1
EX. 10.19
CONFIDENTIAL TREATMENT HAS BEEN SOUGHT FOR
PORTIONS OF THIS EXHIBIT PURSUANT TO RULE 24B-2
UNDER THE SECURITIES EXCHANGE AC TO 1934, AS AMENDED.
THIS AGREEMENT is made the 22nd day of January 1998
BY AND BETWEEN
ELAN CORPORATION, PLC
An Irish company, of Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx
AND
ENDOREX VACCINE DELIVERY TECHNOLOGIES, INC.
A Delaware corporation of 000 Xxxxx Xxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxx 00000,
Xxxxxx Xxxxxx of America
LICENSE AGREEMENT
1
2
TABLE OF CONTENTS
CLAUSE NO. CLAUSE PAGE NO.
1 Definitions
2 Grant of Rights
3 Improvements
4 Intellectual Property Rights
5 Exploitation of Licensed Technology
6 Financial Provisions
7 Right of Audit and Inspection
8 Patents
9 Confidential Information
10 Trademarks
11 Term and Termination
12 Warranties/Indemnities
13 Insurance
14 Impossibility of Performance - Force Majeure
15 Settlement of Disputes; Proper Law
16 Assignment
17 Notices
18 Miscellaneous Clauses
2
3
WHEREAS
A. Elan is knowledgeable in the discovery, research, development,
manufacture and marketing of pharmaceutical formulations capable of
delivering drugs, including oral or mucosal Vaccine delivery. Elan owns
or has licensed the Elan Technology. Elan also owns and uses certain
trademarks in connection with the manufacture, marketing and sale of such
compounds, including the Elan Trademarks.
B. Orasomal has proprietary know-how and expertise relating, inter alia, to
immunology and is knowledgeable in the discovery, research, development,
manufacture and marketing of pharmaceutical formulations capable of
delivering drugs, including oral or mucosal Vaccine delivery. Orasomal
owns or has licensed the Orasomal Technology. Orasomal also owns and uses
certain trademarks in connection with the manufacture, marketing and sale
of such compounds, including the Orasomal Trademarks.
C. Elan and Endorex have agreed to co-operate in the establishment and
management of the Company, the business of which will be to research and
develop certain Products incorporating the technologies developed and/or
to be developed by Elan and Orasomal and to commercialize such Products
throughout the world.
D. Simultaneously herewith, Elan, Endorex and Orasomal are entering into the
Development Agreement for the purpose of recording the terms and
conditions of the joint venture and of regulating their relationship with
each other and certain aspects of the affairs of and their dealings with
the Company.
E. Under the Development Agreement, the Company shall own all rights in
technology developed pursuant to certain Research and Development
Programs being conducted or to be conducted by the Company or by Orasomal,
Elan or an Independent Third Party on behalf of the Company, including the
Company Program Technology, the Orasomal Program Technology and the Elan
Program Technology.
F. The Company desires to enter into this Agreement with Elan so as to (a)
permit the Company to utilize the Elan Patents, the Elan Know-How and the
Elan Trademarks in the research, development, manufacture, distribution
and sale of the Products in the Field and (b) to permit Elan to utilise
the Orasomal Program Technology, the Elan Program Technology and the
Company Program Technology in connection with (i) Elan's research and
development work on behalf of the Company and (ii) Elan's manufacturing
and supplying the Company or its designee(s) with the Products and other
components.
G. Simultaneously herewith, the Company and Orasomal are entering into a
similar license agreement relating to the Company's use of the Orasomal
Patents, the Orasomal Know-
3
4
How and the Orasomal Trademarks and Orasomal's use of the Elan Program
Technology, the Orasomal Program Technology and the Company Program
Technology.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS
1.1. In this present Agreement, including the Recitals, Schedules and
Appendices, the following definitions shall prevail unless the context
otherwise requires:
"ACQUIRED" means a transfer or license of a Patent, Know-How or other
forms of Intellectual Property Rights or information from an
Independent Third Party to Elan or Orasomal, as the case may
be, to the extent to which there are no obligations or
restrictions (such as confidentiality) in respect of that
information which prohibit disclosure to or use by the
Company;
"AFFILIATE" means any corporation or entity other than the Company
controlling, controlled or under the common control of Elan,
Orasomal or the Company as the case may be. For the purpose
of this definition, subject to the provisions of Clause
11.4. "control" shall mean direct or indirect ownership of
fifty percent (50%) or more of the stock or shares entitled
to vote for the election of directors;
"AGREEMENT" means this agreement (which expression shall be deemed to
include the Recitals, the Schedules and Appendices hereto);
"BUSINESS PLAN" means a plan for the business of the Company to be
reasonably agreed to by Elan, Orasomal, Endorex and the
Company prior to signing this Agreement or as soon
thereafter as is practicable and in any event within thirty
(30) days of signing this Agreement;
"CLOSING DATE" means January 22, 1998;
"COMPANY" means Endorex Vaccine Delivery Technologies, Inc.; ;
"COMPANY PROGRAM
PATENTS" means the inventions and underlying Patents that constitute
the Company Program Technology;
4
5
"COMPANY PROGRAM
TECHNOLOGY" shall have the meaning assigned to it in the Development
Agreement;
"COMPANY SUBSCRIPTION
AGREEMENT" means the Subscription and Stockholders' Agreement of
Endorex Vaccine Delivery Technologies, Inc., made by and
between EIS, Endorex and the Company as of the date hereof;
"DEVELOPMENT
AGREEMENT" means the Joint Development & Operating Agreement of even
date entered into between Orasomal, Elan, EIS, Endorex and
the Company;
"EFFECTIVE DATE" means December 31, 1997;
"EIS" means Elan International Services Ltd.;
"ELAN" means Elan Corporation, plc (Elan will be acting through its
division Elan Pharmaceutical Technologies);
"ELAN EXCLUDED
TECHNOLOGY" has the meaning set forth in Schedule 1;
"ELAN KNOW-HOW" means Elan's drug delivery Know-How (including oral or
mucosal Vaccine delivery Know-How) and Know-How relating to
oral or mucosal Vaccines, other than the Elan Program
Know-How and the Elan Excluded Technology;
"ELAN PATENTS" means Elan's drug delivery inventions and underlying Patents
(including oral or mucosal Vaccine delivery inventions) and
inventions and underlying Patents relating to oral or
mucosal Vaccines, other than the Elan Program Patents and
the Elan Excluded Technology;
"ELAN PROGRAM
PATENTS" means the inventions and underlying Patents that constitute
Elan Program Technology;
"ELAN PROGRAM
TECHNOLOGY" has the meaning assigned to it in the Development Agreement;
"ELAN TECHNOLOGY" means the Elan Patents and/or the Elan Know-How (which
exclude the Elan Excluded Technology). The primary examples
of the Elan
5
6
Technology existing as of the Effective Date are set forth
on Schedule 1; for the avoidance of doubt the Parties
confirm that the said list is not necessarily exhaustive.
The Elan Technology also includes the inventions and know
how that are the subject of the Maynooth Agreement or any
agreement with Maynooth University Enterprise Development
Limited envisaged by the Maynooth Agreement. For the
avoidance of doubt, Elan Technology shall exclude Patents
and Know How [****] or [****], including, but not limited
to, [****].
