EXHIBIT 10.40
This Agreement is made the 15th day of October 1997
BY AND BETWEEN
ELAN CORPORATION, plc
An Irish company, of Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx.
AND
BIOJECT JV SUBSIDIARY INC.
A Corporation organised and existing under the laws of the State of
Oregon having an office at 0000 X.X. Xxxxxxxxxx Xxxx,
Xxxxxxxx, Xxxxxx 00000, Xxxxxx Xxxxxx of America.
WHEREAS
-ELAN owns and is beneficially entitled to the use of various patents,
including the ELAN PATENT RIGHTS, which have been granted or are pending under
the International Convention in relation to the development and production of
monitoring devices and drug delivery devices and processes, and
-ELAN is knowledgeable in the development of devices and methods for directly
or indirectly monitoring the concentration of glucose in a subject and has
developed unique monitoring devices and methods, and
-JV SUB is desirous of entering into a licensing agreement with ELAN to
further develop, manufacture and have manufactured in accordance with the
terms of this AGREEMENT and to market, sell and distribute the PRODUCTS in the
TERRITORY without infringing the ELAN GLUCOSE MONITOR TECHNOLOGY, and
-ELAN is prepared to license the ELAN PATENT RIGHTS in the TERRITORY to JV SUB.
NOW IT IS HEREBY AGREED AS FOLLOWS:
ARTICLE I : DEFINITIONS
0.0.Xx the present AGREEMENT and any further agreements based thereon between
the Parties hereto, the following definitions shall prevail:
AFFILIATE shall mean any corporation or entity controlling, controlled by or
under the common control of ELAN or JV SUB as the case may be. For the
purpose of this paragraph, "control" shall mean the direct or indirect
ownership of at least fifty per cent (50%) of the outstanding shares or other
voting rights of the subject entity to elect directors, or if not meeting the
preceding criteria, any entity owned or controlled by or owning or controlling
at the maximum control or ownership right permitted in the country where such
entity exists.
2 AGREEMENT shall mean this agreement.
BIOJECT shall mean Bioject Medical Technologies Inc. and its AFFILIATES,
excluding JV SUB.
4. BUSINESS PLAN shall mean the business plan to be adopted by the Board of
Directors of JV SUB and approved by ELAN (which approval shall not be
unreasonably withheld or delayed) from time to time. The initial form of the
BUSINESS PLAN will be adopted and approved as soon as is practicable, the
Parties agreeing that both expect that such initial BUSINESS PLAN will be
approved in any event not later than forty five (45) days after the
EFFECTIVE DATE.
5. cGP shall mean, depending on the regulatory context, current Good Clinical
Practises and/or current Good Laboratory Practises and/or current Good
Manufacturing Practises.
6. COMPETING PRODUCT shall mean a product [CONFIDENTIAL PORTION OMITTED].
7. CONFIDENTIAL INFORMATION shall mean information, material or data relating
to the FIELD not generally known to the public. CONFIDENTIAL INFORMATION in
tangible form disclosed hereunder shall be marked as "Confidential" at the
time it is delivered to the receiving Party. CONFIDENTIAL INFORMATION
disclosed orally shall be identified as confidential or proprietary when
disclosed and such disclosure of CONFIDENTIAL INFORMATION shall be confirmed
in writing within thirty (30) days by the disclosing Party.
8.EARLY STAGE DEVELOPMENT PLAN shall have the meaning set forth in Article III
Paragraph 2.
9. EFFECTIVE DATE shall mean the 15th day of October 1997.
10. ELAN shall mean Elan Corporation, plc and any of its AFFILIATES (which for
the avoidance of doubt shall exclude JV SUB and BIOJECT).
11.ELAN GLUCOSE MONITOR TECHNOLOGY shall mean the ELAN PATENT RIGHTS
and/or the ELAN KNOW-HOW.
12. ELAN KNOW-HOW shall mean all scientific or technical knowledge, information
or expertise, including clinical data and test results, which is not generally
known to the public, developed, produced, created or acquired by or on behalf
of ELAN, whether prior to or during the term of this AGREEMENT, including
without limitation in the course of the development activities called for
under Article III (including ELAN IMPROVEMENTS but excluding JOINT
IMPROVEMENTS), relating to the FIELD, whether or not covered by any patent,
copyright, design patent, trademark, trade secret or other industrial or
intellectual property rights. Insofar as ELAN licenses or acquires third party
technology, ELAN shall use commercially reasonable efforts to exclude or where
applicable to minimise the extent of any limitations or restrictions on the
inclusion of such technology in the ELAN KNOW-HOW.
13. ELAN PATENT RIGHTS shall mean all issued patents and/or pending patent
applications relating to the FIELD owned or licensed by or on behalf of ELAN,
whether prior to or at any time during the TERM including without limitation
issued patents and /or pending applications to the extent directed to any of
the ELAN KNOW-HOW (including ELAN IMPROVEMENTS but excluding JOINT
IMPROVEMENTS). The current status of the ELAN PATENT RIGHTS is described by
ELAN in APPENDIX A. ELAN PATENT RIGHTS shall also include all continuations,
continuations-in-part, divisionals, re-issues and re-examinations of such
patents and patent applications and any patents issuing thereon and extensions
of any patents licensed hereunder and periods of market exclusivity.
[CONFIDENTIAL PORTION OMITTED].
14.ELAN TRADEMARK shall have the meaning set forth in Article II Paragraph
11.4.
15.FDA shall mean the United States Food and Drug Administration or any other
successor agency, whose approval is necessary to market the PRODUCTS in the
United States of America.
16.FIELD shall mean [CONFIDENTIAL PORTION OMITTED].
00.XX MARKET shall mean [CONFIDENTIAL PORTION OMITTED].
18. JOINT IMPROVEMENTS shall have the meaning set forth in Article VIII
Paragraph 1.
19.JV SUB shall mean BIOJECT JV SUBSIDIARY INC. and any of its AFFILIATES,
including BIOJECT.
20 JV SUB KNOW-HOW shall mean all scientific or technical knowledge, including
clinical data and test results, information or expertise developed, produced,
created or acquired by or on behalf of JV SUB which is not generally known to
the public, which is developed by or on behalf of JV SUB whether prior to or
during the TERM, to the extent it constitutes: (I) a modification of or an
improvement on the ELAN GLUCOSE MONITORING TECHNOLOGY having potential
application outside the FIELD and/or (II) technology that is necessary for the
research, development or commercialisation of the PRODUCTS, whether or not
covered by any patent, copyright, design patent, trademark, trade secret or
other industrial or intellectual property rights (but excluding ELAN KNOW-HOW
and JOINT IMPROVEMENTS).
21. JV SUB PATENT RIGHTS shall mean all issued patents and/or pending patent
applications to the extent directed to any of the JV SUB KNOW-HOW owned or
licensed by or on behalf of JV SUB (excluding ELAN PATENT RIGHTS and JOINT
IMPROVEMENTS), together with all continuations, continuations-in-part,
divisionals, re-issues and re-examinations of such patents and patent
applications and any patents issuing thereon and extensions of any patents
licensed hereunder.
22. LISTED COMPANIES shall mean the legal entities set out in APPENDIX B or
any subsidiary of any such entity, where the entity directly or indirectly
owns at least [CONFIDENTIAL PORTION OMITTED] of the outstanding shares or
other voting rights of the subsidiary to elect directors, or if not meeting
the preceding criteria, where the entity owns or controls the maximum control
or ownership right permitted in the country where such subsidiary exists;
provided, however, that if ELAN or any of its AFFILIATES (for the avoidance of
doubt other than BIOJECT and JV SUB) at any time becomes owner to the extent of
more than [CONFIDENTIAL PORTION OMITTED] of the fully-diluted equity by any
of the LISTED COMPANIES, then that LISTED COMPANY shall thereupon be removed
from the LISTED COMPANIES.
23. MAJOR MARKETS shall mean [CONFIDENTIAL PORTION OMITTED].
24. NET REVENUES shall mean:
24.1. [CONFIDENTIAL PORTION OMITTED].
24.2. [CONFIDENTIAL PORTION OMITTED].
24.2.1. [CONFIDENTIAL PORTION OMITTED].
24.2.2. [CONFIDENTIAL PORTION OMITTED].
24.2.3. [CONFIDENTIAL PORTION OMITTED].
24.2.4. [CONFIDENTIAL PORTION OMITTED].
24.2.5 [CONFIDENTIAL PORTION OMITTED].
[CONFIDENTIAL PORTION OMITTED].
[CONFIDENTIAL PORTION OMITTED].
[CONFIDENTIAL PORTION OMITTED].
25. Party shall mean JV SUB or ELAN, as the case may be. "Parties" shall
mean JV SUB and XXXX.
00. PMA shall mean one or more of (I) a Pre-Market Application, (II) New Drug
Applications or (III) 510(k) or other substantially similar applications which
JV SUB shall file, including any supplements or amendments thereto, which JV
SUB may file for a PRODUCT with the FDA and/or a REGULATORY AUTHORITY.
27. PRODUCT(S) shall mean all devices or any parts thereof used, developed,
manufactured, offered for sale or sold by or on behalf of JV SUB within the
FIELD which but for the granting of the licenses by ELAN pursuant to Article
II would infringe the ELAN PATENT RIGHTS or the patents incorporated in the
JOINT IMPROVEMENTS and/or which incorporate or apply the ELAN KNOW-HOW and/or
the JOINT IMPROVEMENTS. [CONFIDENTIAL PORTION OMITTED].
