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EXHIBIT 10.8
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4),
200.83 AND 240.24B-2
LICENSE AGREEMENT
BY AND BETWEEN
ORASENSE LTD
A BERMUDA LIMITED COMPANY
AND
ISIS PHARMACEUTICALS, INC.
A DELAWARE CORPORATION
APRIL 20, 1999
2
TABLE OF CONTENTS
SECTION PAGE
1. DEFINITIONS..........................................................................1
2. GRANT OF RIGHTS......................................................................9
3. IMPROVEMENTS AND AFTER ACQUIRED TECHNOLOGY..........................................13
4. DEVELOPMENT OF PRODUCTS.............................................................14
5 REGULATORY APPROVALS................................................................15
6 FINANCIAL PROVISIONS................................................................15
7 CONFIDENTIAL INFORMATION............................................................19
8 WARRANTIES/INDEMNITIES..............................................................21
9. INTELLECTUAL PROPERTY OWNERSHIP RIGHTS..............................................25
10. RIGHTS EXPLOITATION OUTSIDE THE FIELD...............................................26
11. NON-COMPETITION.....................................................................27
12. TERM AND TERMINATION OF AGREEMENT...................................................27
13. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE........................................30
14. SETTLEMENT OF DISPUTES; GOVERNING LAW...............................................30
15. ASSIGNMENT..........................................................................30
16. NOTICES.............................................................................31
17. MISCELLANEOUS CLAUSES...............................................................32
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LICENSE AGREEMENT dated as of March 31, 1999 between Orasense Ltd,. a Bermuda
limited company, and Isis Pharmaceuticals, Inc., a Delaware corporation.
RECITALS:
A. Contemporaneously herewith, Elan and Isis (capitalized terms used herein
are defined below) propose to enter 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 Orasense.
B. Isis 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 drug delivery technologies and
drug products.
C. Orasense desires to enter into this Agreement with Isis so as to permit
Orasense to utilize the Isis Intellectual Property in the research,
development, manufacture, distribution and sale of the Products in the
Field and in the Territory.
D. Elan, EIS and Isis entered into a letter agreement dated March 31, 1999
(the "Letter Agreement") pursuant to which they agreed to enter into
definitive documents, including this Agreement, and the Elan License
Agreement relating to Orasense's use of the Elan Intellectual Property.
NOW THEREFORE IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS; INTERPRETATION.
A. Definitions. In this Agreement, the following definitions shall
apply:
1.1. "Affiliate" shall mean, with respect to Elan or Isis, any
corporation or entity other than Orasense (and entities controlled by it)
controlling, controlled or under the common control of Elan or Isis, as the case
may be, and, with respect to Orasense, any corporation or entity under control
of Orasense. A corporation or non-corporate entity shall be regarded as in
control of another corporation if it owns or directly or indirectly controls at
least 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 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. "cGCP", "cGLP" and "cGMP" shall mean current Good Clinical
Practices, current Good Laboratory Practices and current Good Manufacturing
Practices respectively;
1.4. "Change of Control" shall mean, with respect to a Party, the
acquisition of
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fifty percent (50%) or more of its voting securities, the ability, by contract
or otherwise, to control the board of directors or management of any such
entity, or a sale of all or substantially all of the business of such Party to
which the Definitive Documents relate, whether by merger, sale of stock, sale of
assets or otherwise;
1.5. "Commercialization" shall mean the manufacture, promotion,
distribution, marketing and sale of the Products;
1.6. "Competitive Change of Control Event" shall mean that a Primary
Technological Competitor of Elan acquires directly or indirectly voting stock or
equivalent securities in Isis or Orasense representing [...***...] percent or
more of the stock which carries entitlement to vote, or a Primary Technological
Competitor of Elan acquires by all or substantially all of the business of Isis
or Orasense to which the Definitive Documents relate, whether by merger, sale of
stock, sale of assets or otherwise;
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
third party;
1.8. "Cost of Living Increase" shall mean, with respect to any year of
the Term, any increase in the Consumer Price Index published by the Bureau of
Labor Statistics of the United States Department of Labor, All Urban Consumers,
United States City Average, All Items (1982/84=100);
1.9. "Definitive Documents" shall have the same meaning as given to the
term "Transaction Documents" in the Development Agreement;
1.10. "Development Agreement" shall mean the Joint Development and
Operating Agreement of even date entered into among Isis, Elan, EIS and
Orasense;
1.11. "Development Candidate" shall mean [...***...] antisense inhibitor
of TNF-(alpha), as more specifically detailed in Exhibit A hereto;
1.12. "Development Product" shall mean any product containing as an
active ingredient the Development Candidate (or a Substituted Development
Candidate) in an Oral formulation for humans;
1.13. "Effective Date" shall mean the date of execution and delivery of
the Definitive Documents;
1.14. "EIS" shall mean Elan International Services, Ltd., a Bermuda
limited company;
1.15. "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;
*CONFIDENTIAL TREATMENT REQUESTED
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1.16. "Elan Improvements" shall mean any improvements to the Elan
Patents and Elan Know-How developed by Elan (other than pursuant to the Research
and Development Program). Subject to contractual restrictions, Elan Improvements
shall be deemed part of and shall be included in the term "Elan Intellectual
Property" and shall be deemed, immediately upon development by Elan, to be
included in the license of the Elan Intellectual Property hereunder. If the
inclusion of an Elan Improvement in the license of Elan Intellectual Property is
restricted or limited by a third party agreement, Elan shall use reasonable
commercial efforts to exclude or where applicable minimize any such restriction
or limitation;
1.17. "Elan Intellectual Property" shall mean the Elan Know-How, the
Elan Patent Rights and/or the Elan Improvements. Examples of the Elan
Intellectual Property existing as of the Effective Date include, but are not
limited to, technology related to the modification of the solubility, intrinsic
dissolution, stability and/or permeability of a drug or modification of the
surface(s) of particles, pharmaceutical formulation excipient technology,
formulation, scale-up and manufacturing know-how. Schedule 1 to the Elan License
Agreement shall contain, by way of illustration but not limitation, examples of
Elan Intellectual Property. For the avoidance of doubt, Elan Intellectual
Property shall consist of Oral drug delivery technology Controlled by Elan doing
business as Elan Pharmaceutical Technologies and shall exclude (a) the Excluded
Elan Technology, as such term is defined in the Elan License Agreement, (b)
inventions, patents and know-how Controlled by all other affiliates or
subsidiaries of Elan, including, but not limited to the Elan Pharmaceuticals
division which incorporates Athena Neurosciences, Inc., Carnrick Laboratories,
Targon Corporation and Neurex Corporation and (c) inventions, patents and
know-how that are subject to contractual obligations of Elan to third parties as
of the Effective Date to the extent the licensing of such inventions, patents
and know-how is restricted or limited;
1.18. "Elan Know-How" shall mean any and all rights Controlled by Elan
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 Oral drug delivery;
1.19. "Elan License" shall have the meaning set forth in Section 2.1 of
the Elan License Agreement;
1.20. "Elan License Agreement" shall mean that certain license
agreement, of even date herewith, entered into between Elan and Orasense;
1.21. "Elan Patents" shall mean any and all patents and patent
applications Controlled by Elan, existing and/or pending as of the Effective
Date or hereafter filed or obtained relating to Oral drug delivery technology
Controlled by Elan on the Effective Date. Elan Patent Rights shall also include
all extensions, continuations, continuations-in-part,
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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;
1.22. "Elan Program Technology" shall mean all Program Technology solely
conceived or made by Elan and/or its agents;
1.23. "Excluded Isis Technology" shall mean any Isis [...***...]
