EXHIBIT 1.6
EXECUTION COPY
LICENSE AGREEMENT
BY AND BETWEEN
TARGETED GENETICS NEWCO, LTD.
A Bermuda Limited Company
AND
TARGETED GENETICS CORPORATION
A Washington Corporation
July 21, 1999
TABLE OF CONTENTS
1. DEFINITIONS................................................ 1
2. GRANT OF RIGHTS............................................ 9
3. IMPROVEMENTS AND AFTER ACQUIRED TECHNOLOGY................. 14
4. DEVELOPMENT OF PRODUCTS.................................... 15
5. REGULATORY APPROVALS....................................... 15
6. FINANCIAL PROVISIONS....................................... 16
7. CONFIDENTIAL INFORMATION................................... 20
8. WARRANTIES/INDEMNITIES..................................... 22
9. INTELLECTUAL PROPERTY OWNERSHIP RIGHTS..................... 26
10. RIGHTS EXPLOITATION OUTSIDE THE FIELD...................... 28
11. NON-COMPETITION............................................ 28
12. TERM AND TERMINATION OF AGREEMENT.......................... 30
13. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE............... 33
14. SETTLEMENT OF DISPUTES; GOVERNING LAW...................... 33
15. ASSIGNMENT................................................. 34
16. NOTICES.................................................... 34
17. MISCELLANEOUS CLAUSES...................................... 35
LICENSE AGREEMENT dated as of July 21, 1999 between Targeted Genetics
Newco, Ltd., a Bermuda limited company, and Targeted Genetics Corporation, a
Washington corporation.
RECITALS:
A. Contemporaneously herewith, Elan and TGEN (capitalized terms used herein
are defined below) are entering into the Development Agreement for the
purpose of recording the terms and conditions of a joint venture and of
regulating their relationship with each other and certain aspects of the
affairs of and their dealings with Newco.
B. TGEN is beneficially entitled to the use of certain know-how and certain
patents that have been granted or are pending in relation to the
development and production of various Gene Delivery Technologies.
C. Newco desires to enter into this Agreement with TGEN so as to permit Newco
to utilize the TGEN Intellectual Property in the research, development,
manufacture, distribution and sale of the Products in the Field and in the
Territory.
D. Elan, EIS and TGEN entered into a letter agreement dated June 30, 1999 (the
"Letter Agreement") pursuant to which they agreed to enter into definitive
documents, including this Agreement, and the Elan License Agreement
relating to Newco's use of the Elan Intellectual Property.
NOW THEREFORE IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS
A. In this Agreement, the following definitions shall apply:
1.1. "Affiliate" shall mean, with respect to Elan or TGEN, any corporation
or entity other than Newco (and entities controlled by it) controlling,
controlled by or under the common control of Elan or TGEN, as the case may be,
and, with respect to Newco, any corporation or entity under control of Newco. A
corporation or non-corporate entity shall be regarded as in control of another
corporation if it owns or directly or indirectly controls more than fifty
percent (50%) of the voting stock of the other corporation or (a) in the absence
of the ownership of at least fifty percent (50%) of the voting stock of a
corporation or (b) in the case of a non-corporate entity, the
[*] OMITTED, CONFIDENTIAL MATERIAL, WHICH MATERIAL HAS BEEN SEPARATELY FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT.
power to direct or cause the direction of the management and policies of such
corporation or non-corporate entity, as applicable;
1.2. "Agreement" shall mean this agreement (which expression shall be
deemed to include the Recitals and the Schedules hereto);
1.3. "Antisense" shall mean [*];
1.4. "Base Technologies" shall mean technologies, techniques and
formulations for the administration of an active agent to a mammal: (i) in
formulations of the active agent with one or more substantially inert
ingredients, including, without limitation, tonicity modifiers and bulking
agents; or (ii) with or through devices or mechanical targeting systems or
mechanical delivery systems (other than Elan's MEDIPAD(R) Drug Delivery System
or devices utilizing autoinjector technology);
1.5. "cGCP", "cGLP" and "cGMP" shall mean current Good Clinical Practices,
current Good Laboratory Practices and current Good Manufacturing Practices
respectively;
1.6. "Commercialization" shall mean the manufacture, promotion,
distribution, marketing and sale of the Products;
1.7. "Control" shall mean the ability to grant a license or sublicense as
contemplated herein without violating the terms of any agreement with any
Independent Third Party;
1.8. "Definitive Documents" shall have the same meaning as given to the
term "Transaction Documents" in the Development Agreement;
1.9. "Development Agreement" shall mean the Subscription, Joint Development
and Operating Agreement of even date entered into among TGEN, Elan, EIS and
Newco;
1.10. "Development Candidate(s)" shall mean a TGEN Proprietary Gene, or a
Gene obtained from an Independent Third Party, jointly selected by the
Participants and Newco to be developed for incorporation in Products. For the
avoidance of doubt, if it is subsequently determined by the Management Committee
of Newco that the TGEN Proprietary Gene initially offered for development as a
Product is not suitable for use in a Product, TGEN shall offer an additional
TGEN Proprietary Gene to the extent available, as described in Section 9.5 of
the Development Agreement, and such additional TGEN Proprietary Gene shall in
that instance become the Development Candidate;
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1.11. "Drug Delivery Technologies" shall mean formulation and/or excipient
systems and technologies for delivery of a therapeutic agent to a mammal,
including but not limited to [*] allowing such agent, without limitation on
other features that may be sought in addition to or instead of the following, to
be administered on an optimized schedule, and/or to be administered with reduced
side effects, and/or to be administered with enhanced efficacy, and/or to be
administered with better patient compliance, and/or to be administered in
reduced dosages. Drug Delivery Technologies shall also include Elan device
delivery technologies including the MEDIPAD(R) Drug Delivery System and devices
utilizing autoinjector technology. Notwithstanding the foregoing, Drug Delivery
Technologies shall not include Base Technologies or Gene Delivery Technologies;
1.12. "Effective Date" shall mean the "Closing Date" as such term is
defined in the Development Agreement;
1.13. "EIS" shall mean Elan International Services, Ltd., a Bermuda
limited company;
1.14. "Elan" shall mean Elan Pharmaceutical Technologies, a division of
Elan Corporation, plc, a public limited company incorporated under the laws of
Ireland, its, successors and permitted assigns; and, shall also include, for
purposes of the option contained in Section 2.2 below and the inclusion of the
NanoCrystal technology covered by such option and referenced in the definition
of "Elan Intellectual Property," Elan Pharma International Limited;
1.15. "Elan Improvements" shall have the meaning set forth in the Elan
License Agreement;
1.16. "Elan Intellectual Property" shall have the meaning set forth in the
Elan License Agreement;
1.17. "Elan License" shall have the meaning set forth in the Elan License
Agreement;
1.18. "Elan License Agreement" shall mean that certain license agreement,
of even date herewith, entered into between Elan and Newco;
1.19. "Elan Patents" shall have the meaning set forth in the Elan License
Agreement;
1.20. "Elan Program Technology" shall mean all Program Technology that
relates solely to Drug Delivery Technologies or Antisense whether conceived or
made
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by Elan and/or its agents or TGEN or Newco and/or its agents pursuant to the
Research and Development Program;
1.21. "Elan Right of First Negotiation" shall have the meaning set forth
in the Elan License Agreement;
1.22. "Enabling Gene" shall mean a Gene selected by the Research Committee
for research purposes only.
1.23. "Excluded Elan Technology" shall mean transdermal or transcutaneous
Drug Delivery Technology (i.e., pertaining to delivery, onto, into and through
the skin);
1.24. "Excluded TGEN Technology" shall mean inventions, patents and know-
how: (a) to the extent relating to transdermal or transcutaneous drug delivery
technology (as above described); (b) to the extent relating to the treatment of
cystic fibrosis or the delivery of Genes directed therefor; (c) to the extent
relating to Antisense; or (d) that are subject to contractual obligations of
TGEN to third parties as of the Effective Date to the extent the licensing of
such inventions, patents and know-how is restricted or limited.
