THIS AGREEMENT CONTAINS CONFIDENTIAL TERMS WHICH HAVE BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
This Agreement is made the 14th day of April 1997
BY AND BETWEEN
ELAN CORPORATION plc
An Irish company, of ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇. ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
AND
IOMED, Inc.
A Corporation organized and existing under the laws of the State of Utah,
having an office at 3385 West 1820 South, Salt ▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America.
WHEREAS
ELAN is beneficially entitled to the use of various patents, including
the ELAN IONTOPHORETIC PATENT RIGHTS, which have been granted or are
pending under the International Convention in relation to the
development and production of iontophoretic transdermal devices and
drug specific dosage forms for pharmaceutical devices, products and
processes, and
ELAN is knowledgeable in the development of iontophoretic transdermal
devices and drug specific dosage forms and has developed a unique range
of device and delivery systems designed to provide improved devices and
formulations of medicaments, and
IOMED 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 any of the ELAN
IONTOPHORETIC INTELLECTUAL PROPERTY rights held by ELAN, and
ELAN is prepared to license the ELAN IONTOPHORETIC PATENT RIGHTS in the
TERRITORY to IOMED.
NOW IT IS HEREBY AGREED AS FOLLOWS:
ARTICLE I: DEFINITIONS
1.1. In the present Agreement and any further agreements based thereon between
the Parties hereto, the following definitions shall prevail:
1. ADDITIONAL TERM shall have the meaning set forth in Article
VIII, Paragraph 2.
2. AFFILIATE shall mean any corporation or entity controlling,
controlled by or under the common control of ELAN or IOMED as
the case may be. For the purpose of this paragraph, "control"
shall mean the direct or indirect ownership of at least fifty
percent (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.
3. Agreement shall mean this agreement.
4. *****.
5. *****.
6. ****.
7. ASSETS shall mean those items of tangible property being
transferred by ELAN to IOMED the details of which are set out
in Appendix A.
8. cGCP, cGLP and cGMP shall mean current Good Clinical
Practices, current Good Laboratory Practices and current Good
Manufacturing Practices respectively.
9. 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.
10. DDS shall mean Drug Delivery Systems, Inc.
11. DDS AGREEMENT shall mean the license agreement entered into
between IOMED and DDS on the EFFECTIVE DATE.
12. DDS IONTOPHORETIC PATENT RIGHTS shall have the meaning as
defined in Article I of the agreement being entered into by
IOMED and Drug Delivery Systems, Inc. on the EFFECTIVE DATE.
13. EFFECTIVE DATE shall mean the 14th day of April 1997.
14. ELAN shall mean Elan Corporation plc and any of its AFFILIATES
15. ELAN EXCLUDED TECHNOLOGY shall mean all intellectual property
including, without limitation any inventions, discoveries,
material and data whether or not protectable by patents, trade
secrets, trademark or copyright in relation *****.
16. ELAN IONTOPHORETIC INTELLECTUAL PROPERTY shall mean the ELAN
IONTOPHORETIC PATENT RIGHTS and/or the ELAN IONTOPHORETIC
KNOW-HOW.
▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇ KOW-HOW shall mean all scientific
or-technical knowledge, information or expertise developed,
produced, created or acquired by or on behalf of ELAN which is
not generally known to the public, or to be developed by ELAN
during the term of this Agreement, relating to the FIELD,
whether or not covered by any patent, copyright, design,
trademark or other industrial or intellectual property rights
as further set forth in Appendix B. For the avoidance of doubt
ELAN IONTOPHORETIC KNOW-HOW shall exclude the ELAN EXCLUDED
TECHNOLOGY.
18. ELAN IONTOPHORETIC PATENT RIGHTS shall mean all granted
patents and pending patent applications owned by, or licensed
by ELAN, the current status of which is set forth in Appendix
C. ELAN IONTOPHORETIC 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 all foreign counterparts thereto. ELAN
IONTOPHORETIC PATENT RIGHTS shall further include any patents
or Patent applications covering any improved PRODUCTS or
methods of making or using the PRODUCTS invented by ELAN
during the term of this Agreement pursuant to such research
and development if any conducted by ELAN pursuant to Article
III Paragraph 1.