technology including, without limitation, [...***...];
1.24. "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;
1.25. "Field" shall mean the research, development and Commercialization
of in an Oral Platform for delivery of Oligonucleotide Drugs;
1.26. "Full Time Equivalent Rate" shall mean, for the services proposed
to be rendered by Isis, $[...***...] for developmental chemistry (including
pharmaceutics) and $[...***...] for all other services (including pharmacology,
toxicology, clinical work, etc.);
1.27. "Independent Third Party" shall mean any person other than
Orasense, Isis, Elan or any of their respective Affiliates;
1.28. "In market" shall mean sales of Products whether by Orasense 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;
1.29. "Isis" shall mean Isis Pharmaceuticals, Inc., a Delaware
corporation;
1.30. "Isis Delivery Know-How" shall mean any and all rights Controlled
by Isis 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 Oral Oligonucleotide drug delivery;
1.31. "Isis Delivery Patents" shall mean any and all patents and patent
applications Controlled by Isis, existing and/or pending as of the Effective
Date or hereafter filed or obtained relating to Oral drug delivery technology
Controlled by Isis on the Effective Date. Isis Delivery 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;
*CONFIDENTIAL TREATMENT REQUESTED
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1.32. "Isis Delivery Technology" shall mean Isis Delivery Patents, Isis
Delivery Know-How and Isis Improvements with respect thereto. Schedule 1A
contains by way of illustration but not limitation, examples of existing Isis
Delivery Technology;
1.33. "Isis Development Candidate Know-How" shall mean any and all
rights Controlled by Isis to any discovery, invention (whether or not
patentable), know-how, substances, data, techniques, processes, systems,
formulations and designs which are necessary or useful for the manufacture or
Commercialization of the Development Product;
1.34. "Isis Development Candidate Patents" shall mean any and all
patents and patent applications Controlled by Isis, existing and/or currently
pending as of the Effective Date or hereafter filed or obtained relating to the
Development Candidate, or, if applicable, the Substituted Development Candidate,
Controlled by Isis on the Effective Date which are necessary or useful for the
manufacture or Commercialization of the Development Product. Isis Development
Candidate 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;
1.35. "Isis Development Candidate Technology" shall mean Isis
Development Candidate Patents, Isis Development Candidate Know-How and Isis
Improvements with respect thereto. Schedule 1B contains by way of illustration
but not limitation, examples of existing Isis Development Candidate Technology;
1.36. "Isis Improvements" shall mean any improvements to the Isis
Delivery Technology and Isis Development Candidate Technology developed by Isis
(other than pursuant to the Research and Development Program). Isis Improvements
shall be deemed part of and shall be included in the term "Isis Intellectual
Property" and shall be deemed, immediately upon development by Isis, to be
included in the license of the Isis Delivery Technology and Isis Development
Candidate Technology hereunder;
1.37. "Isis Intellectual Property" shall mean the Isis Delivery
Technology and the Isis Development Candidate Technology. For the avoidance of
doubt, Isis Intellectual Property shall exclude the Excluded Isis Technology.
1.38. "Isis License" shall have the meaning set forth in Section 2.2
hereof;
1.39. "Isis Oligonucleotide" shall mean any Oligonucleotide Drug
Controlled by Isis other than the Development Candidate;
1.40. "Isis Products" shall mean Products based upon Isis
Oligonucleotides that are made, designed, or otherwise created by or on behalf
of Isis or any of its Affiliates after the
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date hereof pursuant to the Project using the Orasense Technology and/or the
Licensed Technologies;
1.41. "Isis Program Technology" shall mean all Program Technology solely
conceived by Isis and/or its agents.
1.42. "Licensed Technologies" shall mean the Elan Intellectual Property
and the Isis Intellectual Property;
1.43. "Licenses" shall mean the Elan License and the Isis License;
1.44. "Lien" shall mean any and all liens, security interests,
restrictions, claims, encumbrances or rights of third parties of every kind and
nature;
1.45. "Management Committee" shall have the meaning given to such term
in the Development Agreement;
1.46. "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;
1.47. "Net Sales" shall mean the amount billed, invoiced and/or received
on sales of a Product sold by Orasense or its Affiliates or sublicensees 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 actually allowed, 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 paid for
and separately identified on 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 actually paid and 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
Orasense or its Affiliates or sublicensees in respect of Products, whether such
consideration is payment in kind, exchange or another form. If a Product is
provided to an Independent Third Party by Orasense or its Affiliates or
sublicensees without charge or provision of invoice and used by such Independent
Third Party, then Orasense or its Affiliates or sublicensees 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 Orasense and its
respective Affiliates or authorized licensees shall be excluded from the
computation of Net Sales. A "sale" of a Product is deemed to occur upon the
earlier of invoicing, shipment or transfer of title in the Product to an
Independent Third Party. For avoidance of doubt, Net Sales shall include
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royalties received by Orasense or its Affiliates from any Independent Third
Party in respect of Products;
1.48. "Oligonucleotide Drug" shall mean any single stranded, [...***...]
oligonucleotide including those [...***...] used as a human therapeutic and/or
prophylactic compound containIng between [...***...] nucleotides and/or
nucleosides including oligonucleotide analogs which may include [...***...]. For
purposes of this agreement, Oligonucleotide Drug shall specifically exclude
oligonucleotides used in [...***...], oligonucleotides used as [...***...] an
oligonucleotide, oligonucleotides used as [...***...] or oligonucleotides used
as adjuvants. Oligonucleotide Drug shall also specifically exclude polymers in
which the [...***...] but shall not exclude [...***...]. Should Isis develop
[...***...] oligonucleotides or should Elan independently discover drug delivery
technology it believes to be potentially applicable to [...***...]
oligonucleotides, then the Participants shall discuss in good faith whether such
oligonucleotides can be formulated for Oral delivery using the Oral Platform,
and whether such formulation appears feasible without requiring a significant
further investment in developing or enhancing the Oral Platform; if such
formulation appears feasible, the Participants shall discuss in good faith the
inclusion of such oligonucleotides as Oligonucleotide Drugs;
1.49. "Oral" shall mean administration by way of the mouth for the
purpose of topical or systemic delivery by way of the alimentary canal;
1.50. "Oral Delivery Devices" shall mean devices for delivering an
active agent orally such as those employing [...***...] technologies;
1.51. "Oral Platform" shall mean formulation and excipient systems and
technologies including [...***...] and including the use of [...***...], which
can be employed to develop dosage forms of Oligonucleotide Drugs, deliver said
dosage forms to the alimentary canal and facilitate and promote the systemic and
topical delivery of Oligonucleotide Drugs;
1.52. "Orasense" shall mean Orasense, Ltd., a Bermuda limited company;
1.53. "Orasense Program Technology" shall mean all Program Technology
other than Elan Program Technology and Isis Program Technology;
1.54. "Orasense Technology" shall mean all Program Technology and all
technology licensed or acquired by Orasense or developed by Orasense whether or
not
*CONFIDENTIAL TREATMENT REQUESTED
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pursuant to the Research and Development Program, excluding, however, Isis
Intellectual Property and Elan Intellectual Property;
1.55. "Participant" shall mean Elan or Isis, as the case may be.