1.25. "FDA" shall mean the United States Food and Drug Administration or
any successors or agency the approval of which is necessary to market a product
in the United States of America;
1.26. "Field" shall mean the research, development and Commercialization
of a Platform for delivery of Genes to mammals. For avoidance of doubt, the
Field shall exclude (i) cell therapy, (ii) ex vivo gene therapy, (iii) Antisense
delivery and (iv) transcutaneous and/or transdermal delivery (as above
described);
1.27. "Gene" shall mean any nucleotide sequence that includes a region or
regions (or gene cassette(s)) capable of coding, causing or modulating the
expression of a protein or other genetic element (other than directly modulating
expression where the nucleic acid sequence is an Antisense) and includes one or
more elements that can control expression of said protein(s) or other genetic
element(s);
1.28. "Gene Delivery Technologies" shall mean [*];
1.29. "Independent Third Party" shall mean any person other than Newco,
TGEN, Elan or any of their respective Affiliates;
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1.30. "In market" shall mean sales of Products whether by Newco or its
Affiliates, or where applicable by a sublicensee, to an Independent Third Party
being a wholesaler, distributor, managed care organization, hospital, pharmacy
and/or the like;
1.31. "Licensed Technologies" shall mean the Elan Intellectual Property
and the TGEN Intellectual Property;
1.32. "Licenses" shall mean the Elan License and the TGEN License;
1.33. "Lien" shall mean any and all liens, security interests,
restrictions, claims, encumbrances or rights of third parties of every kind and
nature;
1.34. "Management Committee" shall have the meaning given to such term in
the Development Agreement;
1.35. "Marketing Authorization" shall mean the procurement of
registrations and permits required by applicable government authorities in a
country in the Territory for the marketing, sale, and distribution of a Product
in such country;
1.36. "MEDIPAD(R) Drug Delivery System" shall mean the ambulatory
continuous micro infusion device having a drug reservoir volume ranging from 3.3
to 5.0 ml. and associated technology;
1.37. "Net Proceeds" shall mean the net amount realized by Newco or its
Affiliates in the form of upfront payments, milestones or royalty payments from
Independent Third Parties with respect to Products or the grant of rights
therein or to the Commercialization thereof, after deduction of all costs,
commissions and fees payable by Newco or its Affiliates associated with or
incurred with respect to such upfront payments, milestones or royalties,
including without limitation royalties and other compensations paid or payable
to any Independent Third Party (or to either of the Participants, where such
Participant has separately licensed any rights or intellectual properties to
Newco on a royalty-bearing basis).
1.38. "Net Sales" shall mean the amount billed or invoiced for sales of a
Product by Newco or its Affiliates to an Independent Third Party, less, to the
extent included in such invoice price the total of: (1) ordinary and customary
trade, quantity or cash discounts and nonaffiliated brokers' or agents'
commissions, including government managed care and other contract rebates,
pharmacy incentive programs, including chargebacks of pharmacy or hospital
performance incentive programs or similar programs; (2) credits, rebates and
returns (including, but not limited to, wholesaler and retailer returns); (3)
freight, postage and duties separately identified on
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the invoice or other documentation maintained in the ordinary course of
business, and (4) import, export and sales taxes, excise taxes, other
consumption taxes, customs duties, tariffs and compulsory payments to
governmental authorities separately identified on the invoice or other
documentation maintained in the ordinary course of business and based on sales
or turnover or delivery of the Products. Net Sales shall also include the amount
or fair market value of all other consideration received by Newco or its
Affiliates in respect of sales of Products by Newco or its Affiliates to an
Independent Third Party, whether such consideration is payment in kind, exchange
or another form, less the applicable deductions, as described above. If a
Product is provided to an Independent Third Party by Newco or its Affiliates
without charge or provision of invoice and used by such Independent Third Party,
then Newco or its Affiliates shall be treated as having sold such Product to
such Independent Third Party for an amount equal to the fair market value of
such Product. Sales between or among Newco and its respective Affiliates or
authorized licensees shall be excluded from the computation of Net Sales;
1.39. "Newco" shall mean Targeted Genetics Newco, Ltd., a Bermuda limited
company;
1.40. "Newco Program Technology" shall mean all Program Technology other
than Elan Program Technology and TGEN Program Technology;
1.41. "Newco Technology" shall mean all Program Technology and all
technology licensed or acquired by Newco or developed by Newco whether or not
pursuant to the Research and Development Program, excluding, however, TGEN
Intellectual Property and Elan Intellectual Property;
1.42. "Participant" shall mean Elan or TGEN, as the case may be.
"Participants" shall mean both Elan and TGEN;
1.43. "Parties" shall mean TGEN and Newco;
1.44. "Person" shall mean an individual, partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture, or other entity of whatever nature;
1.45. "Plan" shall mean that portion of the Business Plan defined in the
Development Agreement that relates to the Project and Newco's program of
development agreed to by Elan and TGEN within sixty (60) days of the date
hereof, with respect to the research, development and Commercialization of the
Products,
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which Plan shall be reviewed and mutually agreed to in writing by Elan and TGEN
on an annual basis;
1.46. "Platform" shall mean the combined utilization of Drug Delivery
Technologies and Gene Delivery Technologies for delivery of Genes by any route
of administration;
1.47. "Product" shall mean a Gene formulated for administration to
mammals, including humans, by use of a Platform;
1.48. "Program Technology" shall mean all technology developed by or on
behalf of Newco, whether by Elan, TGEN, a third party or jointly by any
combination thereof, pursuant to the Research and Development Program;
1.49. "Project" shall mean all activity as undertaken by Elan, TGEN and
Newco to develop the Platform and Products in accordance with the Plan;
1.50. "Regulatory Authority" shall mean any regulatory authority outside
the United States of America, the approval of which is necessary to market a
Product;
1.51. "Research and Development Program" shall have the same meaning given
to such term in the Development Agreement;
1.52. "Research and Development Term" shall mean the period commencing on
the Effective Date and continuing for a period of [*] thereafter, or as extended
by agreement of the Participants, up to an aggregate of [*]; provided, however,
that if a Participant shall be prevented by (i) events beyond the Participants'
control, or (ii) by such Participant's delay or negligent act or omission, from
performing its obligations under the Definitive Documents within said [*] period
(or as extended), then the other Participant at its option, may extend the
duration of the Research and Development Term by a term equal in length to the
period during which the first Participant was unable to perform its obligations
hereunder;
1.53. "Technological Competitor of TGEN" shall mean any entity which has a
significant program for the discovery and development of Gene Delivery
Technology, a listing of which is contained on Schedule 4 to the Development
Agreement, and as such list may be supplemented by TGEN from time to time with
the consent of Elan, which consent shall not be unreasonably withheld if the
proposed additions are within the parties' contemplation as to the purpose of
the original list;
1.54. "Term" shall have the meaning given to it in Clause 12 below;
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1.55. "Territory" shall mean all the countries of the world;
1.56. "TGEN" shall mean Targeted Genetics Corporation, a Washington
corporation;
1.57. "TGEN Improvements" shall mean, other than Excluded TGEN Technology,
any improvements to the TGEN Patents and TGEN Know-How developed by TGEN
independently or in collaboration with an Independent Third Party, which
improvements TGEN at any time during the Research and Development Term Controls
within the Field (other than pursuant to the Research and Development Program);
1.58. "TGEN Intellectual Property" shall mean the TGEN Patents, TGEN Know-
How and TGEN Improvements;
1.59. "TGEN Know-How" shall mean, other than Excluded TGEN Technology, any
and all rights (i) Controlled by TGEN as of the Effective Date to any discovery,
invention (whether or not patentable), know-how, substances, data, techniques,
processes, systems, formulations and designs relating to Base Technologies, Gene
Delivery Technologies or Drug Delivery Technologies and useful for the conduct
of the Project or Commercialization of Products and (ii) any discovery,
invention (whether or not patentable), know-how, substances, data, techniques,
processes, systems, formulations and designs relating to Base Technologies, Gene
Delivery Technologies or Drug Delivery Technologies and useful for the conduct
of the Project or Commercialization of Products developed by TGEN independently
or in collaboration with an Independent Third Party after the Effective Date;
1.60. "TGEN License" shall mean the license of TGEN Intellectual Property
to Newco pursuant to Section 2.1 hereof;
1.61. "TGEN Patents" shall mean, other than Excluded TGEN Technology, any
and all patents and patent applications relating to Base Technologies, Gene
Delivery Technologies or Drug Delivery Technologies (i) Controlled by TGEN on
the Effective Date and (ii) Controlled by TGEN and hereafter filed or obtained
(to the extent covering inventions made by TGEN independently or in
collaboration with an Independent Third Party). TGEN Patents shall also include
all extensions, continuations, continuations-in-part, continuing prosecution
applications divisionals, patents-of-additions, re-examinations, re-issues,
supplementary protection certificates and foreign counterparts of such patents
and patent applications and any patents issuing thereon and extensions of any
patents licensed hereunder;
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1.62. "TGEN Program Technology" shall mean all Program Technology which
relates solely to Gene Delivery Technologies, whether conceived or made by TGEN
and/or its agents or Elan or Newco pursuant to the Research and Development
Program;
1.63. "TGEN Proprietary Gene" shall mean any Gene Controlled by TGEN;
1.64. "TGEN Right of First Negotiation" shall have the meaning provided in
Section 2.12 hereof;
1.65. "Trademark" shall mean the trademark(s) belonging to TGEN as may be
selected by Newco or its permitted sub-licensees, with TGEN's consent, for use
in connection with the Products;
1.66. "United States Dollar" and "US$" shall mean the lawful currency for
the time being of the United States of America;
B. Interpretation. In this Agreement the following shall apply:
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1.1 The singular includes the plural and vice versa, the masculine
includes the feminine and vice versa.
1.2. Any reference to a Clause, Section or Schedule shall, unless
otherwise specifically provided, be to a Clause, Section or Schedule of
this Agreement.
1.3. The headings of this Agreement are for ease of reference only
and shall not affect its construction or interpretation.
