculation.com   Global   None   Johnson & Johnson   March 23, 2005
prematureejaculation.com.my   Malaysia   premature ejaculation   Johnson &
Johnson SDN BHD   June 23, 2009 prematureejaculation.com.sg   Singapore   n/a  
Johnson & Johnson PTE. LTD.   June 25, 2010 premature-ejaculation.gr   Greece  
n/a   Johnson & Johnson   February 1, 2009 prematureejaculation.md   Moldova  
None   Johnson & Johnson   May 10, 2004 premature-ejaculation.md   Moldova  
None   Johnson & Johnson   May 10, 2004 prematureejaculation.my   Malaysia  
premature ejaculation   Johnson & Johnson SDN BHD   June 23, 2009
prematureejaculationfacts.com   Global   None   Johnson & Johnson   January 27,
2005 prematureejaculationtruth.com   Global   None   Johnson & Johnson   January
27, 2005 prematurejaculation.se   Sweden   premature ejaculation   Johnson &
Johnson   February 27, 2009 prematurejakulasyon.com   Global   Premature
Ejaculation   Johnson & Johnson   October 30, 2009 preventpe.com   Global   None
  Johnson & Johnson   September 29, 2005 prilagy.com   Global   None   Johnson &
Johnson   September 29, 2005 prilegy.com   Global   None   Johnson & Johnson  
September 29, 2005 prilgiy.com   Global   None   Johnson & Johnson   September
29, 2005 priligi.de   Germany   n/a   Johnson & Johnson   August 29, 2011
priligy.at   Austria   priligy   Johnson & Johnson   October 1, 2008 priligy.biz
  Global   None   Johnson & Johnson   June 9, 2004 priligy.ca   Canada   priligy
  Johnson & Johnson   October 1, 2008 priligy.cl   Chile   priligy   Johnson &
Johnson   August 20, 2009 priligy.co.nz   New Zealand   PRILIGY   Johnson &
Johnson   June 19, 2009 priligy.com   Global   None   Johnson & Johnson   June
9, 2004 priligy.com.au   Australia   priligy   JOHNSON JOHNSON PACIFIC PTY
LIMITED   October 2, 2008 priligy.com.bo   Bolivia   priligy   Johnson & Johnson
  August 24, 2009 priligy.com.br   Brazil   priligy   Janssen-Cilag Farmacêutica
Ltda   August 15, 2009

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

priligy.com.ec   Ecuador   priligy   Johnson & Johnson   August 28, 2009
priligy.com.hk   Hong Kong   priligy   Johnson & Johnson (HK) Ltd   May 19, 2009
priligy.com.mx   Mexico   None   Johnson & Johnson   September 6, 2005
priligy.com.my   Malaysia   about premature ejaculation - product site   Johnson
& Johnson SDN BHD   November 30, 2007 priligy.com.pe   Peru   priligy   Johnson
& Johnson   August 19, 2009 priligy.com.py   Paraguay   priligy   Johnson &
Johnson   January 8, 2010 priligy.com.tr   Turkey   Priligy   Johnson & Johnson
  December 2, 2010 priligy.com.tw   Taiwan   n/a   Johnson & Johnson Taiwan Ltd.
  January 20, 2009 priligy.com.uy   Uruguay   priligy   Johnson & Johnson  
September 15, 2009 priligy.com.ve   Venezuela   Priligy   Johnson & Johnson  
September 9, 2009 priligy.de   Germany   priligy   Johnson & Johnson   August
29, 2011 priligy.dk   Denmark   priligy   Johnson & Johnson   October 1, 2008
priligy.es   Spain   None   Janssen Pharmaceutica N.V.   September 30, 2005
priligy.eu   European Union   priligy   Janssen Pharmaceutica N.V.   September
26, 2008 priligy.fi   Finland   priligy   Janssen-Cilag Oy   January 10, 2009
priligy.fr   France   priligy   Johnson & Johnson Consumer France SAS   October
1, 2008 priligy.gr   Greece   n/a   Johnson & Johnson   January 26, 2009
priligy.hk   Hong Kong   priligy   Johnson & Johnson (HK) Ltd   May 19, 2009
priligy.info   Global   None   Johnson & Johnson   June 9, 2004 priligy.it  
Italy   priligy   Johnson & Johnson SPA   October 3, 2008 priligy.mobi   Global
  priligy mobile apps?   Johnson & Johnson   February 3, 2009 priligy.my  
Malaysia   about premature ejaculation - product site   Johnson & Johnson SDN
BHD   June 23, 2009 priligy.net   Global   None   Johnson & Johnson   June 9,
2004 priligy.org   Global   None   Johnson & Johnson   June 9, 2004 priligy.pt  
Portugal   priligy   Janssen Pharmaceutica N.V.   October 15, 2008

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

priligy.se   Sweden   priligy   Johnson & Johnson   October 1, 2008 priligy.us  
US   None   Johnson & Johnson   June 14, 2004 priligyautentico.com   Global  
genuine priligy   Johnson & Johnson   January 29, 2009 priligyautentico.com.pt  
Portugal   authentic prigliy   Johnson & Johnson   March 20, 2009
priligyautentico.es   Spain   authentic prigliy   Johnson & Johnson   March 20,
2009 priligyauthentique.ca   Canada   authentic prigliy   Johnson & Johnson  
March 20, 2009 priligyauthentique.com   Global   authentic prigliy   Johnson &
Johnson   March 20, 2009 priligyauthentique.fr   France   authentic prigliy  
Johnson & Johnson Consumer France SAS   April 1, 2009 priligybuy.com   Global  
priligy buy   Johnson & Johnson   February 3, 2009 priligy-buy.com   Global  
priligy buy   Johnson & Johnson   March 25, 2010 priligy-canada.com   Global  
canada priligy   Johnson & Johnson   June 21, 2010 priligyconsult.com   Global  
consult priligy   Johnson & Johnson   April 28, 2010 priligy-dapoxetina.com  
Global   priligy dapoxetine   Johnson & Johnson   August 27, 2010
priligydapoxetine.com   Global   priligy dapoxetine   Johnson & Johnson   March
31, 2010 priligy-dapoxetine.com   Global   priligy dapoxetine   Johnson &
Johnson   March 31, 2010 priligydapoxetine.org   Global   priligy dapoxetine  
Johnson & Johnson   August 8, 2009 priligydapoxetinereview.com   Global   review
priligy   Johnson & Johnson   May 5, 2010 priligyecht.at   Austria   genuine
priligy   Johnson & Johnson   February 3, 2009 priligyecht.ch   Switzerland  
genuine priligy   Johnson & Johnson   February 2, 2009 priligyecht.com   Global
  genuine priligy   Johnson & Johnson   January 29, 2009 priligyecht.de  
Germany   genuine priligy   Johnson & Johnson   September 20, 2010
priligyfacts.com   Global   None   Johnson & Johnson   September 29, 2005
priligyfaq.com   Global   priligy frequently asked questions   Johnson & Johnson
  October 7, 2005 priligyfrance.com   Global   priligy France   Johnson &
Johnson   May 11, 2010 priligygenuino.com   Global   genuine priligy   Johnson &
Johnson   January 29, 2009 priligygenuino.com.br   Brazil   genuine priligy  
Janssen-Cilag Farmacêutica Ltda   November 17, 2009 priligygenuino.es   Spain  
genuine priligy   Johnson & Johnson   January 31, 2009