"Participants" shall mean both Elan and Isis;
1.56. "Parties" shall mean Isis and Orasense;
1.57. "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;
1.58. "Plan" shall mean the business plan and program of development
agreed to by Elan and Isis within sixty (60) days of the date hereof, with
respect to the research, development, prosecution and commercialization of the
Products, which Plan shall be reviewed and mutually agreed to in writing by Elan
and Isis on an annual basis;
1.59. "Primary Technological Competitor of Elan" shall have the meaning
given to such term in the Elan License Agreement;
1.60. "Project" shall mean all activity as undertaken by Elan, Isis and
Orasense to develop the Products in accordance with the Plan;
1.61. "Product" shall mean any Oligonucleotide Drug under development or
developed by or on behalf of Orasense in an Oral formulation for administration
to humans;
1.62. "Program Technology" shall mean all technology developed by or on
behalf of Orasense, whether by Elan, Isis, a third party or jointly by any
combination thereof, pursuant to the Research and Development Program;
1.63. "Regulatory Authority" shall mean any regulatory authority outside
the United States of America, the approval of which is necessary to market a
Product;
1.64. "Research and Development Program" shall have the same meaning as
ascribed to such term in the Development Agreement;
1.65. "Research Term" shall mean the period commencing on the Effective
Date and continuing for a period of [...***...] thereafter, unless extended by
the mutual writTen agreement of Elan and Isis; 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
[...***...], then the other Participant at its option, may extend the duration
of the Research Term by a term equal in length to the period during which the
first Participant was unable to perform its obligations hereunder;
*CONFIDENTIAL TREATMENT REQUESTED
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1.66. "Technological Competitor of Elan" shall have the meaning given to
such term in the Elan License Agreement;
1.67. "Technological Competitor of Isis" shall mean any entity listed on
Schedule 2 hereto, subject to amendment from time to time upon mutual written
agreement of Orasense, Isis and Elan;
1.66. "Term" shall have the meaning given to it in Clause 12 below;
1.67. "Territory" shall mean all the countries of the world;
1.68. "Third Party Oligonucleotide Drug" shall mean any Oligonucleotide
Drug Controlled by an Independent Third Party, other than an Isis
Oligonucleotide Drug;
1.69. "Third Party Product" shall mean Products based upon Third Party
Oligonucleotide Drug that are made, designed, or otherwise created by or on
behalf of an Independent Third Party after the date hereof pursuant to the
Project using the Orasense Technology and/or the Licensed Technologies. For
avoidance of doubt, any Product based upon an Oligonucleotide Drug jointly
developed by an Independent Third Party and Isis other than pursuant of the
Program shall be deemed to be an Isis Product;
1.70. "Trademark" shall mean the trademark(s) belonging to Isis as may
be selected by Orasense or its permitted sub-licensees, with Isis's consent, for
use in connection with the Products.
1.71. "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:
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 or Schedule shall, unless otherwise
specifically provided, be to a Clause 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. Subject to the terms and conditions contained herein and, in
consideration of the payments specified in Clause 6.1(i), Isis hereby grants to
Orasense for the Term a non-
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exclusive license, including the limited right to grant sublicenses pursuant to
Clause 2.6 hereof, to the Isis Delivery Technology within the Field for the
Territory, solely to research, develop, manufacture, have manufactured, and
Commercialize the Products in the Territory, subject to any contractual
obligations of Isis to Independent Third Parties as of the Effective Date and,
unless prohibited by the paragraph below titled Non Competition, contractual
obligations to Independent Third Parties that Isis may enter into after the
Effective Date.
2.2. Subject to the terms and conditions contained herein and, in
consideration of the payments specified in Clause 6.1(i), Isis hereby grants to
Orasense for the Term an exclusive license in the Territory of Isis's rights in
the Isis Development Candidate Technology to manufacture and Commercialize the
Development Candidate, or if applicable, the Substituted Development Candidate,
in an Oral formulation for administration to humans, subject to any contractual
obligations of Isis to Independent Third Parties as of the Effective Date. The
licenses granted by Isis pursuant to Sections 2.1 and 2.2 are hereafter referred
to as the "Isis License".
2.3. In the event, as of the Effective Date, the Isis License granted to
Orasense hereunder is restricted or limited by any contractual obligations of
Isis to Independent Third Parties, then Isis shall use reasonable commercial
efforts to exclude or, where applicable, to minimize any such restriction or
limitation. Except as expressly provided herein, all proprietary rights and
rights of ownership with respect to the Isis Intellectual Property shall at all
times remain solely with Isis. Isis shall disclose to Orasense inventions made
by or on behalf of Isis in connection with the performance of the Project, any
patentable inventions and discoveries within the Isis Intellectual Property that
relate to the Field and any patentable Isis Improvements developed by or on
behalf of Isis.
2.4. To the extent royalty or other compensation obligations to
Independent Third Parties that are payable with respect to Isis Intellectual
Property would be triggered by a proposed use of Isis Intellectual Property in
connection with the Project, Isis will inform Orasense and Elan of such royalty
or compensation obligation. If Orasense decides to utilize such Isis
Intellectual Property in connection with the Project, Orasense will be
responsible for the payment of such royalty or other compensation obligations
relating thereto.
2.5. Notwithstanding anything contained in this Agreement to the
contrary, Isis shall have the right, and subject to the paragraph below titled
Non-Competition, to fully exploit and grant licenses and sublicenses with
respect to the Isis Delivery Technology. Isis's rights to exploit and grant
licenses referred to in the immediately preceding sentence shall include the
right to research, develop, manufacture, license or Commercialize products.