2. GRANT OF RIGHTS
2.1 TGEN hereby grants to Newco a license in the Territory to TGEN's rights in
(i) the TGEN Intellectual Property for all research, development, and
Commercialization purposes solely in the Field, and (ii) the Enabling Gene
for all research and development purposes solely in the Field, in each case
subject to contractual obligations that TGEN may have as of the Effective
Date, and, unless prohibited by the Section 11 ("Non-Competition"),
contractual obligations that TGEN may enter into after the Effective Date
(the "TGEN License"). The TGEN License shall be nonexclusive to Newco
during the Research and Development Term, and thereafter during the License
Term shall be exclusive to the extent applicable to the Commercialization
(i) of a Product or Products which has (have) been successfully developed
by Newco during
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the Research and Development Term, and (ii) of any Product containing the
same Gene that would be competitive (i.e., directed at the same indication)
with any Product being Commercialized by Newco. Otherwise, the TGEN License
shall be nonexclusive during the License Term after the Research and
Development Term.
2.2 If the inclusion of any TGEN Patents, TGEN Know-How, the Enabling Gene or
TGEN Improvements with respect to any of the foregoing in the license of
TGEN Intellectual Property is restricted or limited by a third party
agreement, TGEN shall use reasonable commercial efforts to exclude or where
applicable minimize any such restriction or limitation.
2.3 To the extent royalty or other compensation obligations to Independent
Third Parties that are payable with respect to TGEN Intellectual Property
would be triggered by a proposed use of such TGEN Intellectual Property in
connection with the Project, TGEN will inform Newco and Elan of such
royalty or compensation obligation. If Newco and Elan agree to utilize
such TGEN Intellectual Property in connection with the Project, Newco will
be responsible for the payment of such royalty or other compensation
obligations relating thereto.
2.4 Except as expressly provided herein, all proprietary rights and rights of
ownership with respect to the TGEN Intellectual Property shall at all times
remain solely with TGEN. TGEN shall disclose to Newco inventions made by or
on behalf of TGEN in connection with the performance of the Project, any
patentable inventions and discoveries within the TGEN Intellectual Property
that relate to the Field and any patentable TGEN Improvements developed by
or on behalf of TGEN.
2.5 Notwithstanding anything contained herein to the contrary, TGEN shall have
the right, outside the scope of the exclusivity under the TGEN License, and
subject to Section 11 below, to fully exploit and grant licenses and
sublicenses with respect to the TGEN Intellectual Property.
2.6 Notwithstanding the grant of the TGEN License, TGEN will not be required to
disclose to Elan or Newco proprietary manufacturing know-how, unless and
until it is determined, as described in Sections 2.13 and 2.14 below, that
a party other than TGEN will perform relevant manufacturing services for
Newco, and then such disclosures may be limited to those that are required
to support such manufacturing services by such other party.
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2.7 Newco shall not be permitted to (a) encumber any of its rights under the
Licenses or the Newco Technology without the prior written consent of TGEN;
(b) assign or sublicense any of its rights under the licenses for the
Licensed Technologies and the Newco Technology without the prior written
consent of TGEN, which consent may be withheld in TGEN's sole discretion.
Notwithstanding the foregoing, subject to the TGEN Right of First
Negotiation, TGEN shall not unreasonably withhold, condition or delay its
consent to the licensing of rights to Commercialize Products to Independent
Third Parties who are not Technological Competitors of TGEN. Any agreement
between Newco and any permitted Independent Third Party for the development
or exploitation of the TGEN Intellectual Property shall require such
Independent Third Party to maintain the confidentiality of all information
concerning the TGEN Intellectual Property and shall permit an assignment of
rights by Newco to TGEN in accordance with the terms of this Agreement.
Rights of permitted third party sublicensees in and to TGEN Intellectual
Property shall survive the termination of the license and sublicense
agreements granting said intellectual property rights to Newco; and Newco
and TGEN shall in good faith agree upon the form most advantageous to TGEN
in which the rights of the sublicensor under any such sublicenses are to be
held (which form may include continuation of Newco solely as the holder of
such licenses or assignment of such rights to a third party or parties,
including an assignment to TGEN).
2.8 Newco will use its reasonable commercial efforts to exploit the Elan
Intellectual Property, the TGEN Intellectual Property and Newco Technology
in accordance with this Agreement, the Elan License Agreement and the Plan.
Newco and/or its contractors or licensees/sublicensees shall employ
reasonably diligent efforts to research, develop, register, and
Commercialize the Products in appropriate regions in the Territory. Newco
and/or its contractors or licensees/sublicensees shall employ or have
employed on its or their behalf a level of advertising, sales, marketing,
and promotion efforts in each country in the Territory where Marketing
Authorization for Product has been obtained which is: (i) commensurate
with that used by other pharmaceutical marketers for products of similar
market potential in that country in the Territory, and (ii) consistent with
the market potential for the Product as depicted in the Plan and as
determined by the Management Committee in accordance with the Development
Agreement.
2.9 Newco will be solely responsible for ensuring that it or its sublicensees
manufacture and Commercialize the Products within each country of the
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Territory strictly in accordance with all the legal and regulatory
requirements of each country of the Territory.
2.10 Upon the request of Newco and with the consent of TGEN, TGEN shall grant
to Newco during the Term a non-exclusive royalty free license in the
Territory, solely for use in connection with the sale of the Products, to
use one or more Trademark, on the following terms:
2.10.1 Newco shall as soon as it becomes aware of any infringement of a
Trademark give to TGEN in writing full particulars of any use or
proposed use by any other person, firm or company of a service xxxx,
trade name or trademark or promotional or advertising activity which
may constitute infringement.
2.10.2 If Newco becomes aware that any other person, firm or company
alleges that such Trademark is invalid or that the use of such
Trademark infringes any rights or constitutes an unauthorized use of
intellectual property of another party or that the Trademark is
otherwise attacked or attackable, Newco shall immediately give to
TGEN full particulars thereof in writing and shall make no comment
or admission to any third party in respect thereof.
2.10.3 TGEN shall have the right to conduct all proceedings relating to
such Trademark and shall in its sole discretion decide what action,
if any, to take in respect of any actual, threatened or alleged
infringement of such Trademark or any other claim or counter-claim
brought or threatened relating to the use or registration of such
Trademark. Any such proceedings shall be conducted at TGEN's expense
and for its own benefit.
2.10.4 Nothing contained in this Agreement shall grant to Newco any right,
title, or interest in or to such Trademark, whether or not
specifically recognized or perfected under applicable laws, except
for the non-exclusive license described herein. At no time during or
after the term of this Agreement shall Newco challenge or assist
others to challenge any such Trademark or the registration thereof
or attempt to register any trademarks, service marks, or trade names
confusingly similar to any such trademark. All displays of any such
Trademark that Newco intends to adopt shall first be submitted to
TGEN for approval (which shall not be unreasonably withheld,
conditioned or delayed) of design, color, and other details, or
shall be exact copies of those used by TGEN or
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previously approved by it for the same uses. In addition, Newco
shall fully comply with all reasonable guidelines communicated by
TGEN concerning the use of any such Trademark as well as all rules
and regulations of such use throughout the Territory.
2.10.5 The rights granted to Newco under this Section 2.10 shall
automatically terminate with respect to a Product in a country in
the Territory upon termination of Newco's right to market such
Product in any such country.
2.11 When packaged, and to the extent permitted by law, a product label shall
include an acknowledgement that the Product is made under license from TGEN
unless the incorporation of TGEN Intellectual Property is so limited that
such acknowledgment would be unreasonable. Any such acknowledgment shall
take into consideration regulatory requirements and Newco's reasonable
commercial requirements. In such event, Newco shall wherever possible give
due acknowledgement and recognition to TGEN in all printed promotional and
other material regarding the Product such as stating that the Product is
under license from TGEN and that the applicable TGEN Intellectual Property
has been applied to the Products. Newco shall consult with and obtain the
written approval of TGEN as to the format and content of the promotional
and other material insofar as it relates to a description of, or other
reference to, the application of the TGEN Intellectual Property, such
approval not to be unreasonably withheld, conditioned or delayed. The
further consent of TGEN shall not be required where the format and content
of such materials is substantively similar as the materials previously
furnished to and approved in writing by TGEN.
2.12 Notwithstanding anything contained in this Agreement to the contrary, at
such time, during or within [*] following the end of the Research and
Development Term as Newco intends to develop and Commercialize Products [*]
TGEN shall have [*] on the following terms and conditions:
2.12.1 If Newco intends to [*] then Newco immediately shall notify TGEN in
writing that TGEN may elect to [*] referred to in this Section.
TGEN shall indicate its desire to [*] pursuant to this Section by
delivering written notice to Newco within forty-five (45) days of
TGEN's receipt of the written notification from Newco to TGEN. If
TGEN elects to [*], the Parties shall [*].
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2.12.2 If, [*] TGEN and Newco do not [*] within [*] from the notification
in writing by Newco to TGEN, then Newco shall be free [*]__
2.12.3 Following the [*] period described in Section 2.12.2, [*]
2.13 Elan and TGEN shall have preferential rights to negotiate agreements with
Newco whereby Elan and/or TGEN will manufacture Products to meet Newco's
requirements. Newco shall evaluate each such manufacturing agreement in
light of which of Elan or TGEN (or neither, or both) has the capability and
the committed resources to perform such manufacturing services in the best
interests of Newco. If the parties cannot come to mutual agreement on who
is best qualified to perform such manufacturing services, the matter will
be resolved through the dispute resolution procedures of the Joint
Development and Operating Agreement. To the extent Elan or TGEN performs
any manufacturing services to Newco, it shall be paid a price equal to [*]
and other terms and conditions customary in a supply agreements shall
apply.