19. EX WORKS shall have the meaning as such term is defined in the
ICC Incoterms, 1990, International Rules for the
Interpretation of Trade Terms, ICC Publication No. 460.
20. 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 and its
foreign equivalents in such other countries of the TERRITORY
where IOMED intends to obtain regulatory approval.
21. FIELD shall mean ****.
22. IOMED shall mean IOMED, Inc. and any of its AFFILIATES,
including DERMION Inc.
22. IOMED KNOW-HOW shall mean all scientific or technical
knowledge, information or expertise developed, produced,
created or acquired by or on behalf of IOMED which is not
generally known to the public, or developed by or on behalf of
IOMED during the term of this Agreement, relating to the
PRODUCTS, excluding ELAN IONTOPHORETIC KNOW-HOW, whether or
not covered by any patent, copyright, design, trademark or
other industrial or intellectual property rights.
23. IOMED PATENT RIGHTS shall mean all granted patents and pending
patent applications owned or licensed by IOMED relating to the
FIELD, excluding ELAN IONTOPHORETIC PATENT RIGHTS and DDS
PATENT RIGHTS. IOMED 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 thereof and all
foreign counterparts thereto. IOMED PATENT RIGHTS shall
further include any patents or patent applications covering
any improved methods of making or using the PRODUCTS invented
or acquired by IOMED during the term of this Agreement.
24. IND shall mean one or more investigational new drug
applications filed by ELAN or to be filed by IOMED with the
FDA.
26. NET REVENUES shall mean:
26.1. *****:
26.1.1. ****
26.1.2. ****
26.1.3. ****
****; and
26.2. ****;
26.2.1. ****;
26.2.2. ****;
26.2.3. ****;
26.2.4 ****; and
26.2.5. ****.
****.
****,
****.
****.
27. NDA shall mean one or more of the New Drug Applications which
IOMED shall file, including any supplements or amendments
thereto and 510(k)s which IOMED may file, for the PRODUCTS
with the FDA.
28. OFFERING PARTY shall mean ****.
29. Party shall mean IOMED or ELAN, as the case may be, "Parties"
shall mean IOMED and ▇▇▇▇.
▇▇. PRODUCT(S) shall mean all devices or any parts thereof
developed, manufactured or sold by or on behalf of IOMED
within the FIELD, ****.
31. RESEARCH AND DEVELOPNIENT COST shall mean in the case of
research and development being conducted by or on behalf of
ELAN for IOMED pursuant to Article III Paragraph 1, the fully
allocated costs thereof calculated in accordance with
generally accepted Irish accounting principles consistently
applied.
32. TERM shall have the meaning set forth in Article VIII
Paragraph 1.
33. TERRITORY means ****.
34. $ 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
specified provided, be to an Article or Appendix of this
Agreement.
1.2.3 the headings of this Agreement are for case reference only and
shall not affect its construction or interpretation.
ARTICLE II: THE LICENSE
1.1. ELAN shall remain proprietor of all the ELAN IONTOPHORETIC
INTELLECTUAL PROPERTY but hereby grants to IOMED for the term
of the Agreement an exclusive (including as to ELAN) license
in the TERRITORY, with the right to grant sublicenses pursuant
to and in accordance with the provisions of Article II
Paragraph 2, to research develop, manufacture, have
manufactured for IOMED (or its permitted sublicenses), use,
sell and otherwise commercialize the ELAN IONTOPHORETIC
INTELLECTUAL PROPERTY and the PRODUCTS in the FIELD under the
terms and conditions set out herein. The exclusive nature of
the licenses granted by ELAN are subject to **** as set out in
Appendix C. ELAN's license to IOMED shall specifically exclude
ELAN EXCLUDED TECHNOLOGY.
1.2. ****.
2.1. IOMED may sublicense rights which incorporate the ELAN
IONTOPHORETIC INTELLECTUAL PROPERTY ****, without the prior
written consent of ELAN.
2.2. Any sublicense other than permitted by paragraph 2.1. above,
****, shall require the prior written consent of ELAN, which
may be withheld in the sole discretion of ELAN.