2.6. Orasense shall not be permitted to (a) encumber any of its rights
under the Licenses or the Orasense Technology without the prior written consent
of Isis; (b) assign or sublicense any of its rights under the licenses for the
Licensed Technologies and the Orasense Technology without the prior written
consent of Isis, which consent may be withheld in Isis's sole discretion. Any
agreement between Orasense and any permitted third party for the
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development or exploitation of the Isis Intellectual Property shall require such
third party to maintain the confidentiality of all information concerning the
Isis Intellectual Property and shall provide that any Isis Improvements shall
belong to Isis and shall permit an assignment of rights by Orasense to Isis in
accordance with the terms of this Agreement. Orasense shall remain responsible
for all acts and omissions of any sub-licensee, as if they were acts and
omissions by Orasense. Rights of permitted third party sublicensees in and to
the Isis Intellectual Property shall survive the termination of the license and
sublicense agreements granting said intellectual property rights to Orasense;
and Orasense and Isis shall in good faith agree upon the form most advantageous
to Isis in which the rights of the sublicensor under any such sublicenses are to
be held (which form may include continuation of Orasense solely as the holder of
such licenses or assignment of such rights to a third party or parties,
including an assignment to Isis).
2.7. Orasense will use its reasonable commercial endeavours to exploit
the Elan Intellectual Property, the Isis Intellectual Property and Orasense
Technology in accordance with this Agreement, the Elan License Agreement and the
Plan. Orasense shall employ diligent efforts to research, develop, register, and
Commercialize the Products in the Territory. Orasense shall employ or have
employed on its 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 manufacturers for products of similar market potential in that
country in the Territory, and (ii) sufficient with respect to the potential for
that country to fully exploit the market potential for the Product as depicted
in the Plan and as determined by the Management Committee in accordance with the
Development Agreement.
2.8. Orasense will be solely responsible for ensuring that it or its
sublicensees manufacture and Commercialize the Products within each country of
the Territory strictly in accordance with all the legal and regulatory
requirements of each country of the Territory.
2.9. Upon the request of Orasense and with the consent of Isis, Isis
shall grant to Orasense 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:
2.9.1 Orasense shall as soon as it becomes aware of any infringement
give to Isis in writing full particulars of any use or
proposed use by any other person, firm or company of a trade
name or trademark or promotional or advertising activity which
may constitute infringement.
2.9.2 If Orasense 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 of another party or
that the Trademark is otherwise attacked or attackable,
Orasense shall immediately give to Isis full particulars in
writing thereof and shall make no comment or admission to any
third party
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in respect thereof.
2.9.3 Isis 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 infringement or
alleged infringement of such Trademark or any other claim or
counter-claim brought or threatened in respect of the use or
registration of such Trademark. Any such proceedings shall be
conducted at Isis's expense and for its own benefit.
2.9.4 Nothing contained in this Agreement shall grant to Orasense
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 granted herein. At
no time during or after the term of this Agreement shall
Orasense challenge or assist others to challenge any such
Trademark or the registration thereof or attempt to register
any trademarks, marks, or trade names confusingly similar to
any such trademark. All displays of any such Trademark that
Orasense intends to adopt shall first be submitted to Isis for
approval (which shall not be unreasonably withheld) of design,
color, and other details, or shall be exact copies of those
used by Isis. In addition, Orasense shall fully comply with
all reasonable guidelines, if any, communicated by Isis
concerning the use of any such Trademark as well as all rules
and regulations of such use throughout the Territory.
2.9.5 The rights granted to Orasense under this Article 2.9 shall
automatically terminate respect to a Product in a country in
the Territory upon termination of Orasense's right to market
such Product in any such country.
2.10. When packaged, and to the extent permitted by law, a product label
shall include an acknowledgement that the Product is made under license from
Isis. Such acknowledgement shall take into consideration regulatory requirements
and Orasense's reasonable commercial requirements. Orasense shall wherever
possible give due acknowledgement and recognition to Isis in all printed
promotional and other material regarding the Product such as stating that the
Product is under license from Isis and that the applicable Isis Intellectual
Property has been applied to the Products. Orasense shall consult with and
obtain the written approval of Isis 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 Isis Intellectual Property, such
approval not to be unreasonably withheld or delayed. The further consent of Isis
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 Isis.
2.11. Isis shall have the first option to manufacture the active
ingredient of the
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Development Product for Orasense and meet its requirements, and Orasense shall
agree to utilize Isis as its sole supplier, subject to the customary terms and
conditions contained in a supply agreement to be executed by the parties at a
price equal to [...***...]. If, despite good faith negotiations, Isis and
Orasense do not reach agreement on the terms of such manufacturing agreement
within [...***...] from the Parties' commencement of discussion of such terms,
then Orasense shall be free to offer a third party (other than a Technological
Competitor of Isis unless consented to by Isis which consent may be withheld for
any reason, and otherwise subject to the terms and conditions of this Agreement)
terms to manufacture the active ingredient of the Development Product in the
Territory, which terms when taken as a whole, are more favorable to Orasense
than the principal terms of the last written proposal offered to Orasense by
Isis, or by Orasense to Isis, as the case may be. Subject to the foregoing
rights of Isis with respect to the Development Product, Orasense shall not be
permitted to contract the manufacture or Commercialization of any Product
without the prior written consent of Elan and Isis, which consent will not be
unreasonably withheld or delayed; provided that such reasonableness standard, in
the case of Elan, shall not be applicable in the case of a proposed sublicense
to any Technological Competitor of Elan and in the case of Isis, shall not be
applicable in the case of a proposed sublicense to any Technological Competitor
of Isis.
3. IMPROVEMENTS AND AFTER ACQUIRED TECHNOLOGY
3.1 Isis Improvements shall be deemed, immediately upon development, to
be included in the license of the Isis Intellectual Property granted to Orasense
hereunder.
3.2 The Isis License specifically excludes any right to use Isis
Improvements outside of the Field.
3.3 If the inclusion of an Isis Improvement in the license of Isis
Intellectual Property granted to Orasense hereunder is restricted or limited by
a third party agreement, then Isis 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 Isis Improvements developed
by Orasense, Isis or any third party shall be the property of Isis. Orasense,
Isis and any such third party shall execute and deliver documents, and take such
other actions as Isis may reasonably request, to effect or evidence such
ownership.
3.5 If Isis acquires know-how or patent rights relating to the Field, or
if Isis acquires or merges with an Independent Third Party that has know-how or
patent rights relating to the Field, then Isis shall offer to license such
know-how and patent rights to Orasense (subject to existing contractual
obligations), on such terms as would be offered to an Independent Third Party
negotiating in good faith on an arms-length basis, and if the Management
Committee determines that Orasense should not acquire such license, then Isis
*CONFIDENTIAL TREATMENT REQUESTED
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shall be free to fully exploit such know-how and patent rights, and to grant to
third parties licenses and sublicenses with respect thereto.
4. DEVELOPMENT OF PRODUCTS
4.1 During the Research Term, Orasense will diligently pursue the
research and development of the Elan Intellectual Property, Isis Intellectual
Property and Orasense Technology in accordance with the Research and Development
Program. The objectives of this initial phase of the Research and Development
Program will be (a) to develop the Oral Platform, and (b) to develop the
Development Product.