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

priligyinfo.com   Global   None   Johnson & Johnson   September 29, 2005
priligykills.com   Global   None   Johnson & Johnson   September 29, 2005
priligymexico.com   Global   priligy Mexico   Johnson & Johnson   June 21, 2010
priligynews.com   Global   priligy news   Johnson & Johnson   September 16, 2005
priligynotes.com   Global   priligy notes   Johnson & Johnson   April 28, 2010
priligynow.com   Global   priligy now   Johnson & Johnson   February 3, 2009
priligyny.com   Global   priligy ny (new york?)   Johnson & Johnson   April 28,
2010 priligynyc.com   Global   priligy nyc (new york city?)   Johnson & Johnson
  April 28, 2010 priligy-online.net   Global   online priligy   Johnson &
Johnson   November 18, 2010 priligy-online.org   Global   online priligy  
Johnson & Johnson   November 13, 2010 priligyoriginal.at   Austria   original
priligy   Johnson & Johnson   February 10, 2009 priligyoriginal.com   Global  
original priligy   Johnson & Johnson   February 6, 2009 priligyoriginal.de  
Germany   original priligy   Johnson & Johnson   August 29, 2011
priligyoriginale.com   Global   original priligy   Johnson & Johnson   January
29, 2009 priligyoriginale.it   Italy   original priligy   Johnson & Johnson SPA
  February 5, 2009 priligypublicationtoolkit.com   Global   n/a   Johnson &
Johnson   October 15, 2008 priligyresource.com   Global   priligy resource  
Johnson & Johnson   April 28, 2010 priligyreview.com   Global   priligy review  
Johnson & Johnson   February 17, 2009 priligysmart.com   Global   priligy smart
  Johnson & Johnson   April 28, 2010 priligysucks.com   Global   None   Johnson
& Johnson   September 29, 2005 prillagy.com   Global   None   Johnson & Johnson
  September 29, 2005 prillegy.com   Global   None   Johnson & Johnson  
September 29, 2005 prilligi.de   Germany   n/a   Johnson & Johnson   August 29,
2011 prilligy.com   Global   None   Johnson & Johnson   September 29, 2005
prilligy.de   Germany   n/a   Johnson & Johnson   August 29, 2011 prillogy.com  
Global   None   Johnson & Johnson   September 29, 2005 prligy.com   Global  
None   Johnson & Johnson   September 29, 2005 rapidejaculation.biz   Global  
None   Johnson & Johnson   October 14, 2003 rapid-ejaculation.biz   Global  
None   Johnson & Johnson   October 14, 2003 rapidejaculation.com   Global   None
  Johnson & Johnson   October 14, 2003

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

rapidejaculation.info   Global   None   Johnson & Johnson   October 14, 2003
rapid-ejaculation.info   Global   None   Johnson & Johnson   October 14, 2003
rapidejaculation.md   Moldova   None   Johnson & Johnson   May 10, 2004
rapid-ejaculation.md   Moldova   None   Johnson & Johnson   May 10, 2004
rapidejaculation.net   Global   None   Johnson & Johnson   October 14, 2003
rapid-ejaculation.net   Global   None   Johnson & Johnson   October 14, 2003
rechtzeitigstattvorzeitig.de   Germany   timely-instead of-premature   Johnson &
Johnson   August 29, 2011 rechtzeitig-statt-vorzeitig.de   Germany  
timely-instead of-premature   Johnson & Johnson   August 29, 2011
registera-priligy.se   Sweden   register priligy   Johnson & Johnson   March 14,
2009 talkaboutpe.com   Global   None   Johnson & Johnson   September 29, 2005
talkingaboutpe.asia   Asia   Talking About Premature Ejaculation   Johnson &
Johnson PTE.LTD.   September 7, 2010 talkingaboutpe.cn   China   Talking About
Premature Ejaculation   Johnson & Johnson HK Ltd.   December 2, 2010
talkingaboutpe.co.id   Indonesia   Talking About Premature Ejaculation   Johnson
& Johnson Indonesia   September 15, 2010 talkingaboutpe.co.in   India   Talking
About Premature Ejaculation   Johnson & Johnson   September 7, 2010
talkingaboutpe.co.kr   Korea   Talking About Premature Ejaculation   Johnson &
Johnson Korea Ltd.   September 15, 2010 talkingaboutpe.co.nz   New Zealand  
Talking About Premature Ejaculation   Johnson & Johnson   September 8, 2010
talkingaboutpe.com   Global   Talking About Premature Ejaculation   Johnson &
Johnson   August 27, 2010 talkingaboutpe.com.au   Australia   Talking About
Premature Ejaculation   Johnson & Johnson Pty Ltd   September 8, 2010
talkingaboutpe.com.cn   cina   Talking About Premature Ejaculation   Johnson &
Johnson HK Ltd.   December 2, 2010 talkingaboutpe.com.hk   Hong Kong   Talking
About Premature Ejaculation   Johnson & Johnson HK Ltd.   September 8, 2010
talkingaboutpe.com.my   Malaysia   Talking About Premature Ejaculation   Johnson
& Johnson SDN BHD   September 7, 2010 talkingaboutpe.com.ph   Philippines  
Talking About Premature Ejaculation   Johnson & Johnson   September 3, 2010
talkingaboutpe.com.sg   Singapore   Talking About Premature Ejaculation  
Johnson & Johnson PTE. LTD.   September 8, 2010

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

talkingaboutpe.com.tw   Taiwan   Talking About Premature Ejaculation   Johnson &
Johnson   September 8, 2010 talkingaboutpe.com.vn   Vietnam   Talking About
Premature Ejaculation   Johnson & Johnson   September 8, 2010 talkingaboutpe.hk
  Hong Kong   Talking About Premature Ejaculation   Johnson & Johnson  
September 8, 2010 talkingaboutpe.in   India   Talking About Premature
Ejaculation   Johnson & Johnson   September 7, 2010 talkingaboutpe.jp   Japan  
Talking About Premature Ejaculation   Johnson & Johnson K.K.   September 8, 2010
talkingaboutpe.kr   Korea   Talking About Premature Ejaculation   Johnson &
Johnson Korea Ltd.   September 15, 2010 talkingaboutpe.mobi   Global   Talking
About Premature Ejaculation   Johnson & Johnson   September 2, 2010
talkingaboutpe.my   Malaysia   Talking About Premature Ejaculation   Johnson &
Johnson SDN BHD   September 7, 2010 talkingaboutpe.ph   Philippines   Talking
About Premature Ejaculation   Johnson & Johnson   September 9, 2010
talkingaboutpe.sg   Singapore   Talking About Premature Ejaculation   Johnson &
Johnson PTE. LTD   September 8, 2010 talkingaboutpe.tw   Taiwan   Talking About
Premature Ejaculation   Johnson & Johnson   September 8, 2010 talkingaboutpe.vn
  Vietnam   Talking About Premature Ejaculation   Johnson & Johnson   September
8, 2010 thetruthaboutpe.com   Global   None   Johnson & Johnson   January 27,
2005 thetruthaboutprematureejaculation.com   Global   None   Johnson & Johnson  
January 27, 2005 tidigutlosning.se   Sweden   premature ejaculation .se  
Johnson & Johnson   March 4, 2009 treatpe.co.nz   New Zealand   Treat Premature
Ejaculation   Johnson & Johnson   June 19, 2009 treatpe.com   Global   None  
Johnson & Johnson   September 29, 2005 treatpe.com.au   Australia   Treat
Premature Ejaculation   Johnson & Johnson   September 25, 2009 truthaboutpe.com
  Global   None   Johnson & Johnson   January 27, 2005 truthaboutpe.net   Global
  None   Johnson & Johnson   February 28, 2005 truthaboutpe.org   Global   None
  Johnson & Johnson   February 28, 2005 truthaboutprematureejaculation.com  
Global   None   Johnson & Johnson   January 27, 2005 truthaboutpriligy.com  
Global   None   Johnson & Johnson   September 29, 2005