2.3. No sublicense granted by IOMED pursuant to Article II
Paragraph 2 shall authorize or permit the sublicense to grant
further sublicenses ****. IOMED shall use its reasonable
endeavors 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 IOMED.
2.4. Insofar as the obligations owed by IOMED to ELAN are
concerned, IOMED shall remain responsible for all acts and
omissions of any sublicenses as if such acts and omissions
were by IOMED; provided that no such acts or omissions of such
sublicensee will constitute a material breach by IOMED for the
purpose of Article VIII Paragraph 3. In the event that ELAN
terminates the Agreement pursuant to the provisions of Article
VIII Paragraph 3, due to the default of IOMED, then ELAN
shall, with IOMED's consent and assistance, notify each
sublicensee appointed pursuant to Article II Paragraphs 2.1.
and 2.2. of its termination. If any sublicensee elects to
notify ELAN that it requires the continuation of the licenses
granted to IOMED pursuant to this Agreement, ELAN shall
promptly enter into good faith negotiations with sublicensee
to establish a direct contractual nexus between ELAN and such
sublicensee. Such contractual nexus shall, subject to ELAN's
reasonable discretion, be on commercially reasonable terms and
shall to the extent practicable be on terms no less favorable
to the sublicensee than the terms of such sublicensees'
agreement with IOMED, and shall provide that the sublicensee
shall take over the applicable obligations owed by IOMED to
ELAN pursuant to this Agreement. Sales of PRODUCTS and other
consideration payable to such a sublicensee in relation to the
PRODUCTS shall constitute NET REVENUES for the purpose of
calculating the sums payable by the sublicensee to ELAN. ****.
3. It is contemplated that the physical transfer of the ELAN
IONTOPHORETIC KNOW-HOW to be licensed under this Agreement and
the furnishing of copies of relevant patent documentation
regarding the ELAN IONTOPHORETIC PATENT RIGHTS shall be
completed within six months of the EFFECTIVE DATE. ELAN shall,
at its expense, provide all reasonable assistance within such
six-month period to IOMED to facilitate such transfer,
provided, that in the event that IOMED'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. Any dispute under this Paragraph 3 shall be resolved
by referring such dispute to an arbitrator pursuant to the
provisions of Article IX Paragraph 14.
4. Insofar as the exercise by IOMED and its permitted
sublicensees of the ELAN IONTOPHORETIC INTELLECTUAL PROPERTY
rights is concerned, and to the extent permitted pursuant to
its contractual obligations to ****, ELAN agrees that during
the TERM and the ADDITIONAL TERM ELAN shall not cite or
otherwise rely upon the patents licensed by ELAN from ****
pursuant to the **** AGREEMENT, or developed jointly by ELAN
and **** pursuant to the **** AGREEMENT, against IOMED or
IOMED's sublicensees and ELAN shall use its commercially
reasonable endeavors to ensure that ELAN's sublicensees of the
**** TECHNOLOGY shall be bound in similar fashion. ELAN shall
be entitled to disclose such CONFIDENTIAL INFORMATION as ELAN
considers reasonably necessary in using such commercially
reasonable endeavors to potential sublicensees under
obligations of confidentiality. As of the date hereof (I) ELAN
has no such sublicensees and (II) to the knowledge of ELAN,
there are currently no grounds to cite such patents and there
are no express provisions of the **** AGREEMENT requiring ELAN
to cite such patents,
5. IOMED shall ▇▇▇▇ or have marked the patent number an all
PRODUCTS, or otherwise reasonably communicate to the trade
concerning the existence of any ELAN IONTOPHORETIC PATENT
RIGHTS for the countries within the TERRITORY in such a manner
as to ensure compliance with, and enforceability under,
applicable laws.
Performance by IOMED
6. IOMED shall use commercially reasonable efforts consistent
with its financial resources and capital constraints, to
research, develop, register, market and promote the PRODUCTS
and to exploit the ELAN IONTOPHORETIC INTELLECTUAL PROPERTY in
the major markets of the TERRITORY.
7. **** IOMED shall report on the ongoing sales performance of
the PRODUCTS, and the exploitation of the ELAN IONTOPHORETIC
INTELLECTUAL PROPERTY in the TERRITORY, ****. 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.
8. ****.
9. ****.