4.2 The results of Orasense's research pursuant to the Research and
Development Program shall be shared with Isis and, in the event Isis utilizes
such data in connection with a product based upon the Development Candidate in a
non-Oral formulation and includes such data in any regulatory submission and the
use of such data substantially enhances such application, and a product which is
the subject of such application is Commercialized, Isis agrees to negotiate in
good faith reasonable compensation to Orasense for the use of such data.
4.3 Isis agrees to provide at Orasense's cost such amounts of the Isis
Oligonucleotide Drugs designated by Isis as [...***...] and [...***...] as
Orasense shall require for testing and research purposes only; provided however,
that no clinical studies on humans may be performed utilizing [...***...].
4.4 Orasense will diligently pursue the research, development and
Commercialization of the Development Product and other Products in accordance
with the Plan, this Agreement, the Elan License Agreement and the Development
Agreement.
4.5 In the event the Management Committee, by unanimous vote of its
members, shall determine that preclinical toxicology or pharmacology studies
indicate that clinical trials of the Development Candidate should not be
undertaken, or the Management Committee determines that development of the
Development Candidate is not economically viable, Isis in good faith shall
offer, and the Management Committee, by unanimous vote of its members shall
approve, an Isis Oligonucleotide in pre-clinical development that it deems
economically viable as a Substituted Development Candidate, subject to the
agreement of the Participants, negotiating in good faith, to changes concerning
the budget, Plan and funding of Orasense.
4.6 Except as otherwise provided herein, upon designation of an Isis
Oligonucleotide as a Substituted Development Candidate, (i) all rights to the
Development Candidate shall revert to Isis and (ii) all provisions contained
herein other than in the preceding clause (i) relating to the Development
Candidate shall be deemed to apply to the Substituted Development Candidate as
if it were the Development Candidate.
*CONFIDENTIAL TREATMENT REQUESTED
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5 REGULATORY APPROVALS
5.1 Orasense shall, or shall cause its sublicensees, at its or their
sole cost file and shall use its reasonable best efforts to prosecute to
approval or cause its sublicensees to prosecute to approval, the Marketing
Authorizations for the Products in the Territory in accordance with the Plan.
During any Marketing Authorization registration procedure, Orasense shall keep
Isis promptly and fully advised of Orasense's registration activities, progress
and procedures. Each Party shall inform the other Party and Isis 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
Orasense, remain the property of Orasense, provided that Orasense shall allow
Isis access thereto to enable Isis to fulfill its obligations and exercise its
rights under this Agreement and the Development Agreement. Orasense shall
maintain or cause its sublicensees to maintain such Marketing Authorizations at
its or their own cost.
5.3 Orasense shall indemnify and hold harmless Isis, its agents and
employees from and against all claims, damages, losses, liabilities and expenses
to which Isis, its agents, and employees may become subject related to or
arising out of Orasense'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 Isis Patents, Orasense shall
pay to Isis, and, in consideration for license to Isis of Orasense Technology in
connection with the Commercialization of Isis Products, Isis shall pay to
Orasense, the following amounts:
6.1.1 Development Product Fees and Royalties. Payments to Isis
with respect to services rendered in connection with the Development
Product shall be paid as provided below and net proceeds derived by
Orasense from the Development Product shall be allocated as additional
royalties in proportion to [...***...], as more particularly or as
otherwise set forth below.
(a) Development Work - Research and development work
performed during the Research Term pursuant to the Research and
Development Program regarding the Oral Platform and the Development
Candidate contracted by Orasense to Isis shall be payable by Orasense to
Isis based on [...***...] at Isis's Full Time Equivalent Rate, with
annual Cost of Living Increases. In the event Isis is required to
perform additional research and development work beyond that
*CONFIDENTIAL TREATMENT REQUESTED
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contemplated during the Research Term (without any extensions thereto),
Orasense shall pay to Isis [...***...].
(b) Milestone Payments - If any Independent Third Party shall
make milestone payments (e.g., for NDA filing, approvals, etc.) to
Orasense, Orasense shall pay to Elan and Isis an additional royalty in
the amount of [...***...].
(c) Royalties payable to Isis Upon Sales of the Development
Product - Isis shall receive royalties of [...***...] of the In-market
Net Sales of Development Products by OraseNse or its sublicensees.
Notwithstanding the foregoing, in no event shall royalties payable to
[...***...] with respect to sales of the Development Product
[...***...].
6.1.2 Isis Product Fees and Royalties. Net proceeds derived by
Orasense from Isis Products shall be allocated between the Participants
as additional royalties in proportion to [...***...], as more
particularly or as otherwise set forth below.
(a) Milestone Payments - If any Independent Third party shall
make milestone payments (e.g., for NDA filing, approvals, etc.) to Isis
with respect to an Isis Product, then [...***...] of such milestone
payment shall be paid to Orasense by Isis as an additional royalty and
Orasense shall pay a royalty equal in such amount to Elan; provided
however, that development related milestone payments with respect to any
Isis Product shall not be payable by Isis to Orasense or by Orasense to
Elan except to the extent such payments exceed [...***...] with respect
to such Isis Product (or, in the event the milestone is intended to be
applied towards future work to be performed by Isis, in excess of
[...***...].
(c) Royalty Payments. Any marketing and/or development agreement
between Orasense and Isis with respect to Isis Products shall provide
for a royalty payment by Isis to Orasense of [...***...] of In-market
Net Sales of the Isis Products. At such time as royalty payments by Isis
to Orasense shall equal [...***...] for the particular Isis Product
subject to any such agreement, the royalty payable by Isis to Orasense
with respect to In-market Net Sales of the Isis Product shall be
[...***...] and the royalty payable by Orasense to Elan with respect to
such Isis Product shall be [...***...] of In-market Net Sales of such
Isis Product.
6.1.3 Third Party Products. Payments to Isis with respect to
services
*CONFIDENTIAL TREATMENT REQUESTED
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rendered in connection with Third Party Products shall be paid as
provided below and net proceeds derived by Orasense from Third Party
Products shall be allocated as additional royalties with [...***...] of
such amount being paid to Elan and [...***...] to Isis, as more
particularly or as otherwise set forth below set forth below; provided,
however, that in the event [...***...] significantly contributes to the
research And development work related to a Third Party Product, the
Participants shall negotiate in good faith an appropriate adjustment to
the allocation of such additional royalties to reflect their relative
contributions to the development of such Third Party Product.
(a) Development Work - Research and development work performed
by Isis for Orasense related to Third Party Products shall be payable
Isis at [...***...]. Orasense shall Pay to Isis an additional fee equal
to [...***...] of all amounts paid by an Independent Third Parties to
Orasense for development work to the extent the amounts paid to Orasense
for such work exceeds any charges by Elan and Isis; with the remaining
[...***...] of such excess amount being payable to Elan.
(b) Royalty Payments - In the event Orasense contracts
development work to Elan for any Third Party Product, Orasense shall pay
Isis, a royalty equal to [...***...] of the royalties it receives with
respect to such Product (with the remaining [...***...] of such
royalties payable to Elan) until such time as Elan has been paid a sum
equal to [...***...] paid to it. Thereafter, [...***...] of the
royalties received by Orasense With respect to such Third Party Product
shall be paid to Isis (with the balance payable to Elan).
(c) Milestone Payments - If any Independent Third Party shall
make milestone payments (e.g., for NDA filing, approvals, etc.) to
Orasense, then [...***...] of such milestone payment shall be paid by
Orasense to Elan as an additional royalty and [...***...] shall be paid
by Orasense to Isis as an additional royalty to Isis.
(d) Manufacturing and Supply of Products - In the event Orasense
contracts with Elan to manufacture Third Party Products, Orasense shall
pay to Isis an additional fee equal to [...***...] of all amounts paid
by an Independent Third Parties to Orasense for the manufacture of such
Third Party Products to the extent such amounts exceed the amount
previously charged by Elan; with the remaining [...***...] of such
excess amount being payable to Elan.
6.2 Payment of royalties pursuant to Clauses 6.1.2-6.1.4, 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 Isis and shall be
*CONFIDENTIAL TREATMENT REQUESTED
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nonrefundable to Orasense. Each payment made to Isis shall be accompanied by a
true accounting of all Products sold by Orasense, 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 or royalties
received by Orasense (and the calculation thereof) and each calculation of
royalties with respect thereto, including the calculation of all adjustments and
currency conversions.
6.3 Orasense 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 can be determined.
6.4 All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product or royalties received by Orasense with
respect to any Product 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 Orasense claims in good faith that one or more of its devices,
products, parts or components thereof, compounds and/or drug products does not
utilize, incorporate, apply or is not based on the Elan Intellectual Property,
the Isis Intellectual Property and/or Orasense Technology, then Orasense shall
immediately notify Isis in writing and establish same to Isis's reasonable
satisfaction.
6.6 If, at any time, legal restrictions in the Territory prevent the
prompt payment when due of royalties or any portion thereof, the Parties shall
meet to discuss suitable and reasonable alternative methods of reimbursing Isis
the amount of such royalties. In the event that Orasense 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 Isis's account in a bank acceptable to Isis in the country the
currency of which is involved or as otherwise agreed by the Parties.
6.7 Isis and Orasense 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.
6.8 Any taxes payable by Isis on any payment made to Isis pursuant to
this Agreement shall be for the account of Isis. If so required by applicable
law, any payment made pursuant to this Agreement shall be made by Orasense after
deduction of the appropriate withholding tax, in which event the Parties shall
co-operate to obtain the
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appropriate tax clearance as soon as is practicable. On receipt of such
clearance, Orasense shall forthwith procure that the amount so withheld is paid
to Isis.
6.9 Orasense shall, not more than once in each calendar year, permit
Isis or its duly authorized representatives upon reasonable notice and at any
reasonable time during normal business hours to have access to inspect and audit
the accounts and records of Orasense and any other book, record, voucher,
receipt or invoice relating to the calculation of the royalty payments on Net
Sales submitted to Isis. Any such inspection of Orasense's records shall be at
the expense of Isis, except that if any such inspection reveals a deficiency in
the amount of the royalty actually paid to Isis hereunder in any calendar
quarter of five percent (5%) or more of the amount of any royalty actually due
to Isis hereunder, then the expense of such inspection shall be borne solely by
Orasense. Any amount of deficiency shall be paid promptly to Isis by Orasense.
If such inspection reveals a surplus in the amount of royalties actually paid to
Isis by Orasense, Isis shall reimburse Orasense the surplus within fifteen (15)
days after determination.
6.10 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 24.9 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
Field, the Products, Elan Intellectual Property, Isis Intellectual Property or
the Orasense Technology, as the case may be, processes, services and 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 those employees, representatives and agents requiring knowledge
thereof in connection with their duties directly related to the fulfilling of
the Party's obligations under this Agreement. Each Party further agrees to
inform all such 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, and protection to 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
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documents and any copies thereof containing Confidential Information belonging
to or disclosed by, such Party.
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 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, provided that if a Party is required to make any such
disclosure of the other Party's Confidential Information, other than pursuant to
a confidentiality agreement, such Party shall inform the recipient 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.
7.4 Any breach of this Clause 7 by any of the Persons informed by one
of the Parties is considered a breach by the Party itself.
7.5 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;
(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;
(v) 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;
(vi) 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
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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.
7.6 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 but
shall not apply to any information which a Party is required to file or
otherwise disclose in accordance with requirements which are legally binding on
it.
7.7 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 Isis represents and warrants to Orasense that:
(a) Isis 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) Isis has full corporate power and authority enter into this
Agreement and to perform its obligations hereunder, which have been duly
authorized by
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all requisite corporate action of Isis. This Agreement is the valid and binding
obligation of Isis, 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 Isis of this
Agreement will not: (i) violate any provision of applicable law, statute, rule
or regulation known by and applicable to Isis or any ruling, writ, injunction,
order, judgment or decree of any court, arbitrator, administrative agency or
other governmental body applicable to Isis 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, or constitute (with notice or lapse of time or both) a default
(or give rise to any right of termination, cancellation or acceleration) under
the charter or organizational documents of Isis to which Isis is a party, except
where such violation, conflict or breach would not, individually or in the
aggregate, have an adverse material effect on the business, assets, liabilities
(contingent or otherwise), operations, condition (financial or otherwise), or
prospects of Isis;
(d) To Isis best knowledge, except as set forth on Schedule 3
hereto, (i) Isis has the right to grant the Isis License and any other rights
granted herein, (ii) Schedule 1 contains primary examples of the Isis
Intellectual Property existing as of the Effective Date, which listing is not
necessarily exhaustive, (iii) there are no agreements between Isis and any third
parties that conflict with the Isis License which would have a material adverse
effect on the ability of Orasense to conduct its business as presently proposed
to be conducted, (iv) Isis is the owner or licensee of all rights, title and
interest in the Isis Intellectual Property; and (v) Isis has no knowledge of any
pending or threatened action, suit, proceeding or claim by others challenging
Isis`s rights in or to such Isis Intellectual Property as related to the Field,
which would have a material adverse effect on the ability of Orasense to conduct
its business as presently proposed to be conducted.
8.2 Orasense represents and warrants to Isis the following:
(a) Orasense 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 Orasense), and Orasense is in compliance with all applicable laws,
rules, regulations or orders relating to its business and assets;
(b) Orasense 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 Orasense and is enforceable against Orasense in accordance
with its terms; and the execution, delivery and performance of this Agreement
and the transactions contemplated hereby will not violate
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or result in a default under or creation of lien or encumbrance under Orasense's
certificate of incorporation, by-laws or other organic documents, any material
agreement or instrument binding upon or affecting Orasense, or its properties or
assets or any applicable laws, rules, regulations or orders affecting Orasense
or its properties or assets;
(c) Orasense is not in default of its charter or by-laws, any
applicable laws or regulations or any material contract or agreement binding
upon or 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) Orasense represents and warrants to Elan that the execution
of this Agreement by Orasense and the full performance and enjoyment of the
rights of Orasense under this Agreement will not breach the terms and conditions
of any license, contract, understanding or agreement, whether express, implied,
written or oral between Orasense and any third party.
8.3 Orasense represents and warrants to and covenants with Isis that
it has the sole, exclusive and unencumbered right to grant the licenses and
rights herein granted to Isis and that it has not granted and will not grant any
option, license, right or interest in or to the Isis Intellectual Property, the
Orasense Technology, or other property to any third party which would conflict
with the rights granted by this Agreement and the Definitive Documents.
8.4 Orasense represents and warrants to and covenants and agrees with
Isis that 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.
8.5 Orasense represents and warrants to Isis that 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. Orasense 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.
8.6 In addition to any other indemnifications provided for herein,
Isis shall indemnify and hold harmless Orasense 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
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Orasense arising out of or in connection with any (a) breach of any
representation, covenant, warranty or obligation by Isis hereunder, or (b) any
act or omission on the part of Isis or any of its agents or employees in the
performance of this Agreement.
8.7 In addition to any other indemnifications provided for herein,
Orasense shall indemnify and hold harmless Isis 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 Isis arising out of or in connection with
any (a) breach of any representation, covenant, warranty or obligation by
Orasense hereunder, or (b) any act or omission on the part of Orasense or any of
its agents or employees in the performance of this Agreement.
8.8 The Party seeking an indemnity shall:
8.8.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
8.8.2 permit the indemnifying Party to take full care and control of
such claim or proceeding;
8.8.3 cooperate in the investigation and defense of such claim or
proceeding;
8.8.4 not compromise or otherwise settle any such claim or proceeding
without the prior written consent of the other Party, which
consent shall not be unreasonably withheld, conditioned or
delayed; and
8.8.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
8.9 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT,
NEITHER ISIS NOR ORASENSE SHALL BE LIABLE TO THE OTHER PARTY, OTHER 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, OR 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 OF ITS EMPLOYEES OR AGENTS OR
OTHERWISE
8.10 EXCEPT AS SET FORTH IN THIS CLAUSE 8, ISIS IS GRANTING THE ISIS
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.
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9. INTELLECTUAL PROPERTY OWNERSHIP RIGHTS
9.1 Subject to the terms and conditions of this Agreement, including,
without limitation Section 11 below, Orasense shall own the legal and equitable
title to the Orasense Technology.
9.2 Isis shall own the legal and equitable title to the Isis
Intellectual Property, including without limitation, Isis Improvements.
9.3 Orasense shall permanently ▇▇▇▇ or otherwise use reasonable
efforts to cause any third party to permanently ▇▇▇▇ 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 Isis Delivery Patents or Isis Development Candidate Patents for the
countries of the Territory and in such manner as Isis may reasonably request in
writing prior to the sale or commercial use thereof.
9.4 Isis, at its expense, shall make a good faith effort (i) to
secure the grant of any material patent applications within the Isis Delivery
Patents that relate to the Field and the Isis Development Candidate Patents;
(ii) to file and prosecute patent applications on material patentable inventions
and discoveries within the Isis Improvements that relate to the Field or the
Isis Development Candidate Patents; (iii) to defend all such applications
against third party oppositions; and (iv) to maintain in force any material
issued letters patent within the Isis Delivery Patents that relate to the Field
and the Isis Development Candidate Patents (including any letters patent that
may issue covering any such Isis Improvements that relate to the Field or the
Development Candidate). Isis shall have the right in its discretion to control
such filing, prosecution, defense and maintenance provided that Orasense 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.
9.5 In the event that Isis informs the Orasense and Elan that it does
not intend to file patent applications on patentable inventions and discoveries
within the Isis Intellectual Property that relate to the Field in one or more
countries in the Territory or fails to file such an application within a
reasonable period of time, Orasense shall have the option at its expense to file
and prosecute such patent application(s) in the joint names of Orasense and
Isis. Upon written request from Orasense, Isis shall execute all documents,
forms and declarations and to do all things as shall be reasonably necessary to
enable Orasense to exercise such option.
9.6 Orasense, Isis and Elan shall promptly inform each other in
writing of any alleged infringement of any patents within the Isis Patents or
any alleged misappropriation of trade secrets within the Isis Intellectual
Property by a third party of which it becomes aware and provide the others with
any available evidence of such infringement or misappropriation
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insofar as such infringements or misappropriation relate solely to the Field.
9.7 Orasense shall have the right to prosecute at its own expense and
for its own benefit any infringements of the Isis Patents or misappropriation of
the Isis Intellectual Property, insofar as such infringements or
misappropriation relate solely to the Field. In the event that Orasense takes
such action, Orasense shall do so at its own cost and expense. At Orasense's
request, Isis shall cooperate with such action. Any recovery remaining after the
deduction by Orasense of the reasonable expenses (including attorney's fees and
expenses) incurred in relation to such infringement proceeding [...***...].
Should Orasense 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 Isis may in its discretion initiate
such proceedings in its own name, at its expense and for its own benefit, and at
Isis's request, Orasense 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 Isis
Patents affects both the Field as well as other products being developed or
commercialized by Isis or its commercial partners outside the Field, Orasense
and Isis 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 Orasense shall indemnify, defend and hold harmless Isis, 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 Isis 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 Orasense, not to be unreasonably
withheld or delayed. At its option, Elan or Isis, as the case may be, may elect
to take over the conduct of such proceedings from Orasense provided that
Orasense's indemnification obligations shall continue; the costs of defending
such claim shall be borne by Elan or Isis, as the case may be and such
Participant shall not compromise or settle any such claim or proceeding without
the prior written consent of Orasense, such consent not to be unreasonably
withheld or delayed.
10. RIGHTS EXPLOITATION OUTSIDE THE FIELD
10.1 Licenses to Isis Program Technology. Orasense hereby grants to
Isis a perpetual, exclusive, royalty free and sublicensable license to Isis
Program Technology outside of the Field.
10.2 Licenses for Orasense Program Technology Outside the Field.
Orasense hereby grants to Isis a perpetual exclusive license for the use of
Orasense Program
*CONFIDENTIAL TREATMENT REQUESTED
26.
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Technology outside the Field in the Territory solely for use in connection with
Isis proprietary drug products (including drug products discovered or developed
in collaborative partnerships). The terms of such license for the use of
Orasense Program Technology shall be decided by the unanimous decision of the
Management Committee on such terms and conditions as the Management Committee
shall approve after good faith negotiations with Isis.
11. NON-COMPETITION
11.1. During the Research Term (and any extension thereto), Isis shall
not develop or Commercialize, or assist in the development or Commercialization
of Oligonucleotide Drugs in the Field or develop or Commercialize, or assist in
the development or Commercialization of an Oral Platform for systemic and
topical delivery of Oligonucleotide Drugs, except (a) for or on behalf of
Orasense, or (b) with the prior written, unanimous consent of the Management
Committee. During the Term and provided that Orasense is maintaining an active
program for the development and Commercialization of the Development Candidate
in the Field, Isis shall not develop or Commercialize or assist in the
development for Commercialization of an Oral TNF-(alpha) inhibitor, or, if a
Substituted Development Candidate is selected, an Oral inhibitor of the
Substituted Development Candidate. Nothing contained herein shall be construed
as (i) limiting the activities of an existing third party licensee of Isis from
developing Oligonucleotide Drugs utilizing Isis Delivery Technology to the
extent such rights have been previously granted by Isis, provided Isis does not
provide any active support to any such activities in excess of its existing
contractual obligations or (ii) prohibiting Isis from licensing Isis Delivery
Technology to an Independent Third Party or limiting the activities of any such
future Independent Third Party licensee of Isis from developing Oligonucleotide
Drugs utilizing Isis Delivery Technology; provided that the primary purpose of
any such license is not the development of an Oral Platform for Oligonucleotide
Drugs and Isis does not provide any active support to any such activities.
.
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 on or 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.
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12.2. 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 breaches any material 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 corrected 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 or (y) the default involves
a good faith dispute regarding the amount of any required payment, provided any
undisputed amount is paid, such default shall be stayed and the remainder may be
withheld for a reasonable period during which a good faith resolution of the
amount owed is being pursued.
12.4. In the event that the Elan License Agreement shall be terminated,
at the sole option of Isis and upon written notice to Elan and Orasense, the
Isis License shall be immediately terminated.
12.5. Upon the occurrence of an Event of Bankruptcy with respect to
Orasense or Elan, the other Party may, upon written notice to Isis and the Party
with respect to which such Event of Bankruptcy has occurred, immediately
terminate the Elan License. As used in this Clause 12.5, the term "Event of
Bankruptcy" relating to either Orasense or Elan shall mean:
12.5.1.the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of either Party of it or over
all or a substantial part of its assets under the law of any
applicable jurisdiction, including without limit, Bermuda, the United
States of America or Ireland; or
12.5.2 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 of it or of 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.
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12.6. Upon exercise of those rights of termination as specified in
Clause 12.1 to Clause 12.5 inclusive or elsewhere within this Agreement, this
Agreement shall, subject to the other provisions of this Agreement,
automatically terminate forthwith and be of no further legal force or effect.
12.7. Upon expiration or termination of the Agreement:
12.7.1 any sums that were due from Orasense to Isis with respect
to license granted hereunder, including without limitation on Net Sales, 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);
12.7.2 any provisions clearly meant to survive termination or
expiration of this Agreement, including without limitation Clause 7, shall
remain in full force and effect;
12.7.3 all representations, warranties and indemnities shall
insofar as are appropriate remain in full force and effect;
12.7.4 the rights of inspection and audit set out in Clause 6
shall continue in force for a period of one year;
12.7.5 termination of this Agreement for any reason shall not
release any Party hereto from any liability which, at the time of such
termination, has already accrued to the other Party or which is attributable to
a period prior to such termination nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement;
12.7.6 the Isis Intellectual Property and all rights, licenses
and sublicenses granted by Isis in and 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 Isis and all Isis Program
Technology shall be deemed immediately transferred and assigned to Elan.
Following such expiration or termination, Orasense 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 Isis Patents, (b) any Isis Intellectual
Property that remains confidential or otherwise proprietary to Isis, and/or (c)
Trademarks. All rights to Orasense Technology (other than Elan Program
Technology and Isis Program Technology) shall be transferred to and jointly
owned by Elan and Isis and may only be utilized by such parties royalty-free,
consistent with the other restriction contained in Section 10 of this Agreement
and the comparable section of the Elan License Agreement regarding the
limitation of such rights outside the Field. Rights of permitted Independent
Third Party sublicensees in and to the Isis Intellectual Property shall survive
the termination of the license and sublicense agreements granting said
intellectual property rights to Orasense; and Orasense, Elan and Isis
29.
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shall in good faith agree upon the form most advantageous to Elan and Isis in
which the rights of the sublicensor under any such sublicenses are to be held
(which form may include continuation of Orasense 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 Isis). Any sublicense agreement between Orasense and
such permitted sublicensee shall permit an assignment of rights by Orasense to
Isis and shall contain additional reasonable confidentiality protections which
an assignee shall reasonably require. Upon any such assignment, Elan and Isis
shall enter into good faith negotiations 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 24.9 of the
Development Agreement, which is incorporated by reference and shall for such
purposes survive 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 the conflict of law principles.
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) subject
to the rights of Elan under the Development Agreement upon the occurrence of a
Change of Control and the rights of Elan under the Elan License Agreement upon
the occurrence of a Competitive Change of Control Event, Isis may assign its
rights and obligations hereunder in connection with a sale of all or
substantially all of the business of Isis to which the Transaction 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 Isis Intellectual Property licensed hereunder). Isis and
Orasense 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
30.
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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 Orasense at: Orasense Ltd.
c/o Isis Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Telefax: (▇▇▇) ▇▇▇-▇▇▇▇
If to Isis to: Isis Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Telefax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to: Cooley Godward LLP
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: L. ▇▇▇ ▇▇▇▇▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Telefax: (▇▇▇) ▇▇▇-▇▇▇▇
If to Elan at: Elan Corporation plc
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇▇
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + ▇▇▇ ▇ ▇▇▇ ▇▇▇▇
Telefax: + 353 1 709 4124
31.
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with a copy to: ▇▇▇▇▇ & ▇▇▇▇▇▇ LLP
1350 Avenue of the ▇▇▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Telefax: (▇▇▇) ▇▇▇-▇▇▇▇
or to such other address(es) and telefax numbers as may from time to
time be notified by either Party 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 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 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 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 to cause Orasense to enforce Orasense's rights against Isis.
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
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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 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 Isis, which approval shall not be unreasonably withheld 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.
17.10. Nothing contained in this Agreement is intended or is to be
construed to constitute Elan, Isis and Orasense as partners, or Isis as an
employee of Orasense and Elan, or Orasense and Elan as an employee of Isis.
Neither Party hereto shall have any express or implied right or authority to
assume or create any obligations on behalf of or in the name of
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the other Party or to bind the other Party to any contract, agreement or
undertaking with any third party.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the
date first set forth above.
ISIS PHARMACEUTICAL, INC.
By: /s/ B. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
-----------------------
B. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Executive Vice President
ORASENSE LTD.
By: /s/ B. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
-----------------------
B. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
President
AGREED TO:
ELAN PHARMACEUTICAL TECHNOLOGIES,
A DIVISION OF ELAN CORPORATION, PLC
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇
-----------------------
▇▇▇▇▇ ▇▇▇▇▇▇
Authorized Signatory
[ISIS LICENSE AGREEMENT EXECUTION PAGE]
34.
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EXHIBIT A
DESCRIPTION OF DEVELOPMENT CANDIDATE
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
35.