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

trypriligy.com   Global   None   Johnson & Johnson   September 29, 2005
understandingpe.ca   Canada   Understanding PE   Johnson & Johnson   June 29,
2009 understandingpe.com   Global   None   Johnson & Johnson   December 15, 2004
understandingprematureejaculations.ca   Canada   Understanding Premature
Ejaculations   Johnson & Johnson   June 29, 2009
understandingprematureejaculations.com   Global   Understanding Premature
Ejaculations   Johnson & Johnson   June 29, 2009 uzunsursun.com   Global   Last
longer   Johnson & Johnson   August 31, 2009 validarpriligy.com   Global  
validate priligy   Johnson & Johnson   January 29, 2009 vorzeitigkommen.de  
Germany   vorzeitig kommen - prematurely coming   Johnson & Johnson   August 30,
2011 vorzeitig-kommen.de   Germany   vorzeitig kommen - prematurely coming  
Johnson & Johnson   August 30, 2011 whatispe.ca   Canada   What is PE   Johnson
& Johnson   June 29, 2009 whatispe.com   Global   What is PE   Johnson & Johnson
  June 29, 2009 zufruehkommen.de   Germany   zu frueh kommen - coming too
quickly   Johnson & Johnson   August 30, 2011 zu-frueh-kommen.de   Germany   zu
frueh kommen - coming too quickly   Johnson & Johnson   August 30, 2011
zuschnellersamenerguss.de   Germany   zu schneller samenerguss - too quick
ejaculation   Johnson & Johnson   August 30, 2011 zu-schneller-samenerguss.de  
Germany   zu schneller samenerguss - too quick ejaculation   Johnson & Johnson  
August 30, 2011

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

Schedule 4.2B1

Trademarks to be Assigned to GENUPRO

 

Trademark name

  

Country

  

Filing
number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY    CANADA    1221594    18-Jun-04          J&J ONE J&J PLAZA - USA
PRILIGY LOGO    CANADA    1267689    8-Aug-05          J&J ONE J&J PLAZA - USA
PRILIGY    JAPAN    76599    16-Aug-05    4949950    12-May-06    J&J ONE J&J
PLAZA - USA PRILIGY    JAPAN    71912    4-Aug-04    4858569    22-Apr-05    J&J
ONE J&J PLAZA - USA PRILIGY    JAPAN    15093    23-Feb-05    4910950   
2-Dec-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO    JAPAN    84184    8-Sep-05
   4958979    9-Jun-06    J&J ONE J&J PLAZA - USA PRILIGY    UNITED STATES OF
AMERICA    77/749577    2-Jun-09          J&J ONE J&J PLAZA - USA PRILIGY LOGO
   UNITED STATES OF AMERICA    77/749584    2-Jun-09          J&J ONE J&J PLAZA
- USA PRILOGY    UNITED STATES OF AMERICA    85/261793    9-Mar-11          J&J
ONE J&J PLAZA - USA

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

Schedule 4.2B2

Trademarks to be Assigned to Menarini

 

Trademark
name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY    ALBANIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY    ALGERIA    831673    11-Jun-04    831673   
13-Aug-04    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    ANTIGUA    6432   
27-Sep-04    6432    27-Sep-04    J&J ONE J&J PLAZA - USA PRILIGY    ARGENTINA
   2528136    16-Jul-04    2070127    2-Mar-06    J&J ONE J&J PLAZA - USA
PRILIGY    ARMENIA    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY    ARMENIA    866467    6-Oct-05    866467   
6-Oct-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    ARMENIA    831673   
11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY   
ARUBA    **    9-Nov-04    23191    8-Nov-04    J&J ONE J&J PLAZA - USA PRILIGY
   AUSTRALIA    1010194    8-Jul-04    1010194    4-Mar-05    J&J ONE J&J PLAZA
- USA PRILIGY    AZERBAIJAN    866466    6-Oct-05    866466    6-Oct-05   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    AZERBAIJAN    866467    6-Oct-05   
866467    6-Oct-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    AZERBAIJAN   
831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA NV - I3090
PRILIGY    BAHAMAS    27181    16-Nov-04    27181    16-Nov-08    J&J ONE J&J
PLAZA - USA PRILIGY    BAHRAIN    81732    7-Jun-10          J&J ONE J&J PLAZA -
USA PRILIGY    BANGLADESH    86712    15-Jul-04          J&J ONE J&J PLAZA - USA
PRILIGY    BARBADOS    81/19650    21-Jul-04    81/19650    21-Jul-05    J&J ONE
J&J PLAZA - USA PRILIGY    BELARUS    866466    6-Oct-05    866466    6-Oct-05
   JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    BELARUS    866467    6-Oct-05   
866467    6-Oct-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    BELARUS   
831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA NV - I3090
PRILIGY    BENELUX    1083189    11-Aug-05    770678    18-Aug-05    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY    BENELUX    1056959    11-Jun-04    749301   
11-Jun-04    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    BENELUX    1083190   
11-Aug-05    770679    18-Aug-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY   
BERMUDA    41229    21-Jul-04    41229    2-Mar-05    J&J ONE J&J PLAZA - USA

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

Trademark
name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY    BOLIVIA    1949    29-Jun-04    102045-C    25-Jan-06    J&J ONE J&J
PLAZA - USA PRILIGY    BOSNIA-HERZEGOVINA    831673    11-Jun-04    831673   
13-Aug-04    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    BRAZIL    826692826   
13-Jul-04    826692826    21-Aug-07    J&J ONE J&J PLAZA - USA PRILIGY   
BULGARIA    79737    28-Jun-05    62921    16-Jan-08    J&J ONE J&J PLAZA - USA
PRILIGY    BULGARIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY    BURUNDI    **    11-Oct-04    4221   
11-Oct-04    J&J ONE J&J PLAZA - USA PRILIGY    CAMBODIA (ex-KAMPUCHEA)    20847
   5-Jul-04    20223    5-Jul-04    J&J ONE J&J PLAZA - USA PRILIGY    CHILE   
654045    21-Jul-04    709529    23-Nov-04    J&J ONE J&J PLAZA - USA PRILIGY   

CHINA, PEOPLES

REPUBLIC (PRC)

   7644176    25-Aug-09    7644176    21-Nov-10    J&J ONE J&J PLAZA - USA
PRILIGY   

CHINA, PEOPLES

REPUBLIC (PRC)

   4152873    5-Jul-04    4152873    7-May-07    J&J ONE J&J PLAZA - USA PRILIGY
  

CHINA,PEOPLES

REPUBLIC (PRC)

   4697667    3-Jun-05    4697667    14-Nov-08    J&J ONE J&J PLAZA - USA
PRILIGY   

CHINA, PEOPLES

REPUBLIC (PRC)

   9177193    7-Mar-11          J&J ONE J&J PLAZA - USA PRILIGY   

CHINA, PEOPLES

REPUBLIC (PRC)

   7644175    25-Aug-09    7644175    21-Nov-10    J&J ONE J&J PLAZA - USA
PRILIGY    CONGO, DEMOCRATIC REPUBLIC (ex- Zaire)    353    15-Jul-04    10431
   15-Jul-04    J&J ONE J&J PLAZA - USA PRILIGY    COSTA RICA    5162   
14-Jul-04    153508    11-Aug-05    J&J ONE J&J PLAZA - USA PRILIGY    CROATIA
   831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090 PRILIGY    CUBA    831673    11-Jun-04    831673    13-Aug-04   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY    CYPRUS [REPUBLIC]    71282   
8-Apr-05    71282    8-Apr-05    J&J ONE J&J PLAZA - USA

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

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Filing date

  

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Reg. date

  

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PRILIGY

   CZECH REPUBLIC    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   DENMARK    2405    18-Jun-04    2129    1-Jul-04    J&J ONE J&J PLAZA - USA

PRILIGY

   DOMINICAN REPUBLIC    59698    23-Jul-04    144251    15-Oct-04    J&J ONE
J&J PLAZA - USA

PRILIGY

   ECUADOR    146701    20-Jul-04    1508    27-Oct-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   EGYPT    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   EL SALVADOR    41852    21-Apr-05    185/37    21-Apr-05    J&J ONE J&J PLAZA
- USA

PRILIGY

   ESTONIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   ETHIOPIA    5584    6-Sep-03    5584    6-Sep-03    J&J ONE J&J PLAZA - USA