2.14 Subject to the rights of Newco as provided in Section 2.12 herein and the
rights of Elan and TGEN as provided in Section 2.13 herein, Newco shall not
be permitted to contract the development or Commercialization of any
Product without the prior written consent of TGEN, which consent will not
be unreasonably withheld, conditioned or delayed; provided that such
reasonableness standard, shall not be applicable in the case of a proposed
sublicense to any Technological Competitor of TGEN.
3. IMPROVEMENTS AND AFTER ACQUIRED TECHNOLOGY
3.1 Subject to contractual restrictions permissible under Section 11 ("Non-
Competition"), TGEN Improvements shall be deemed, immediately upon
development, to be included in the license of the TGEN Intellectual
Property granted to Newco hereunder.
3.2 For the avoidance of doubt, and without limitation on the applicability of
the same exclusion as to other TGEN Intellectual Property, it is understood
that the TGEN License specifically excludes any right to use TGEN
Improvements outside of the Field.
3.3 If the inclusion of an TGEN Improvement in the license of TGEN Intellectual
Property granted to Newco hereunder is restricted or limited by a third
party
* Confidential Treatment Required
-14-
agreement, then TGEN shall use reasonable commercial efforts to exclude, or
where applicable, to minimize any such restriction or limitation.
3.4 All rights, title, and interest to any TGEN Improvements shall be the
property of TGEN. Newco, Elan and any such third party shall execute and
deliver documents, and take such other actions as TGEN may reasonably
request, to effect or evidence such ownership.
3.5 If, after the Effective Date, TGEN acquires know-how or patent rights
relating to the Field, through acquisition of or merger with an Independent
Third Party that has know-how or patent rights relating to the Field, then
TGEN shall offer, as soon as practicable, to license such know-how and
patent rights to Newco (subject to existing contractual obligations binding
on such Independent Third Party at the time of such acquisition or merger),
on such terms as would be offered to an Independent Third Party negotiating
in good faith on an arms-length basis, and if Elan determines that Newco
should not acquire such license, then TGEN shall be free (subject to the
provisions of Section 11, below) to fully exploit such know-how and patent
rights (without the TGEN Intellectual Property then licensed to Newco,
other than outside the scope of the exclusivity of the TGEN License), and
to grant to third parties licenses and sublicenses with respect thereto.
4. DEVELOPMENT OF PRODUCTS
4.1 During the Research and Development Term, Newco will diligently pursue the
research and development of the Elan Intellectual Property, TGEN
Intellectual Property and Newco Technology in accordance with the Research
and Development Program. The objectives of this research and development
work will be (a) to develop the Platform, and (b) to develop one or more
Products in the Field.
4.2 Subject to contractual commitments made prior to, on, or after the
Effective Date (which it is understood shall be within TGEN's discretion,
subject only to its compliance with Section 11 hereof), TGEN agrees to
offer to Newco the opportunity to designate a TGEN Proprietary Gene to be
the Development Candidate. The selection of any Gene to be a Development
Candidate shall be by unanimous vote of the Management Committee. Subject
to the provisions of Section 9.5 of the Development Agreement, TGEN shall
be under no obligation to provide more than one TGEN Proprietary Gene to
serve as a Development Candidate. The obligations of TGEN under this
Section 4.2 shall terminate on such date as Newco Commercializes a Product.
-15-
5. REGULATORY APPROVALS
5.1 Newco shall, or shall cause its sublicensees to, at its or their sole cost
file and shall use its reasonable best efforts to prosecute to approval,
the Marketing Authorizations for the Products in appropriate countries in
the Territory in accordance with the Plan. During any Marketing
Authorization registration procedure, Newco shall keep TGEN promptly and
fully advised of Newco's registration activities, progress and procedures.
Each Party shall inform the other Party and Elan of any dealings such Party
has with the FDA and any other Regulatory Authority. The Parties and Elan
shall collaborate in relation to obtaining any approval of the FDA or
Regulatory Authority for final approved labeling.
5.2 Subject to agreement to the contrary, any and all Marketing Authorizations
filed hereunder for Products shall, to the extent owned by Newco, remain
the property of Newco, provided that Newco shall allow TGEN access thereto
solely to enable TGEN to fulfill its obligations and exercise its rights
under this Agreement and the Development Agreement. Newco shall maintain
or cause its sublicensees to maintain such Marketing Authorizations at its
or their own cost.
5.3 Newco shall indemnify and hold harmless TGEN, its agents and employees from
and against all claims, damages, losses, liabilities and expenses to which
TGEN, its agents, and employees may become subject related to or arising
out of Newco's bad faith, negligence or intentional misconduct in
connection with the filing or maintenance of the Marketing Authorizations.
6. FINANCIAL PROVISIONS
6.1 In consideration of the license to the TGEN Patents, Newco shall pay to
TGEN the following amounts:
6.1.1 Product based upon the Development Candidates. Newco shall make the
---------------------------------------------
following payments with respect to Products based upon the
Development Candidates:
(a) Development Work - Initial research and development work
----------------
pursuant to the Research and Development Program regarding the
development of the Platform and one or more Development
Candidates contracted by Newco to TGEN and/or Elan shall be
payable by Newco to each of TGEN and Elan based on [*] (or
* Confidential Treatment Requested
-16-
less, where the terms of a third party agreement do not support
such fees, and are otherwise acceptable to the Management
Committee).
(b) Upfront or Milestone Payments - If any Independent Third Party
-----------------------------
shall make upfront or milestone payments (e.g., for NDA filing,
approvals, etc.) to Newco, then [*] of the Net Proceeds from
such upfront or milestone payments shall be retained by Newco,
and Newco shall pay to each of Elan and TGEN, in proportion to
their respective ownership interests in Newco, royalties in the
amount of the remaining [*] of such Net Proceeds.
(c) Royalties payable to Elan and TGEN Upon Sales of the Products
-------------------------------------------------------------
based upon the Development Candidates - If Newco makes any In
-------------------------------------
market sales of such Products, Newco shall pay Elan a royalty
on Net Sales derived therefrom, at a rate to be determined by
the Management Committee prior to the market launch thereof to
be appropriate under the circumstances with respect to each
such Product. Newco shall retain [*] of the Net Proceeds from
all royalties derived from sales of Products based upon the
Development Candidates, and shall pay to each of Elan and TGEN
the remaining [*] of all such Net Proceeds in proportion to
their respective ownership interests in Newco.
(d) Special Provisions for TGEN Proprietary Genes. Notwithstanding
---------------------------------------------
the foregoing, in the event a Product is based upon a
Development Candidate which incorporates a TGEN Proprietary
Gene, [*] of the aggregate Net Proceeds from all upfront,
milestone and royalty payments made to Newco by an Independent
Third Party with respect to such Product shall be paid as an
additional royalty to TGEN, and the remaining [*] of such Net
Proceeds shall be paid as an additional royalty to Elan.
Thereafter, such amounts shall be allocated as provided above.
6.1.2 Products Based Upon TGEN Proprietary Genes. In the event Newco shall
------------------------------------------
desire to develop a Product incorporating a TGEN Proprietary Gene other
than a Product based upon the Development Candidate, Newco, Elan and TGEN
shall negotiate in good faith the terms for the licensing of such Gene
and royalties to be paid to each of TGEN and Elan; provided, however,
that with respect to Newco, the terms of such license shall be no less
favorable than those that would have be obtained
* Confidential Treatment Requested
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in an arm's length transaction between unrelated parties and, with
respect to TGEN, the terms of such license shall be no less favorable
than those granted to any other licensor to Newco
6.1.3 Products Based on Proprietary Genes of Independent Third Parties. Newco
----------------------------------------------------------------
shall make the following payments with respect to Products based on
proprietary Genes of Independent Third Parties:
(a) Development Work - Research and development work related to
----------------
Products based upon proprietary Genes of Independent Third Parties
performed by Elan or TGEN for Newco, as the case may be, shall be
payable to such Participant at [*] (or less, where the terms of a
third party agreement do not support such fees, and are otherwise
acceptable to the Management Committee). [*] of any profit received
by Newco for direct charges for such development following payment
of Elan's or TGEN's charges shall be payable as an additional
royalty by Newco to Elan and TGEN, in proportion to their respective
ownership interests in Newco.
(b) Upfront or Milestone Payments - If any Independent Third Party
---------- ------------------
shall make upfront or milestone payments (e.g., for NDA filing,
approvals, etc.) to Newco with respect to Products based upon
proprietary Genes of such third party, then [*] of the Net Proceeds
from such upfront or milestone payments shall be retained by Newco,
and Newco shall pay to each of Elan and TGEN the remaining [*] of
such Net Proceeds in proportion to their respective ownership
interests in Newco.
(c) Royalty Payments to Participants - If Newco makes any In market
--------------------------------
sales of such Products, Newco shall pay TGEN a royalty on Net Sales
derived therefrom, at a rate to be determined by the Management
Committee prior to the market launch thereof to be appropriate under
the circumstances with respect to each such Product. Newco shall
retain [*] of Net Proceeds derived by it from all royalties paid to
it by Independent Third Parties with respect to Products based upon
proprietary Genes of such parties, and shall pay to each of Elan and
TGEN the remaining [*] of all such Net Proceeds in proportion to
their respective ownership interests in Newco.