28. PROJECT shall mean all activity as undertaken by ELAN and JV SUB in order
to develop the PRODUCT in accordance with the BUSINESS PLAN.
29. PROJECT TEAM shall mean the group to be established pursuant to Article
VII.
30. REGULATORY APPROVAL shall mean (i) approval for sale and marketing of one
or more of the PRODUCTS by the FDA in the United States of America, and/or
(ii) approval for sale and marketing of one or more of the PRODUCTS in the
other countries of the TERRITORY by the applicable REGULATORY AUTHORITIES.
31. REGULATORY AUTHORITIES shall mean one or more regulatory authorities
whose approval is necessary to market the PRODUCTS in the TERRITORY outside
of the United States of America where JV SUB intends to obtain REGULATORY
APPROVAL.
32. RESEARCH AND DEVELOPMENT COST shall mean in the case of research and
development being conducted by or on behalf of ELAN for JV SUB pursuant to
Article III, the fully allocated costs thereof calculated in accordance
with generally accepted Irish accounting principles consistently applied.
33. SHAREHOLDER APPROVAL shall have the meaning as defined in the Securities
Purchase Agreement entered into on the EFFECTIVE DATE between BIOJECT and
Elan International Services Limited.
34. SUBLICENSEE shall mean a sublicensee appointed by JV SUB or ELAN as the
case may be, or where applicable a sublicensee appointed by such a
sublicensee, pursuant to the provisions of the AGREEMENT.
35. TERM shall have the meaning set forth in Article IX Paragraph 1.
36. TERRITORY shall mean the United States of America, Canada and Mexico;
however if SHAREHOLDER APPROVAL is granted, the TERRITORY shall be world-wide.
37. US$ shall mean United States Dollars.
1.2 In this AGREEMENT
1.2.1 the singular includes the plural and vice versa, the masculine includes
the feminine and vice versa and references to natural persons include corporate
bodies, partnerships and vice versa.
1.2.2 any reference to a Article or Appendix shall, unless otherwise
specifically provided, be to an Article or Appendix of this AGREEMENT.
1.2.3 the headings of this AGREEMENT are for ease of reference only and shall
not affect its construction or interpretation.
ARTICLE II : THE LICENCE
1.1. ELAN shall remain proprietor of the ELAN GLUCOSE MONITOR TECHNOLOGY
but hereby grants to JV SUB for the TERM a sole and exclusive (including as
to ELAN) licence in the TERRITORY, with the right to grant sublicences pursuant
to and in accordance with the provisions of Article II Paragraph 2, to
research, develop, manufacture, have manufactured for JV SUB (or its permitted
SUBLICENSEES), import and have imported, use, sell, offer for sale and
otherwise commercialise the ELAN GLUCOSE MONITOR TECHNOLOGY, ELAN's interest
in the JOINT IMPROVEMENTS in the FIELD and the PRODUCTS under the terms and
conditions set out herein.
1.2. [CONFIDENTIAL PORTION OMITTED].
1.3. [CONFIDENTIAL PORTION OMITTED].
2.1. JV SUB may sublicense rights which incorporate the ELAN GLUCOSE MONITOR
TECHNOLOGY with the prior written consent of ELAN which shall not be
unreasonably withheld or delayed; provided, that such reasonableness standard
shall not apply in the case of a proposed sublicence to any of the entities
listed on the LISTED COMPANIES. The nature and extent of the proposed
sub-licence (such as the extent of the territory of the sublicence, the
material terms of the proposed sublicence, and whether the SUBLICENSEE has
the rights of further sublicensing) shall be a relevant factor in determining
whether or not ELAN has acted reasonably or otherwise in making such
determination. JV SUB shall use its reasonable endeavours to ensure that
ELAN shall have the same rights of audit and inspection vis a vis the
SUBLICENSEE as ELAN has pursuant to this AGREEMENT concerning JV SUB.
2.2. Insofar as the obligations owed by JV SUB to ELAN are concerned, JV SUB
shall remain responsible for all acts and omissions of any SUBLICENSEE as if
such acts and omissions were by JV SUB; provided that no such acts or
omissions of such SUBLICENSEE will constitute a material breach of the
AGREEMENT by JV SUB for the purposes of Article IX Paragraph 2. [CONFIDENTIAL
PORTION OMITTED].
3. It is contemplated that the physical transfer of the ELAN KNOW-HOW to be
licensed under this AGREEMENT and the furnishing of copies of relevant patent
documentation regarding the ELAN PATENT RIGHTS shall be completed within
[CONFIDENTIAL PORTION OMITTED] of the EFFECTIVE DATE (it being understood
that this is without prejudice to the later physical transfer of ELAN
IMPROVEMENTS thereafter developed, produced, created or acquired by or on
behalf of ELAN licensed pursuant to the AGREEMENT, including the furnishing
of copies of patent documentation regarding any applicable ELAN PATENT RIGHTS
with respect to ELAN IMPROVEMENTS). ELAN shall, at its expense, provide all
notices and reasonable assistance within such [CONFIDENTIAL PORTION OMITTED]
period to JV SUB to facilitate such transfer (and later, as to any subsequent
transfer of ELAN IMPROVEMENTS); provided, that in the event that JV SUB's
requirements relating to such transfer are in excess of the Parties' current
reasonable, good faith, expectations, the Parties shall negotiate in good
faith reimbursement of ELAN's out-of-pocket expenses.
4. JV SUB shall xxxx or have marked the patent number on all PRODUCTS, or
otherwise reasonably communicate to the trade concerning the existence of
any ELAN PATENT RIGHTS for the countries within the TERRITORY in such a
manner as to ensure compliance with, and enforceability under, applicable
laws.
Performance by JV SUB
5. [CONFIDENTIAL PORTION OMITTED].
6. [CONFIDENTIAL PORTION OMITTED] JV SUB shall report on the ongoing sales
performance of the PRODUCTS, and the exploitation of the ELAN GLUCOSE MONITOR
TECHNOLOGY in the TERRITORY, [CONFIDENTIAL PORTION OMITTED]. For the
avoidance of doubt, the Parties agree that all information furnished to
ELAN pursuant to this Paragraph shall constitute CONFIDENTIAL INFORMATION
for the purposes of this AGREEMENT.
7. When packaged, and to the extent permitted by law, a product label shall
include an acknowledgement that the PRODUCT is made under licence from or
manufactured by ELAN. Such acknowledgement shall take into consideration
regulatory requirements and JV SUB's commercial requirements. JV SUB shall
wherever possible give due acknowledgement and recognition to ELAN in all
printed promotional and other material regarding the PRODUCT such as stating
that the PRODUCT is under license from ELAN and that the applicable ELAN
GLUCOSE MONITOR TECHNOLOGY has been applied to the PRODUCT. JV SUB shall
consult with and obtain the approval of ELAN 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 ELAN GLUCOSE MONITOR TECHNOLOGY.
It shall be presumed that ELAN approved of such use unless ELAN provides
written notice of disapproval of such use to JV SUB within thirty (30) days
of delivery of such materials to ELAN, such approval not to be unreasonably
withheld or delayed. The further consent of ELAN shall not be
required where the format and content of such materials is substantively
materially similar as the materials previously furnished to and approved by
ELAN.
8.1. JV SUB shall effect a national commercial launch of the PRODUCT in each
MAJOR MARKET within [CONFIDENTIAL PORTION OMITTED] of REGULATORY APPROVAL
thereof in such MAJOR MARKET. If JV SUB does not make a national commercial
launch in one or more of the MAJOR MARKETS within the [CONFIDENTIAL PORTION
OMITTED], or such longer period permitted by the provisions of this
Paragraph 8.1, the licences granted to JV SUB hereunder shall with thirty
(30) days notice from ELAN terminate in the applicable country and ELAN shall
be entitled to a licence to commercialise the PRODUCT that was given such
REGULATORY APPROVAL under the JV SUB PATENT RIGHTS and the JV SUB KNOW-HOW
developed, produced, created or acquired by JV SUB, in the applicable country
on the terms set out in Article II Paragraph 8.3. and to the TRADEMARK on
the terms set out in Article II Paragraph 11.2 for such purpose. If in JV
SUB's reasonable commercial judgement, one or more of the [CONFIDENTIAL
PORTION OMITTED] periods specified in this Paragraph 8.1. is insufficient,
the Parties shall negotiate in good faith the applicable extension to the
said [CONFIDENTIAL PORTION OMITTED] period. Notwithstanding the above, in
the event that the Parties disagree whether or not JV SUB has satisfied its
obligations under this AGREEMENT in any country listed above, the
matter may be submitted to arbitration by either Party, and JV SUB's rights
and licenses shall remain in effect until and unless the arbitrator makes a
decision that JV SUB's right and license in such country should terminate.
8.2. JV SUB will use commercially reasonable efforts to file and obtain
REGULATORY APPROVAL in the MAJOR MARKETS as soon as practicable. In the
event of any failure by ELAN to diligently pursue any submission in any
application for regulatory approval in any country which results in JV SUB's
failure to obtain regulatory approval or any delay thereof, the Parties
through the PROJECT TEAM shall make reasonable and appropriate adjustments
to the period in which JV SUB shall have to obtain the applicable regulatory
approvals.