PRILIGY

   EUROPEAN COMMUNITY (EUROPEAN UNION)    8907925    24-Feb-10    8907925   
18-Aug-10    J&J ONE J&J PLAZA - USA

PRILIGY

   FRANCE    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   GAZA STRIP    9561    21-Aug-04    9561    21-Aug-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   GEORGIAN REPUBLIC    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   GEORGIAN REPUBLIC    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   GEORGIAN REPUBLIC    866467    6-Oct-05    866467    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   GHANA    34693    26-Jun-04    34693    26-Jun-04    J&J ONE J&J PLAZA - USA

PRILIGY

   GREECE    149810    25-Jun-04    149810    25-Jun-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   GUATEMALA    5340    20-Jul-04    137304    17-Aug-05    J&J ONE J&J PLAZA -
USA

PRILIGY

   GUYANA    20298A    15-Jul-04    20298    15-Jul-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   HAITI    *    16-Jul-04    355/144    30-Nov-04    J&J ONE J&J PLAZA - USA

PRILIGY

   HONDURAS    12683    10-Jan-05    93024    10-Jan-05    J&J ONE J&J PLAZA -
USA

PRILIGY

   HONG KONG    300572742    26-Jan-06    300572742    26-Jan-06    J&J ONE J&J
PLAZA - USA

PRILIGY

   HONG KONG    300243459    3-Jul-04    300243459    30-Jul-04    J&J ONE J&J
PLAZA - USA

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

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number

  

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Reg. date

  

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PRILIGY

   HONG KONG    300384002    11-Mar-05    300384002    11-Mar-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   HONG KONG    300383986    11-Mar-05    300383986    11-Mar-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   HONG KONG    300410200    27-Apr-05    300410200    27-Apr-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   HONG KONG    300410192    27-Apr-05    300410192    2-Sep-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   HONG KONG    300383995    11-Mar-05    300383995    11-Mar-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   HONG KONG    300383977    11-Mar-05    300383977    11-Mar-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   HUNGARY    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   ICELAND    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   INDIA    1296820    19-Jul-04    1296820    19-Jul-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   INDONESIA    21260-21425    27-Jul-04    66611    27-Jul-04    J&J ONE J&J
PLAZA - USA

PRILIGY

   IRAN    8304015    21-Jun-04    114415    22-Sep-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   IRAQ    57934    24-Nov-10          J&J ONE J&J PLAZA - USA

PRILIGY

   IRELAND    1310    21-Jun-04    229755    14-Dec-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   ISRAEL    173069    28-Jun-04    173069    28-Jun-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   JAMAICA    45548    27-Jul-04    45548    27-Jul-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   JORDAN    75781    23-Jun-04    75781    21-Mar-05    J&J ONE J&J PLAZA - USA

PRILIGY

   KAZAKHSTAN    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   KAZAKHSTAN    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   KAZAKHSTAN    866467    6-Oct-05    866467    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   KENYA    55347    22-Feb-05    55347    22-Feb-05    J&J ONE J&J PLAZA - USA

PRILIGY

   KIRGHIZISTAN (Kyrgyz Republic)    866466    6-Oct-05    866466    6-Oct-05   
JANSSEN PHARMACEUTICA NV - I3090

PRILIGY

   KIRGHIZISTAN (Kyrgyz Republic)    831673    11-Jun-04    831673    13-Aug-04
   JANSSEN PHARMACEUTICA NV - I3090

PRILIGY

   KIRGHIZISTAN (Kyrgyz Republic)    866467    6-Oct-05    866467    6-Oct-05   
JANSSEN PHARMACEUTICA NV - I3090

PRILIGY

   KOREA (NORTH)    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   KOSOVO    7946    19-Nov-08    **    19-Nov-08    JANSSEN PHARMACEUTICA NV -
I3090

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

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PRILIGY

   KUWAIT    68852    19-Feb-05    62507    19-Feb-05    J&J ONE J&J PLAZA - USA

PRILIGY

   LAOS    11446    19-Jul-04    10936    19-Jul-04    J&J ONE J&J PLAZA - USA

PRILIGY

   LATVIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   LIBERIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   LIBYA    4663    30-Jul-05          J&J ONE J&J PLAZA - USA

PRILIGY

   LIECHTENSTEIN    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   LITHUANIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MACAO    14325    6-Jul-04    14325    8-Oct-04    J&J ONE J&J PLAZA - USA

PRILIGY

   MACEDONIA (F.Y.R.)    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MALTA    42302    18-Jun-04    42302    18-Jun-04    J&J ONE J&J PLAZA - USA

PRILIGY

   MOLDOVA (REP)    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MOLDOVA (REP)    866467    6-Oct-05    866467    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MOLDOVA (REP)    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MONACO    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   MONTENEGRO    831673    1-Dec-07    831673    1-Dec-07    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MOROCCO    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   MYANMAR (ex-BURMA)    4981    27-Aug-04    4981    27-Aug-04    J&J ONE J&J
PLAZA - USA

PRILIGY

   NETHERLANDS ANTILLES    400372    23-Jul-04    10715    23-Jul-04    J&J ONE
J&J PLAZA - USA

PRILIGY

   NICARAGUA    1383    20-Apr-06    703313    10-Dec-07    J&J ONE J&J PLAZA -
USA

PRILIGY

   NIGERIA    100146    13-Apr-05    71153    4-Oct-07    J&J ONE J&J PLAZA -
USA

PRILIGY

   NORWAY    6827    6-Jul-04    227670    12-Aug-05    J&J ONE J&J PLAZA - USA

PRILIGY

   OMAN    33718    29-Jun-04    33718    16-May-06    J&J ONE J&J PLAZA - USA

PRILIGY

   PAKISTAN    200723    8-Sep-04    200723    8-Sep-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   PANAMA    136886    19-Aug-04    136886    19-Aug-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   PARAGUAY    16931    28-Jun-04    274584    15-Dec-04    J&J ONE J&J PLAZA -
USA

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

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name

  

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PRILIGY

   PERU    213910    30-Jun-04    100176    23-Sep-04    J&J ONE J&J PLAZA - USA

PRILIGY

   POLAND    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   QATAR    33147    22-Jul-04    33147    13-Nov-07    J&J ONE J&J PLAZA - USA

PRILIGY

   ROMANIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   RUSSIAN FEDERATION    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   RUSSIAN FEDERATION    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   RUSSIAN FEDERATION    866467    6-Oct-05    866467    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   RWANDA    5300    21-Sep-04    5300    21-Sep-04    J&J ONE J&J PLAZA - USA

PRILIGY

   SAN MARINO    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   SAUDI ARABIA    90266    15-Jun-04    789/62    31-May-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   SERBIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   SIERRA LEONE    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   SLOVAK REPUBLIC    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   SLOVENIA    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   SOUTH AFRICA    4902    8-Mar-06    2006/04902    17-Dec-09    J&J ONE J&J
PLAZA - USA

PRILIGY

   SRI LANKA    121132    30-Aug-04          J&J ONE J&J PLAZA - USA

PRILIGY

   ST. KITTS & NEVIS    2006/0200    4-May-06    2006/0200    4-May-06    J&J
ONE J&J PLAZA - USA

PRILIGY

   ST. LUCIA    210    22-Jul-04    210    14-Jan-05    J&J ONE J&J PLAZA - USA

PRILIGY

   SUDAN    831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   SURINAME    19215    9-Jul-04    19215    9-Jul-04    J&J ONE J&J PLAZA - USA

PRILIGY

   SWITZERLAND    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   TADJIKISTAN (TAJIKISTAN)    831673    11-Jun-04    831673    13-Aug-04   
JANSSEN PHARMACEUTICA NV - I3090

PRILIGY

   TADJIKISTAN (TAJIKISTAN)    866466    6-Oct-05    866466    6-Oct-05   
JANSSEN PHARMACEUTICA NV - I3090

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

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name

  

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Filing number

  

Filing date

  

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Reg. date

  