* Confidential Treatment Requested
-18-
6.2 Payment of those royalties that are payable to TGEN pursuant to Clauses
6.1.1-6.1.3, if any, shall be made quarterly in arrears within forty-five
(45) days after the expiry of the calendar quarter. The method of payment
shall be by wire transfer to an account specified by TGEN and shall be
nonrefundable to Newco. Each payment made to TGEN shall be accompanied by a
true accounting of all Products sold by Newco, its Affiliates and its
permitted sublicensees, if any, during such quarter. Such accounting shall
show, on a country-by-country and Product-by-Product basis, Net Sales and
Net Proceeds invoiced and received by Newco (and the calculation thereof)
and each calculation of royalties with respect thereto, including the
calculation of all adjustments and currency conversions.
6.3 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of three (3) years following the completion
of such records so: (i) as to enable any royalties which shall have accrued
hereunder to be determined; and (ii) that any deductions made in arriving
at the Net Sales and Net Proceeds can be determined.
6.4 All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product and Net Proceeds with respect to
any Product invoiced and received by Newco for each calendar quarter made
in a currency other than United States Dollars shall first be calculated in
the foreign currency and then converted to United States Dollars on the
basis of the average exchange rate in effect for such quarter for the
purchase of United States Dollars with such foreign currency quoted in the
Wall Street Journal (or comparable publication if not quoted in the Wall
Street Journal) with respect to the currency of the country of origin of
such payment, determined by averaging the rates so quoted on each business
day of such quarter.
6.5 If, at any time, legal restrictions in the Territory prevent the prompt
payment when due of royalties payable hereunder to TGEN or any portion
thereof, the Parties shall meet to discuss suitable and reasonable
alternative methods of reimbursing TGEN the amount of such royalties. In
the event that Newco is prevented from making any payment under this
Agreement by virtue of the statutes, laws, codes or government regulations
of the country from which the payment is to be made, then such payments may
be paid by depositing them in the currency in which they accrue to TGEN's
account in a bank acceptable to TGEN in the country the currency of which
is involved or as otherwise agreed by the Parties.
-19-
6.6 TGEN and Newco agree to co-operate in all respects necessary to take
advantage of any double taxation agreements or similar agreements as may,
from time to time, be available.
6.7 Any taxes payable by TGEN on any payment made to TGEN pursuant to this
Agreement shall be for the account of TGEN. If so required by applicable
law, any payment made pursuant to this Agreement shall be made by Newco
after deduction of the appropriate withholding tax, in which event the
Parties shall co-operate to obtain the appropriate tax clearance as soon as
is practicable. On receipt of such clearance, Newco shall forthwith
procure that the amount so withheld is paid to TGEN.
6.8 Newco shall, not more than once in each calendar year, nor more than once
with respect to any accounting period, permit representatives of an
internationally-recognized firm of independent certified accountants
selected by TGEN upon reasonable notice and at any reasonable time during
normal business hours to have access to inspect and audit the accounts and
records of Newco and any other book, record, voucher, receipt or invoice
relating to the calculation of the royalty payments on Net Sales and Net
Proceeds submitted to TGEN. Any such inspection of Newco's records shall
be at the expense of TGEN, except that if any such inspection reveals a
deficiency in the amount of the royalty actually paid to TGEN hereunder in
any calendar quarter of five percent (5%) or more of the amount of any
royalty actually due to TGEN hereunder, then the expense of such inspection
shall be borne solely by Newco. Any amount of deficiency shall be paid
promptly to TGEN by Newco. If such inspection reveals a surplus in the
amount of royalties actually paid to TGEN by Newco, TGEN shall reimburse
Newco the surplus within fifteen (15) days after determination.
6.9 In the event of any unresolved dispute regarding any alleged deficiency or
overpayment of royalty payments hereunder, the matter will be subject to
resolution in accordance with Clause 19 of the Development Agreement, which
is incorporated by reference and shall for such purposes survive
termination of the Development Agreement.
7. CONFIDENTIAL INFORMATION
7.1 The Parties acknowledge that it may be necessary, from time to time, to
disclose to each other confidential and proprietary information, including
without limitation, inventions, works of authorship, trade secrets,
specifications, designs, data, know-how and other information relating to
the
-20-
Field, the Products, Elan Intellectual Property, TGEN Intellectual Property
or the Newco Technology, as the case may be, or otherwise as to processes,
services or business of the disclosing Party. The foregoing shall be
referred to collectively as "Confidential Information". Any Confidential
Information revealed by a Party to another Party shall be used by the
receiving Party exclusively for the purposes of fulfilling the receiving
Party's obligations under this Agreement and the Development Agreement and
for no other purpose.
7.2 Each Party agrees to disclose Confidential Information of another Party
only to another Participant and to those employees, representatives and
agents of Newco or such participant requiring knowledge thereof in
connection with their duties directly related to the fulfilling of the
Party's obligations under this Agreement, the Development Agreement or the
Elan License Agreement. Each Party further agrees to inform all such
Participants and employees, representatives and agents of the terms and
provisions of this Agreement and their duties hereunder and to obtain their
consent hereto as a condition of receiving Confidential Information. Each
Party agrees that it will exercise the same degree of care, but in no event
less than a reasonable degree of care, to protect and preserve the
proprietary and confidential nature of the Confidential Information
disclosed by a Party, as the receiving Party would exercise to preserve its
own proprietary and confidential information. Each Party agrees that it
will, upon request of a Party, return all documents and any copies thereof
containing Confidential Information belonging to or disclosed by, such
Party, and that it will obtain the same agreement from the other
Participant.
7.3 Notwithstanding the above, each Party may use or disclose Confidential
Information disclosed to it by another party to the extent such use or
disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with patent
applications, complying with applicable governmental regulations, including
without limitation those relating to securities regulations and
disclosures, or otherwise submitting information to tax or other
governmental authorities, conducting clinical trials, or making a permitted
sub-license or otherwise exercising its rights hereunder.
7.4 Confidential Information shall not be deemed to include:
(i) information that is generally available to the public;
(ii) information which is made public by the disclosing Party;
-21-
(iii) information which is independently developed by a Party as evidenced
by such Party's written records, without the aid, application or use
of the disclosing Party's Confidential Information;
(iv) information that is published or otherwise becomes part of the
public domain without any disclosure by a Party, or on the part of a
Party's directors, officers, agents, representatives or employees;
(vii) information that becomes available to a Party on a non-confidential
basis, whether directly or indirectly, from a source other than a
Party, which source did not acquire this information on a
confidential basis;
(viii) information which the receiving Party is required to disclose
pursuant to:
(A) a valid order of a court or other governmental body or any
political subdivision thereof or otherwise required by law; or
(B) any other requirement of law;
provided that if the receiving Party becomes legally required to
disclose any Confidential Information, the receiving Party shall
give the disclosing Party prompt notice of such fact so that the
disclosing Party may obtain a protective order or other appropriate
remedy concerning any such disclosure. The receiving Party shall
fully cooperate with the disclosing Party in connection with the
disclosing Party's efforts to obtain any such order or other remedy.
If any such order or other remedy does not fully preclude
disclosure, the receiving Party shall make such disclosure only to
the extent that such disclosure is legally required;
(v) information which was already in the possession of the receiving
Party at the time of receiving such information, as evidenced by its
written records, provided such information was not previously
provided to the receiving Party from a source which was under an
obligation to keep such information confidential; or
(vi) information that is the subject of a written permission to disclose,
without restriction or limitation, by the disclosing Party.
-22-
7.5 The provisions relating to confidentiality in this Clause 7 shall remain in
effect during the term of this Agreement, and for a period of seven (7)
years following the expiration or earlier termination of this Agreement.
7.6 The Parties agree that the obligations of this Clause 7 are necessary and
reasonable in order to protect the Parties' respective businesses, and each
Party expressly agrees that monetary damages would be inadequate to
compensate a Party for any breach by the other Party of its covenants and
agreements set forth herein. Accordingly, the Parties agree and
acknowledge that any such violation or threatened violation will cause
irreparable injury to a Party and that, in addition to any other remedies
that may be available, in law and equity or otherwise, any Party shall be
entitled to obtain injunctive relief against the threatened breach of the
provisions of this Clause 7, or a continuation of any such breach by the
other Party, specific performance and other equitable relief to redress
such breach together with its damages and reasonable counsel fees and
expenses to enforce its rights hereunder, without the necessity of proving
actual or express damages.