10. ****.
11. In consideration for the sum of ****, ELAN shall transfer
title only to the ASSETS which are relevant to the
IONTOPHORETIC INTELLECTUAL PROPERTY (but for the avoidance of
doubt shall not include the time or employment of any
employees), as set forth on Appendix A hereto. ELAN shall
deliver the ASSETS EX WORKS the appropriate ELAN facilities,
to IOMED, and/or any party designated by IOMED, in proper
packaging so as to permit safe storage and transport. It is
contemplated that the physical transfer of the ASSETS shall be
completed within **** of the EFFECTIVE DATE. ****. ELAN shall
not transfer title to the ELAN IONTOPHORETIC INTELLECTUAL
PROPERTY.
12. Insofar as the obligations of ELAN set out in this Agreement
concerning the **** AGREEMENT is concerned, ELAN hereby
confirms that ****, a wholly owned subsidiary and AFFILIATE of
ELAN which is a contracting party to the **** AGREEMENT, is
aware of the terms of this Agreement and consents to such
obligations as ELAN is undertaking in this Agreement as relate
to the **** AGREEMENT being undertaken by ELAN on its behalf,
including the obligations set forth in Article II Paragraphs 9
and 10.
13. IOMED 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, eGLP, cGCP and cGMP.
ARTICLE III: DEVELOPMMNT OF THE PRODUCTS
1. IOMED shall be responsible for the cost of the further
development, registration, manufacture and marketing of the
PRODUCTS. The Parties shall each negotiate in good faith the
extent to which ELAN shall provide research and development
services to IOMED. In the event that ELAN provides such
services, such services shall be reimbursed by IOMED ****.
ARTICLE IV: FINANCIAL PROVISIONS
1. License Royalties
1. In consideration of the rights and license granted to IOMED to
the ELAN IONTOPHORETIC PATENT RIGHTS by virtue of this
Agreement, IOMED shall pay to ELAN, the sum of **** United
States Dollars **** in cash by wire transfer due upon
execution of this Agreement and payable within two business
days of the EFFECTIVE DATE.
2. Royalty on NET REVENUES
2.1. In consideration of the license of the ELAN IONTOPHORETIC
PATENT RIGHTS to IOMED, and subject to the provisions of
Article IV Paragraphs 2.2. and 2.3, the royalty payable by
IOMED to ELAN shall be **** percent (****%) on NET REVENUES
generated on or after the EFFECTIVE DATE.
2.2. ****.
2.3. ****.
2.4. IOMED shall not discriminate in its commercialization strategy
and pricing policy as between the PRODUCTS referred to in
Article IV Paragraphs 2.1. and 2.2.
2.5. ****.
Royalty Payments, Reports and Records
3.1. Within forty five (45) days of the end of each quarter, IOMED
shall notify ELAN of the NET REVENUES of each of the PRODUCTS
and arising from the exploitation of the ELAN IONTOPHORETIC
INTELLECTUAL PROPERTY and/or the IOMED PATENT RIGHTS and/or
the IOMED KNOW-HOW, 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.
3.2. IOMED 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 REVENUS, and
the royalties payable to ELAN under Article IV hereof and
shall deliver to ELAN a written statement thereof within forty
five (45) days following the and of each calendar quarter (or
any past thereof in the first or last calendar quarter of this
Agreement) for such calendar quarter. Said written statements
shall set forth (I) for each PRODUCT on ****, 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 arising from the exploitation of the ELAN
IONTOPHORETIC INTELLECTUAL PROPERTY and/or the IOMED PATENT
RIGHTS and/or the IOMED KNOW-HOW as are relevant to the
calculation of NET REVENUES (the "Royalty Statement").
3.3. AU 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.
3.4. ELAN shall have the right to have access, on reasonable
notice, to IOMED's or IOMED's sublicensee's 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.
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 IX Paragraph 14. If the
adjustment payable to ELAN is greater than ****, then the cost
to ELAN for the inspection and if applicable the arbitration
she be paid by IOMED. In addition, IOMED shall pay interest to
ELAN at **** (applicable as of the date on which payment
should have been made pursuant to Article IV Paragraph 3.3.),
from the date on which payment should have been made pursuant
to Article IV paragraph 3.3. until the date of payment.