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PRILIGY

   TADJIKISTAN (TAJIKISTAN)    866467    6-Oct-05    866467    6-Oct-05   
JANSSEN PHARMACEUTICA NV - I3090

PRILIGY

   TAIWAN    25058    27-May-05    1185649    16-Dec-05    J&J ONE J&J PLAZA -
USA

PRILIGY

   TAIWAN    29466    28-Jun-04    1147857    16-Apr-05    J&J ONE J&J PLAZA -
USA

PRILIGY

   TANZANIA, UNITED REPUBLIC    6337    15-Jul-05          J&J ONE J&J PLAZA -
USA

PRILIGY

   THAILAND    557744    5-Jul-04    212477    5-Jul-04    J&J ONE J&J PLAZA -
USA

PRILIGY

   TRINIDAD & TOBAGO    35171    12-Jul-04    35171    9-Mar-05    J&J ONE J&J
PLAZA - USA

PRILIGY

   TUNISIA    EE041724    17-Aug-04          J&J ONE J&J PLAZA - USA

PRILIGY

   TURKEY    8546    15-Mar-05    8546    15-Mar-05    J&J ONE J&J PLAZA - USA

PRILIGY

   TURKMENISTAN    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   TURKMENISTAN    866467    6-Oct-05    866467    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

TURKMENISTAN

      831673    11-Jun-04    831673    13-Aug-04    JANSSEN PHARMACEUTICA NV -
I3090

PRILIGY

   UKRAINE    8684    29-Jul-05    73419    15-Mar-07    J&J ONE J&J PLAZA - USA

PRILIGY

   UKRAINE    866466    6-Oct-05    866466    6-Oct-05    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   UKRAINE    866467    6-Oct-05    866467    6-Oct-05    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY

   UKRAINE    8682    29-Jul-05    73418    15-Mar-07    J&J ONE J&J PLAZA - USA

PRILIGY

   UKRAINE    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   UNITED ARAB EMIRATES    63015    17-Aug-04    51200    14-Feb-05    J&J ONE
J&J PLAZA - USA

PRILIGY

   UNITED KINGDOM (Great Britain)    2366357    22-Jun-04    2366357   
26-Nov-04    J&J ONE J&J PLAZA - USA

PRILIGY

   URUGUAY    355616    30-Jun-04    355616    17-Jan-05    J&J ONE J&J PLAZA -
USA

PRILIGY

   UZBEKISTAN    866466    6-Oct-05    866466    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   UZBEKISTAN    831673    11-Jun-04    831673    13-Aug-04    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY

   UZBEKISTAN    866467    6-Oct-05    866467    6-Oct-05    JANSSEN
PHARMACEUTICA NV - I3090

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

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PRILIGY

   VENEZUELA    10361    7-Jul-04    P261699    18-Jul-05    J&J ONE J&J PLAZA -
USA

PRILIGY

   VIETNAM    7170    20-Jul-04    69579    17-Jan-06    J&J ONE J&J PLAZA - USA

PRILIGY

   WEST BANK    10980    21-Dec-04    10980    29-May-07    J&J ONE J&J PLAZA -
USA

PRILIGY

   YEMEN, REPUBLIC OF    52876    22-Sep-10          J&J ONE J&J PLAZA - USA

PRILIGY

   ZAMBIA    458    30-Jul-04    458    29-Mar-05    J&J ONE J&J PLAZA - USA

PRILIGY

   ZIMBABWE    536    14-Jul-04    536    1-Nov-04    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   ALBANIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   ALGERIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   ANTIGUA    *    1-Jan-06    6642    1-Jan-06    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   ARGENTINA    2631743    15-Feb-07    2142449    15-Feb-07    J&J ONE J&J
PLAZA - USA

PRILIGY LOGO

   ARMENIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   ARUBA    25095    12-Aug-05    25095    12-Aug-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   AUSTRALIA    1070657    17-Aug-05    1070657    15-Dec-05    J&J ONE J&J
PLAZA - USA

PRILIGY LOGO

   AZERBAIJAN    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   BAHAMAS    28175    6-Oct-05    28175    6-Oct-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   BAHRAIN    81733    7-Jun-10          J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   BANGLADESH    95087    25-Oct-05          J&J ONE J&J PLAZA - USA

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

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PRILIGY LOGO

   BARBADOS    *    22-Aug-05    81/20907    14-Nov-08    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   BELARUS    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   BENELUX    1082717    2-Aug-05    770282    8-Aug-05    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY LOGO

   BOLIVIA    4188    9-Nov-05    110177-C    20-Aug-07    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   BOSNIA-HERZEGOVINA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   BRAZIL    827954417    29-Nov-05    827954417    27-Jan-09    J&J ONE J&J
PLAZA - USA

PRILIGY LOGO

   BULGARIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   BURUNDI    4426    4-Oct-05    4426    4-Oct-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   CAMBODIA (ex-KAMPUCHEA)    23354    29-Aug-05    23354    29-Aug-05    J&J
ONE J&J PLAZA - USA

PRILIGY LOGO

   CHILE    701360    19-Aug-05    741210    1-Dec-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   CHINA, PEOPLES REPUBLIC (PRC)    4893424    13-Sep-05    4893424    14-Jan-09
   J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   CONGO, DEMOCRATIC REPUBLIC (ex- Zaire)    570    14-Sep-05    11285   
3-Nov-06    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   COSTA RICA    165667    26-Jan-07    165667    26-Jan-07    J&J ONE J&J PLAZA
- USA

PRILIGY LOGO

   CROATIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

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

Trademark name

  

Country

  

Filing number

  

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Reg. date

  

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PRILIGY LOGO

   CUBA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY LOGO

   CYPRUS [REPUBLIC]    71896    22-Nov-05    71896    22-Nov-05    J&J ONE J&J
PLAZA - USA

PRILIGY LOGO

   CZECH REPUBLIC    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   DENMARK    3344    16-Aug-05    3375    5-Sep-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   DOMINICAN REPUBLIC    151659    30-Dec-05    151659    30-Dec-05    J&J ONE
J&J PLAZA - USA

PRILIGY LOGO

   ECUADOR    165538    16-Dec-05    1126    20-Nov-06    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   EGYPT    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY LOGO

   EL SALVADOR    53426    16-Nov-05    173/66    20-Jul-06    J&J ONE J&J PLAZA
- USA

PRILIGY LOGO

   ESTONIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   ETHIOPIA    2723    6-Apr-07    5609    20-Sep-07    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   FRANCE    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA
NV - I3090

PRILIGY LOGO

   GAZA STRIP    10329    22-Oct-05    10329    22-Dec-05    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   GEORGIAN REPUBLIC    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   GHANA    *    15-Sep-05          J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   GREECE    150856    10-Aug-05    150856    10-Aug-05    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   GUATEMALA    142530    10-Jul-06    142530    10-Jul-06    J&J ONE J&J PLAZA
- USA

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY LOGO

   GUYANA    21017A    6-Sep-05          J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   HAITI    *    30-Aug-05          J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   HONDURAS    31342    27-Jul-06    97577    27-Jul-06    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   HONG KONG    300488331    2-Sep-05    300488331    2-Sep-05    J&J ONE J&J
PLAZA - USA

PRILIGY LOGO

   HUNGARY    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   ICELAND    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

PRILIGY LOGO

   INDIA    1396999    7-Nov-05    1396999    7-Nov-05    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   INDONESIA    18851    13-Sep-05          J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   IRAN    84052076    20-Aug-05    126237    20-Aug-05    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   IRAQ    57937    24-Nov-10          J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   IRELAND    1674    16-Aug-05    232455    16-Aug-05    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   ISRAEL    183085    17-Aug-05    183085    17-Aug-05    J&J ONE J&J PLAZA -
USA

PRILIGY LOGO

   JAMAICA    47445    3-Oct-05    47445    3-Oct-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   JORDAN    81143    14-Aug-05    81143    14-Aug-05    J&J ONE J&J PLAZA - USA