8. WARRANTIES/INDEMNITIES
8.1 TGEN represents and warrants to Newco and Elan, as a third party
beneficiary, that:
(a) TGEN is a corporation duly organized under the laws of its
jurisdiction of organization and has all the requisite corporate power
and authority to own and lease its respective properties, to carry on
its respective business as presently conducted and as proposed to be
conducted and to carry out the transactions contemplated hereby;
(b) TGEN has full corporate power and authority to enter into this
Agreement and to perform its obligations hereunder, which have been
duly authorized by all requisite corporate action of TGEN. This
Agreement is the valid and binding obligation of TGEN, enforceable
against it in accordance with its terms, except as limited by
applicable bankruptcy, insolvency, reorganization, moratorium and
other laws of general application affecting the enforcement of
creditors' rights generally, and by general equity principles and
limitations on the availability of equitable relief, including
specific performance;
(c) The execution, delivery and performance by TGEN of this Agreement will
not: (i) violate any provision of applicable law, statute, rule or
-23-
regulation known by and applicable to TGEN or any ruling, writ,
injunction, order, judgment or decree of any court, arbitrator,
administrative agency or other governmental body applicable to TGEN or
any of its properties or assets; or (ii) conflict with or result in
any breach of any of the terms, conditions or provisions of the
charter or organizational documents of TGEN;
(d) To TGEN's best knowledge, except as set forth on Schedule 2 hereto, as
of the Effective Date: (i) TGEN has the right to grant the TGEN
License and any other rights granted herein, (ii) Schedule 1 contains
primary examples of the Elan Intellectual Property existing as of the
Effective Date, which listing is not necessarily exhaustive, (iii)
there are no agreements between Elan and any third parties that
conflict with the TGEN License which would have a material adverse
effect on the ability of Newco to conduct the Project, and (iv) TGEN
is the owner or licensee of all rights, title and interest in the TGEN
Intellectual Property.
8.2 Newco represents and warrants to TGEN that:
(a) Newco is duly and validly existing in good standing in the
jurisdiction of its incorporation and each other jurisdiction in which
the conduct of its business requires such qualification (except where
such failure to so qualify shall not have a material adverse affect on
the business and assets of Newco), and Newco is in compliance with all
applicable laws, rules, regulations or orders relating to its business
and assets;
(b) Newco has full corporate authority to execute and deliver this
Agreement and to consummate the transactions contemplated hereby; this
Agreement has been duly executed and delivered and constitutes the
legal and valid obligations of Newco and is enforceable against Newco
in accordance with its terms; and the execution, delivery and
performance of this Agreement and the transactions contemplated hereby
will not violate or result in a default under or creation of lien or
encumbrance under Newco's certificate of incorporation, by-laws or
other organic documents, any material agreement or instrument binding
upon or affecting Newco, or its properties or assets or any applicable
laws, rules, regulations or orders affecting Newco or its properties
or assets;
(c) Newco is not in default of its charter or by-laws, any applicable laws
or regulations or any material contract or agreement binding upon or
-24-
affecting it or its properties or assets and the execution, delivery
and performance of this Agreement and the transactions contemplated
hereby will not result in any such violation;
(d) The execution of this Agreement by Newco and the full performance and
enjoyment of the rights of Newco under this Agreement will not breach
the terms and conditions of any license, contract, understanding or
agreement, whether express, implied, written or oral between Newco and
any third party;
(e) Newco has the sole, exclusive and unencumbered right to grant the
licenses and rights herein granted to TGEN and that it has not granted
and will not grant any option, license, right or interest in or to the
TGEN Intellectual Property, the Newco Technology, or other property to
any third party which would conflict with the rights granted by this
Agreement and the Definitive Documents;
(f) The Products shall be developed, manufactured, transported, stored,
handled, packaged, marketed, promoted, distributed, offered for sale
and sold in accordance with all regulations and requirements of the
FDA and foreign regulatory authorities including, without limitation,
cGCP, cGLP, cGMP regulations. The Products shall not be adulterated or
misbranded as defined by the Federal Food, Drug and Cosmetic Act (or
applicable foreign law) and shall not be a product which would violate
any section of such Act if introduced in interstate commerce; and
(g) It is fully cognizant of all applicable statutes, ordinances and
regulations of the United States of America and countries in the
Territory with respect to the manufacture of the Products including,
but not limited to, the U.S. Federal Food, Drug and Cosmetic Act and
regulations thereunder and similar statutes in countries outside of
the United States. Newco shall manufacture or procure the manufacture
of the Products in conformity with the Marketing Authorizations and in
a manner which fully complies with all United States of America and
foreign statutes, ordinances, regulations and practices.
8.3 In addition to any other indemnifications provided for herein, TGEN shall
indemnify and hold harmless Newco, Elan and their Affiliates and their
respective employees, agents, partners, officers and directors from and
against any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Newco arising out of
or in connection
-25-
with any (a) breach of any representation, covenant, warranty or obligation
by TGEN hereunder, or (b) any act or omission on the part of TGEN or any of
its agents or employees in the performance of this Agreement.
8.4 In addition to any other indemnifications provided for herein, Newco shall
indemnify and hold harmless TGEN and its Affiliates and their respective
employees, agents, partners, officers and directors from and against any
claims, losses, liabilities or damages (including reasonable attorney's
fees and expenses) incurred or sustained by TGEN arising out of or in
connection with any (a) breach of any representation, covenant, warranty or
obligation by Newco hereunder, or (b) any act or omission on the part of
Newco or any of its agents or employees in the performance of this
Agreement.
8.5 The Person seeking an indemnity shall:
8.5.1 fully and promptly notify the indemnifying Party of any claim or
proceeding, or threatened claim or proceeding;
8.5.2 permit the indemnifying Party to take full care and control of such
claim or proceeding;
8.5.3 cooperate in the investigation and defense of such claim or
proceeding;
8.5.4 not compromise or otherwise settle any such claim or proceeding
without the prior written consent of the indemnifying Party, which
consent shall not be unreasonably withheld, conditioned or delayed;
and
8.5.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
8.6 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER TGEN
NOR NEWCO SHALL BE LIABLE TO THE OTHER PARTY, BY REASON OF ANY
REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON
LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL OR
INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND
WHETHER OCCASIONED BY THE APPLICABLE PARTY'S NEGLIGENCE OR THAT OF ITS
EMPLOYEES OR AGENTS OR OTHERWISE
-26-
8.7 EXCEPT AS SET FORTH IN THIS SECTION 8, TGEN IS GRANTING THE TGEN LICENSE
HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY
WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS,
AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.
9. INTELLECTUAL PROPERTY OWNERSHIP RIGHTS
9.1 Subject to the terms and conditions of this Agreement, Newco shall own the
legal and equitable title to the Newco Technology.
9.2 TGEN shall own the legal and equitable title to the TGEN Intellectual
Property, including without limitation, TGEN Improvements.
9.3 Newco shall permanently xxxx or otherwise use reasonable efforts to cause
any third party to permanently xxxx all Products and/or the packaging
therefor with such license or patent notices to comply with the laws of the
country of sale or otherwise to generally communicate the existence of any
TGEN Patents for the countries of the Territory and in such manner as TGEN
may reasonably request in writing prior to the sale or commercial use
thereof.
9.4 TGEN, at its expense, shall make a good faith effort (i) to secure the
grant of any material patent applications within the TGEN Patents that
relate to the Field; (ii) to defend all such applications against third
party oppositions and interferences; and (iii) to maintain in force any
material issued letters patent within the TGEN Patents that relate to the
Field (including any letters patent that may issue covering any such Elan
Improvements that relate to the Field). TGEN shall have the right in its
discretion to control such filing, prosecution, defense and maintenance
provided that Newco and Elan at their request shall be provided with copies
of all documents relating to such filing, prosecution, defense and
maintenance in sufficient time to review such documents and comment thereon
prior to filing. Notwithstanding the foregoing, it is understood that TGEN
retains the discretion, in its sole judgment, as to whether and where to
file or to prosecute patent applications on any such technologies or rights
relating to the TGEN Intellectual Property.
9.5 Newco, TGEN and Elan shall promptly inform each other in writing of any
alleged infringement of any patents within the Elan Patents, the TGEN
Patents, or any Newco patents or any alleged misappropriation of trade
secrets within
-27-
the TGEN Intellectual Property or the TGEN Intellectual Property by a third
party of which it becomes aware and provide the others with any available
evidence of such infringement or misappropriation insofar as such
infringements or misappropriation relate solely to the Field.
9.6 Newco shall have the right to prosecute at its own expense and for its own
benefit any infringements of the TGEN Patents or misappropriation of the
TGEN Intellectual Property, insofar as such infringements or
misappropriation relate solely to the Field. In the event that Newco takes
such action, Newco shall do so at its own cost and expense. At Newco's
request, TGEN shall cooperate with such action. Any recovery remaining
after the deduction by Newco of the reasonable expenses (including
attorney's fees and expenses) incurred in relation to such infringement
proceeding shall belong to Newco. Should Newco decide not to pursue such
infringers, within a reasonable period but in any event within twenty (20)
days after receiving written notice of such alleged infringement or
misappropriation TGEN may in its discretion initiate such proceedings in
its own name, at its expense and for its own benefit, and at TGEN's
request, Newco shall cooperate with such action. Alternatively, the
Participants may agree to institute such proceedings in their joint names
and shall reach agreement as to the proportion in which they shall share
the proceeds of any such proceedings, and the expense of any costs not
recovered, or the costs or damages payable to the third party. If the
infringement of the TGEN Patents affects both the Field as well as other
products being developed or commercialized by TGEN or its commercial
partners outside the Field, Newco and TGEN shall endeavor to agree as to
the manner in which the proceedings should be instituted and as to the
proportion in which they shall share the proceeds of any such proceedings,
and the expense of any costs not recovered, or the costs or damages payable
to the third party.