"ELAN TRADEMARKS" means, depending on the context, one or more of the
trademarks owned by, Acquired by, assigned or licensed to
Elan which are relevant to the Elan Technology or the
Products;
"ENDOREX" means Endorex Corp.;
"FDA" means 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 or any
other relevant regulatory authority the approval of which is
necessary to market a product in any other country of the
Territory;
"FIELD" shall mean the [****];
"FIRST RIGHT OF
NEGOTIATION" shall have the meaning assigned to such term in Clause 9.5.
of the Development Agreement;
"IMPROVEMENTS" means inventions, discoveries and developments relating
to (A) the Elan Technology that can usefully be applied to
the Field, and (B) which were first reduced to practice
during the Term by Elan [but shall for the avoidance of
doubt exclude Program Technology and the Elan Excluded
Technology;
"INDEPENDENT
THIRD PARTY" means any person other than the Company, Elan, Endorex,
Orasomal or any of their respective Affiliates;
"IN-MARKET" means [****] (or where applicable by [****]) to an [****]
such as a
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
6
7
[****], and shall exclude [****];
"INTELLECTUAL
PROPERTY RIGHTS" means proprietary rights in Patents, Know-How, registered
and unregistered designs, copyrights, trademarks, trade
dress, and other like legal rights for the protection of
intellectual property but shall for the avoidance of doubt
exclude the Elan Excluded Technology;
"KNOW-HOW" means all trade secrets, confidential scientific, technical
and medical information and expertise, technical data and
marketing information, studies and data from time to time
developed, produced by or on behalf of Elan, Orasomal or the
Company, as the case may be, whether before the Effective
Date or during the Term including, but not limited to,
unpatented inventions, discoveries, theories, plans, ideas
(whether or not reduced to practice) relating to the
research and development, manufacture, registration for
marketing, use or sale of the Product, toxicological,
pharmacological, analytical and clinical data,
bioavailability studies, product forms and formulations,
control assays and specifications, methods of preparation
and stability data;
"LISTED COMPANY" means the companies set forth in Schedule 2 and their
respective controlled (as such term is used in the
definition of Affiliates above) subsidiaries;
"MAJOR COUNTRY" means those countries of the Territory set forth in
Schedule 3;
"MANAGEMENT
COMMITTEE" means the management committee appointed by the directors of
the Company pursuant to the Development Agreement;
"MAYNOOTH means that certain Proposal Concerning the Exploitation of
AGREEMENT" Intellectual Property Rights by and between Elan and
Maynooth University Enterprise Development Limited dated
March 25, 1996, a copy of which is attached as Schedule 4;
"MIT" means the Massachusetts Institute of Technology;
"MIT AGREEMENT" means that certain Patent License Agreement by and
between Orasomal and the Massachusetts Institute of
Technology dated December 16, 1996 a copy of which is
attached to Schedule 3 of the Orasomal License Agreement;
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
7
8
"MIT PATENTS" means the Patents licensed by the Massachusetts Institute
of Technology pursuant to the MIT Agreement;
"MIT PATENTED
PRODUCT" means any product or part thereof which: (a) is covered in
whole or in part by an issued, unexpired claim in the MIT
Patents in the country in which any such product or part
thereof is made, used or sold; or (b) is manufactured by
using a process or is employed to practice a process which
is covered in whole or in part by an issued, unexpired
claim in the MIT Patents in the country in which any MIT
Patented Process is used or in which such product or part
thereof is used or sold;
"MIT PATENTED
PROCESS" means any process which is covered in whole or in part by
an issued, unexpired claim or a pending claim contained in
the MIT Patents;
"NET SALES" means [****];
"ORASOMAL" means Orasomal Technologies, Inc.;
"ORASOMAL
KNOW-HOW" means Orasomal's drug delivery Know-How (including oral or
mucosal Vaccine delivery Know-How) and Know-How relating
to oral or mucosal Vaccines, other than Orasomal Program
Know-How;
"ORASOMAL LICENSE
AGREEMENT" means the license agreement of even date herewith entered
into between the Company and Orasomal;
"ORASOMAL PATENTS" means Orasomal's drug delivery inventions and underlying
Patents (including oral or mucosal Vaccine delivery
inventions) and inventions and underlying Patents relating
to oral or mucosal Vaccines, other than Orasomal Program
Technology. The Orasomal Patents include the MIT Patents
and are listed on Schedule 1 of the Orasomal License
Agreement;
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
8
9
"ORASOMAL PROGRAM
PATENTS" means the inventions and the underlying Patents that
constitute Orasomal Program Technology;
"ORASOMAL PROGRAM
TECHNOLOGY" shall have the meaning assigned to it in the Development
Agreement;
"ORASOMAL
TECHNOLOGY" means the [****] and/or the [****]. The Orasomal
Technology also includes [****]. For the avoidance of
doubt, Orasomal Technology shall exclude [****], including
[****];
"ORASOMAL
TRADEMARKS" means, depending on the context, one or more of the
trademarks and any other relevant trademark owned by,
Acquired by, assigned or licensed to Orasomal which are
relevant to the Orasomal Technology or the Products;
"PARTIES" means Elan and the Company;
"PATENTS" means all and any patents and any applications therefor in
the Territory (including any and all divisions,
continuations, continuations-in-part, extensions,
additions or reissues thereto or thereof);
"PERSON" means an individual, partnership, corporation, limited
liability company, business trust, joint stock company,
trust, unincorporated association, joint venture, or other
entity of whatever nature;
"PLA" means the Product License Approval, or its equivalent, as
such term is understood by the FDA;
"PRE-EXISTING THIRD
PARTY TECHNOLOGY" has the meaning set forth in Clause 2.3;
"PRODUCT" means any [****];
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
9
10
"PROGRAM
TECHNOLOGY" has the meaning assigned to it in the Development Agreement;
"RELEVANT EVENT" has the meaning set forth in Clause 11.3.1;
"RESEARCH AND
DEVELOPMENT
PROGRAM" means depending on the context, one or more programs of
research and development work being conducted or to be
conducted by, inter alia, Orasomal and Elan for and on
behalf of the Company which have been devised by the
Research Committee and approved by the Management Committee;
"TECHNOLOGIES" means collectively, the Orasomal Technology together with
the Elan Technology;
"TERM" has the meaning set forth in Clause 11.1;
"TERRITORY" means [****];
"THIRD PARTY
TECHNOLOGY" has the meaning set forth in Clause 9.5. of the Development
Agreement;
"VACCINES" means a biologically or synthetically derived substance
administered to [****]; and
"UNITED STATES
DOLLAR" AND "US$" means the lawful currency for the time being of the United
States of America.
1.2. Words importing the singular shall include the plural and vice versa.
1.3. Unless the context otherwise requires, reference to a recital, article,
paragraph, provision, clause or schedule is to a recital, article,
paragraph, provision, clause or schedule of or to this Agreement.
1.4. Reference to a statute or statutory provision includes a reference to it
as from time to time amended, extended or re-enacted.
1.5. The headings in this Agreement are inserted for convenience only and do
not affect its construction.
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
10
11
1.6. Unless the context or subject otherwise requires, references to words in
one gender include references to the other genders.
1.7. References to "include" or "including" shall be construed as examples
only, and in no way be read as limiting.