PRILIGY LOGO

   KAZAKHSTAN    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY LOGO    KENYA    58089    23-Sep-05    58089    23-Sep-05    J&J ONE J&J
PLAZA - USA PRILIGY LOGO    KIRGHIZISTAN (Kyrgyz Republic)    869784   
16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY
LOGO    KOREA (NORTH)    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY LOGO    KUWAIT    72172    22-Aug-05    59496
   22-Aug-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO    LAOS    13160   
30-Aug-05    12710    30-Aug-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
LATVIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV
- I3090 PRILIGY LOGO    LIBERIA    869784    16-Sep-05    869784    16-Sep-05   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    LIBYA    21712    15-Dec-10   
      J&J ONE J&J PLAZA - USA PRILIGY LOGO    LIECHTENSTEIN    869784   
16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY
LOGO    LITHUANIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY LOGO    MACAO    18796    21-Sep-05    18796   
5-Jan-06    J&J ONE J&J PLAZA - USA PRILIGY LOGO    MACEDONIA (F.Y.R.)    869784
   16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY
LOGO    MALTA    43833    4-Aug-05    43833    7-Apr-06    J&J ONE J&J PLAZA -
USA PRILIGY LOGO    MOLDOVA (REP)    869784    16-Sep-05    869784    16-Sep-05
   JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    MONACO    869784   
16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY
LOGO    MOROCCO    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY LOGO    MYANMAR (ex-BURMA)    7199    1-Sep-05          J&J ONE J&J
PLAZA - USA PRILIGY LOGO    NETHERLANDS ANTILLES    500458    19-Aug-05    11546
   19-Aug-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO    NICARAGUA    2010-003355
   29-Oct-10          J&J ONE J&J PLAZA - USA PRILIGY LOGO    NIGERIA    105151
   28-Sep-05    74976    28-Sep-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
NORWAY    8176    29-Aug-05    232184    26-Apr-06    J&J ONE J&J PLAZA - USA
PRILIGY LOGO    OMAN    37356    27-Aug-05          J&J ONE J&J PLAZA - USA
PRILIGY LOGO    PAKISTAN    216394    15-Dec-05    216394    15-Dec-05    J&J
ONE J&J PLAZA - USA PRILIGY LOGO    PANAMA    147353    7-Dec-05    147353   
7-Dec-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO    PARAGUAY    34664   
10-Nov-05    332948    31-May-10    J&J ONE J&J PLAZA - USA PRILIGY LOGO    PERU
   260505    15-Nov-05    113690    28-Mar-06    J&J ONE J&J PLAZA - USA PRILIGY
LOGO    POLAND    869784    16-Sep-05    869784    16-Sep-05    JANSSEN
PHARMACEUTICA NV - I3090 PRILIGY LOGO    QATAR    36753    23-Aug-05    36753   
7-Apr-08    J&J ONE J&J PLAZA - USA PRILIGY LOGO    ROMANIA    869784   
16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY
LOGO    RUSSIAN FEDERATION    869784    16-Sep-05    869784    16-Sep-05   
JANSSEN PHARMACEUTICA NV - I3090

PRILIGY LOGO

   RWANDA    5604    5-Sep-05    5604    5-Sep-05    J&J ONE J&J PLAZA - USA

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY LOGO    SAN MARINO    869784    16-Sep-05    869784    16-Sep-05   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    SAUDI ARABIA    99224   
15-Aug-05    861/55    27-Aug-06    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
SERBIA    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV
- I3090 PRILIGY LOGO    SIERRA LEONE    869784    16-Sep-05    869784   
16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    SLOVAK REPUBLIC   
869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090
PRILIGY LOGO    SLOVENIA    869784    16-Sep-05    869784    16-Sep-05   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    SOUTH AFRICA    2005/17253   
22-Aug-05    2005/17253    11-Mar-10    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
SPAIN    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV
- I3090 PRILIGY LOGO    SRI LANKA    128763    11-Nov-05          J&J ONE J&J
PLAZA - USA PRILIGY LOGO    ST. KITTS & NEVIS    2006/0230    19-May-06   
2006/0230    19-May-06    J&J ONE J&J PLAZA - USA PRILIGY LOGO    ST. LUCIA   
182    25-Aug-05    182    2-Mar-06    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
SUDAN    869784    16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV
- I3090 PRILIGY LOGO    SURINAME    19813    29-Aug-05    19813    29-Aug-05   
J&J ONE J&J PLAZA - USA PRILIGY LOGO    SWITZERLAND    869784    16-Sep-05   
869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO   
TADJIKISTAN (TAJIKISTAN)    869784    16-Sep-05    869784    16-Sep-05   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    TAIWAN    43223    9-Sep-05   
1211043    1-Jun-06    J&J ONE J&J PLAZA - USA

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY LOGO    TANZANIA, UNITED REPUBLIC    *    26-Aug-05          J&J ONE J&J
PLAZA - USA PRILIGY LOGO    THAILAND    600144    17-Aug-05    238272   
17-Aug-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO    TRINIDAD & TOBAGO    36385
   26-Aug-05    36385    28-Mar-06    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
TUNISIA    EE052873    22-Dec-05          J&J ONE J&J PLAZA - USA PRILIGY LOGO
   TURKEY    2010/63092    4-Oct-10          J&J ONE J&J PLAZA - USA PRILIGY
LOGO    UGANDA    32477    26-Oct-09    32477    26-Oct-09    J&J ONE J&J PLAZA
- USA PRILIGY LOGO    UKRAINE    869784    16-Sep-05    869784    16-Sep-05   
JANSSEN PHARMACEUTICA NV - I3090 PRILIGY LOGO    UNITED ARAB EMIRATES    73368
   21-Sep-05    62009    21-Sep-05    J&J ONE J&J PLAZA - USA PRILIGY LOGO   
UNITED KINGDOM (Great Britain)    2398554    4-Aug-05    2398554    30-Dec-05   
J&J ONE J&J PLAZA - USA PRILIGY LOGO    URUGUAY    366804    10-Nov-05    366804
   13-Oct-06    J&J ONE J&J PLAZA - USA PRILIGY LOGO    UZBEKISTAN    869784   
16-Sep-05    869784    16-Sep-05    JANSSEN PHARMACEUTICA NV - I3090 PRILIGY
LOGO    VENEZUELA    25600    21-Nov-05    ***    17-Nov-09    J&J ONE J&J PLAZA
- USA PRILIGY LOGO    VIETNAM    15032    9-Nov-05    81520    25-Apr-07    J&J
ONE J&J PLAZA - USA PRILIGY LOGO    WEST BANK    12154    29-Jan-06    12154   
29-Jan-06    J&J ONE J&J PLAZA – USA PRILIGY LOGO    YEMEN, REPUBLIC OF    52877
   22-Sep-10          J&J ONE J&J PLAZA - USA

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

Trademark name

  

Country

  

Filing
number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

PRILIGY LOGO    ZAMBIA    673/2005    4-Nov-05    673/2005    4-Nov-05    J&J
ONE J&J PLAZA - USA PRILIGY LOGO    ZIMBABWE    934/2005    24-Aug-05   
934/2005    23-Jan-06    J&J ONE J&J PLAZA - USA PRILIGY MAS CONTROL MAS TIEMPO
   EL SALVADOR    E-104407-2010    12-Oct-10          J&J ONE J&J PLAZA - USA
PRILIGY MAS CONTROL MAS TIEMPO    NICARAGUA    2011-001133    8-Apr-11         
J&J ONE J&J PLAZA - USA PRILIGY-MAS CONTROL MAS TIEMPO    PERU    425245   
1-Jul-10    169618    4-Nov-10    J&J ONE J&J PLAZA - USA PRILIGY-MAS CONTROL
MAS TIEMPO    TRINIDAD & TOBAGO    42554    30-Jul-10    42554    7-Jul-11   
J&J ONE J&J PLAZA - USA MAS CONTROL MAS TIEMPO    ARGENTINA    3004273   
20-May-10          J&J ONE J&J PLAZA - USA