9.8 Newco shall indemnify, defend and hold harmless Elan and TGEN, against all
actions, losses, claims, demands, damages, costs and liabilities (including
reasonable attorneys fees) relating directly or indirectly to all such
claims or proceedings referred to herein, provided that TGEN, shall not
acknowledge to the third party or to any other person the validity of any
claims of such a third party, and shall not compromise or settle any claim
or proceedings relating thereto without the prior written consent to Newco,
not to be unreasonably withheld, conditioned or delayed. At its option,
Elan or TGEN, as the case may be, may elect to take over the conduct of
such proceedings from Newco provided that Newco's indemnification
obligations shall continue; the costs of defending such claim shall be
borne by Elan or TGEN, as the case may be and
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such Participant shall not compromise or settle any such claim or
proceeding without the prior written consent of Newco, such consent not to
be unreasonably withheld, conditioned or delayed.
10. RIGHTS EXPLOITATION OUTSIDE THE FIELD
10.1 Licenses to TGEN Program Technology. Newco hereby grants to TGEN an
-----------------------------------
exclusive, royalty free and sublicensable license to TGEN Program
Technology outside of the Field. Such license shall be effective and
exclusive on a country-by-country basis for the life of any patents on such
TGEN Program Technology in such country, or, to the extent the TGEN Program
Technology is not patented or covered by pending patent applications in any
country, for fifteen years from the date any products are first introduced
on the market in such country by TGEN under such license, or for such
shorter period as shall be required under the applicable law of any country
in the Territory.
10.2 Licenses for Newco Program Technology Outside the Field. Newco shall
-------------------------------------------------------
negotiate in good faith with Elan and TGEN, respectively, for the grant of
exclusive or non-exclusive licenses for the rights to Newco Program
Technology (other than TGEN Program Technology or Elan Program Technology)
outside the Field in the Territory. All such licenses shall contain such
customary terms contained in similar licenses in the industry, as agreed to
by the licensee and the unanimous decision of the Management Committee,
acting in good faith.
11. NON-COMPETITION
11.1 During the Research and Development Term (and any extensions thereto),
subject to the other provisions of this Agreement, TGEN (subject, however,
to Section 11.2 hereof and Section 20.2 of the Development Agreement) shall
not (i) market, sell, develop, or assist in the development for the use,
manufacture, distribution or sale of Products in the Field, except (a) for
or on behalf of Newco, or (b) with Newco's prior written consent, (ii)
develop, or assist in the development of, [*] in the Field or (iii) market,
sell, develop, or assist in the development for the use, manufacture or
distribution of products having the same [*] with such Product. Following
termination of the Research and Development Term, TGEN shall not during the
License Term market, sell, develop, or assist in the development for the
use, manufacture, distribution of products having the same Gene which is
part of a Product being Commercialized by Newco [*]
* Confidential Treatment Requested
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11.2 If an Independent Third Party desires that TGEN shall, in connection with
the development of a Product, apply Gene Delivery Technologies to such
party's proprietary Gene or to a TGEN Proprietary Gene that is not
incorporated into a Product developed or under development by Newco, then:
(a) TGEN, Elan and Newco shall determine in their reasonable and good
faith judgment whether Newco is capable of developing such Product or
acquiring and assimilating Drug Delivery Technologies necessary to
develop such Product within the time period required by such
Independent Third Party.
(b) In the event that
(i) the Elan Intellectual Property or Newco Technology is not
applicable to such proposed Product, or
(ii) Newco cannot, within the time period required by such
Independent Third Party, acquire and/or assimilate the Drug
Delivery Technologies necessary to develop such Product, or
(iii) such Independent Third Party is unwilling to enter into an
agreement with Newco for development of such Product, or (iv)
the Management Committee, acting in good faith, determines that
Newco should not develop such Product,
TGEN may, at its sole discretion, enter into and perform such an
agreement with such Independent Third Party.
(c) In the event Newco desires to develop such Product and (i) the Elan
Intellectual Property or Newco Technology is applicable to such
proposed Product, or Newco can, within the time period required by
such Independent Third Party, acquire and/or assimilate the Drug
Delivery Technologies necessary to develop such Product, and (ii) such
Independent Third Party is willing to enter into an agreement with
Newco for development of such Product, TGEN may not enter into such an
agreement with such Independent Third Party to the extent doing so
would be otherwise prohibited by TGEN's agreement under Section 11.1
above.
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12. TERM AND TERMINATION OF AGREEMENT
12.1 The term of this Agreement and the term of the Licenses granted hereunder
with respect to a Product utilizing or based on the Licensed Technologies
shall commence as of the Effective Date and continue, on a Product-by-
Product basis and country by country basis, for the life of the patent
rights upon which such Product is based or which such Product utilizes in
such country (the "Term"); provided, however, that all royalty and fee
obligations contained herein shall survive for the greater of (i) the Term
or (ii) 15 years from the first commercial sale of such Product.
12.2 Except as otherwise provided in Section 11 hereof, nothing contained herein
shall obligate or restrict any party from utilizing public, non-proprietary
information which is not subject to the protection of applicable patent
laws.
12.3 If either Party materially breaches any provision of this Agreement and if
such breach is (i) not capable of being cured or (ii) is capable of being
cured but is not cured within sixty (60) days after the non-breaching party
gives written notice of the breach to the breaching party, the non-
breaching party may terminate this Agreement immediately by giving notice
of the termination, effective on the date of the notice, provided, however,
-------- -------
that (x) if any such curable breach is not capable of being cured within
such sixty (60) day period, so long as the breaching party commences to
cure the breach promptly after receiving notice of the breach from the non-
breaching party and thereafter diligently prosecutes the cure to completion
as soon as is practicable, the non-breaching Party may not terminate this
Agreement so long as the breaching party is acting in good faith to rectify
such breach and (y) if there is a good faith dispute as to the existence
of the breach or as to its materiality, or regarding the amount of any
required payment, provided, in the case of disputes as to the amount due,
that any undisputed amount is paid, the right of the non-breaching Party to
terminate this Agreement shall be stayed for a reasonable period during
which a good faith resolution of the dispute will be obtained, either by
agreement or, failing that, through the dispute resolution provisions under
Clause 19 of the Development Agreement.
12.4 In the event that a Change of Control Event shall occur, at the sole option
of Elan and upon written notice to TGEN and Newco, the Elan License shall
be terminated. Upon written notice from TGEN to Elan of a proposed Change
of Control Event or the occurrence of a Change of Control Event, Elan shall
have thirty (30) days from such notice or occurrence to provide written
notice to TGEN as to whether it intends to terminate the Elan License
immediately. In
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the event Elan does not provide written notice to TGEN during such thirty
(30) day period of its intention to terminate the Elan License, such
termination right shall be deemed waived with respect to such proposed
Change of Control Event or such occurrence of a Change of Control Event.
12.5 In the event that the Elan License Agreement shall be terminated, at the
sole option of TGEN and upon written notice to Elan and Newco, the TGEN
License shall be immediately terminated.
12.6 Upon the occurrence of an Event of Bankruptcy with respect to Newco or
TGEN, the other Party may, upon written notice to TGEN and the Party with
respect to which such Event of Bankruptcy has occurred, immediately
terminate the TGEN License. As used in this Clause 12.6, the term "Event
of Bankruptcy" relating to either Newco or TGEN shall mean:
12.6.1 the appointment of a liquidator, receiver, administrator, examiner,
trustee or similar officer for either Party or over all or a
substantial part of its assets under the law of any applicable
jurisdiction, including without limitation, Bermuda, the United
States of America or Ireland; or
12.6.2 An application or petition for bankruptcy, corporate re-
organization, composition, administration, examination, arrangement
or any other procedure similar to any of the foregoing under the
law of any applicable jurisdiction, including without limit,
Bermuda, the United States of America or Ireland (other than as
part of a bona fide restructuring or reorganization), is filed, and
is not discharged within forty-five (45) days, or if either Party
applies for or consents to the appointment of a receiver,
administrator, examiner or similar officer for it or all or a
material part of its assets, rights or revenues or the assets
and/or the business of either Party are for any reason seized,
confiscated or condemned.
12.7 Upon exercise of those rights of termination as specified in Clause 12.1
to Clause 12.6 inclusive or elsewhere within this Agreement, this
Agreement shall, subject to the other provisions of this Agreement, and
specifically subject to Section 12.8, automatically terminate forthwith
and be of no further legal force or effect.