8.3. If (x) JV SUB fails to obtain REGULATORY APPROVAL to commercialise the
PRODUCT in the MAJOR MARKETS within a commercially reasonable time, as
determined by the PROJECT TEAM, or (y) JV SUB fails to effect a commercial
launch of the PRODUCT in the MAJOR MARKETS within the period specified in
Paragraph 8.1. above JV SUB shall, at the option of ELAN, make available and
transfer to ELAN all of JV SUB's data, information, applications, approvals
and filings to permit ELAN to commercialise the PRODUCT in the applicable
country or countries (including access to such data, information, applications,
approvals and filings which is of assistance in obtaining or maintaining
approvals and filings in the applicable country or countries), in consideration
for a royalty of [CONFIDENTIAL PORTION OMITTED] of NET REVENUES (for which
purpose the definition of NET REVENUES as set out in Article I shall apply to
mutatis mutandis) of the PRODUCT, after recovery of the expenses incurred by
ELAN related to the development and commercialisation of such PRODUCTS in the
applicable country or countries of the TERRITORY. Such royalty shall
be payable with respect to such NET REVENUES with respect to a term extending
until the expiration of [CONFIDENTIAL PORTION OMITTED] starting from the
EFFECTIVE DATE, or on a country by country basis for the [CONFIDENTIAL PORTION
OMITTED] included in the JV SUB PATENT RIGHTS or the JOINT IMPROVEMENTS,
whichever is longer. In such event ELAN shall be entitled to an exclusive
licence to the JV SUB PATENT RIGHTS and the JV SUB KNOW-HOW developed,
produced, created or acquired by JV SUB whether prior to or after the
granting of the licence to ELAN), and a licence to the JOINT IMPROVEMENTS to
the exclusion of JV SUB to commercialise the PRODUCT on the terms set out in
this Paragraph and to the TRADEMARK on the terms set out in Article II,
Paragraph 11.2. for such purpose. ELAN may sublicense the rights granted to
it pursuant to this Paragraph to one or more SUBLICENSEES with the prior
written consent of JV SUB which shall not be unreasonably withheld or delayed.
Insofar as JV SUB has licensed or acquired third party technology, JV SUB
shall all commercially reasonable efforts to exclude or where applicable to
minimise the extent of any limitations or restrictions on its use for such
purposes, and it is understood that no such limitations or restrictions shall
be permitted as between BIOJECT and JV SUB. In the event that ELAN acquires
a licence, the Parties shall enter into a further written licence agreement
which shall include customary and reasonable terms relating to, inter alia,
the timing of royalty payments to JV SUB, reporting obligations regarding net
sales, audit rights of JV SUB with respect to books and records relating to
net sales, and indemnity provisions, which obligations shall, unless
otherwise agreed by the Parties, be substantially similar to those in this
AGREEMENT with respect to commercialisation of the PRODUCTS by JV SUB.
8.4.1 JV SUB will use its commercially reasonable efforts to obtain regulatory
approval to commercialise the PRODUCT in the other countries of the TERRITORY
that it selects, having regard to the effort and expenditure required to obtain
regulatory approval for the PRODUCT and the commercial opportunities for the
PRODUCT in such other countries of the TERRITORY.
8.4.2. In the event that the Parties disagree whether JV SUB has satisfied its
obligations under Paragraph 8.4.1. above with regard to one or more of such
other countries of the TERRITORY, the matter may be submitted to arbitration
pursuant to Article X Paragraph 14 by either Party, and JV SUB's rights and
licenses shall remain in effect until and unless the arbitrator makes a
decision that JV SUB's right and license in such country should terminate.
8.4.3. If JV SUB indicates to ELAN that it does not intend to obtain
registration approval and commercialise the PRODUCT in a particular country
or countries of the TERRITORY, or fails to commence commercialisation in any
country within one hundred and (180) days after receiving the required
regulatory approval therefore, ELAN shall be entitled to a licence to the
JV SUB PATENT RIGHTS and the JV SUB KNOW-HOW to commercialise the PRODUCT
in such countries on the terms set out in Article II Paragraph 8.3. and to the
TRADEMARK on the terms set out in Article II Paragraph 11.
Grant of rights to ELAN
9.1. ELAN may use the ELAN GLUCOSE MONITOR TECHNOLOGY and all technical and
clinical data or improvements generated by ELAN pursuant to this AGREEMENT in
connection with ELAN's commercial arrangements for the PRODUCTS in any country
which ceases to be a part of the TERRITORY, or in relation to the PRODUCTS in
the TERRITORY in the event of the termination of this AGREEMENT; provided that
ELAN will not, prior to February 1, 1998, make any such commercial
arrangements, nor any grants of any rights to any third party, anywhere in the
world that would be inconsistent with the extension of the TERRITORY to be
world-wide upon the SHAREHOLDER APPROVAL, with the same effect for all purposes
under this AGREEMENT as if the TERRITORY had been world-wide from the EFFECTIVE
DATE and at all times through the SHAREHOLDER APPROVAL.
9.2. For the avoidance of doubt, nothing in the AGEEMENT shall prevent ELAN
from exploiting the ELAN GLUCOSE MONITOR TECHNOLOGY and all technical and
clinical data or improvements generated by ELAN pursuant to this AGREEMENT
outside the FIELD.
10.1. Subject to the confidentiality and non-disclosure provisions set out in
Article X Paragraph 1, ELAN and JV SUB will share (for no additional
consideration) all relevant information developed in connection with the
PROJECT, relating to the development and commercialisation of the PRODUCT
including pre-clinical, methods, clinical protocols and other necessary or
appropriate data; it being understood that neither Party shall have any right
to any intellectual property or products of the other except as expressly set
forth in this AGREEMENT.
10.2. JV SUB shall be and remain the proprietor of all the JV SUB PATENT RIGHTS
and JV SUB KNOW-HOW, but will grant to ELAN a non-exclusive world-wide,
[CONFIDENTIAL PORTION OMITTED] license, to research, develop, package,
manufacture, have manufactured for ELAN (or its permitted SUBLICENSEES),
import and have imported, use, sell, offer for sale, and otherwise
commercialise under the JOINT IMPROVEMENTS and under the JV SUB KNOW-HOW
that is described in Clause (I) of the definition of "JV SUB KNOW-HOW" in
Article I, and the JV SUB PATENT RIGHTS directed to such JV SUB KNOW-HOW
outside the FIELD. The licence granted pursuant to this Paragraph shall
include patent rights and know-how licensed or acquired by JV SUB from one
or more third parties where JV SUB is free to license and disclose such
improvements. [CONFIDENTIAL PORTION OMITTED]. ELAN may
sublicense the rights granted to it pursuant to this Paragraph to one or more
SUBLICENSEES with the prior written consent of JV SUB which shall not be
unreasonably withheld or delayed.
Trademark
11.1. JV SUB shall market the PRODUCT in the TERRITORY under a TRADEMARK,
whether during the TERM or thereafter, which TRADEMARK will be owned by JV SUB.
JV SUB shall take reasonable steps to register such TRADEMARK within the
TERRITORY where JV SUB reasonably believes exploitation of one or more of the
PRODUCTS shall occur. In the event that JV SUB does not intend to
commercialise the PRODUCT and ELAN obtains a license pursuant to Article II
Paragraph 8.3, ELAN shall be entitled to request JV SUB to register the
TRADEMARK in such country, at ELAN's expense.
11.2. In the event that ELAN acquires a license to the JV SUB PATENT RIGHTS
and the JV SUB KNOW-HOW pursuant to Article II Paragraph 8.3, JV SUB shall
grant ELAN an exclusive royalty free licence to the TRADEMARK solely for use
in connection with the sale of the PRODUCT for the applicable country or
countries of the TERRITORY, in which event the following provisions shall
apply:
11.2.1 ELAN shall as soon as it becomes aware of any infringement give to JV
SUB in writing full particulars of any use or proposed use by any other
person, firm or company of a trade name or trademark or mode or promotion or
advertising which amounts to or might amount either to infringement of JV
SUB's rights in relation to the TRADEMARK or to passing off;
11.2.2. if ELAN becomes aware that any other person, firm or company alleges
that the TRADEMARK is invalid or that the use of the TRADEMARK infringes any
rights of another party or that the TRADEMARK is otherwise attacked or
attackable, ELAN shall immediately give to JV SUB full particulars in writing
thereof and shall make no comment or admission to any third party in respect
thereof; and
11.2.3. JV SUB shall have the right to conduct all proceedings relating to the
TRADEMARK and shall in its sole discretion decide what action, if any, to take
in respect of any infringement or alleged infringement of the TRADEMARK or
passing-off or any other claim or counter-claim brought or threatened in
respect of the use or registration of the TRADEMARK. Any such proceedings
shall be conducted at JV SUB's expense and for its own benefit. In the
event that JV SUB fails to take action in respect of any infringement or
alleged infringement of the TRADEMARK or passing-off or any other claim or
counter-claim brought or threatened in respect of the use or registration of
the TRADEMARK, ELAN may request JV SUB to take such action at the expense of
ELAN.
11.3. In the event that ELAN acquires a license to the JV SUB PATENT RIGHTS
and the JV SUB KNOW-HOW pursuant to Article II Paragraph 8.3, ELAN may at its
discretion advertise and promote the PRODUCT under the TRADEMARK. Except as set
forth in this Paragraph 11, nothing contained in this AGREEMENT shall grant to
ELAN any right, title, or interest in or to TRADEMARK, whether or not
specifically recognised or perfected under applicable laws. At no time during
or after the term of this AGREEMENT shall ELAN challenge or assist others to
challenge any TRADEMARK, or the registration thereof or attempt to register
any trademarks, marks, or trade names confusingly similar to any
TRADEMARK. All representations of any TRADEMARK that ELAN intends to use
shall first be submitted to JV SUB for approval (which shall not be
unreasonably withheld) of design, colour, and other details, or shall be exact
copies of those used by JV SUB. In addition, ELAN shall fully comply with all
reasonable guidelines, if any, communicated by JV SUB concerning the use of
any TRADEMARK.
11.4. ELAN grants to JV SUB an exclusive royalty free licence in the TERRITORY
solely for use in connection with the sale of the PRODUCT, for the TERM to use
any ELAN TRADEMARK, if any, which relates to the ELAN GLUCOSE MONITOR
TECHNOLOGY applicable to the PRODUCT (the "ELAN TRADEMARK"), such as an acronym
for the applicable technology applied to the PRODUCT, on the terms set forth in
Article II Paragraph 11.2.1. to 11.2.3.(including the obligation not to
challenge or assist others to challenge any trademark referred to
in this Paragraph, or the registration thereof or attempt to register any
trademarks, marks, or trade names confusingly similar to any such trademark)
as applied mutatis mutandis. JV SUB 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 JV SUB shall not be entitled to a licence to use any trademark owned or
controlled by ELAN which identifies a product and furthermore that nothing in
this Paragraph shall prevent the licensing by ELAN of the ELAN TRADEMARK
outside the FIELD.
12. JV SUB hereby confirms that it intends to manufacture or procure the
manufacture of the PRODUCTS in a manner which fully complies with all
applicable statutes, ordinances and regulations of the United States of
America and other countries 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 cGP.
ARTICLE III: DEVELOPMENT OF THE PRODUCTS
1. Subject to the provisions of Article III Paragraph 2 and Article III
Paragraph 3, JV SUB shall be responsible for the cost of the further
development, registration, manufacture and marketing of the PRODUCTS.
2. The PROJECT TEAM shall prepare and agree upon a development plan in
respect of the PRODUCT, including development work to be undertaken by ELAN
as soon as is practicable and in no event later than forty five (45) days
after the EFFECTIVE DATE (the "EARLY-STAGE DEVELOPMENT PLAN"). The Parties
agree that ELAN shall perform, and shall fund the cost of such development,
pursuant to and in accordance with the EARLY-STAGE DEVELOPMENT PLAN, such
development through and including the first to occur of (I) the first human
clinical trials in healthy human volunteers without regard to the result
thereof;(II) March 31, 1998; or (III) the devotion of ELAN to such further
development pursuant to the EARLY-STAGE DEVELOPMENT PLAN of an aggregate amount
of US$2.5 million (two million five hundred thousand United States dollars)
(using RESEARCH AND DEVELOPMENT COST plus [CONFIDENTIAL PORTION OMITTED]
as the basis for calculating the foregoing aggregate amount.
3. In addition to the research and development to be conducted pursuant to
Paragraph 2 above, the Parties shall each negotiate in good faith the extent
to which ELAN shall provide research and development services to JV SUB.
ELAN will agree to undertake certain research and development work related to
the development and commercialisation of the PRODUCTS as set forth in one or
more development plans agreed to in good faith between ELAN and JV SUB. The
cost of such development work shall be RESEARCH AND DEVELOPMENT COST together
with an additional royalty calculated on the basis of [CONFIDENTIAL PORTION
OMITTED] of the RESEARCH AND DEVELOPMENT COST;
provided, that if SHAREHOLDER APPROVAL is granted, the cost of such
development work shall be at the rate of RESEARCH AND DEVELOPMENT COST
together with an additional royalty calculated on the basis of [CONFIDENTIAL
PORTION OMITTED] of the RESEARCH AND DEVELOPMENT COST.
4. Subject to the provisions of this Article III, JV SUB shall use its
reasonable efforts, as would be deemed commensurate with the achievement of
its own business aims for a similar product of its own to conduct such part
of the PROJECT as the Parties mutually agree shall be conducted by JV SUB.
Subject to the provisions of this Article III, ELAN shall use its
reasonable efforts, as would be deemed commensurate with the achievement of
its own business aims for a similar product of its own, to conduct such part
of the PROJECT as the Parties mutually agree that shall be conducted by ELAN.
JV SUB shall carry out all clinical studies to prevailing cGP and most
specifically in accordance with FDA standards and guidelines.
5. ELAN shall have no liability to JV SUB as a result of any failure or delay
of the PRODUCTS to achieve one or more of the milestones set out in the
PROJECT and/or to obtain the REGULATORY APPROVAL or the approval of the
regulatory authorities in one or more of the other countries of the TERRITORY.
JV SUB shall have no liability to ELAN as a result of any failure or delay of
the PRODUCTS to obtain the REGULATORY APPROVAL or the approval of the
appropriate health regulatory authorities in one or more of the countries of
the TERRITORY.
6. The Parties hereby confirm that each shall undertake its respective part of
the PROJECT as a collaborative effort and that the provisions of this AGREEMENT
requires that each Party diligently carries out those tasks assigned to it
under the PROJECT and as otherwise agreed during the course of the PROJECT.
Each Party shall co-operate with the other in good faith
particularly with respect to unknown problems or contingencies and shall
perform its obligations in good faith and in a commercially reasonable,
diligent and workmanlike manner. Each Party will update the other Party on
the progress of the PROJECT at meetings of the PROJECT TEAM.
7. For the avoidance of doubt, the Parties hereby confirm that a primary
objective of the PROJECT is to generate the PMA and secure REGULATORY APPROVAL
for the PRODUCT from the FDA. As of the date of this AGREEMENT, it is the
Parties' expectation that the body of data so generated in the PROJECT will
also support such applications for regulatory approval that JV
SUB shall make in the other countries of the TERRITORY. In the event however
that such expectation proves unfounded or incorrect and further data is
required to obtain such other approvals as are pursued by JV SUB in the other
countries of the TERRITORY, JV SUB shall determine the viability of proceeding
further with the regulatory application and generation of the further data
requirements.
ARTICLE IV : FINANCIAL PROVISIONS
Initial Royalties
1.1. In consideration for the research and development of the PRODUCT by ELAN
under this AGREEMENT, JV SUB shall pay to ELAN the amounts set out in Article
III Paragraph 3. Subject to the provisions of Article III Paragraph 2, all
research and development work conducted by ELAN pursuant to this AGREEMENT,
including work conducted pursuant to Article III shall be the subject of
Article IV Paragraph 1.
1.2. ELAN will keep accurate records consistent with its normal business
practices, of the efforts expended by it under the PROJECT for which it is
charging JV SUB, which will include the time spent by each person working on
the PROJECT. Each quarter ELAN will send reports to JV SUB in order to
enable JV SUB to monitor ELAN's level of effort to assure JV SUB that the
committed level of effort is being applied.
1.3. If ELAN's development efforts require the use of an unaffiliated third
party, ELAN will, prior to appointing such unaffiliated third party, discuss
with JV SUB the activities to be undertaken by such unaffiliated third party
and the terms and conditions thereof. ELAN will not proceed with such third
party without the prior written approval of JV SUB, which approval shall not
be unreasonably withheld. ELAN shall charge JV SUB for the time spent by
its employees in administering the work conducted by such unaffiliated third
parties on the basis set out in Article III Paragraph 3. ELAN shall have the
right to charge JV SUB for all reasonable out of pocket expenses incurred in
the provision of its obligations thereunder.
Licence Royalties
2. In consideration of the rights and licence granted to JV SUB to the ELAN
PATENT RIGHTS by virtue of this AGREEMENT, JV SUB shall pay to ELAN amounts
as follows:
2.1. [CONFIDENTIAL PORTION OMITTED] upon the date of
execution of this AGREEMENT;
2.2. [CONFIDENTIAL PORTION OMITTED] within ten (10) days
of commencement of pivotal clinical trials relating to the first PRODUCT (it
being a matter for the PROJECT TEAM to determine what constitutes a `pivotal'
clinical trial for the purposes of this Paragraph and Paragraph 2.3. below)
and the concurrent agreement between JV SUB and ELAN of the success criteria
for such pivotal clinical trials, which the Parties intend will include
completed ISS/ISE;
2.3. [CONFIDENTIAL PORTION OMITTED]
within one hundred and twenty (120) days of the successful completion of the
pivotal clinical trials referred to in Paragraph 2.2. above; provided, that JV
SUB shall be liable for interest on such amount at the rate of ten per cent
(10%) per year from and after the date that is sixty (60)days after such
completion;
2.4. [CONFIDENTIAL PORTION OMITTED] within ten (10) days
of the initial filing of a PMA to obtain REGULATORY APPROVAL for marketing of
the first PRODUCT to reach such stage with the FDA; and
2.5. [CONFIDENTIAL PORTION OMITTED] within one hundred
and twenty (120) days of the first REGULATORY APPROVAL for the first PRODUCT
to reach such stage by the FDA provided, that JV SUB shall be liable for
interest on such amount at the rate of ten per cent (10%) per year from and
after the date that is sixty (60) days after such approval; except that, in
the event that SHAREHOLDER APPROVAL is obtained, the following payments shall
be due and owing
2.5.1. [CONFIDENTIAL PORTION OMITTED] within one hundred
and twenty (120) days of the first REGULATORY APPROVAL by the FDA for the
first PRODUCT to reach such stage in the United States of America, provided,
that JV SUB shall be liable for interest on such amount at the rate of ten
per cent (10%) per year from and after the date that is sixty (60) days after
such approval; and
2.5.2. [CONFIDENTIAL PORTION OMITTED] within one hundred
and twenty (120) days of the approval by a REGULATORY AUTHORITY other than the
FDA for the first PRODUCT to reach such stage in one or more MAJOR MARKETS
other than the United States of America, provided, that JV SUB shall be liable
for interest on such amount at the rate of ten per cent (10%) per year from and
after the date that is sixty (60) days after such approval.