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

Trademark name

  

Country

  

Filing
number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

MAS CONTROL MAS TIEMPO    BAHAMAS    33899    9-Jun-10          J&J ONE J&J
PLAZA - USA MAS CONTROL MAS TIEMPO    BARBADOS    *    11-Jun-10          J&J
ONE J&J PLAZA - USA MAS CONTROL MAS TIEMPO    BENELUX    1203539    25-May-10   
881940    26-May-10    JANSSEN PHARMACEUTICA NV - I3090 MAS CONTROL MAS TIEMPO
   BERMUDA    49808    25-May-10    49808    25-May-10    J&J ONE J&J PLAZA -
USA MAS CONTROL MAS TIEMPO    BOLIVIA    SM-2014-2010    19-May-10    124920-C
   30-Dec-10    J&J ONE J&J PLAZA - USA MAS CONTROL MAS TIEMPO    COSTA RICA   
2010-004857    28-May-10    205444    19-Nov-10    J&J ONE J&J PLAZA - USA MAS
CONTROL MAS TIEMPO    CUBA    1061570    26-May-10    1061570    6-Dec-10   
JANSSEN PHARMACEUTICA NV - I3090 MAS CONTROL MAS TIEMPO    ECUADOR    230269   
31-May-10    6104-10    1-Dec-10    J&J ONE J&J PLAZA - USA

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

MAS CONTROL MAS TIEMPO    GUYANA    23755A    4-Jun-10          J&J ONE J&J
PLAZA - USA MAS CONTROL MAS TIEMPO    HAITI    *    7-Jun-10          J&J ONE
J&J PLAZA - USA MAS CONTROL MAS TIEMPO    JAMAICA    55716    28-May-10    55716
   28-May-10    J&J ONE J&J PLAZA - USA MAS CONTROL MAS TIEMPO    PANAMA   
190243    24-May-10    190243    24-May-10    J&J ONE J&J PLAZA - USA MAS
CONTROL MAS TIEMPO    PARAGUAY    18885    14-May-10          J&J ONE J&J PLAZA
- USA MAS CONTROL MAS TIEMPO    PHILIPPINES    4-2010-005687    27-May-10   
4-2010-005687    4-Nov-10    J&J ONE J&J PLAZA - USA MAS CONTROL MAS TIEMPO   
ST. KITTS & NEVIS    81/2010    17-May-10    81/2010    25-Jan-11    J&J ONE J&J
PLAZA - USA MAS CONTROL MAS TIEMPO    ST. VINCENT & GRENADINES    81/2010   
17-May-10    81/2010    25-Jan-11    J&J ONE J&J PLAZA - USA

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

Trademark name

  

Country

  

Filing number

  

Filing date

  

Reg. #

  

Reg. date

  

Owner

MAS CONTROL MAS TIEMPO    SURINAME    22543    4-Jun-10          J&J ONE J&J
PLAZA - USA MAS CONTROL MAS TIEMPO    TRINIDAD & TOBAGO    42557    30-Jul-10   
      J&J ONE J&J PLAZA - USA MAS CONTROL MAS TIEMPO    URUGUAY    414151   
15-Jul-10          J&J ONE J&J PLAZA - USA

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

Schedule 5.1.1

Third Party MAHs

 

[*]

   [*]    [*]

[*]

   [*]    [*]

[*]

   [*]    [*]

[*]

   [*]    [*]

[*]

   [*]    [*]

 

[*] Confidential treatment requested.

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

Schedule 5.2A

Group A Markets

[*]

 

[*] Confidential treatment requested.

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

Schedule 5.2B

Group B Markets

[*]

[*]

 

[*] Confidential treatment requested.

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

Schedule 5.2C

Group C Markets

[*]

 

[*] Confidential treatment requested.

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

Schedule 5.4

Distribution Agreements1

 

[*]

[*]

   [*]   

[*]

   [*]    [*]

[*]

   [*]    [*]

[*]

   [*]    [*]

[*]

   [*]   

[*]

   [*]   

[*]

   [*]   

[*]

   [*]   

[*]

[*]

   [*]    [*]

[*]

   [*]    [*]

[*]

   [*]   

[*] Confidential treatment requested.

 

 

1 

Schedule does not include any wholesale distribution agreements.

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

Schedule 5.7

Product Contracts

 

PRILIGY WHOLESALER AGREEMENT (28.2012)

[*]

       [*]            [*]    

OTHER AGREEMENTS

     

[*]

     

 

[*] Confidential treatment requested.

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

Schedule 5.8.1

Ongoing Clinical Studies

R096769-PRE-1005—A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered
in Subjects Taking Terazosin

R096769PRE3008—A Prospective, Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in
Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With
a Phosphodiesterase-5 Inhibitor; COUPLE: COncomitant Use of PriLigy in Men
Treated for Erectile Dysfunction

R096769-PRE-4001—A Prospective, Observational Study of Men With Premature
Ejaculation Who Are Treated With PRILIGY™ or Alternate Care; The PAUSE Study
(Premature Ejaculation—Actual Use Safety and Effectiveness Study)

R096769PRE4005—PRILIGY Usage Patterns in Selected Populations

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

Schedule 5.8.2A[*]ALZA Universal Calendar

[*]

 

 

[*] Confidential treatment requested.

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

Schedule 5.8.2B[*]Example Invoice

[*]

 

 

[*] Confidential treatment requested.

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

Schedule 5.8.7

Post-marketing clinical study reporting obligations

[*]

 

 

[*] Confidential treatment requested.

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

Schedule 6.1.1

Documents to be Included in Development Records

1. Copies of the complete dossiers and related source documents for all ALZA
Marketing Authorizations and ALZA Regulatory Submissions (including without
limitation all material communications with Regulatory Authorities in the
Territory).

2. To the extent not included in the items referenced in item 1 above, [*].

3. To the extent not included in the items referenced in item 1 above, copies of
[*], including [*] Agreement Product for [*].

4. Copies of any DMFs filed by ALZA in existence with respect to any Agreement
Product.

 

 

[*] Confidential treatment requested.

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

Schedule 6.1.1.1

Listing of Record Categories in Index of Transferred Development Records

[*]

 

 

[*] Confidential treatment requested.

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

Schedule 6.1.2

Third Party Software

 

Software Product

  

File extensions

MS Office

   All office file types for Office 2000, 2003, 2007

Adobe Acrobat

   pdf (v5.0 or higher)

Internet Explorer

   xml, .html

SasViewer

   .lst. .xpt (V9.2 or lower)

Wordpad

   .txt

Any Image Viewer

   .tif

Hangul (Korean word processor)

   .hwp

eCTD Tools

   .mod, .dtd, .xml

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

Schedule 6.1.5

Additional Information to be Included in Electronic Media and Provided to
GENUPRO

1. A copy of the most current (2011) promotional visual aids and other
promotional materials developed and distributed by ALZA or any of its Affiliates
for use in promoting the Agreement Product in the Territory for treatment of
premature ejaculation in men.

2. A list identifying those countries in the Territory where reimbursement
approval for the Agreement Product is being sought or has been granted by the
relevant Regulatory Authorities or other governmental authorities, along with
the relevant approval date or submission date in each country, as applicable. A
copy of the current reimbursement dossier for Agreement Product will also be
provided with respect to each country in the Territory where reimbursement or
pricing approval has been granted. In addition, copies of reimbursement or
pricing dossiers submitted to (where possible together with responses from)
Regulatory Authorities for those countries where reimbursement was denied.

3. A list of ALZA’s or its Affiliate’s current (2011) pricing for Agreement
Product in those countries in the Territory in which it is being marketed and
sold as of the Effective Date.

4. [*] gross sales, net sales, and other material financial information for
Agreement Product, and to the extent any country’s Transition Period extends
into [*], monthly and quarterly information of the type referenced above shall
be provided within [*] ([*]) [*] of [*].