12.8 Upon expiration or termination of this Agreement:
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12.8.1 any sums that were due from Newco to TGEN with respect to license
granted hereunder, including without limitation on Net Sales or on
Net Proceeds, in the Territory or in such particular country or
countries in the Territory (as the case may be) prior to the
expiration or termination of this Agreement as set forth herein
shall be paid in full within sixty (60) days after the expiration
or termination of this Agreement for the Territory or for such
particular country or countries in the Territory (as the case may
be);
12.8.2 any provisions clearly meant to survive termination or expiration
of this Agreement, including without limitation Section 7, shall
remain in full force and effect;
12.8.3 all representations, warranties and indemnities stated herein shall
insofar as are appropriate remain in full force and effect;
12.8.4 the rights of inspection and audit set out in Section 6 shall
continue in force for a period of one year;
12.8.5 termination or expiration of this Agreement for any reason shall
not release any Party hereto from any liability which, at the time
of such termination or expiration, has already accrued to the other
Party or to any third party beneficiary or which is attributable to
a period prior to such termination or expiration, including without
limitation claims for indemnification under Sections 8.3 - 8.5 or
9.7 arising from events, actions, omissions or liabilities that
existed at or prior to such termination or expiration, nor preclude
either Party or any third party beneficiary from pursuing all
rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Agreement;
12.8.6 all rights, licenses and sublicenses granted by TGEN in the TGEN
Intellectual Property pursuant to this Agreement shall cease for
the Territory or for such particular country or countries in the
Territory (as the case may be) and shall immediately revert to TGEN
and all TGEN Program Technology shall be deemed immediately
transferred and assigned to TGEN. Following such expiration or
termination, Newco may not thereafter use in the Territory or in
such particular country or countries in the Territory (as the case
may be) (a) any valid and unexpired TGEN Patents, (b) any TGEN
Intellectual Property that remains confidential or otherwise
proprietary to TGEN, and/or (c) Trademarks. All rights to Newco
Technology (other than Elan Program
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Technology and TGEN Program Technology) shall be transferred to and
jointly owned by Elan and TGEN. Rights of permitted Independent
Third Party sublicensees in and to the TGEN Intellectual Property
shall survive the termination or expiration of the license and
sublicense agreements granting said intellectual property rights to
Newco; and Newco, Elan and TGEN shall in good faith agree upon the
form most advantageous to Elan and TGEN in which the rights of the
sublicensor under any such sublicenses are to be held (which form
may include continuation of Newco solely as the holder of such
licenses or assignment of such rights to a third party or parties,
including an assignment to both Elan and TGEN). Any sublicense
agreement between Newco and such permitted sublicensee shall permit
an assignment of rights by Newco to Elan or TGEN, as the case may
be, and shall contain additional reasonable confidentiality
protections which an assignee shall reasonably require. Upon any
such assignment, TGEN shall enter into good faith negotiations with
TGEN with respect to additional reasonable confidentiality
protections which either party shall reasonably require.
13. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
13.1 Neither Party to this Agreement shall be liable for delay in the
performance of any of its obligations hereunder if such delay results from
causes beyond its reasonable control, including, without limitation, acts
of God, fires, strikes, acts of war, or intervention of a government
authority, non availability of raw materials, but any such delay or failure
shall be remedied by such Party as soon as practicable.
14. SETTLEMENT OF DISPUTES; GOVERNING LAW
14.1 Any dispute between the Parties arising out of or relating to this
Agreement will be subject to resolution in accordance with Clause 19 of the
Development Agreement, which is incorporated by reference and shall for
such purposes survive expiration or termination of the Development
Agreement.
14.2 This Agreement is construed under and ruled by the laws of the State of New
York, without regard to conflicts of law principles.
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15. ASSIGNMENT
15.1 This Agreement may not be assigned by either Party without the prior
written consent of the other, which consent shall not be unreasonably
withheld, conditioned or delayed, save that (i) either Party may assign
this Agreement to its Affiliate without such consent, provided that such
assignment does not have any adverse tax consequences on the other Party,
and (ii) TGEN may assign its rights and obligations hereunder in
connection with a sale of all or substantially all of the business of TGEN
to which the Definitive Documents relate, whether by merger, sale of stock,
sale of assets or otherwise (provided that, in the event of such
transaction, no intellectual property rights of any third party that is the
acquiring corporation in such transaction shall be included in the TGEN
Intellectual Property licensed hereunder). TGEN and Newco will discuss any
assignment by either Party to an Affiliate prior to its implementation in
order to avoid or reduce any additional tax liability to the other Party
resulting solely from different tax law provisions applying after such
assignment to an Affiliate. For the purpose hereof, an additional tax
liability shall be deemed to have occurred if either Party would be subject
to a higher net tax on payments made hereunder after taking into account
any applicable tax treaty and available tax credits than such Party was
subject to before the proposed assignment. Notwithstanding any assignment
hereof to an Affiliate, each Party will remain fully liable hereunder.
16. NOTICES
16.1 Any notice to be given under this Agreement shall be sent in writing in
English by registered airmail or telefaxed to the following addresses:
If to Newco at: Targeted Genetics Newco, Ltd.
c/o Targeted Genetics Corporation
0000 Xxxxx Xxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Executive Officer
Telefax: (000) 000-0000
If to TGEN to: Targeted Genetics Corporation
0000 Xxxxx Xxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Executive Officer
Telefax: (000) 000-0000
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with a copy to: Xxxxxxx Coie LLP
000-000/xx/ Xxxxxx X.X., Xxxxx 0000
Xxxxxxxx, Xxxxxxxxxx 00000-0000
Attention: Xxxxx X. Xxxxxxx, Esq.
Telefax: (000) 000-0000
If to Elan at: Elan Corporation plc
Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telefax: + 353 1 709 4124
with a copy to: Xxxxx & Xxxxxx LLP
1350 Avenue of the Americas
00/xx/ Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxxx X. Xxxxxx
Telefax: (000) 000-0000
or to such other address(es) and telefax numbers as may from time to time be
notified by either Party or TGEN to the other hereunder.
16.2 Any notice sent by mail shall be deemed to have been delivered within seven
(7) working days after dispatch and any notice sent by telex or telefax
shall be deemed to have been delivered within twenty four (24) hours of the
time of the dispatch. Notice of change of address shall be effective upon
receipt.
17. MISCELLANEOUS CLAUSES
17.1 No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the Party or third party
beneficiary charged with such waiver, and no waiver of any breach or
failure to perform shall be deemed to be a waiver of any other breach or
failure to perform or of any other right arising under this Agreement.
17.2 If any provision in this Agreement is agreed by the Parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under any
law that is applicable hereto, (i) such provision will be deemed amended to
conform to applicable laws so as to be valid and enforceable or, if it
cannot be so amended without materially altering the intention of the
Parties, it will be deleted, with
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effect from the date of such agreement or such earlier date as the Parties
may agree, and (ii) the validity, legality and enforceability of the
remaining provisions of this Agreement shall not be impaired or affected in
any way.
17.3 The Parties shall use their respective reasonable endeavors to ensure that
the Parties and any necessary third party shall execute and perform all
such further deeds, documents, assurances, acts and things as any of the
Parties hereto may reasonably require by notice in writing to the other
Party or such third party to carry into effect the provisions of this
Agreement.
17.4 This Agreement shall be binding upon and inure to the benefit of the
Parties hereto, their successors and permitted assigns and sub-licenses.
Elan shall be a third party beneficiary to this Agreement and shall have
the right (subject to the dispute resolution provisions of the Development
Agreement) to cause Newco to enforce Newco's rights against TGEN.
17.5 No provision of this Agreement shall be construed so as to negate, modify
or affect in any way the provisions of any other agreement between the
Parties unless specifically referred to, and solely to the extent provided,
in any such other agreement. In the event of a conflict between the
provisions of this Agreement and the provisions of the Development
Agreement, the terms of the Development Agreement shall prevail unless this
Agreement or the Development Agreement specifically provides otherwise.
17.6 No amendment, modification or addition hereto shall be effective or binding
on either Party unless set forth in writing and executed by a duly
authorized representative of each Party. Amendments hereto shall be subject
to the prior approval of TGEN, which approval, except as otherwise provided
herein, shall not be unreasonably withheld, conditioned or delayed.
17.7 This Agreement may be executed in any number of counterparts, each of which
when so executed shall be deemed to be an original and all of which when
taken together shall constitute this Agreement.
17.8 Each of the Parties undertakes to do all things reasonably within its power
which are necessary or desirable to give effect to the spirit and intent of
this Agreement.
17.9 Each of the Parties hereby acknowledges that in entering into this
Agreement it has not relied on any representation or warranty save as
expressly set out herein or in any document referred to herein.
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17.10 Nothing contained in this Agreement is intended or is to be construed to
constitute Elan, TGEN and Newco as partners, or to constitute any of
Elan, TGEN or Newco as an employee of any of the others. Neither Party
hereto nor Elan shall have any express or implied right or authority to
assume or create any obligations on behalf of or in the name of the other
Party hereto or Elan or to bind the other Party hereto or Elan to any
contract, agreement or undertaking with any third party.
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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of
the date first set forth above.
TARGETED GENETICS
CORPORATION
By: /s/ Xxxxxxx Xxxxxx
---------------------------------
Name: H. Xxxxxxx Xxxxxx
-------------------------------
Title: President & CEO
------------------------------
TARGETED GENETICS NEWCO, LTD.
By: /s/ Xxxxxxx Xxxxxx
---------------------------------
Name: H. Xxxxxxx Xxxxxx
-------------------------------
Title: President
------------------------------
AGREED TO:
ELAN PHARMACEUTICAL
TECHNOLOGIES,
a division of Elan Corporation, plc
By: /s/ Xxxxx Xxxxxx
---------------------------------
Name: Xxxxx Xxxxxx
-------------------------------
Title: Authorized Signatory
------------------------------
[TGEN LICENSE AGREEMENT EXECUTION PAGE]
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SCHEDULE 1
----------
TGEN Intellectual Property
[*]
* Confidential Treatment Requested
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SCHEDULE 2
----------
TGEN Exceptions and Disclosures
[*]
* Confidential Treatment Requested
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