ARTICLE V: REGISTRATION OF THE PRODUCTS
1. During the TERM and the ADDITIONAL TERM, IOMED shall be
responsible for filing and prosecuting all NDAs and other
applications for regulatory approvals. ELAN shall transfer the
INDs held by it in relation to the PRODUCTS. IOMED or its
sublicensees shall file the NDAs with the FDA and will use its
reasonable efforts in prosecuting said NDA to approval. IOMED
shall thereafter maintain at its own cost the NDAs with the
FDA for the term of this Agreement. Subject to IOMED's
reasonable discretion IOMED hereby agrees to provide to ELAN
at ELAN's own cost access to such NDAs as ELAN reasonably
requests. ****. For the avoidance of doubt, the parties agree
that all information furnished to ELAN pursuant to this
Paragraph shall Institute 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.
ARTICLE VI: REPRESENTATIONS, WARRANTIES
WARRANTIES
1. ELAN represents to IOMED 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; and
1.4 ****.
2. IOMED represents to ELAN the following:
2.1. IOMED 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 IOMED is in
compliance with all applicable laws, rules,
regulations or orders relating to its business and
assets;
2.2. IOMED 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 IOMED and is
enforceable against IOMED 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 IOMED's
certificate of incorporation, by-laws or other
organic documents, any material agreement or
instrument binding upon or affecting IOMED or its
properties or assets or any applicable laws, rules,
regulations or orders affecting IOMED or its
properties or assets;
2.3. IOMED 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.
2.4. IOMED represents and warrants that it has not granted
any option, license, right or interest to any third
party which would conflict with the terms of this
Agreement.
2.5. ****.
ARTICLE VII PATENTS
1. ****.
2. The Parties agree that the following provisions of Article VII
Paragraph 2. shall apply as regards the filing, prosecution
and Maintenance of the ELAN IONTOPHORETIC PATENT RIGHTS:
2.1 ****.
2.2. ****.
2.3. ****.
2.4. ****.
3. ****.
4. ****.
ARTICLE VIII: TERM AND TERMINATION
1. This Agreement is concluded for a period commencing as of the
date of this Agreement and shall expire ****.
****.
2. In addition, for a period of **** commencing upon the
expiration of the TERM ("the ADDITIONAL TERM"), the licenses
granted by ELAN pursuant to Article II shall continue,
provided, that the royalties payable during the ADDITIONAL
TERM to ELAN referred to in Article IV shall be ****.
3 . In addition to the rights of early or premature termination
provided for elsewhere in this Agreement, in the event that
any of the term 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 a Party
is entitled to terminate this Agreement, such Party shall also
be entitled to terminate the DDS AGREEMENT. Furthermore in the
event that a Party is entitled to terminate the DDS AGREEMENT,
such Party shall also be entitled to terminate this Agreement.
In the event that the breaching Party disputes the validity of
the 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 IX 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.
4. In the event that IOMED elects to proceed against ELAN for
damages in circumstances where IOMED would have been entitled
to terminate the Agreement pursuant to Article IX Paragraph 3
and IOMED obtains a final order for damages from a court of
competent jurisdiction which is not subject of further appeal,
IOMED may offset the said order for damages against sums
otherwise due to ELAN pursuant to Article IV until recovery of
the said judgment.