2. GRANT OF RIGHTS
2.1. Subject to the terms of this Agreement, under all of Elan's existing and
future Patents and other Intellectual Property Rights covering the Elan
Technology, Elan hereby grants to the Company for the Term an exclusive
licence to the Elan Technology in the Field for all research, development,
and commercial purposes in the Field. All proprietary rights and rights
of ownership with respect to the Elan Technology shall at all times remain
solely with Elan, or where applicable with Elan's licensor. The Company
shall not have any rights to use the Elan Technology other than insofar as
they relate directly to the Field and are expressly granted herein.
2.2. Subject to any restriction in any licenses or other agreements pursuant to
which Elan licenses any of the Elan Trademarks, Elan hereby grants the
Company for the Term of this Agreement a non-exclusive, royalty-free, fully
paid-up license (or, if applicable, sublicense) to use the Elan Trademarks
which relate to the Elan Technology applicable to the Product, such as an
acronym for the applicable technology applied to the Product, on the terms
set forth in Clause 10 upon or in relation to the promotion, marketing,
advertising, sale or offering for sale of the Products. The Company shall
not be obliged to use the Elan Trademark to identify the Product but at
Elan's request shall be obliged to use the Elan Trademark to identify the
applicable Elan Technology embodied in the Product. For the avoidance of
doubt, the Parties hereby confirm that the Company shall not be entitled to
a licence to use any trademark owned or controlled by Elan which identifies
a pharmaceutical product.
2.3. Elan shall not be obliged to license Patents or Know-How licensed or
Acquired by Elan from an Independent Third Party on or before the
Effective Date ("Pre-existing Third Party Technology") to the Company
(including, but not limited to, Patents or Know-How owned jointly or
through a joint venture with [****] and [****]). In the event that Elan
considers that such Pre-existing Third Party Technology may have
application in the Field, Elan shall, subject to contractual constraints,
review such Pre-existing Third Party Technology with the Company and where
applicable use its reasonable endeavours to procure an agreement between
the Company and the applicable Independent Third Party (at the Company's
cost). Where applicable Elan may, at its option, license or sub-license
such Pre-existing Third Party Technology to the Company for the Field,
subject to the payment by the Company to
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
11
12
Elan of such amounts as are payable by Elan to any Independent Third
Party in respect of the exploitation by the Company of the Pre-existing
Third Party Technology.
2.4. Elan hereby confirms that prior to the Effective Date it has not licensed
or Acquired any Patents or Know How in relation to the Field save and
except for those that are the subject of the Maynooth Agreement and the
[****]. Elan shall be responsible for the discharge of the licence fees,
if any, and royalties and any other payments payable under the Maynooth
Agreement, or under any agreement concluded with Maynooth University
Enterprise Development Limited as envisaged in the Maynooth Agreement.
2.5. In addition Elan has entered into a preliminary development agreement
with an Independent Third Party in relation to the Field, the terms of
which are subject to confidentiality restrictions. If such preliminary
development program is successful, Elan shall seek the consent of the
Independent Third Party to disclose the results of the formulation
development program to the Company, and such results shall be deemed Third
Party Technology and governed by the provisions of Clause 2.9. of this
Agreement and Clause 9.5. of the Development Agreement.
2.6. Subject to the terms of this Agreement, the Company hereby grants to Elan
for the Term of this Agreement a [****] license to use the Elan Program
Technology, Orasomal Program Technology and the Company Program
Technology, and, subject to the terms and conditions of the Orasomal
License Agreement, a [****] sublicense to use the Orasomal Technology
insofar as is necessary, in each case, solely to permit Elan to perform
its obligations pursuant to this Agreement and the Development Agreement
for the benefit of the Company, including, without limitation, (a)
conducting research and development pursuant to the Research and
Development Programs, and (b) developing, manufacturing and supplying the
Products and any other chemical or formulation components. All rights of
ownership with respect to the Elan Program Technology, the Orasomal
Program Technology and the Company Program Technology shall at all times
remain solely with the Company.
2.7. Elan is entitled to negotiate a license agreement to exploit the Elan
Program Technology outside the Field in accordance with the provisions of
Clauses 9.3. and 9.8. of the Development Agreement pursuant to which the
Company may in the case of Clause 9.3. of the Development Agreement, and
shall in the case of Clause 9.8. of the Development Agreement grant Elan a
licence to use the Elan Program Technology.
2.8. The Company shall not be permitted to sublicense any of the rights
granted to the Company by Elan pursuant to this Agreement without the
prior written consent of Elan, which consent will not be unreasonably
withheld or delayed; provided that such reasonableness standard shall not
be applicable in the case of a proposed sublicense to
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
12
13
any Listed Company However, the Company shall have the right to grant a
royalty-free sublicense to the Elan Technology in the Field to Orasomal to
enable Orasomal to fulfil its obligations pursuant to the Orasomal License
Agreement and the Development Agreement. Insofar as the obligations owed
by the Company to Elan are concerned, the Company shall remain responsible
for all acts and omissions of any sub-licensee, including Orasomal, as if
they were by the Company. In the event of a termination of this Agreement
due to a breach by the Company, Elan shall have the right but not the
obligation to assume any such sub-license.
2.9. Subject to the other provisions of this Agreement and to the provisions
of [****] of the Development Agreement, [****] (a) for or on behalf of
the Company, (b) in relation to [****] for which the Company has elected
not to [****] or has been unable to [****] after the applicable [****]
has been exercised by the Company, or (c) with the Company's prior
written consent. For the avoidance of doubt the Parties confirm that the
foregoing [****] is applicable to the [****] conducted by [****] through
its division [****] and shall not apply to [****], including, but not
limited to, [****] and if it shall become such, [****].
2.10. Elan shall also provide all reasonable assistance to the Company in
delivering and enabling the Company to utilize the Company's license to
the Elan Technology.
3. IMPROVEMENTS
3.1. Except to the extent prohibited by any undertaking given to any
Independent Third Party (provided that after the Closing Date each Party
shall use all commercially reasonably efforts to exclude or minimise the
extent of any such limitations or restrictions), the licenses to the Elan
Technology granted by Elan pursuant to Clause 2 shall include the
Improvements. If Elan shall develop any Improvements during the Term,
Elan shall communicate to the Company such Improvements and shall provide
to the Company such rights, licenses, information and explanations as the
Company may reasonably require to be able effectively to utilise the
Improvements for the life of this Agreement. Such disclosed Improvements
shall automatically on disclosure to the Company become part of the Elan
Know-How or Elan Patents (as the case may be) and shall be subject to the
provisions of this Agreement. the Company shall not have any right to
use such Improvements outside the Field.
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
13
14
4. INTELLECTUAL PROPERTY RIGHTS
4.1. The respective rights of Elan, the Company and Orasomal to exploit the
Elan Program Technology, Orasomal Program Technology and the Company
Program Technology shall be regulated by the provisions of Clause 6 of the
Development Agreement.
5. EXPLOITATION OF LICENSED TECHNOLOGY
5.1. Except as provided for in this Agreement, the Company's obligations to
exploit the Elan Technology shall be regulated by Clause 9 of the
Development Agreement.
5.2. The Company shall exert its reasonable efforts [****] consistent with the
[****] in each [****] determined in a commercially reasonable manner and
with a view to [****]. The Company will diligently pursue the [****], as
provided in the Business Plan.
5.3. The Company will be solely responsible for ensuring that the manufacture,
promotion, distribution, marketing and sale of the Products within each
country of the Territory is in strict accordance with all the legal and
regulatory requirements of each country of the Territory.