5. A list of any and all pending and current tender offers for the purchase of
Agreement Product in 2011 ([*]) involving governments (e.g. country, state or
region), hospitals or other institutions.

6. A listing of the investigators/institutions and current status for all
ongoing (i.e., those studies for which the final study report has not yet been
issued) investigator-initiated studies, patient registries (if any), or other
medical affairs studies for Agreement Product being supported, financially or
otherwise (e.g. by supply of or access to Agreement Product) by or on behalf of
ALZA or its Affiliates anywhere in the Territory.

 

 

[*] Confidential treatment requested.

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

Schedule 6.2

Initial Transition Managers

ALZA [*]

Furiex [*]

 

 

[*] Confidential treatment requested.

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

Schedule 11

Exceptions to Representations and Warranties in Section 11.2.5

[*]

Exceptions to Representations and Warranties in Section 11.2.8

[*]

Exceptions to Representations and Warranties in Section 11.2.23

[*]

 

 

[*] Confidential treatment requested.

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

Schedule 11.2.15.1A

Alza Marketing Authorizations

 

Authorization Country

  

Registration Number

  

Product Name

Argentina    55.412    Priligy 30 + 60 mg Tablets Aruba    Registration No.
15.12.02.306    Priligy 30 mg Tablets Aruba    Registration No. 15.12.02.305   
Priligy 60 mg Tablets Australia    ARTG No. AUST R 147946    Priligy 30 mg
Tablets Austria    Zul Nr. 1-28010    Priligy 30 mg Tablets Austria    Zul Nr.
1-28011    Priligy 60 mg Tablets Bolivia    II-41872/2010    Priligy 30mg
Tablets Bolivia    II-41879/2010    Priligy 60mg Tablets Brazil    1.1236.3397
   Priligy 30 mg + 60 mg Tablets Chile    Registro I.S.P. No. F-18,266/10   
Priligy 30 mg Tablets Chile    Registro I.S.P. No. F-18,267/10    Priligy 60 mg
Tablets PRC    H20100806    Priligy 30 mg Tablets PRC    H20100807    Priligy 60
mg Tablets Colombia    2010M-0011743    Priligy 30 mg Tablets Colombia   
2010M-0011709    Priligy 60 mg Tablets Curacao    10.10.017    Priligy 30 mg
Tablets Curacao    10.10.018    Priligy 60 mg Tablets El Salvador    No.
F039917082011    Priligy 30 mg Tablets El Salvador    No. F041224082011   
Priligy 60 mg Tablets Finland
   24353    Priligy 30 mg Tablets

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

Authorization Country

  

Registration Number

  

Product Name

Finland    24354    Priligy 60 mg Tablets Germany    71669.00.00    Priligy 30
mg Tablets Germany    71670.00.00    Priligy 60 mg Tablets Ghana   
FDB/SD.113-2072    Priligy 30 mg Tablets Ghana    FDB/SD.111-5268    Priligy 60
mg Tablets Guatemala    PF-4599-2011    Priligy 30 mg Tablets Guatemala   
PF-45600-2011    Priligy 60 mg Tablets Honduras    M-17828    Priligy 30 mg
Tablets Honduras    M-17828    Priligy 60 mg Tablets Hong Kong    Permit No.
HK-60174    Priligy 30 mg Tablets Hong Kong    Permit No. HK-60175    Priligy 60
mg Tablets Italy    039041052/M    Priligy 30 mg Tablets, 1 tablet pack Italy   
039041076/M    Priligy 60 mg Tablets, 1 tablet pack Italy    039041064/M   
Priligy 30 mg Tablets, 2 tablet pack Italy    039041088/M    Priligy 60 mg
Tablets, 2 tablet pack Italy    039041037/M    Priligy 60 mg Tablets, 3 tablet
pack Italy    039041025/M    Priligy 30 mg Tablets, 6 tablet pack Italy   
039041049/M    Priligy 60 mg Tablets, 6 tablet pack Republic of Korea    4945-92
   Priligy 30 mg Tablets Republic of Korea    4945-91    Priligy 60 mg Tablets

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Authorization Country

  

Registration Number

  

Product Name

Lebanon    Reg No. 10/218715    Priligy 30 mg Tablets Lebanon    Reg No.
10/218716    Priligy 60 mg Tablets Macau    AIC039041013/M (import permit)   
Priligy 30 mg Tablets Macau    AIC039041037/M (import permit)    Priligy 60 mg
Tablets Malaysia    Reg No. MAL20102027AR    Priligy 30 mg Tablets Malaysia   
Reg No. MAL20102028AR    Priligy 60 mg Tablets Mexico    Reg San No. 132M2009
SSA    Priligy 30 mg + 60 mg Tablets New Zealand    TT50-8048    Priligy 30 mg
New Zealand    TT50-8048a    Priligy 60 mg Tablets Peru    Reg No. E22537   
Priligy 30 mg Tablets Philippines    BFAD Reg No. DR-XY37906    Priligy 30 mg
Tablets Philippines    BFAD Reg No. DR-XY37907    Priligy 60 mg Tablets Portugal
   5178215    Priligy 30 mg Tablets, 3 tablet pack Portugal    5178231   
Priligy 60 mg Tablets, 3 tablet pack Portugal    5178223    Priligy 30 mg
Tablets, 6 tablet pack Portugal    5178249    Priligy 60 mg Tablets, 6 tablet
pack Singapore    Product License No. SIN13880P    Priligy 30 mg Tablets
Singapore    Product License No. SIN13881P    Priligy 60 mg Tablets Spain   
70.874    Priligy 30 mg Tablets Spain    70.875    Priligy 60 mg Tablets Sweden
   MTnr 26319    Priligy 30 mg Tablets

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Authorization Country

  

Registration Number

  

Product Name

Sweden    MTnr 26320    Priligy 60 mg Tablets Taiwan   

025417

DHA00202541701

   Priligy 30 mg Tablets Turkey   

Registration Certificate No :

14.07.2011- 131/76

   Priligy 30 mg tablets Uruguay    Reg. No. 42800    Priligy 30 mg Tablets
Uruguay    Reg. No. 42801    Priligy 60 mg Tablets

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Schedule 11.2.15.1B

Alza Regulatory Submissions

 

Applicant Country

  

Filing Date

  

Application Number

Canada

   6 JUN 08    NDS 120605/File 9427-J0921-101 South Africa    3 SEP 08   

30 mg: 430692

60 mg: 430693

Venezuela    27 Jan 11   

30 mg: 110033

60 mg: 110034

Israel    27 Apr 09    MOH rejected application 30 AUG 11 – application closed
Thailand    26 JUN 09    Due to the flooding in Thailand, no one is working at
the local office, and all records were moved from the ground floor to higher
floors or were moved offsite. Retrieval remains ongoing. Indonesia    05 AUG 10
   210242030 (30mg and 60mg) Panama    30 DEC 09   

30mg: 20091243411

60mg: 20091243412

Costa Rica    18 JAN 10    application withdrawn due to no commercial interest
Paraguay    18 FEB 10    60 mg: 4407 30 mg: 4409 Nicaragua    N/A    never
officially submitted, commercial team may not be interested in product Dominican
Republic    25 MAY 10    Priligy 30 mg - solicitud 0201-03593-2010
Priligy 60 mg - solicitud 0201-03601-2010

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Applicant Country

  

Filing Date

  

Application Number

Russia    15 APR 10   

30 mg,60 mg:

414954, 23/05/2011

Jamaica    28 JUN 10    Application was rejected by HA (26Jan11) Vietnam    31
AUG 10   

NN-11136, NN-11136

(30mg and 60mg)

Switzerland    6 SEP 10    No application number Jordan    14 JUN 11   
dapoxetine

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Schedule 11.2.15.1C

Pricing Approvals

Canada

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Schedule 11.2.18

ALZA Sublicenses

[*]

 

[*] Confidential treatment requested.

 

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Schedule 11.3.11

Required Consents[*]

[*]

 

[*] Confidential treatment requested.