5. Upon termination of the Agreement:
5.1. any sums that were due from IOMED 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;
5.2. all confidentiality provisions (other than the
obligations set out in Article IX Paragraph 1.1, as
they effect ELAN in the event of termination of this
Agreement by ELAN pursuant to Article VIII Paragraph
3 due to the breach by IOMED) set out in this
Agreement shall remain in full force and effect for a
period of ****;
5.3. all responsibilities and warranties shall insofar are
appropriate remain in full force and effect;
5.4. the rights of inspection and audit shall continue in
force for the period referred to in the relevant
provisions of this Agreement;
5.5 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;
5.6 in the event of termination of this Agreement by ELAN
or IOMED pursuant to Article VIII Paragraph 3, IOMED
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);
5.7 in the event this Agreement is terminated by ELAN or
IOMED pursuant to Article VIII Paragraph 3, IOMED and
its sublicensees shall have the right for a period of
**** from termination to sell or otherwise
dispose of the stock of any PRODUCTS then on hand,
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 2.4;
5.8 in the event this Agreement is terminated by ▇▇▇▇ or
IOMED pursuant to Article VIII Paragraph 3, the
licenses granted by ELAN to IOMED shall terminate and
ELAN shall thenceforth be entitled to exploit the
ELAN INTELLECTUAL PROPERTY together with any
improvements made by IOMED to the ELAN INTELLECTUAL
PROPERTY; provide4 that the foregoing provision shall
be subject to the provisions of Article II Paragraph
2.4. and any agreements entered into pursuant to the
said Paragraph, and
5.9. Articles I, Article II Paragraph 2.4, Article VI,
Article VII Paragraph 1, Article VIII and Article IX
(other than Paragraph 3 thereof) shall survive the
termination or expiration of this Agreement for any
reason.
ARTICLE IX: SUNDRY CLAUSES
1. Secrecy
1.1. Each of the parties agrees, during the TERM and the
ADDITIONAL TERM, to hold in confidence and not
disclose to any third parties, including any of the
OFFERING PARTIES, except to the extent required by
applicable law or administrative or judicial process,
the ELAN IONTOPHORETIC INTELLECTUAL PROPERTY or the
contents or nature thereof, provided, that the
foregoing covenant shall not be applicable to ELAN in
the event that the foregoing covenant shall not be
applicable to ELAN in the event that IOMED (i)
abandons or (ii) ceases to develop or commercialize
(and provides notice thereof to ELAN) any such ELAN
IONTOPHORETIC INTELLECTUAL PROPERTY and ELAN
determines subsequently to develop products or
technologies based on such ELAN IONTOPHORETIC
INTELLECTUAL PROPERTY, irrespective of whether it is
reduced to patent.
Each Party may make such disclosure to its directors, officers
and agents and, in the case of IOMED, its potential and actual
sublicensees and other parties to whom such disclosure is
appropriate to enable IOMED to conduct its regular business
(each of whom shall be bound by IOMED's 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
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 IONTOPHORETIC INTELLECTUAL PROPERTY or the
PRODUCTS that has been or will be communicated or
delivered by ELAN to IOMED, and any information from
time to time communicated or delivered by IOMED to
ELAN, including without limitation, trade secrets,
business methods, and cost, supplier, manufacturing
and customer information, shall be treated by IOMED
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
authorization from the FDA or any other United States
of America or foreign governmental or regulatory
agency or, with the prior written consent of the
other Party, which shall not be unreasonably
withheld, or as may otherwise be required in
connection with the purposes of this Agreement.
1.4. IOMED agrees that it will not use, directly or
indirectly, any ELAN IONTOPHORETIC INTELLECTUAL
PROPERTY, or other CONFIDENTIAL INFORMATION disclosed
to IOMED 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 IOMED KNOW-HOW, IOMED PATENT RIGHTS
or other CONFIDENTIAL INFORMATION disclosed to ELAN
or obtained from IOMED pursuant to this Agreement,
other than as expressly provided herein.
1.5 IOMED and ELAN will not publicize the existence of
this Agreement in any way without the prior written
consent of the other subject to the disclosure
requirements of applicable laws and regulations. In
the event that either Party wishes to make an
announcement concerning the Agreement, that Party
will seek the consent of the other Party. The terms
of any such announcement shall be agreed in good
faith.
2. Assignments/Subcontracting
IOMED may not assign (other than by operation of law in the
event of an acquisition of IOMED, or a merger or similar
transaction, subject to the provisions as set forth in Article
IX Paragraph 3) the rights licensed by ELAN under Article II
without the prior written consent of ELAN, which may be
withheld in ELAN's sole discretion. ELAN shall be entitled to
assign its rights and obligations to an AFFILIATE.
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 IOMED, which
may be withheld in IOMED's sole discretion.
3. Certain Changes of Control.
****.
****.
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 cause 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 IOMED 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 authorized 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 right arising
under this Agreement.