All such payments are due upon achievement of the milestone event and are
payable by JV SUB within the number of days specified above following the
occurrence of the milestone, of which event JV SUB will promptly notify ELAN
and ELAN will send an invoice to JV SUB for the corresponding milestone
payment. The foregoing licence royalties shall be non-recoverable by JV SUB.
Royalty on NET REVENUES
3.1. In consideration of the license of the ELAN PATENT RIGHTS to JV SUB, the
royalties payable by JV SUB to ELAN shall calculated by reference to the NET
REVENUES generated by JV SUB or its sublicensees on or after the EFFECTIVE
DATE.
3.2. The royalty payable shall vary from [CONFIDENTIAL PORTION OMITTED]
to [CONFIDENTIAL PORTION OMITTED] of NET REVENUES based upon the following
([CONFIDENTIAL PORTION OMITTED] amounts refer to royalty rates, and
[CONFIDENTIAL PORTION OMITTED] amounts refer to NET REVENUES in a
fiscal year):
3.2.1. [CONFIDENTIAL PORTION OMITTED] on the first [CONFIDENTIAL PORTION
OMITTED],
3.2.2. [CONFIDENTIAL PORTION OMITTED] on the amount between
[CONFIDENTIAL PORTION OMITTED] and [CONFIDENTIAL PORTION OMITTED], and
3.2.3. [CONFIDENTIAL PORTION OMITTED] on the amount in excess of
[CONFIDENTIAL PORTION OMITTED]; provided, that in the event of SHAREHOLDER
APPROVAL, such royalties shall be as follows:
3.2.4. [CONFIDENTIAL PORTION OMITTED] on the first [CONFIDENTIAL PORTION
OMITTED],
3.2.5. [CONFIDENTIAL PORTION OMITTED] on the amount between [CONFIDENTIAL
PORTION OMITTED] and [CONFIDENTIAL PORTION OMITTED], and
3.2.6. [CONFIDENTIAL PORTION OMITTED] on the amount in excess of
[CONFIDENTIAL PORTION OMITTED].
Royalty Payments, Reports and Records
4.1. Within [CONFIDENTIAL PORTION OMITTED] of the end of each quarter in
which NET REVENUES have been earned, JV SUB shall notify ELAN of the NET
REVENUES for that preceding quarter. Payments shown by each calendar quarter
report to have accrued shall be due on the date such report is due. All
payments due hereunder shall be made to the designated bank account of ELAN
in accordance with such timely written instructions as ELAN shall from time
to time provide.
4.2. JV SUB shall keep and shall cause its AFFILIATES and sublicensees to
keep true and accurate records of sales of PRODUCTS, other transactions giving
rise to NET REVENUES, and the royalties payable to ELAN under Article IV hereof
and shall deliver to ELAN a written statement thereof within [CONFIDENTIAL
[PORTION OMITTED] days following the end of each calendar quarter in which
NET REVENUES have been earned (or any part thereof in the last calendar
quarter of this AGREEMENT in which NET REVENUES are earned) for such calendar
quarter. Said written statements shall set forth (I) for each PRODUCT
[CONFIDENTIAL PORTION OMITTED], the calculation of NET REVENUES from gross
revenues during that calendar quarter, the applicable percentage royalty
rates, and a computation of such royalties due and (II) such details of the
transactions as are relevant to the calculation of NET REVENUES.
4.3. All payments due hereunder shall be made in United States Dollars.
Payments due on NET REVENUES received 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 of the exchange rates 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 or
origin of such payment for the last business day of each month for which the
payment is being made.
4.4. ELAN shall have the right to have access, on reasonable notice, to JV
SUB's or JV SUB's SUBLICENSEES' financial documentation and records during
reasonable business hours for the purpose of verifying the royalties payable
as provided in this AGREEMENT for the two preceding years. This right may
not be exercised more than once in any calendar year, and once a calendar
year is audited it may not be reaudited. For the avoidance of doubt, the
Parties agree that all information furnished to ELAN pursuant to this
Paragraph shall constitute CONFIDENTIAL INFORMATION for the purposes of this
AGREEMENT.
4.5. Any adjustment required by such inspection shall be made within thirty
(30) days of the agreement of the Parties or, if not agreed, upon the
determination of an arbitrator to whom any dispute under this Paragraph shall
be submitted to arbitration pursuant to Article X Paragraph 14. If the
adjustment payable to ELAN is greater than [CONFIDENTIAL PORTION OMITTED] of
the amount paid for the relevant period, then the cost to ELAN for the
inspection, and if applicable the arbitration, shall be paid by JV SUB;
[CONFIDENTIAL PORTION OMITTED]. In addition, JV SUB shall pay interest to
ELAN [CONFIDENTIAL PORTION OMITTED] (applicable as of the date on which
payment should have been made pursuant to Article IV Paragraph 3), from
the date on which payment should have been
made pursuant to Article IV Paragraph 3 until the date of payment.
4.6. Subject to the provisions of Article IV Paragraphs 2.3 and 2.5, JV SUB
shall pay interest to ELAN [CONFIDENTIAL PORTION OMITTED]
(applicable as of the date on which payment should have
been made pursuant to the applicable provisions of this AGREEMENT) from the
date on which payment should have been made pursuant to the applicable
provision until the date of payment.
ARTICLE V REGISTRATION OF THE PRODUCTS
1. During the TERM, JV SUB shall be responsible for filing and prosecuting
all PMAs and other applications for regulatory approvals. JV SUB or its
sublicensees shall file the PMAs with the FDA and will use its reasonable
efforts in prosecuting said PMA to approval. JV SUB shall maintain at its
own cost the PMAs with the FDA for the term of this AGREEMENT. JV SUB
hereby agrees to provide to ELAN at ELAN's own cost access to such PMAs as
ELAN reasonably requests. It is not the intention of the Parties that JV
SUB shall furnish to ELAN a copy of each PMA. [CONFIDENTIAL PORTION OMITTED].
During the PMA registration procedure, JV
SUB shall keep ELAN promptly and fully advised of JV SUB's registration
activities, progress and procedures. For the avoidance of doubt, the
Parties agree that all information furnished to ELAN pursuant to
this Paragraph shall constitute CONFIDENTIAL INFORMATION for the purposes of
this AGREEMENT.
2. It is hereby acknowledged that there are inherent uncertainties involved
in the development and registration of pharmaceutical products with the FDA
or any other regulatory body in the TERRITORY insofar as obtaining approval
is concerned and such uncertainties form part of the business risk involved
in undertaking the form of commercial collaboration as set forth in this
AGREEMENT.
3. JV SUB shall indemnify and hold harmless ELAN, its agents and employees
from and against all claims, damages, losses, liabilities and expenses to
which ELAN, its agents, and employees may become subject related to or
arising out of JV SUB's bad faith, gross negligence or intentional
misconduct in connection with the filing or maintenance of the PMA and its
foreign counterparts.
ARTICLE VI: REPRESENTATIONS, WARRANTIES
1. ELAN represents to JV SUB the following:
1.1. ELAN is duly and validly existing in the jurisdiction of its
incorporation and each other jurisdiction in which the conduct of its
business requires such qualification, and is in compliance with all
applicable laws, rules, regulations or orders relating to its business and
assets;
1.2. ELAN 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 by ELAN and constitutes the legal and valid
obligations of ELAN and is enforceable against ELAN in accordance with its
terms and the execution, delivery and performance of this AGREEMENT and the
transactions contemplated hereby and will not violate or result in a default
under or creation of lien or encumbrance under ELAN's memorandum and articles
of association or other organic documents, any material agreement
or instrument binding upon or affecting ELAN or its properties or assets or
any applicable laws, rules, regulations or orders affecting ELAN or its
properties or assets;
1.3. ELAN is not in material default of its memorandum and articles of
association or similar organic documents, any applicable material 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;
1.4. ELAN represents and warrants that ELAN is the sole and exclusive owner
or licensee of, or controls all right, title and interest to the ELAN GLUCOSE
MONITOR TECHNOLOGY;ELAN has the right to grant the licenses granted herein, and
the ELAN GLUCOSE MONITOR TECHNOLOGY is free and clear of any lien,
encumbrances, security interest or restriction on the licence granted herein;
ELAN will not grant during the term of this AGREEMENT, any right, license or
interest in and to the ELAN GLUCOSE MONITOR TECHNOLOGY or the PRODUCTS, or any
portion thereof, inconsistent with the license granted herein, nor, as provided
in Article II Paragraph 9.1, inconsistent with the expansion of the TERRITORY
upon the SHAREHOLDER APPROVAL; and to the best of ELAN's knowledge and belief
there are no pending or threatened adverse actions, suits, investigations,
claims or proceedings brought by one or more Third Parties related to the ELAN
GLUCOSE MONITOR TECHNOLOGY as of the EFFECTIVE DATE; and
1.5. ELAN represents and warrants that the execution of this AGREEMENT and the
full performance and enjoyment of the rights of JV SUB under this AGREEMENT
will not breach or in any way be inconsistent with the terms and conditions
of any licence, contract, understanding or agreement, whether express, implied,
written or oral between ELAN and any third party.
2. JV SUB represents to ELAN the following:
2.1. JV SUB 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, and JV SUB is in compliance with all
applicable laws, rules, regulations or orders relating to its business and
assets;
2.2. JV SUB 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
JV SUB and is enforceable against JV SUB in accordance with its terms; and the
execution, delivery and performance of this AGREEMENT and the transactions
contemplated hereby will not violate or result in a default under or creation
of lien or encumbrance under JV SUB's certificate of incorporation, by-laws
or other organic documents, any material agreement or instrument
binding upon or affecting JV SUB or its properties or assets or any applicable
laws, rules, regulations or orders affecting JV SUB or its properties or
assets;
2.3. JV SUB 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
letter agreement and the transactions contemplated hereby will not result in
any such violation; and
2.4. JV SUB represents and warrants that it has not granted any option,
licence, right or interest to any third party which would conflict with the
terms of this AGREEMENT.
3. JV SUB represents and warrants that the PRODUCTS shall be manufactured,
packaged, distributed and sold in accordance with all regulations and
requirements of the FDA and foreign regulatory authorities including, without
limitation, the cGP regulations which apply to the manufacture, storage,
packaging and supply of the PRODUCT. JV SUB represents and warrants
that the PRODUCTS shall not be adulterated or mis-branded 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 except to the extent due to components
or materials manufactured or designed by ELAN (which components and material
have been properly used and applied in accordance with ELAN's specifications
or other written instructions or labels) or due to the negligence or wilful
misconduct of ELAN.
4. JV SUB is each fully cognisant of all applicable statutes, ordinances and
regulations of the United States of America 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 cGP. JV SUB shall manufacture
or procure the manufacture the PRODUCTS in conformity with the
REGULATORY APPROVALS and where applicable the Drug Master File and in a
manner which fully complies with all United States of America and foreign
statutes, ordinances, regulations and practices.
5. ELAN shall indemnify, defend and hold harmless JV SUB and its officers,
directors, employees and agents from all actions, losses, claims, demands,
damages, costs and liabilities (including reasonable attorneys' fees) due to
third party claims to which JV SUB is or may become subject insofar as they
arise out of or are alleged or claimed to arise out of (i) any
breach by ELAN of any of its obligations under this AGREEMENT, and (ii) any
breach of a representation or warranty of ELAN made in this AGREEMENT and
(iii) any activities conducted by ELAN in connection with the PROJECT, except
to the extent due to the negligence or wilful misconduct of JV SUB.
6. JV SUB shall indemnify, defend and hold harmless ELAN and its officers,
directors, employees and agents from all actions, losses, claims, demands,
damages, costs and liabilities (including reasonable attorneys' fees) due to
third party claims to which ELAN is or may become subject insofar as they
arise out of or are alleged or claimed to arise out of (i) any
breach by JV SUB of any of its obligations under the AGREEMENT, (ii) any breach
of any representation or warranty of JV SUB made in this AGREEMENT, and (iii)
any activities conducted by JV SUB in connection with the PROJECT, except to
the extent due to the negligence or wilful misconduct of ELAN.
7. JV SUB shall indemnify, defend and hold harmless ELAN and its officers,
directors, employees and agents from all actions, losses, claims, demands,
damages, costs and liabilities (including reasonable attorneys' fees) due to
third party claims to which ELAN is or may become subject insofar as they arise
out of or are alleged or claimed to arise out of activities
conducted by JV SUB in the development, manufacture, transport, packaging,
storage, handling, distribution, promotion, marketing, offer for sale or sale
of the PRODUCT, that was caused by the negligence or wrongful acts or omissions
on the part of JV SUB.
8. ELAN represents and warrants that the manufacture, use, offer for sale, or
sale of the devices and methods exclusively disclosed in either the ELAN PATENT
RIGHTS or the application of the ELAN KNOW-HOW as documented in the transfer of
information to JV SUB as of the EFFECTIVE DATE does not infringe any patent
owned by a third party in the TERRITORY.
9. As a condition of obtaining an indemnity in the circumstances set out above
or elsewhere in the AGREEMENT, the Party seeking an indemnity shall:
9.1. fully and promptly notify the other Party of any claim or proceeding, or
threatened claim or proceeding;
9.2. permit the indemnifying Party to take full care and control of such claim
or proceeding;
9.3. reasonably assist in the investigation and defence of such claim or
proceeding;
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; and
9.5. take all reasonable steps to mitigate any loss or liability in respect
of any such claim or proceeding.
10. Notwithstanding anything to the contrary in this AGREEMENT, ELAN and JV
SUB shall not be liable to the other for any consequential or incidental loss
or damage (whether for loss of profit or otherwise) by reason of any
representation or warranty, condition or other term or any duty of
common law, or under the express or implied terms of this AGREEMENT, and
whether occasioned by the negligence of the respective Parties, their employees
or agents or otherwise.
ARTICLE VII: PROJECT TEAM
1. The Parties have agreed to establish a PROJECT TEAM which shall consist
of a chief representative from each Party together with such additional
business and development personnel from each Party who are deemed necessary to
accomplish the work of the PROJECT. Unless both Parties agree otherwise,
commencing on the EFFECTIVE DATE, the PROJECT TEAM shall meet at least once
each calendar quarter, whether in person or by video conference; provided that
the PROJECT TEAM shall meet face to face at least once in every calendar year.
The PROJECT TEAM shall meet alternatively at the offices of ELAN and JV SUB
or as otherwise agreed by the Parties. [CONFIDENTIAL PORTION OMITTED].
2. At and between meetings of the PROJECT TEAM each Party shall keep the other
fully and regularly informed as to its progress with its respective obligations.
In addition, ELAN and JV SUB will both furnish a quarterly project update in
relation to the research development, regulatory and clinical work being
conducted in relation to the PRODUCT to designated personnel of the Parties.
3. The PROJECT TEAM shall review the manufacturing costs and other costs as
well as the regulatory and commercialisation strategy for the PRODUCT on an
ongoing basis. The PROJECT TEAM may suggest alternative strategies and attempt
to resolve any conflicts or differences of opinion between the Parties as to
how to proceed.
4. The PROJECT TEAM shall not be empowered to alter the terms of this
AGREEMENT. The PROJECT TEAM shall continue to function and meet both prior
to and for a period of one year after the launch of the PRODUCT in the first
MAJOR MARKET, or for such additional period as may be agreed.
5. The PROJECT TEAM may suggest alternative strategies and shall attempt to
resolve any conflicts or differences of opinion between the Parties as to how
to proceed. Any matter as to which the PROJECT TEAM is unable to reach
agreement may be submitted by either Party to binding arbitration for final
resolution pursuant to Article X Paragraph 14, or as otherwise agreed, except
with respect to matters for which JV SUB has authority to make final decisions.
ARTICLE VIII PATENTS
[CONFIDENTIAL PORTION OMITTED]
1. [CONFIDENTIAL PORTION OMITTED]
[CONFIDENTIAL PORTION OMITTED]
2. [CONFIDENTIAL PORTION OMITTED].
2.1. Both Parties shall timely inform the other in writing of any improvement
or development made by such Party relating, respectively, to the ELAN GLUCOSE
MONITOR TECHNOLOGY, the JV SUB KNOW-HOW, and/or the JOINT IMPROVEMENTS so that
any patent protection that may be available for any such improvement or
development is not compromised.
2.2. ELAN shall prepare, prosecute and maintain all initially licensed patent
applications and issued patents as set forth in APPENDIX B, and all
improvements created or developed solely by employees of ELAN relating to the
FIELD ("ELAN IMPROVEMENTS") made pursuant to the AGREEMENT or otherwise.
With respect to the ELAN IMPROVEMENTS, ELAN shall have the right to apply for
patent protection in its own name and at its own expense. Should it however
be doubtful whether a patent may be obtained, then ELAN may at its sole
discretion decide not to apply for a patent in one or more countries of the
TERRITORY. If such a patent is obtained, such a patent shall constitute ELAN
PATENT RIGHTS and JV SUB shall have for the duration of this AGREEMENT a right
thereunder to have manufactured pursuant to the terms of this AGREEMENT, and
to prepare, use and sell the PRODUCT as specified in Article II Paragraph 1.
ELAN shall keep JV SUB fully informed as to the status of such patent matters
relating to the ELAN PATENT RIGHTS. With respect to the ELAN IMPROVEMENTS,
ELAN shall timely apprise JV SUB of the status of any such prosecution and,
in the event ELAN shall decide not to seek patent protection for any ELAN
IMPROVEMENTS and such ELAN IMPROVEMENTS are not otherwise encumbered by
licences to one or more third parties (it being agreed that ELAN shall use
commercially reasonable efforts to exclude or where applicable to minimise
the extent of any such encumbrances), JV SUB shall have the option to take
responsibility for such prosecution and/or maintenance.
2.3. JV SUB shall prepare, prosecute and maintain all patents applications and
issued patents relating to all (I) JV SUB KNOW-HOW and (II) JOINT IMPROVEMENTS
that relate to the FIELD. With respect to JV SUB KNOW-HOW, JV SUB shall timely
apprise ELAN of the status of any such prosecution and, in the event JV SUB
shall decide not to seek patent protection for any JV SUB KNOW-HOW, ELAN shall
have the option to take control of such prosecution. In the event that ELAN
shall determine, in good faith, that any JOINT IMPROVEMENT predominantly
relates to an area other than the FIELD, ELAN shall have the option to take
control of the preparation, prosecution and maintenance of patent
protection directed to such JOINT IMPROVEMENTS. In the event that ELAN shall
exercise such option, ELAN shall have due regard to JV SUB's wishes regarding
the patent prosecution strategy for such JOINT IMPROVEMENTS. In the event that
ELAN does not exercise such right, JV SUB shall have the right to take
responsibility for the preparation, prosecution and maintenance of patent
protection directed to such JOINT IMPROVEMENTS. In the event that any
JOINT IMPROVEMENT predominantly relates to the FIELD but also relates to an
area other than the FIELD, JV SUB shall have due regard to ELAN's wishes as
regards the patent prosecution strategy for such JOINT IMPROVEMENTS.
[CONFIDENTIAL PORTION OMITTED]
3. [CONFIDENTIAL PORTION OMITTED].
4. [CONFIDENTIAL PORTION OMITTED].
[CONFIDENTIAL PORTION OMITTED].
5.1.1. [CONFIDENTIAL PORTION OMITTED].
5.1.2. [CONFIDENTIAL PORTION OMITTED].
5.1.3. [CONFIDENTIAL PORTION OMITTED].
5.1.4. [CONFIDENTIAL PORTION OMITTED].
5.2. [CONFIDENTIAL PORTION OMITTED].
6. [CONFIDENTIAL PORTION OMITTED].
ARTICLE IX: TERM AND TERMINATION
This AGREEMENT is concluded for a period commencing as of the date of this
AGREEMENT and shall expire [CONFIDENTIAL PORTION OMITTED]
starting from the EFFECTIVE DATE, or on a country by country basis for the
[CONFIDENTIAL PORTION OMITTED] included in the ELAN PATENT RIGHTS or the
JOINT IMPROVEMENTS, whichever is longer ("the TERM").
2. In addition to the rights of early or premature termination provided for
elsewhere in this AGREEMENT, in the event that any of the terms or provisions
hereof are incurably breached by either Party, the non-breaching Party may
immediately terminate this AGREEMENT by written notice. An incurable breach
shall be committed when either Party is dissolved, liquidated, discontinued,
becomes insolvent, or when any proceeding is filed or commenced by either
Party under bankruptcy, insolvency or debtor relief laws (and not dismissed
within ninety (90) days). Subject to the other provisions of this AGREEMENT,
in the event of any other material breach, the non-breaching Party may
terminate this AGREEMENT by the giving of written notice to the breaching
Party that this AGREEMENT will terminate on the ninetieth (90th) day from
notice unless cure is sooner effected. 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 ninetieth (90th) day, the said
period shall be extended by such period as is reasonably necessary to permit
the breach to be rectified. In the event that the breaching Party disputes
the validity of the right of the non-breaching Party to terminate the
AGREEMENT pursuant to this Paragraph, either Party may refer the dispute to
an arbitrator pursuant to the provisions of Article X Paragraph 14. Pending
the determination of the arbitrator, neither Party may regard the AGREEMENT
as having been terminated and in particular shall not allege or claim to any
third party that the AGREEMENT has been terminated pursuant to this Paragraph.
3. Upon termination of the AGREEMENT:
3.1. any sums that were due from JV SUB to ELAN prior to the exercise of the
right to terminate this AGREEMENT, shall be paid in full within sixty (60) days
of termination of this AGREEMENT;
3.2. all confidentiality provisions set out in this AGREEMENT shall remain in
full force and effect for a period of [CONFIDENTIAL PORTION OMITTED];
3.3. all representations and warranties shall insofar are appropriate remain in
full force and effect;
3.4. the rights of inspection and audit shall continue in force for the period
referred to in the relevant provisions of this AGREEMENT;
3.5. 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;
3.6. except as is necessary to enable ELAN to exercise the licenses granted by
JV SUB to ELAN pursuant to Article II Paragraph 8.3, Article II Paragraph 10.2.
and Article II Paragraph 11, JV SUB and ELAN shall promptly return to the other
Party all CONFIDENTIAL INFORMATION received from the other Party (except one
copy of which may be retained for archival purposes);
3.7. JV SUB and its SUBLICENSEES shall have an ongoing right to sell or
otherwise dispose of the stock of any PRODUCTS on hand as of the date of
termination of the AGREEMENT, which such sale shall be subject to Article IV
and the other applicable terms of this AGREEMENT. The foregoing provisions
of this Paragraph shall be subject to the provisions of such agreement or
agreements as ELAN and one or more SUBLICENSEES conclude pursuant to Article
II Paragraph 2.2;
3.8. in the event this AGREEMENT is terminated by ELAN pursuant to Article IX
Paragraph 2, the licences granted by ELAN to JV SUB shall terminate and ELAN
shall thenceforth be entitled to exploit the ELAN GLUCOSE MONITOR TECHNOLOGY,
the JV SUB PATENT RIGHTS, the JV SUB KNOW-HOW together with any JV SUB
IMPROVEMENTS, including the data, information, regulatory applications,
regulatory approvals, pricing and reimbursement approvals and the TRADEMARK
to enable ELAN to commercialise the PRODUCTS in which event the royalty
obligations set forth in Article II Paragraph 8.3. shall continue for the
term stated in that Paragraph; provided that the foregoing provisions shall
be subject to the provisions of Article II Paragraph 2.2. and any
agreements entered into pursuant to the said Paragraph; and in the event of
termination of this AGREEMENT, the licences granted by JV SUB to the JV SUB
PATENT RIGHTS and the JV SUB KNOW-HOW and the JOINT IMPROVEMENTS pursuant to
Article II Paragraph 8.3. and to the TRADEMARK pursuant to Article II
Paragraph 11 shall continue after the date of the termination of this
AGREEMENT until the [CONFIDENTIAL PORTION OMITTED] in the JV SUB PATENT
RIGHTS on a country by country basis, or [CONFIDENTIAL PORTION OMITTED]
after the EFFECTIVE DATE (whichever is later) and thereafter the licence
shall be fully paid up and irrevocable; and
3.9. Articles I, Article II Paragraphs 2.2, 8.3, 9, 10.2, 11, Article VI,
Article VIII Paragraphs 1, 5 and 6, Article IX and Article X shall survive
the termination or expiration of this AGREEMENT for any reason.
ARTICLE X: SUNDRY CLAUSES
Secrecy
1.1. Each of the Parties agrees, during the TERM, to hold in confidence and
not disclose CONFIDENTIAL INFORMATION to any third parties, except to the
extent required by applicable law or administrative or judicial process.
Each Party may make such disclosure to its directors, officers and agents and,
in the case of JV SUB, its potential and actual sublicensees and other parties
to whom such disclosure is appropriate to enable JV SUB to conduct its regular
business (each of whom shall be bound by JV SUB's customary confidential
disclosure agreements), who shall be informed of such confidentiality
obligation and for whose breach the disclosing Party shall be responsible.
1.2. Subject to the provisions of Paragraph 1.1, any information, whether
written or oral (oral information shall be reduced to writing within one month
by the Party giving the oral information and the written form shall be
furnished to the other Party) pertaining to the ELAN GLUCOSE MONITOR TECHNOLOGY
or the PRODUCTS that has been or will be communicated or delivered by ELAN to
JV SUB, and any information from time to time communicated or delivered by
JV SUB to ELAN, including, without limitation, trade secrets, business methods,
and cost, supplier, manufacturing and customer information, shall be treated
by JV SUB and ELAN, respectively, as CONFIDENTIAL INFORMATION, and shall
not be disclosed or revealed to any third party whatsoever or used in any
manner except as expressly provided for herein; provided, however, that such
CONFIDENTIAL INFORMATION shall not be subject to the restrictions and
prohibitions set forth in this section to the extent that such CONFIDENTIAL
INFORMATION:
1.2.1. is available to the public in public literature or otherwise, or after
disclosure by one Party to the other becomes public knowledge through no
default of the Party receiving such information; or
1.2.2. was known to the Party receiving such information prior to the receipt
of such information by such Party, whether received before or after the date
of this AGREEMENT; or
1.2.3. is obtained by the Party receiving such information from a third party
not subject to a requirement of confidentiality with respect to such
information; or
1.2.4. is required to be disclosed pursuant to: (A) any order of a court having
jurisdiction and power to order such information to be released or made public;
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 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; or
1.2.5. is independently developed by or for the Party by persons not having
access to the CONFIDENTIAL INFORMATION of the other Party.
1.3. Each Party shall take all such precautions as it normally takes with its
own CONFIDENTIAL INFORMATION to prevent any improper disclosure of such
CONFIDENTIAL INFORMATION to any third party; provided, however, that such
CONFIDENTIAL INFORMATION may be disclosed within the limits required to obtain
any authorisation from the FDA or any other REGULATORY AUTHORITY or, with the
prior written consent of the other Party, which shall not be unreasonably
withheld or delayed, or as may otherwise be required in connection with the
purposes of this AGREEMENT.
1.4. JV SUB agrees that it will not use, directly or indirectly, the ELAN
GLUCOSE MONITOR TECHNOLOGY, or other CONFIDENTIAL INFORMATION disclosed to JV
SUB or obtained from ELAN pursuant to this AGREEMENT, other than as expressly
provided herein. ELAN agrees that it will not use, directly or indirectly, any
JV SUB KNOW-HOW, JV SUB PATENT RIGHTS, or other CONFIDENTIAL INFORMATION
disclosed to ELAN or obtained from JV SUB pursuant to this AGREEMENT, other
than as expressly provided herein.
1.5. The Parties shall not (a) disclose to any person or entity, publicly or
privately, this AGREEMENT or the substance of the transactions contemplated
hereby without the prior written consent of the other Party; provided, that
the foregoing covenant shall not be applicable to the extent required by
applicable law or judicial or administrative process or periodic SEC reports
filed by ELAN or BIOJECT in connection herewith, so long as the text
thereof shall have been provided to the non disclosing Party and such non
disclosing Party shall have approved the text thereof, which consent shall
not be unreasonably withheld or delayed.
2. Assignments/ Subcontracting
JV SUB shall not be permitted to assign any of its rights under the AGREEMENT
without the prior written consent of ELAN, which consent will not be
unreasonably withheld or delayed; provided, that such reasonableness standard
shall not apply in the case of a proposed assignment or sublicense to any of
the entities listed on the LISTED COMPANIES. ELAN may not assign to an
unaffiliated third party (other than by operation of law in the event of an
acquisition of ELAN, or a merger or similar transaction) its rights under this
AGREEMENT without the prior written consent of JV SUB, which may be withheld
in JV SUB's sole discretion. ELAN may assign all or part of its right and
interest to an AFFILIATE without the prior written consent of JV SUB.
3. Certain changes of Control.
In the event that JV SUB (or an interest therein in excess of [CONFIDENTIAL
PORTION OMITTED] of the fully-diluted equity) is acquired (by merger, sale
of assets or stock or otherwise) by (a) any of the LISTED COMPANIES or
(b) any other entity to which ELAN does not consent, which consent shall not
be unreasonably withheld or delayed, such reasonableness to be determined by
reference to JV SUB's and/or its controlling persons' intention to continue
diligent development and commercialisation of the Products, at the option of
ELAN, the AGREEMENT shall be immediately terminated, without any further
liability on the part of ELAN to JV SUB; provided that in such event the
provisions of Article II Paragraph 8.3. and Article IX Paragraph 3.8.
shall apply.
4. Parties bound
This AGREEMENT shall be binding upon and enure for the benefit of Parties
hereto, their successors and permitted assigns.
5. Severability
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.
6. Force Majeure
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.
7. Relationship of the Parties
Nothing contained in this AGREEMENT is intended or is to be construed to
constitute ELAN and JV SUB as partners or joint venturers or either Party as an
employee of the other. 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 third party.
8. Amendments
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 both Parties.
9. Waiver
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 future breach or failure to perform or of any other right
arising under this AGREEMENT.
10. Headings
The section headings contained in this AGREEMENT are included for convenience
only and form no part of the agreement between the Parties. Save as otherwise
provided herein, references to articles, paragraphs, clauses and appendices
are to those contained in this AGREEMENT.
11. No effect on other agreements
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.
12. Applicable Law
This AGREEMENT (a) shall be governed by and construed in accordance with the
laws of the State of New York, without regard to principles of conflicts of
laws.
13. Notice
13.1. Any notice to be given under this AGREEMENT shall be sent in writing in
English by registered airmail or telefaxed to:
- ELAN at
Elan Corporation, plc.
Xxxxxxx Xxxxx,
Xxxxxxx Xxxxx,
Xxxxxx 0
Xxxxxxx.
Attention: President, Elan Pharmaceutical Technologies, a division of ELAN
Corporation plc
Telephone: 000 0 000 0000
Telefax : 353 1 6624960
- JV SUB at
Bioject JV Subsidiary Inc.
0000 X.X. Xxxxxxxxxx Xxxx,
Xxxxxxxx,
Xxxxxx 00000,
Xxxxxx Xxxxxx of America.
Attention: President and Chief Executive Officer
Telephone: 0 000-000-0000
Telefax : 0 000-000-0000
or to such other address(es) and telefax numbers as may from time to time be
notified by either Party to the other hereunder.
13.2. Any notice sent by mail shall be deemed to have been delivered within
seven (7) working days after despatch and any notice sent by telefax shall be
deemed to have been delivered within twenty four (24) hours of the time of the
despatch. Notice of change of address shall be effective upon receipt;
provided that such date of receipt must be a business day for the Party to
whom the notice is delivered.
14. Arbitration
Should the Parties fail to reach agreement with respect to a dispute or
difference (other than as to a question relating to patent validity or as to
a matter left to the discretion of a Party hereunder) between the Parties
arising out of or in connection with this AGREEMENT, then the dispute or
difference will be determined by arbitration in New York in accordance with
the Non-Administered Arbitration Rules & Commentary (Amended 1993) of the CPR
Institute for Dispute Resolution by one independent and impartial arbitrator
who shall have had both training and experience as an arbitrator of general
corporate and commercial matters, or depending on the nature of the dispute
have experience of pharmaceutical device development and marketing (including
clinical development and regulatory affairs) or be an independent patent
attorney as the case may be. If the Parties to this AGREEMENT cannot agree on
the identity of the arbitrator, then the arbitrator will be selected by the
President of the CPR Institute for Dispute Resolution in accordance with the
criteria set forth in the preceding sentence. The arbitrator may decide any
issue as to whether, or as to the extent to which, any dispute is subject to
the arbitration and other dispute resolution provisions in this
AGREEMENT. The arbitrator must base the award on the provisions of this
AGREEMENT and must render the award in a writing which must include an
explanation of the reasons for such award. Any arbitration pursuant to this
section will be governed by the substantive laws of the State of New York
applicable to contracts made and to be performed in that state,
without regard to conflicts of law rules, and by the arbitration law of the
Federal Arbitration Act, and judgement upon the award rendered by the
arbitrator may be entered by any court having jurisdiction thereof. The
statute of limitations of the State of New York applicable to the
commencement of a lawsuit will apply to the commencement of an arbitration
under this section, except that no defences will be available based upon the
passage of time during any active negotiation between the Parties in an
attempt to resolve the dispute without arbitration. All fees, costs and
expenses of the arbitrator, and all other costs and expenses of the
arbitration, will be shared equally by the Parties to this AGREEMENT unless
such Parties agree otherwise or unless the arbitrator in the award assesses
such costs and expenses against one of such Parties or allocates such costs
and expenses other than equally between such Parties. Each Party to this
AGREEMENT acknowledges receipt of a copy of the Non-Administered Arbitration
Rules & Commentary (Amended 1993) of the CPR Institute for Dispute
Resolution. [CONFIDENTIAL PORTION OMITTED].
15. Withholding
Any income or other taxes which JV SUB is required by law to pay or withhold on
behalf of ELAN with respect to royalties and any other moneys payable to ELAN
under this AGREEMENT shall be deducted from the amount of such royalties and
moneys due. JV SUB shall furnish ELAN with proof of such payments. Any such
tax required to be paid or withheld shall be an expense of and borne solely by
ELAN. JV SUB shall promptly provide ELAN with a certificate or other
documentary evidence to enable ELAN to support a claim for a refund or a
foreign tax credit with respect to any such tax so withheld or deducted by JV
SUB. Both Parties will reasonably cooperate in completing and filing
documents required under the provisions of any applicable tax treaty or under
any other applicable law, in order to enable JV SUB to make such payments to
ELAN without any deduction or withholding.
16. Entire Agreement
This AGREEMENT including its Appendices sets forth the entire agreement and
understanding of the Parties with respect to the subject matter hereof, and
supersedes all prior discussions, agreements and writings in relating thereto,
including the letter of agreement of 30th September 1997.
17. Counterparts
This AGREEMENT may be executed in two counterparts, each of which shall be
deemed an original and which together shall constitute one instrument.
IN WITNESS THEREOF the Parties hereto have executed this AGREEMENT in
duplicate.
Executed by JV SUB on 15 October, 1997
By :/s/ Xxxxx X. X'Xxxx
Name: Xxxxx X. X'Xxxx
Title: President
Executed by ELAN on 15 October, 1997
By:/s/ Xxxxxx X. Xxxxx
Name: Xxxxxx X. Xxxxx
Title: Director
APPENDIX A
Part I
ELAN PATENT RIGHTS
(where the TERRITORY is the United States of America, Canada and Mexico)
[CONFIDENTIAL PORTION OMITTED]
COUNTRY/
OUR DOCKET NO. APPLICATION NO. FILING DATE PATENT NUMBER ISSUE DATE
[CONFIDENTIAL PORTION OMITTED]
[CONFIDENTIAL PORTION OMITTED]
COUNTRY/
OUR DOCKET NO. APPLICATION NO. FILING DATE PATENT NUMBER ISSUE DATE
[CONFIDENTIAL PORTION OMITTED]
APPENDIX A
Part II
ELAN PATENT RIGHTS
(where the TERRITORY is world-wide)
[CONFIDENTIAL PORTION OMITTED]
COUNTRY/
OUR DOCKET NO. APPLICATION NO. FILING DATE PATENT NUMBER ISSUE DATE
[CONFIDENTIAL PORTION OMITTED]
[CONFIDENTIAL PORTION OMITTED]
COUNTRY/
OUR DOCKET NO. APPLICATION NO. FILING DATE PATENT NUMBER ISSUE DATE
[CONFIDENTIAL PORTION OMITTED]
APPENDIX B
LISTED COMPANIES
[CONFIDENTIAL PORTION OMITTED]