5.4. All advertising, promotional materials and marketing costs needed to
exploit the Products are to be paid for by the Company. Any packaging for
the Products shall contain information to the effect that the Product has
been developed by Elan in conjunction with Orasomal and the Company and is
to be agreed upon by Elan in advance. Such acknowledgement shall take
into consideration regulatory requirements and the Company's reasonable
commercial requirements. The Company shall submit copies of all forms of
trade package cartons and labels and other printed materials to Elan for
approval before commercial sale of the Product commences. If a change in
such materials from that initially approved which would require regulatory
approval or filing or any other material change is proposed, all such
package cartons and labels and printed materials shall be resubmitted for
approval before commercial use thereof. It shall be presumed that Elan
approved of such use unless Elan provides written notice of disapproval of
such use to the Company within ten (10) business days of delivery of such
materials to Elan, such approval not to be unreasonably withheld. The
further consent of Elan shall not be required where the format and content
of such materials is substantively similar as the materials previously
furnished to and approved by Elan.
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
14
15
6. FINANCIAL PROVISIONS
6.1. In consideration of the rights and licences granted to the Company
pursuant to this Agreement, the Company shall pay the following amounts to
Elan in the manner and on the dates set forth below:
6.1.1. [****]
6.1.2. [****]
6.1.3. [****]
6.1.4. [****].
6.2. In consideration of the rights and licences granted to the Company
pursuant to this Agreement, the Company shall [****] of any and all [****]
received by the Company to Elan; provided, that Elan's [****] of the
aggregate of [****] shall not be less than [****]without Elan's prior
consent, unless the Company shall establish, to Elan's reasonable
satisfaction, consistent with then-current prudent and customary business
standards, that an aggregate [****] of less than [****] is necessary in
order to enable the Company to commercialize the subject Product without
undue hardship; provided further, that the Company shall use commercially
reasonable good faith efforts to seek to obtain the [****] on a case-by
case basis.
6.3. In the event that Elan shall cease to be a shareholder of the Company,
the Parties shall negotiate in good faith such amendments to the Agreement
as are equitable and applicable having regard to the fact that Elan no
longer has any representation on the Board of Directors of the Company or
the Management Committee (for example the royalty provisions and such
provisions of the Development Agreement as are applicable), provided that
such negotiations shall not apply to the existence of the Agreement.
6.4. Payment of royalties shall be made quarterly within forty-five (45) days
after the expiry of the calendar quarter. The method of payment shall be
by way of wire transfer to an account specified by Elan. Each payment made
to Elan shall be accompanied by a
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
15
16
written report, prepared and signed by a senior financial officer of the
Company. In addition the report shall clearly show the Net Sales for the
months of the calendar quarter for which payment is being made on a
country by country basis. In the event that no royalty is due to Elan
for any calendar quarter, the senior financial officer shall so report.
In addition to the written reports accompanying each payment, the Company
shall notify Elan, within thirty (30) days of the end of each calendar
quarter, of the Net Sales of the Product(s) for that preceding quarter on
a country by country basis.
6.5. The Company shall maintain and keep clear, detailed, complete, accurate
and separate records so:
6.5.1. as to enable any royalties on Net Sales of a Product which shall
have accrued hereunder to be determined; and
6.5.2. that any deductions made in arriving at the Net Sales of a Product
can be determined.
6.6. All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of the Product 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 exchange
rate in effect 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 for the day prior to
the date on which the payment by the Company is being made.
6.7 Subject to the provisions of Clauses 6.8. and 6.10. of this Agreement,
the Company shall pay all royalties at the full rates specified in this
Clause 6.
6.8. If, at any time, legal restrictions in the Territory prevent the prompt
payment of royalties or any portion thereof, the Parties shall meet to
discuss suitable and reasonable alternative methods of reimbursing Elan
the amount of such running royalties. In the event that the Company 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 Elan's account in a bank
acceptable to Elan in the country the currency of which is involved or as
otherwise agreed by the Parties.
6.9. Elan and the Company agree to co-operate in all respects reasonably
necessary to take advantage of any double taxation agreements or similar
agreements as may, from time to time, be available.
16
17
6.10. Any taxes payable by Elan on any payment made to Elan pursuant to this
Agreement shall be for the account of Elan. If so required by applicable
law any payment made pursuant to this Agreement shall be made by the
Company after deduction of the appropriate withholding tax in which event
the Parties shall co-operate to the extent reasonably necessary to obtain
the appropriate tax credits as soon as is practicable. In the event of a
credit, the Company shall forthwith forward copies of the credit
documentation to Elan.
7. RIGHT OF AUDIT AND INSPECTION
7.1. On not more than two times in each calendar year, the Company shall
permit Elan or its duly authorised 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 the Company and any other
book, record, voucher, receipt or invoice relating to the calculation of
the royalty payments on Net Sales submitted to Elan and to the accuracy
of the reports which accompanied them. Any such inspection of the
Company's records shall be at the expense of Elan, except that if any
such inspection reveals a deficiency in the amount of the running royalty
actually paid to Elan hereunder in any calendar quarter of [****] or more
of the amount of any running royalty actually due to Elan hereunder, then
the expense of such inspection shall be borne solely by the Company. Any
amount of deficiency shall be paid promptly to Elan. If such inspection
reveals a surplus in the amount of running royalty actually paid to Elan
by the Company, Elan shall promptly reimburse the Company the surplus.
The Company shall maintain the foregoing records for a period of at least
five (5) years following the end of the calendar year to which they
pertain.
7.2. In the event of any unresolved dispute regarding any alleged deficiency
or overpayment of royalty payments hereunder, the matter will be referred
to an independent firm of chartered accountants for a resolution of such
dispute mutually acceptable to both parties. Any decision by the said
firm of chartered accountants shall be binding on the Parties.
8. PATENTS
8.1. The Company shall permanently xxxx or otherwise cause Orasomal or any
Independent Third Party to permanently xxxx all Products and/or the
packaging therefor with such license or patent notices and in such manner
as Elan may reasonably request in writing prior to the sale or commercial
use thereof.
8.2. Elan shall be obliged to disclose promptly to the Company inventions
and discoveries made by or on behalf of Elan otherwise than in connection
with the performance of a
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
17
18
Research and Development Program (which inventions and discoveries
shall be regulated by the provisions of the Development Agreement), any
patentable inventions and discoveries within the Elan Know-How which
relate to the Field as well as any Improvements developed by or on behalf
of Elan.
8.3. The Parties shall discuss in good faith all material issues relating to
filing, prosecution and maintenance of Elan Patents (insofar as the Elan
Patents are of relevance to the Field), the Elan Program Patents, any
patentable inventions and discoveries within the Elan Know-How that relate
to the Field and any Improvements developed by or on behalf of Elan (other
than pursuant to one or more of the Research and Development Programs).
Subject to agreement to the contrary the following provisions shall apply:
8.3.1. Elan [****] shall have the right but shall not be obligated (a)
to secure the grant of any patent from applications within the Elan
Patents that relate to the Field; (b) to file and prosecute patent
applications on patentable inventions and discoveries within the
Elan Know-How that relate to the Field and patentable Improvements
developed by or on behalf of Elan (other than pursuant to one or
more of the Research and Development Programs); (c) to defend all
such applications against Independent Third Party oppositions;
and/or (d) to maintain in force any issued letters patent within
the Elan Patents that relate to the Field (including any letters
patent that may issue covering any Improvements). Elan shall have
the sole right in its reasonable business discretion to control
such filing, prosecution, defence and maintenance; provided
however, that the Company shall be provided with copies of all
documents relating to such filing, prosecution, defence, and
maintenance in sufficient time to review such documents and comment
thereon prior to filing of such documents.
8.3.2. In the event that Elan (i) elects that it does not intend to
file patent applications on patentable inventions and discoveries
within the Elan Know-How that relate to the Field or patentable
Improvements developed by or on behalf of Elan (other than pursuant
to one or more of the Research and Development Programs) in one or
more countries in the Territory, (ii) fails to file such an
application within a reasonable period of time, or (iii) elects or
fails to maintain or prosecute further any such pending application
or issued patent then Elan shall so notify the Company in writing
no less than two (2) months prior to the expiration of any
applicable due date or time bar, and after receipt of such notice,
the Company shall have the right, but not the obligation, at the
Company's sole expense to file and prosecute such patent
application(s) in the joint names of the Company and Elan, and Elan
upon written request from the Company shall execute all documents,
forms and declarations and to do all things as shall be reasonably
necessary to enable the Company to exercise such option and right.
8.3.3. In relation to the Elan Program Patents, the Company at its
expense shall have the right but shall not be obligated (a) to
secure the grant of any patent from
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
18
19
applications within the Elan Program Patents; (b) to file and
prosecute patent applications on patentable inventions and
discoveries within the Elan Program Know-How; (c) to defend all
such applications against Independent Third Party oppositions; and
(d) to maintain in force any issued letters patent within the Elan
Program Patents (including any patents that issue on patentable
inventions and discoveries within the Elan Program Know-How). The
Company shall have the right to control such filing, prosecution,
defence and maintenance; provided however Elan and Orasomal shall
be provided with copies of all documents relating to such filing,
prosecution, defence, and maintenance in sufficient time to review
such documents and comment thereon prior to filing of such
documents.
8.3.4. In the event that the Company (i) elects that it does not
intend to file patent applications on patentable inventions and
discoveries within the Elan Program Know-How, (ii) fails to file
such an application within a reasonable period of time or, (iii)
elects or fails to maintain or prosecute further any such pending
application or issued patent then the Company shall so notify Elan
in writing no less than two (2) months prior to the expiration of
any applicable due date or time bar, and after receipt of such
notice, Elan shall, insofar as it is necessary to enable Elan to
exploit the Elan Program Know-How pursuant to Clauses 2.6. and 2.7.
of this Agreement or Clause 6.5. of the Development Agreement, have
the right, but not the obligation at Elan's sole expense to file
and prosecute such patent application(s) in the Company's name and
the Company upon written request from Elan shall execute all
documents, forms and declarations and to do all things as shall be
reasonably necessary to enable Elan to exercise such option and
right. In the event that Elan and the Company negotiate a license
to enable Elan to exploit the Elan Program Technology outside the
Field pursuant to Clause 6.5. of the Development Agreement, the
Parties shall take the patent related expenditures incurred by Elan
as referred to above into account to the extent they are incurred
in relation to the Patents being licensed to Elan in determining
the royalty payable by Elan to the Company. Notwithstanding
anything herein to the contrary, the Parties agree that the Company
shall own all right, title and interest in such patent applications
and any patents that may issue thereon (including any and all
divisions, continuations, continuations-in-part, extensions,
additions or reissues thereto or thereof). Insofar as any patent
filing has application within and outside the Field, the Company
and Elan will negotiate, in good faith, on the course of action to
be taken.
8.4. Elan and the Company shall promptly inform the other in writing of any
alleged infringement of any Patents within the Elan Patents that relate to
the Field, the Elan Program Patents, the Orasomal Program Patents, or the
Company Program Patents or any alleged misappropriation of trade secrets
within the Elan Know-How that relate to the Field, the Elan Program
Know-How, the Orasomal Program Know-How or the
19
20
Company Program Technology by an Independent Third Party of which it
becomes aware and provide the other with any available evidence of such
infringement or misappropriation.
8.4.1. During the Term, the Company shall have the right to bring suit
or otherwise take action at its own expense and for its own
benefit any such alleged infringements of the Elan Patents or
misappropriation of the Elan Know-How, insofar as such
infringements or misappropriation relate to the Field. In the
event that the Company takes such action, the Company shall do so
at its own cost and expense. At the Company's request, Elan will
co-operate with such action insofar as the said action relates to
the Field at the Company's sole cost and expense. Any recovery
remaining after the deduction by the Company of the reasonable
expenses (including attorney's fees and expenses) incurred in
relation to such an infringement proceeding shall constitute Net
Sales for the purpose of this Agreement and the Orasomal License
Agreement and prior to commencing, or at an early stage in the
proceedings, the Company, Elan and Orasomal shall agree upon the
royalty that shall be due to each of Elan and Orasomal in respect
of such deemed Net Sales. Should the Company decide not to pursue
such infringers, within a reasonable period but in any event (i)
within sixty (60) days after receiving written notice of such
alleged infringement or misappropriation or (ii) ten (10) days
before the time limit, if any, set forth in the appropriate laws
and regulations for the filing of such actions, whichever comes
first, or if such alleged infringement or misappropriation does
not relate to the Field, Elan may in its discretion initiate such
proceedings in its own name, at its expense and for its own
benefit, and at Elan's request, the Company will co-operate with
such action at Elan's sole cost and expense. In the alternative,
the Parties may agree to institute such proceedings in their joint
names and shall reach agreement as to the proportion in which they
will share the proceeds of any such proceedings, and the expense
of any costs not recovered, or the costs or damages payable to the
Independent Third Party. If the infringement of the Elan Patents
affects the Field as well as other products being developed or
commercialised by Elan or its commercial partners outside the
Field, the Parties shall agree as to the manner in which the
proceedings should be instituted and shall reach agreement as to
the proportion in which they will share the proceeds of any such
proceedings, and the expense of any costs not recovered, or the
costs or damages payable to the Independent Third Party.
8.4.2. During the Term, the Company shall have the first right but not
the obligation to bring suit or otherwise take action against any
alleged infringement of the Elan Program Patents or the Company
Program Patents (and as appears from Clause 8.4.2. of the Orasomal
License Agreement, the Orasomal Program Patents) or alleged
misappropriation of the Elan Program Know-How (and as appears from
20
21
Clause 8.4.2. of the Orasomal License Agreement, the Orasomal
Program Know-How) within the Field. If any such alleged
infringement or misappropriation occurs which gives rise to a
cause of action both inside and outside the Field, the Parties
shall negotiate, together with Orasomal, in good faith to
determine the cause of action to be taken. In the event that the
Company takes such action, the Company shall do so solely at its
own cost and expense. At the Company's request, Elan will
co-operate with any such action at the Company's sole cost and
expense. Any recovery remaining after the deduction by the
Company of the reasonable expenses (including attorney's fees and
expenses) incurred in relation to such an infringement proceeding
shall constitute Net Sales for the purpose of this Agreement and
the Orasomal License Agreement and prior to commencing, or at an
early stage in the proceedings, the Company, Elan and Orasomal
shall agree upon the royalty that shall be due to each of Elan and
Orasomal in respect of such deemed Net Sales. In the event that
the Company decides not to take such action against such
infringement or misappropriation or fails to do so within a
reasonable period but in any event (i) within sixty (60) days
after receiving written notice of such alleged infringement or
misappropriation or (ii) ten (10) days before the time limit, if
any, set forth in the appropriate laws and regulations for the
filing of such actions, whichever comes first, Elan may in its
discretion initiate such proceedings in its own name regarding the
Elan Program Technology (or in the Company's name if required by
law; provided, however, that Elan identifies itself as the real
party in interest and does not take any action that would expose
the Company to liability of any kind). In the event that Elan
initiates such action, it shall do so solely at its sole cost and
expense and all damages and monetary award recovered in or with
respect to such action shall be the property of Elan. At Elan's
request, the Company agrees to co-operate with Elan in any such
proceeding at Elan's sole cost and expense. In the alternative,
the Parties may agree to institute such proceedings in their joint
names and shall reach agreement as to the proportion in which they
will share the proceeds of any such proceedings, and the expense
of any costs not recovered, or the costs or damages payable to the
Independent Third Party.
8.5. In the event that a claim or proceedings are brought against the Company
by an Independent Third Party alleging that the sale, distribution or use
of the Product in the Territory solely because of the Company's use of the
Elan Technology infringes the intellectual property rights of such an
Independent Third Party, the Company shall promptly advise Elan of such
threat or suit.
8.6. Elan shall have no liability to the Company whatsoever or howsoever
arising for any losses incurred by the Company as a result of having to
cease selling Product or having to defer the launch of selling Product as
a result of any infringement proceedings.
21
22
9. CONFIDENTIAL INFORMATION
9.1. The Parties acknowledge that it may be necessary, from time to time, to
disclose to each other confidential and/or proprietary information,
including without limitation, the Technologies, Program Technology,
Improvements and the Patents relating thereto, inventions, works of
authorship, trade secrets, specifications, designs, data, know-how and
other information relating to the Field, the MIT Agreement, the Maynooth
Agreement, the terms of the Definitive Documents, the Products, processes
and services, or the business of the disclosing Party ("Confidential
Information").
Confidential Information shall be deemed not to include:
(i) information that is in the public domain;
(ii) information which is made public by the disclosing Party;
(iii) information which is independently developed by a Party without the
aid or application of the 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, to the best of the Party's knowledge, did not
acquire this information on a confidential basis; or
(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) other requirement of law; provided that if the receiving Party
becomes legally required to disclose any confidential
information, the receiving Party shall give the disclosing
Party prompt notice of such fact so that the disclosing Party
may obtain a protective order or other appropriate remedy
concerning any such disclosure. The receiving Party shall
fully co-operate 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.
22
23
9.2. 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.
9.3. 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 documents and any
copies thereof containing Confidential Information belonging to or
disclosed by, such Party.
9.4. 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, prosecuting or defending litigation, 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 other
Party, allow the other Party to participate in the process and generally
limit disclosure to the greatest extent possible and seek confidential
treatment or a protective order.
9.5. The provisions relating to confidentiality in this Clause 9 shall remain
in effect during the Term, and for a period of [****] following the
expiration or earlier termination of this Agreement.
9.6. The Parties agree that the obligations of this Clause 9 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
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
23
24
relief against the threatened breach of the provisions of this Clause 9,
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.
10. TRADEMARKS
10.1. The Company undertakes that all Products and all materials utilised in
connection with the provision, marketing, distribution, advertising
and/or marketing thereof that bear or incorporate the Elan Trademarks
shall be of a consistent and high standard of quality, commensurate with
the prestige of the Elan Trademarks and that its use of the Elan
Trademarks shall conform to such reasonable standards as Elan shall from
time to time specify. The Company shall co-operate fully with the
reasonable instructions of Elan with respect to the maintenance of such
standards.
10.2. The Company shall:
10.2.1. subject to the agreement of the Company's commercial partner
such as a sub-licensee, favourably consider promoting and using
the Elan Trademarks in each country of the Territory and provide
proof of use of the Elan Trademarks if requested by Elan;
10.2.2. use the Elan Trademarks strictly in compliance with any
applicable trademark and other laws and regulations and to use
such legends, markings and notices in connection therewith as are
required by law or otherwise reasonably required by Elan to
protect Elan's rights therein;
10.2.3. do nothing to mislead the public as to the nature or quality of
any Product on which the Elan Trademarks are affixed nor use it
on advertising or display materials which are unethical, immoral
or offensive to good taste;
10.2.4. at Elan's reasonable request, supply samples of the Products
and any materials utilized in connection with the distribution,
advertising and/or marketing thereof that bear or incorporate the
Elan Trademarks for inspection by Elan;
10.2.5. not adopt or seek to register any trademark, design or logo
confusingly similar to the Elan Trademarks without Elan's prior
written consent; and
10.2.6. promptly notify Elan in writing if any alleged infringement or
unauthorized use of the Elan Trademarks comes to the Company's
attention.
24
25
10.3. The Company undertakes to use the Elan Trademarks in relation only to
the Products (or materials for advertising and promotion thereof), and in
accordance with any reasonable specifications and directions given by
Elan from time to time. In particular, but without limitation, the
Company agrees to state on the Products or materials for the advertising
or promotion thereof that the Elan Trademarks are used under license from
Elan.
10.4. The Company shall take no action which could prejudice the validity,
re-registration or reputation of the Elan Trademarks or which could
impair the reputation, business standing or prestige of Elan.
10.5. Elan shall remain the owner of the Elan Trademarks and the goodwill
associated with the same and the Company agrees not to assert any
ownership interest in the Elan Trademarks or the goodwill associated
therewith. The Company shall own and retain all right, title, and
interest in and to any trademark or trademarks (other than the Elan
Trademarks and the Orasomal Trademarks) used in the Territory in
connection with the sale of the Products.
10.6. Elan shall have the exclusive right to take such action in respect of
the registration, defence, infringement and maintenance of the Elan
Trademarks as Elan in its reasonable business judgement deems
appropriate. The Company shall provide all such assistance and
co-operation, including the furnishing of documents and information and
the execution of registered user documentation or the like, as may be
required to give effect to any action as may be taken, or required to be
taken, by Elan. In taking any such action, Elan shall consider the
legitimate commercial interests of the Company.
10.7. New trademarks used in relation to the Elan Program Technology, the
Orasomal Program Technology, the Company Program Technology, or the
Products and all registrations thereof and applications therefor shall be
owned and registered by the Company. New trademarks used in relation to
the Elan Technology and all registrations thereof and applications
therefor shall be owned and registered by Elan and shall constitute Elan
Trademarks.
11. TERM AND TERMINATION
11.1. This Agreement is concluded for a period commencing as of the Effective
Date and expiring on a Product by Product basis and on a country by
country basis on the later to occur of:
11.1.1. fifteen (15) years starting from the date of the launch of the
Product in the country concerned; and
25
26
11.1.2. the last to expire Patent included in the Elan Patents and/or the Elan
Program Patents and/or the Orasomal Program Patents and/or the Company
Program Patents (the "Term").
11.2. At the end of the Term, the Company shall have a paid-up non-exclusive
licence to the Elan Technology for the Field.
11.3.1. For the purpose of this Clause 11.3, a "Relevant Event" is committed by
Elan or the Company if:
(i) it commits a material breach of its obligations under this
Agreement and fails to remedy it within sixty (60) days of being
specifically required in writing to do so by the other Party;
provided, however, that if the breaching Party has proposed a
course of action to rectify the breach and is acting in good
faith to rectify same but has not cured the breach by the
sixtieth (60th) day, such rectifying period shall be extended by
an amount of time as is reasonably necessary to permit the breach
to be rectified;
(ii) it ceases , wholly or substantially, to carry on its business,
other than for the purpose of a reorganization, without the prior
written consent of the other Participant (such consent not to be
unreasonably withheld);
(iii) the voluntary appointment of a liquidator, receiver,
administrator, examiner, trustee or similar officer over all or
substantially all of its assets under the laws of such
Participant's state or country of incorporation; or
(iv) an application or petition for bankruptcy, corporate
reorganization, composition, administration, examination,
arrangement or any other procedure similar to any of the
foregoing under the laws of such Participant's state or country
of incorporation, is filed, and is not discharged within ninety
(90) days.
11.3.2. If either Party commits a Relevant Event, the other Party shall have
in addition to all other legal and equitable rights and remedies
hereunder, the right to terminate this Agreement upon thirty (30) days'
written notice; provided, that such written notice be given within
sixty (60) days following the date that the other Party becomes aware
of the Relevant Event.
11.4. In the event that (a) [****], or otherwise [****] their management or
business, or (b) [****] or more of the [****], or otherwise
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
26
27
[****] or [****] with any of such entities, [****] if Elan provides
written notice of its election to so terminate within [****] of the date
on which Elan [****] , or should [****], of the event; provided, however,
that the foregoing shall not apply in [****] by Elan or Endorex as
contemplated by the Company Subscription Agreement.
11.5. Upon exercise of those rights of termination as specified in Clause 11.1
to Clause 11.4, inclusive or elsewhere within the Agreement, this
Agreement shall, subject to the other provisions of the Agreement,
automatically terminate forthwith and be of no further legal force or
effect.
11.6. Upon expiration or termination of the Agreement:
11.6.1. any sums that were due from the Company to Elan 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 of 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);
11.6.2. all confidentiality provisions set out herein shall remain in
full force and effect;
11.6.3. the rights of inspection and audit set out in Clause 7 shall
continue in force for a period of one year;
11.6.4. except as expressly provided for under Clause 11.6.5. all
rights, licenses and sublicenses granted 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).
Following such expiration or termination, the Company may not
thereafter, except as expressly provided for in Clause 11.6.5,
use in the Territory or in such particular country or countries
in the Territory (as the case may be) (a) any valid and unexpired
Elan Patents, (b) any Elan Know-How that remains confidential or
otherwise proprietary to Elan, and/or (c) any Elan Trademarks;
and
11.6.5. the Company shall promptly make an accounting to Elan of the
inventory of the Product which it has in the Territory or for
such particular country or countries in the Territory (as the
case may be), if any, as of the date of such termination and the
Company shall thereafter have the right for a period of six (6)
months after said expiration or termination to sell such
inventory of the Product in the Territory or in such particular
country or countries in the Territory (as the case
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
27
28
may be) or, if appropriate and legally permissible, to transport
such inventory of Product for sale in another country or
countries in the Territory within such six month period; provided
that the Net Sales thereof shall be subject to the royalty
provisions of Clause 6 and so payable to Elan. Thereafter, any
remaining inventory of Product shall be disposed of by mutual
agreement of the Parties in accordance with regulatory
requirements.
12. WARRANTIES/INDEMNITIES
12.1. Elan represents and warrants to the Company that to Elan's best
knowledge, after reasonable investigations, (a) Elan has the right to
grant the licenses and rights granted herein, (b) Schedule 1 contains a
summary of the Elan Technology existing as of the Effective Date, (c)
other than the Maynooth Agreement there are no agreements with any third
parties that relate to Elan Technology existing as of Effective Date, (d)
that to the best of its knowledge and belief, Elan is not in breach or
threatened breach of the Maynooth Agreement and will in the future not
procure a breach and (e) there are no agreements with any Independent
Third Parties that conflict with the rights granted by Elan pursuant to
this Agreement.
12.2. Elan represents and warrants to the Company that it has the sole,
exclusive and unencumbered right to grant the licenses and rights herein
granted to the Company, and that it has not granted any option, license,
right or interest in or to the Elan Technology to any Independent Third
Party which would conflict with the rights granted by this Agreement.
12.3. The Company represents and warrants to Elan that it has the sole,
exclusive and unencumbered right to grant the licenses and rights herein
granted to Elan and that it has not granted any option, license, right or
interest in or to the Elan Program Technology, the Orasomal Program
Technology or the Company Program Technology to any Independent Third
Party which would conflict with the rights granted by this Agreement.
12.4. Elan represents and warrants to the Company that to the best of its
knowledge, the true inventors of the subject matter claimed are named in
the Elan Patents and all such inventors have irrevocably assigned all
their rights and interests therein to Elan.
12.5. Elan and the Company each represent and warrant to and for the benefit
for each other that the execution of this Agreement by them and the full
performance and enjoyment of the rights of them under this Agreement will
not breach the terms and conditions of any license, contract,
understanding or agreement, whether express, implied, written or oral
between them and any Independent Third Party.
28
29
12.6. In addition to any other indemnifications provided for herein, Elan
shall indemnify and hold harmless the Company 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 the
Company arising out of or in connection with any breach of any
representation, covenant, warranty or obligation by Elan hereunder.
12.7. In addition to any other indemnifications provided for herein, the
Company shall indemnify and hold harmless Elan 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 Elan
arising out of or in connection with any breach of any representation,
covenant, warranty or obligation by the Company hereunder.
12.8. The Company shall assume the sole and entire responsibility and shall
indemnify and save harmless Elan from any and all claims, liabilities,
expenses, including reasonable attorney's fees, responsibilities and
damages by reason of any claim, proceedings, action, liability or injury
arising out of any faults of the Product resulting from the transport,
packaging, storage, handling, distribution, marketing or sale of the
Product by the Company, to the extent that it was caused by the
negligence or wrongful acts or omissions on the part of the Company.
12.9. As a condition of obtaining an indemnity in the circumstances set out
above, the Party seeking an indemnity shall:
12.9.1. fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
12.9.2. permit the indemnifying Party to take full care and control of
such claim or proceeding;
12.9.3. co-operate in the investigation and defence of such claim or
proceeding;
12.9.4. 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
12.9.5. take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
29
30
12.10. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND
NEWCO SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION
OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER
THE TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INDIRECT OR
INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND
WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
EMPLOYEES OR AGENTS OR OTHERWISE.
13. INSURANCE
13.1. Elan shall maintain comprehensive general liability insurance,
including product liability insurance on the Products manufactured
and/or sold by Elan in such prudent amount as shall be determined by the
Management Committee. Elan shall provide the Company with a certificate
from the insurance company verifying the above and undertakes to notify
the Company directly at least thirty (30) days prior to the expiration
or termination of such coverage. Elan shall also provide the Company
with a vendor's certificate substantially in a form to be agreed between
the Parties.
13.2. The Company shall maintain comprehensive general liability insurance,
including product liability insurance on Products manufactured and/or
sold by the Company that incorporate intellectual property licensed
hereunder by Elan in such prudent amount as shall be determined by the
Management Committee. The Company shall provide Elan with a certificate
from the insurance company verifying the above and undertakes to notify
Elan thirty (30) days prior to the expiration or termination of such
coverage.
14. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
14.1. 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.
15 SETTLEMENT OF DISPUTES; PROPER LAW
30
31
15.1. The Parties will attempt in good faith to resolve any dispute arising
out of or relating to this Agreement promptly by negotiation between
executives of the Parties, failing which the Parties shall invoke the
dispute resolution provisions set forth in Clause 16 of the Development
Agreement.
15.2. This Agreement shall be governed by and construed in accordance with
the laws of New York and subject to the provisions of Clause 15.1, the
Parties agree to submit to the jurisdiction of the courts of New York for
the resolution of disputes hereunder, which the Parties have not
otherwise agreed should be subject to the binding determination of an
Expert or Panel, pursuant to the terms of this Agreement.
16. ASSIGNMENT
16.1. This Agreement may not be assigned by either Party without the prior
written consent of the other, which consent in relation to the proposed
assignment to an Affiliate of Elan or the Company, as the case may be,
shall not be unreasonably withheld, conditioned or delayed.
17. NOTICES
17.1. Any notice to be given under this Agreement shall be sent in writing in
English by registered mail, airmail, reputable courier or recorded
delivery post, or telecopied (with a confirmation copy promptly sent by
mail) to:
- if to Elan: Elan Corporation, plc
Xxxxxxx Xxxxx
Xxxxxxx Xxxxx
Xxxxxx 0, Xxxxxxx
Telecopier: 353 1 662 4960
Attention: Vice President & General Counsel
Elan Pharmaceutical Technologies
with a copy to: Xxxxx Xxxxxxxxxxxx Xxxxxxxxxxx & XxXxxxxxx LLC
000 Xxxx 00xx Xxxxxx
00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: 1 212 371 5500
Attention: Xxxxx Xxxxxxx
31
32
- if to the Company: Endorex Vaccine Delivery Technologies, Inc.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 1 847 604 8570
Attention: President
with a copy to: Xxxxxxx Xxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: 1 212 586 7878
Attention: Xxxxxxx Xxxxxxxxx
or to such other address(es) as may from time to time be notified by any
Party to the others hereunder.
17.2. Any notice sent by mail shall be deemed to have been delivered within
seven (7) working days after dispatch, any notice sent by reputable
courier shall be deemed to have been delivered within two (2) working
days after dispatch and any notice sent by telecopy shall be deemed to
have been delivered within twenty four (24) hours of the time of the
dispatch. Notices of change of address shall be effective upon receipt.
18. MISCELLANEOUS CLAUSES
18.1. 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.
18.2. 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.
18.3. The Parties shall use their respective reasonable endeavours to ensure
that the Parties and any necessary Independent Third Party shall do,
execute and perform all such further deeds, documents, assurances, acts
and things as any of the Parties hereto may
32
33
reasonably require by notice in writing to the other Party or such
Independent Third Party to carry the provisions of this Agreement.
18.4. This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns and sub-licensees.
18.5. No provision of this Agreement shall be construed so as to negate,
modify or affect in any way the provisions of any other agreement
between the Parties unless specifically referred to, and solely to the
extent provided, in any such other agreement. In the event of a
conflict between the provisions of this Agreement and the provisions of
the Development Agreement, the terms of the Development Agreement shall
prevail unless this Agreement specifically provides otherwise.
18.6. No amendment, modification or addition hereto shall be effective or
binding on either Party unless set forth in writing and executed by a
duly authorised representative of each Party.
18.7. 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.
18.8. Each of the Parties undertake to do all things reasonably within its
power which are necessary or desirable to give effect to the spirit and
intent of this Agreement.
18.9. 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.
18.10. Nothing contained in this Agreement is intended or is to be construed
to constitute Elan and the Company as partners, or Elan as an employee
of the Company, or the Company as an employee of Elan. 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 the other Party or
to bind the other Party to any contract, agreement or undertaking with
any Independent Third Party.
33
34
IN WITNESS THEREOF the Parties hereto have executed this License Agreement in
duplicate.
/s/ Xxxxxx X. Xxxxx
SIGNED BY Xxxxxx X. Xxxxx
For and on behalf of
ELAN CORPORATION, PLC
/s/ Xxxxxxx X. Xxxxx
SIGNED BY Xxxxxxx X. Xxxxx
For and on behalf of
ENDOREX VACCINE DELIVERY TECHNOLOGIES, INC.
34
35
SCHEDULE 1
1. EXISTING ELAN TECHNOLOGY
[****]
2. EXCLUDED ELAN TECHNOLOGY
[****]
**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
36
SCHEDULE 2
[****]
(as may be amended with mutual agreement of all the Parties in writing from
time to time)
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
37
SCHEDULE 0
XXXXX XXXXXXXXX XXXXXXX XX XXX XXXXXX XXXXXX
[****]
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
38
SCHEDULE 4
THE MAYNOOTH AGREEMENT
39
PROPOSAL CONCERNING THE EXPLOITATION OF INTELLECTUAL
PROPERTY RIGHTS
PARTIES:
This agreement is made and is effective this 25th day of March 1996 by and
between Elan Corporation Plc (hereinafter THE COMPANY), its successors and
assigns of Xxxxxxxxx, Xxxxxxx, Xxxxxx Xxxxxxxxx, Xxxxxxx and Maynooth
University Enterprise Development Limited, x/x Xx. Xxxxxxx'x Xxxxxxx, Xxxxxxxx,
Xxxxxx Xxxxxxx, Xxxxxxx (hereinafter THE COLLEGE).
PROJECT
"Evaluation of Biodegradable Microparticles as a delivery system for an
Accelular Pertussis Vaccine"
OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS:
With respect to inventions and know-how made wholly or in part by personnel at
The Department of Biology, North Campus, St. Patrick's College, Maynooth,
relating to this project, THE COMPANY and THE COLLEGE agree to the following:
THE COMPANY will file, prosecute and maintain patent applications in
territories where it shall deem appropriate. THE COLLEGE shall have
the right to file, prosecute and maintain, at its own expense, patent
applications in additional territories where appropriate.
Patentable inventions and other know-how resulting from the project
shall be assigned to THE COMPANY.
In the event of commercial exploitation of a patentable invention, THE
COMPANY and THE COLLEGE will negotiate an appropriate compensation to
THE COLLEGE not to exceed a value of 2% of the net sales income earned
by THE COMPANY in the case of a product resulting from a product
patent claim or in the case of a product resulting from a process
patent claim not to exceed 1% of the net sales income earned by THE
COMPANY. The compensation shall depend, inter alia, upon the
contribution by THE COLLEGE to the patentable invention.
DEFINITION:
NET SALES shall mean the gross receipts, royalties, fees or other
valuable consideration of any kind received or credited to the benefit
of THE COMPANY for sale of the product/process exclusive of taxes and
less any allowances for returned goods or retroactive price reductions
and transport or insurance costs and other directly sales related
charges.
The parties shall negotiate and conclude an agreement to reflect the foregoing
when it becomes appropriate to do so.
For and on behalf of For and on behalf of
/s/ Xxx XxXxx /s/ Xxxxxxx Xxxxxx
_____________________ ______________________________
Elan Corporation, Plc. Maynooth University Enterprise
Development Limited.
Date: 25-3-96 Date: 28/3/96