10. Headlines
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 up 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 internal laws of the State of New York,
without regard to principles of conflicts of law, and subject
to those provisions where the Parties have conflicts of law
expressly agreed to submit a dispute to arbitration, each
party consents to the exclusive jurisdiction of any Federal or
state court sitting in the County, City and State of New York
over any dispute arising from this Agreement.
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 PIC.
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇. ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇.
Attention: President Elan Pharmaceutical Technologies,
a division of Elan Corporation
plc
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇▇
Telefax: 353 902 92427
IOMED at
IOMED, Inc.
3385 West ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
Attention: President and Chief Executive Officer
Telephone: ▇-▇▇▇-▇▇▇-▇▇▇▇
Telefax: ▇-▇▇▇-▇▇▇-▇▇▇▇
or to such other addresses) 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
dispatch and any notice sent by telefax shall be
deemed to have been delivered within twenty four (24)
hours of the time of the dispatch. Notice of change
of address shall be effective upon receipt provided
that such date of receipt must be a business day for
the Party to whom the notice is delivered.
14. Arbitration
Any dispute under this Agreement which is not settled by
mutual consent and which is the subject of an arbitration
clause shall be finally settled by binding arbitration
conducted in accordance with the Commercial Arbitration Rules
of the American Arbitration Association by an arbitrator
appointed in accordance with said rules. The arbitration shall
be held in New York, New York and the arbitrator shall be to
the extent practicable experienced as to the subject matter of
the dispute such as an independent expert in pharmaceutical
product development and marketing (including clinical
development and regulatory affairs) or an independent patent
attorney as the case may be. The arbitrator shall determine
what discovery will be permitted, consistent with the goal of
limiting the cost and time which the Parties must expend for
discovery; provided the arbitrator shall permit such discovery
as he deems necessary to permit an equitable resolution of the
dispute. Any written evidence originally in a language other
than English shall be submitted in English translation
accompanied by the original or a true copy thereof. The costs
of the arbitration, including administrative and arbitrator's
fees, shall be shared equally by the Parties and each Party
shall bear its own costs and attorneys' and witness' fees
incurred in connection with the arbitration, provided that the
prevailing Party may be awarded the reasonable costs and fees
incurred in connection with the arbitration at the discretion
of the arbitrator.
A disputed performance or suspended performance pending the
resolution of the arbitration must be completed within thirty
(30) days following the final decision of the arbitrators or
such other reasonable period as the arbitrators determine in a
written opinion. Any arbitration subject to this Paragraph 14
shall be completed within one (1) year from the filing of
notice of a request for such arbitration. The arbitration
proceedings and the decision shall not be made public without
the joint consent of the Parties and each Party shall maintain
the confidentiality of such proceedings and decision unless
(a) otherwise permitted by the other Party or (b) otherwise
required by the applicable law in which case the provisions of
Article IX Paragraph 1.2.4. shall be applicable. ****.
15. Withholding
Any income or other taxes which IOMED 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. IOMED 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. IOMED 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 IOMED.
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 IOMED to make such payments to ELAN without
any deduction or withholding.
16. Indemnity
16.1. ELAN shall indemnify, defend and hold harmless IOMED
from all actions, losses, claims, demands, damages,
costs and liabilities (including reasonable
attorneys' fees) to which IOMED is or may become
subject insofar as they arise out of or are alleged
or claimed to arise out of any breach by ELAN of any
of its obligations under this Agreement or warranties
of ELAN.
16.2. ****.
16.3. As a condition of obtaining an indemnity in the
circumstances set out above, the Party seeking an
indemnity shall:
16.3.1 ****;
16.3.2. ****;
16.3.3. ****;
16.3.4. ***;
and
16.3.5. ****.
16.4. Notwithstanding anything to the contrary in this
Agreement, ELAN and IOMED 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 express terms of this Agreement for any
consequential or incidental loss or damage (whether
for loss of profit or otherwise) and whether
occasioned by the negligence of the respective
Parties, their employees or agents or otherwise.
17. Entire Agreement
This Agreement including its Appendices, together with ****
and the further documents referred to therein, each of which
are being executed of even date herewith, set 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, ****.
18. 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 IOMED on ____ April, 1997
By:
Name:
Title:
Executed by ELAN _____ April, 1997
By:
Name:
Title: