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EXHIBIT 10.3
This Agreement is made the 14th day of April 1997
BY AND BETWEEN
DRUG DELIVERY SYSTEMS, INC.
A Corporation organized and existing under the laws of the State of New
York, having an office at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
AND
IOMED, Inc.
A Corporation organized and existing under the laws of the State of Utah,
having an office at 3385 West ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇
▇▇▇▇▇▇ of America.
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WHEREAS:
-- DDS is beneficially entitled to the use of various patents, including the
DDS 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
-- IOMED is desirous of entering into a licensing agreement with DDS 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 DDS IONTOPHORETIC PATENT
RIGHTS held by DDS, and
-- DDS is prepared to license the DDS IONTOPHORETIC PATENT RIGHTS in the
TERRITORY to IOMED, and
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 DDS 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
criterion 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.
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3. Agreement shall mean this agreement.
4. cGCP, cGLP and cGNO shall mean current Good Clinical Practices,
current Good Laboratory Practices and current Good Manufacturing
Practices respectively.
5. 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.
6. DDS shall mean Drug Delivery Systems, Inc. and any of its
AFFILIATES.
7. DDS IONTOPHORETIC PATENT RIGHTS shall mean all granted patents and
pending patent applications owned by, or licensed by DDS, the
current status of which is set forth in Appendix C. DDS
IONTOPHORETIC PATENT RIGHTS shall also include all conditions,
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.
8. EFFECTIVE DATE shall mean the 14th day of April 1997.
9. ELAN shall mean Elan Corporation plc and any of its AFFILIATES.
10. ELAN AGREEMENT shall mean the license agreement entered into between
IOMED and ELAN on the EFFECTIVE DATE.
11. ELAN IONTOPHORETIC KNOW-HOW shall have the meaning as defined in
Article I of the ELAN AGREEMENT.
12. ELAN IONTOPHORETIC PATENT RIGHTS shall have the meaning as defined
in Article I of the ELAN AGREEMENT.
13. 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.
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14. FIELD shall mean ****.
15. IOMED shall mean IOMED, Inc. and any of its AFFILIATES, including
DERMION Inc.
16. IOMED KNOW-HOW shall mean all scientific or technical knowledge,
information or expertise developed, produced, created or acquired by
or an 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.
17. 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
IONTOPHORETIC 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 application covering any improved methods of
making or using the PRODUCTS invented or acquired by IOMED during
the term of this Agreement.
18. IND shall mean one or more investigational new drug applications
filed by ELAN or to be filed by IOMED with the FDA-
19. NET REVENUES shall mean:
19.1. ****:
19.1.1 ****, or
19.1.2. ****, or
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19.1.3. ****; and
19.2. ****:
19.2.1. ****;
19.2.2. ****;
19.2.3. ****;
19.2.4. ****; and
19.2.5. ****.
****.
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****.
****.
****.
20. 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.
21. OFFERING PARTY shall mean ****.
22. Party shall mean IOMED or DDS, as the case may be. "Parties" shall
mean IOMED and DDS.
23. PRODUCT(S) shall mean all devices or any parts thereof developed,
manufactured or sold by or on behalf of IOMED within the FIELD,
****.
24. TERM shall have the meaning set forth in Article VIII Paragraph 1.
25. TERRITORY means ****.
26. $ shall mean United States Dollars.
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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 verse.
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 LICENSE
1.1. DDS shall remain Proprietor of all the DDS IONTOPHORETIC PATENT RIGHTS but
hereby grants to IOMED for the term of the Agreement an exclusive
(including as to DDS) 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 sublicensees), use, sell and otherwise
commercialize the DDS IONTOPHORETIC PATENT RIGHTS and the PRODUCTS in the
FIELD under the terms and conditions set out herein.
1.2. ****.
2.1. IOMED may sublicense rights which incorporate the DDS IONTOPHORETIC PATENT
RIGHTS ****, without the prior written consent of DDS .
2.2. Any sublicense other than permitted by Paragraph 2. 1. above, ****,
shall require the prior written consent of DDS, which may be withheld in
the sole discretion of DDS.
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2.3. NO sublicense granted by IOMED pursuant to Article II Paragraph 2 shall
authorize or permit the sublicensee to grant further sublicenses ****,
IOMED shall use its reasonable endeavors to ensure that DDS shall have the
same rights of audit and inspection vis a vis the sublicensee as DDS has
pursuant to this Agreement concerning IOMED.
2.4. Insofar as the obligations owed by IOMED to DDS are concerned, IOMED shall
remain responsible for all acts and omissions of any sublicensee 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 purposes of Article VIII Paragraph 3. In the event that DDS
terminates the Agreement pursuant to the provisions of Article VIII
Paragraph 3, due to the default of IOMED, then DDS 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 DDS that it requires the continuation of the licenses
granted to IOMED pursuant to this Agreement, DDS shall promptly enter into
good faith negotiations with such sublicensee to establish a direct
contractual nexus between DDS and such sublicensee. Such contractual
nexus shall subject to DDS's reasonable discretion be on commercially
reasonable terms and shall to the extent practicable be on terms no less
favorable to the 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 DDS 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 DDS.
****.
3. It is contemplated that the furnishing of copies of relevant patent
documentation regarding the DDS IONTOPHORETIC PATENT RIGHTS shall be
completed within six months of the EFFECTIVE DATE.
4. LEFT DELIBERATELY BLANK
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5. IOMED shall ▇▇▇▇ or have marked the patent number on all PRODUCTS, or
otherwise reasonably communicate to the trade concerning the existence of
any DDS 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 DDS
IONTOPHORETIC PATENT RIGHTS in the major markets of the TERRITORY.
7. **** IOMED shall report on the ongoing sales performance of the PRODUCTS,
and the exploitation of the DDS IONTOPHORETIC PATENT RIGHTS in the
TERRITORY, ****. For the avoidance of doubt, the Parties agree that all
information furnished to DDS pursuant to this Paragraph shall constitute
CONFIDENTIAL INFORMATION for the purpose of this Agreement.
8. LEFT DELIBERATELY BLANK
9. LEFT DELIBERATELY BLANK
10. LEFT DELIBERATELY BLANK
11. LEFT DELIBERATELY BLANK
12. LEFT DELIBERATELY BLANK
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, cGLP, cGCP and cGMP.
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ARTICLE III: DEVELOPMENT OF THE PRODUCT
1. IOMED shall be responsible for the cost of the further development,
registration, manufacture and marketing of the PRODUCTS.
ARTICLE IV: FINANCIAL PROVISIONS
1. License Royalties
1. In consideration of the rights and license granted to IOMED to the DDS
IONTOPHORETIC PATENT RIGHTS by virtue of this Agreement, IOMED shall pay
to DDS, 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 DDS 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 DDS shall be **** percent (****%) on
NET REVENUES generated on or after the EFFECTIVE DATE.
2.2. ****.
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IOMED shall not be required to pay a royalty to DDS in excess of one
percent (1%) of NET REVENUES on commercialization of the products listed
in Appendix D hereto which, the Parties acknowledge, are
presently-marketed products of IOMED. In the event of any dispute
relating to the foregoing provisions of this Paragraph, the Parties shall
cause such dispute to be arbitrated before an experienced patent attorney.
In such event the procedure set forth in Article VIII Paragraph 14 shall
to the extent practicable apply to the conduct of such arbitration.
2.3. LEFT DELIBERATELY BLANK
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
DDS of the NET REVENUES of- each of the PRODUCTS and arising from the
exploitation of the DDS IONTOPHORETIC PATENT RIGHTS 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 DDS in accordance with such timely
written instructions as DDS 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 REVENUES, and the royalties payable to DDS under Article IV
hereof and shall deliver to DDS a written statement thereof within forty
five (45) days following the end of each calendar quarter (or any part
thereof in the first or last calendar quarter of this Agreement) for such
calendar quarter.
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Said written statements shall set forth (I) for each PRODUCT ****,
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 DDS IONTOPHORETIC PATENT RIGHTS and/or the IOMED
KNOW-HOW as are relevant to the calculation of NET REVENUES (the "Royalty
Statement").
3.3. 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 mouth for which the payment is being made.
3.4. DDS shall have the right to have access, on reasonable notice, to IOMED's
or IOMED'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 DDS 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 DDS is greater than ****, then the cost to DDS
for the inspection and if applicable the arbitration shall be paid by
IOMED. In addition, IOMED shall pay interest to DDS 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.
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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. 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 DDS at DDS's own cost access to such
NDAs as DDS reasonably requests. **** For the avoidance of doubt, the
Parties agree that all information furnished to DDS 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.
ARTICLE VI: REPRESENTATIONS, WARRANTIES
1. DDS represents to IOMED the following:
1.1. DDS 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
is in compliance with all applicable laws, rules, regulations or
orders relating to its business and assets;
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1.2. DDS 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 DDS and
constitutes the legal and valid obligations of DDS and is
enforceable against DDS 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 DDS's
certificate of incorporation, by-laws or other organic documents,
any material agreement or instrument binding upon or affecting DDS
or its properties or assets or any applicable laws, rules,
regulations or orders affecting DDS or its properties or assets;
1.3. DDS is not in material default of its charter or by-laws, 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 DDS 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;
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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. ****.
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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
DDS IONTOPHORETIC PATENT RIGHTS:
2.1. ****.
2.2. ****.
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****.
2.3. ****.
2.4. ****.
3. ****.
4. ****.
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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 DDS pursuant to
Article II shall continue; provided, that the royalties payable during the
ADDITIONAL TERM to DDS 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 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.
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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 ELAN
AGREEMENT. Furthermore in the event that a Party is entitled to terminate
the ELAN AGREEMENT, such Party shall also be entitled to terminate this
Agreement. 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 IX Paragraph 14. Pending the
determination of the arbitrator, neither Party may regard the Agreement as
having been terminated an 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 DDS 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 other due to DDS 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 DDS prior to the exercise of
the right to terminate this Agreement, shall be paid in full within
sixty (60) days of terminate of this Agreement.
5.2. all confidentiality provisions (other than the obligations set out
in Article IX Paragraph 1.1. as they affect DDS in the event of
termination of this Agreement by DDS 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;
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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 DDS or IOMED
pursuant to Article VIII Paragraph 3. IOMED and DDS 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 DDS 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 DDS and
one or more sublicensees conclude pursuant to Article II Paragraph
2.4;
5.8 In the event this Agreement is terminated by DDS or IOMED pursuant
to Article VIII Paragraph 3, the licenses granted by DDS to IOMED
shall terminate and DDS shall thenceforth be entitled to exploit the
DDS IONTOPHORETIC PATENT RIGHTS together with any improvements made
by IOMED to the DDS IONTOPHORETIC PATENT RIGHTS; provided 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. Article 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.
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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 DDS IONTOPHORETIC PATENT RIGHTS or
the contents or nature. thereof provided that the foregoing covenant shall
not be applicable to DDS in the event that IOMED (i) abandons or (ii)
ceases to develop or commercialize (and provides notice thereof to DDS)
any such DDS IONTOPHORETIC PATENT RIGHTS and DDS determines subsequently
to develop products or technologies based an such DDS IONTOPHORETIC PATENT
RIGHTS, irrespective of whether it is reduced to patent. Each law 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 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 DDS IONTOPHORETIC
PATENT RIGHTS or the PRODUCTS that has been or will be communicated or
delivered by DDS to IOMED, and any information from time to time
communicated or delivered by IOMED to DDS, including, without limitation,
trade secrets, business methods, and cost, supplier, manufacturing and
customer information, shall be treated by IOMED and DDS, 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
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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 DDS
IONTOPHORETIC PATENT RIGHTS, or other CONFIDENTIAL INFORMATION disclosed
to IOMED or obtained from DDS pursuant to this Agreement, other than as
expressly provided herein. DDS agrees that it will not use, directly or
indirectly, any IOMED KNOW-HOW, IOMED PATENT RIGHTS or other CONFIDENTIAL
INFORMATION disclosed to DDS or obtained from IOMED pursuant to this
Agreement, other than as expressly provided herein.
23
1.5. IOMED and DDS 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 went
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 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
DDS under Article II without the prior written consent of DDS , which may
be withheld in DDS's sole discretion. DDS shall be entitled to assign its
rights and obligations to an AFFILIATE. DDS may not assign to an
unaffiliated third party (other than by operation of law in the event of
an acquisition of DDS, 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.
****.
24
****.
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 DDS 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
contact, agreement or undertaking with any third party.
25
8. Amendments
No amendment, modification or addition hereto shall be effective or
binding an 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
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 internal laws of the State of New York, without regard to principles
of conflicts of laws, and subject to those provisions where the Parties
have expressly earned 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.
26
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:
DDS at
Drug Delivery Systems, Inc.
▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
Attention: President
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇
Telefax: ▇▇▇ ▇▇▇ ▇▇▇▇
IOMED at
IOMED, Inc.
▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
Attention: President and Chief Executive Officer
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇
Telefax: ▇▇▇ ▇▇▇ ▇▇▇▇
or to such other address(es) and telefax numbers as may from time
-to time be notified by either Party to the other hereunder.
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.
27
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
attorney's 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 performances 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. ****.
28
15. Withholding
Any income or other taxes which IOMED is required by law to pay or
withhold on behalf of DDS with respect to royalties and any other moneys
payable to DDS under this Agreement shall be deducted from the amount of
such royalties and moneys due. IOMED shall furnish DDS with proof of such
payments. Any such tax required to be paid or withheld shall be an
expense of and borne solely by DDS. IOMED shall promptly provide DDS with
a certificate or other documentary evidence to enable DDS 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 DDS without any deduction or
withholding.
16. Indemnity
16.1. DDS 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 DDS of any of its obligations under this Agreement or warranties
of DDS.
16.2. ****.
16.3. ****:
16.3.1. ****;
29
16.3.2. ****;
16.3.3. ****;
16.3.4. ****
16.3.5. ****.
16.4. Notwithstanding anything to the contrary in this Agreement, DDS 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
17.1. 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, including ****.
17.2. The Parties agree that the obligations of IOMED to provide access to the
NDAs pursuant to Article V Paragraph 1 to DDS shall be discharged if such
access is provided to ELAN pursuant to the equivalent provisions of the
ELAN AGREEMENT.
17.3. The Parties agree that the obligations of IOMED to furnish the
documentation and information to DDS pursuant to the provisions of Article
II Paragraph 7, shall be discharged by furnishing such documentation to
ELAN pursuant to the equivalent provisions of the ELAN AGREEMENT.
30
17.4. The Parties agree that the obligations of IOMED to obtain the prior
written consent of IOMED pursuant to Article II Paragraphs 2.1. or 2.2.
shall be satisfied by obtaining the consent of ELAN pursuant to the
equivalent provisions of the ELAN AGREEMENT.
17.5. The Parties agree that DDS's right of access and audit in any particular
calendar year pursuant to Article IV Paragraph 3.4. shall be exhausted if
such rights are exercised by ELAN pursuant to the equivalent provisions of
the ELAN AGREEMENT; provided that nothing in this Paragraph shall limit or
restrict DDS's rights to seek an adjustment to the royalties payable,
whether by agreement between the Parties or pursuant to arbitration.
17.6. The Parties agree that the obligations of IOMED to obtain the prior
written consent of DDS pursuant to Article IX Paragraph 3 shall be
satisfied by obtaining the consent of ELAN pursuant to the equivalent
provisions of the ELAN AGREEMENT. In addition the Parties agree that the
right of DDS to exercise its rights to conduct appropriate due diligence
and to make an offer as envisaged by Article IX Paragraph 3 shall be
discharged by the exercise of such rights by ELAN pursuant to the
equivalent provisions of the ELAN AGREEMENT. In the event that an
OFFERING PARTY consummates a Control Transaction (as defined in Article IX
Paragraph 3) without the consent of the IOMED's Board of Directors (as
such Board is comprised at the time such transaction is first publicly
announced or commenced) (including without limitation, in connection with
a tender offer or offers or proxy solicitation), and in the event that
ELAN determines at its sole discretion that it shall not terminate the
licenses granted by ELAN pursuant to the ELAN AGREEMENT, DDS shall be
deemed to have elected not to have terminated the licenses granted by DDS
pursuant to this Agreement.
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.
31
IN WITNESS WHEREOF the Parties hereto have executed this Agreement in duplicate.
Signed by IOMED on _____ April, 1997.
By: ________________________________
Name: ______________________________
Title: _____________________________
Executed by DDS ______ April, 1997.
By: _______________________________
Name: _____________________________
Title: ____________________________
32
[ELAN LOGO]
APPENDIX A
DDS IONTOPHORETIC PATENT RIGHTS
33
PROPRIETARY & CONFIDENTIAL INFORMATION
SUMMARY OF DDS'S PENDING PATENT APPLICATIONS
FOR IONTOPHORETIC TECHNOLOGY
****
34
PROPRIETARY & CONFIDENTIAL INFORMATION
****
*indicates claims have been allowed
Europe(4) indicates the designation of the following countries: Germany,
France, Great Britain and Italy
Europe(10) = Europe(4) + Austria, Belgium, Switzerland/Liechtenstein,
Luxembourg, Netherlands & Sweden
Europe(12) = Europe(10) + Greece & Spain
Europe(13) = Europe(12) + Denmark, Portugal & Monaco
Europe(15) = Europe(13) + Ireland
<> This file is the subject of an opposition proceeding in the Japanese Patent
Office. The opposer is Hiroyuki Shigero, and individual. We filed our answer
and supporting documents to the opposition in November 1995 and await further
action from the Japanese Patent Office.
35
DOCKET FAMILY: P1
[ELAN LOGO] ART = PANODERM
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
----------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 31850/84 563137
▇▇.▇-▇.▇▇ August 13, 1994 October 2, 1987
----------------------------------------------------------------------------------------------------------
CANADA DDS 461304 1224993
▇▇.▇-▇.▇▇ August 17, 1984 August 4, 1987
----------------------------------------------------------------------------------------------------------
EPO DDS 84109840.3 147524
84.P-1.EP(10) August 17, 1984 July 10, 1985 ▇▇▇▇▇▇ ▇, ▇▇▇▇
----------------------------------------------------------------------------------------------------------
▇▇▇▇▇ DDS 171396/1984 1764538
▇▇.▇-▇.▇▇ August 17, 1984 June 9, 1992 May 20, 1993
----------------------------------------------------------------------------------------------------------
SOUTH KOREA DDS 4970/84 67091
▇▇.▇-▇.▇▇ August 17, 1984 June 15, 1993 June 15, 1993
----------------------------------------------------------------------------------------------------------
MEXICO DDS 202435 158181
▇▇.▇-▇.▇▇ August 17, 1984 January 13, 1989
----------------------------------------------------------------------------------------------------------
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation PANODERM ISSUED PATENTS 3:39:06 PM
36
DOCKET FAMILY: P-1
----------------------------------------------------------------------------------------------------------
TAIWAN DDS 73113316 30312
84.P-1.71 August 10, 1984 September 11, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
----------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 524,252 4,557,723
▇▇.▇-▇.▇▇ August 18, 1983 December 10, 1985
----------------------------------------------------------------------------------------------------------
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Sweden, Switzerland & ▇▇▇▇▇▇▇▇▇▇▇▇
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation PANODERM ISSUED PATENTS 2:39:08 PM
37
DOCKET FAMILY: P-2
[ELAN LOGO] Art = Panoderm
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 660,192 4,862,031
▇▇.▇-▇.▇▇ October 12, 1984 November 11, 1986
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 822,518 4,713,050
86.P-2 ▇.▇▇ October 24, 1986 December 15, 1987
------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
38
DOCKET FAMILY: P-3
[ELAN LOGO] Art = Panoderm
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 38352/85 580585
▇▇.▇-▇.▇▇ January 17, 1985 July 17, 1986 January 17, 1985
------------------------------------------------------------------------------------------------------
CANADA DDS 474498 1226777
▇▇.▇-▇.▇▇ February 15, 1985 September 15, 1985
------------------------------------------------------------------------------------------------------
EPO DDS 85112811.4 178,601 178601
65.P-3.EP(10) October 17, 1986 April 23, 1986 ▇▇▇▇▇▇ ▇▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇ DDS 47885A/85 1186798
▇▇.▇-▇.▇▇ February 14, 1985
------------------------------------------------------------------------------------------------------
JAPAN DDS 219971/1985 1825721
▇▇.▇-▇.▇▇ October 2, 1985 June 4, 1983 March 16, 1994
------------------------------------------------------------------------------------------------------
SOUTH KOREA DDS 7418/85 73321
▇▇.▇-▇.▇▇ October 5, 1985 January 5, 1994 May 3, 1994
------------------------------------------------------------------------------------------------------
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:08 PM
PANODERM ISSUED PATENTS
39
DOCKET FAMILY: P-3
-------------------------------------------------------------------------------------------------------
MEXICO DDS 204285 161423
▇▇.▇-▇.▇▇ February 11, 1985 September 24, 1990
-------------------------------------------------------------------------------------------------------
TAIWAN DDS 75201891 33845
85.P-3.TI February 12, 1985 November 18, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
-------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 778,183 4,708,716
▇▇.▇-▇.▇▇ August 16, 1985 November 24, 1987
-------------------------------------------------------------------------------------------------------
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Sweden, Switzerland & ▇▇▇▇▇▇▇▇▇▇▇▇
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
40
DOCKET FAMILY: P-4
[ELAN LOGO]
ART = PANODERM
*
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER OF
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
--------------------------------------------------------------------------------------------
AUSTRALIA DDS 60222/86 597890
▇▇.▇-▇.▇▇ July 16, 1988 June 14, 1990 July 16, 1988
--------------------------------------------------------------------------------------------
CANADA DDS 614514 1287665
▇▇.▇-▇.▇▇ July 23, 1986 August 13, 1991
--------------------------------------------------------------------------------------------
EPO DDS 86110164.0 240593
86.P-4.EP(10) July 24, 1998 October 14, 1987 May 10, 1993
--------------------------------------------------------------------------------------------
SPAIN DDS 8801519 6801519
▇▇.▇-▇.▇▇ May 18, 1983 June 5, 1989
--------------------------------------------------------------------------------------------
JAPAN DDS 186,721/1988 1921999
▇▇.▇-▇.▇▇ August 8, 1986 April 7, 1995
--------------------------------------------------------------------------------------------
SOUTH KOREA DDS 6303/86 100,195
▇▇.▇-▇.▇▇ July 31, 1986 December 27, 1995 June 3, 1996
--------------------------------------------------------------------------------------------
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:06 PM
PANODERM ISSUED PATENTS
41
DOCKET FAMILY: P-4
--------------------------------------------------------------------------------------------
MEXICO DDS 3577 172928
▇▇.▇-▇.▇▇ August 20, 1996 January 24, 1994
--------------------------------------------------------------------------------------------
TAIWAN DDS 79203115 58937
80.P-4.TI July 16,1985 August 21, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇, ▇▇▇▇
--------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 839,050 4,840,669
▇▇.▇-▇▇.▇▇ March 12, 1988 February 3, 1987
--------------------------------------------------------------------------------------------
UNITED STATES DDS 196,663 4,919,649
▇▇.▇-▇▇▇.▇▇ May 20, 1988 April 24, 1990
--------------------------------------------------------------------------------------------
UNITED STATES DDS 196,664 4,921,475
▇▇.▇-▇▇▇.▇▇ May 20, 19$$ May 1, 1990
--------------------------------------------------------------------------------------------
UNITED STATES DDS 426,476 5,087,240
▇▇.▇-▇▇▇.▇▇ October 30, 1989 February 11, 1992
--------------------------------------------------------------------------------------------
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Sweden, Switzerland & Lischtenstein
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:06 PM
PANODERM ISSUED PATENTS
42
DOCKET FAMILY: P-5
[ELAN LOGO] Art = Panoderm
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 44943/85 591672
▇▇.▇-▇.▇▇ June 10, 1985 June 10, 1985
------------------------------------------------------------------------------------------------------
CANADA DDS 509791 1279542
▇▇.▇-▇.▇▇ May 22, 1984 January 29, 1991
------------------------------------------------------------------------------------------------------
EPO DDS 85903470.4 225672
85.P-5.EP(10) June 10, 1985 September 2, 1992
------------------------------------------------------------------------------------------------------
SPAIN DDS 8801520 8801520
▇▇.▇-▇.▇▇ May 16, 1985 May 3, 1989
------------------------------------------------------------------------------------------------------
JAPAN DDS 502839/1985(S60) 2016549
▇▇.▇-▇.▇▇ June 10, 1985 February 19, 1995
------------------------------------------------------------------------------------------------------
SOUTH KOREA DDS 700091/87 27793
▇▇.▇-▇.▇▇ February 2, 1987 November 28, 1985 April 20, 1989
------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
43
DOCKET FAMILY: P-5
------------------------------------------------------------------------------------------------------
MEXICO DDS 2747 169673
▇▇.▇-▇.▇▇ June 5, 1989 July 19, 1993
------------------------------------------------------------------------------------------------------
TAIWAN DDS 79202103 58100
87 P-5.TI January 12, 1987 October 11, ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 711,589 5,135,479
91.P-5 ▇▇.▇▇ June 5, ▇▇▇▇ ▇▇▇▇▇▇ ▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 711,590 5,224,928
91.P-5 ▇▇.▇▇ June 5, 1991 July 5, 1993
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 08/381,141 5,591,123
91.P-5 ▇▇.▇▇ January 10, 1995 January 7, 1997
P-1
------------------------------------------------------------------------------------------------------
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Sweden, Switzerland & Liechtenstein
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
44
Docket Family: P-6
Art = Pandoderm
[ELAN LOGO]
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 44944/85 582764
85.P-6 .AU June 10, 1985 June 10, 1985
-------------------------------------------------------------------------------------------------------
CANADA DDS 509801 1277882
86.P-6 .CA May 23, 1986 December 10, 1990
-------------------------------------------------------------------------------------------------------
EPO DDS 85903469.6 225,871 225871
85.P-6 .EP(10) June 10, 1985 June 24, 1987 ▇▇▇▇▇ ▇▇, ▇▇▇▇
-------------------------------------------------------------------------------------------------------
▇▇▇▇▇ DDS 502861/1985 1802335
85.P-8 .JP June 10, 1985 October 13, 1982 November 26, 1993
-------------------------------------------------------------------------------------------------------
SOUTH KOREA DDS 87700089 26954
88.P-6 .KR September 12, 1988 September 12, 1988
-------------------------------------------------------------------------------------------------------
MEXICO DDS 2748 168830
86.P-6 .MX June 9, 1986 June 2, 1993
-------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:08 PM
45
Docket Family: P-6
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTS FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
TAIWAN DDS 76100076 30926
87.P-6 .TI January 12, 1987 December 11, ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 000,554 4,808,152
87.P-6 .US DDS January 6, 1987 February 28, 1989
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy
Luxembourg, Netherlands, Sweden, Switzerland & Liechtenstein
PANODERM ISSUED PATENTS
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:08 PM
46
Docket Family: P-7
[ELAN LOGO]
Art=Panoderm
****
Control Assignee/ Application No./ Publication Number/ Patent Number/
Docket No. Patentee Filing Date Publication Date Patent Census Date
-------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 66193/88 591738
86.P-7 .AU December 8, 1988 December 8, 1986
-------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 16550/88 618734
88.P-7 DIV.AU May 24, 1988 May 24, 1988
-------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 65713/81 533228
91.P-7 DIV2.AU October 10, 1991 November 25, 1992
-------------------------------------------------------------------------------------------------------
CANADA DDS 524873 1267340
85.P-7 .CA December 10, 1985 April 3, 1990
-------------------------------------------------------------------------------------------------------
CANADA DDS 568748 1322921
88.P-7 ▇▇▇.▇▇ June 8, 1988 October 12, 1993
-------------------------------------------------------------------------------------------------------
COLUMBIA DDS 263611 22484
86.P-7 .CO December 5, 1989 April 27, 1990
-------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:08 PM
47
Docket Family: P-7
-----------------------------------------------------------------------------
COLUMBIA DDS 287287 24152
88.P-7 .CO June 5, 1988 September 8, 1989 July 6, 1993
-----------------------------------------------------------------------------
EPO DDS 86116547.0 225556
86.P-7 .EP November 28, 1988 June 16, 1987 January 23, 1992
-----------------------------------------------------------------------------
SPAIN DDS 6861521 8801521
88.P-7 .ES May 18, 1986 May 18, 1996
-----------------------------------------------------------------------------
JAPAN DDS 293319/1986 1964597
86.P-7 .JP December 9, 1986 December 7, 1984 August 25, 1996
-----------------------------------------------------------------------------
SOUTH KOREA DDS 10126/86 3/25/94 76691
86.P-7 .KR November 28, 1984 April 21, 1994
-----------------------------------------------------------------------------
SOUTH KOREA DDS 6772/88 107098
88.P-7 ▇▇▇.▇▇ June 4, 1986 August 17, 1994
-----------------------------------------------------------------------------
MEXICO DDS 4602 171173
86.P-7 .MX December 9, 1986 October 8, 1993
-----------------------------------------------------------------------------
MEXICO DDS 11766 175067
88.P-7 ▇▇▇.▇▇ June 3, 1988 July 4, 1994
-----------------------------------------------------------------------------
TAIWAN DDS 75105482 30365
86.P-7 .TI November 18, 1986 October 1, 1990
-----------------------------------------------------------------------------
UNITED STATES DDS 807,234 4,731,926
85,P-7 .US December 10, ▇▇▇▇ ▇▇▇▇▇ ▇▇, ▇▇▇▇
-----------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 58,527 4,083,457
87.P-7 ▇.▇▇ June 6, 1987 November 28, 1989
-----------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:08 PM
▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇: ▇-▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ 105,869 4,856,188
87.P-7 ▇▇.▇▇ DDS OCTOBER 7, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ 169,385 4,665,582
88.P-7 ▇▇.▇▇ DDS MARCH 17, 1998 SEPTEMBER 12, 1989
------------------------------------------------------------------------------------------------------
UNITED STATES 380,196 5,167,617
89.P-7 ▇▇.▇▇ DDS JULY 14, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ 949,721 5,358,483
92.P-7 ▇▇.▇▇ DDS SEPTEMBER 23, 1992 OCTOBER 25, 1994
------------------------------------------------------------------------------------------------------
EP(8) FRANCE, GERMANY, GREAT BRITAIN, ITALY, SWEDEN, SWITZERLAND & LIECHTENSTEIN
PANODERM ISSUED PATENTS
INTELLECTUAL PROPERTY DEPARTMENT MARCH 3, 1997
ELAN PHARMACEUTICAL RESEARCH CORPORATION 2:39:06 P.M.
49
DOCKET FAMILY: P-9
[ELAN LOGO]
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
----------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------
AUSTRALIA 75633/87 586382
87.P-9 .AU DDS JULY 14, 1987 JULY 14, 1987
----------------------------------------------------------------------------------------------------------------------------------
CANADA 540624-2 1274738
87.P-9 .CA DDS JUNE 25, 1987 OCTOBER 2, 1990
----------------------------------------------------------------------------------------------------------------------------------
EPO 87110049.1 254,166 254166
87.P-9 .EP (10) DDS JULY 11, 1987 MARCH 31, 1993
----------------------------------------------------------------------------------------------------------------------------------
JAPAN 176935/1987 1922042
87.P-9 .JP DDS JULY 15, 1987 APRIL 7, 1995
----------------------------------------------------------------------------------------------------------------------------------
MEXICO 7418 166018
87.P-9 .MX DDS JULY 17, 1987 DECEMBER 16, 1992
----------------------------------------------------------------------------------------------------------------------------------
TAIWAN 78103514 38185
87.P-9 .TI DDS JUNE 18, 1987 APRIL 1, 1990
----------------------------------------------------------------------------------------------------------------------------------
INTELLECTUAL PROPERTY DEPARTMENT MARCH 3, 1997
ELAN PHARMACEUTICAL RESEARCH CORPORATION 2:39:08 PM
PANODERM ISSUED PATENTS
50
DOCKET FAMILY: P-9
--------------------------------------------------------------------------------------------
UNITED STATES 886,151 4,734,090
▇▇.▇-▇.▇▇ DDS July 18, 1986 March 29, 19$$
--------------------------------------------------------------------------------------------
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Sweden, Switzerland & Liechtenstein
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:06 PM
PANODERM ISSUED PATENTS
51
DOCKET FAMILY: P-10
[ELAN LOGO]
ART-PANODERM
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 10986/88 6097699
▇▇.▇-▇▇.▇▇ January 30, 1988 January 29, 1988
------------------------------------------------------------------------------------------------------
CANADA DDS 558559 1319608
▇▇.▇-▇▇.▇▇ February 10, 1993 JUNE 29, 1993
------------------------------------------------------------------------------------------------------
EPO DDS 88101856.8 278473 278473
88.P-10.3P(11) February 9, 1993 August 17, 1992 August 5, 1992
------------------------------------------------------------------------------------------------------
MEXICO DDS 10386 168981
▇▇.▇-▇▇.▇▇ February 10, 1993 June 16, 1993
------------------------------------------------------------------------------------------------------
TAIWAN DDS 77100550 32711
88.P-10.TI January 2, ▇▇▇▇ ▇▇▇▇ ▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 279,315 4,940,456
88.P-10 ▇.▇▇ December 1, 1990 July 10, 1990
------------------------------------------------------------------------------------------------------
EP(11) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Spain, Sweden, Switzerland & Liechtenstein
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:06 PM
PANODERM ISSUED PATENTS
52
DOCKET FAMILY: P-11
[ELAN LOGO]
ART-PANODERM
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 10984/88 10,984 608278
▇▇.▇-▇▇.▇▇ January 20, 1988 August 11, 1988 January 28, 1988
------------------------------------------------------------------------------------------------------
CANADA DDS 558559 1317679
▇▇.▇-▇▇.▇▇ February 10, 1993 May 18, 1993
------------------------------------------------------------------------------------------------------
EPO DDS 88101857.6 278,474 278474
88.P-11.3P(10) February 9, 1988 August 17, 1988 ▇▇▇▇▇ ▇▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇ DDS 26618/1988 1922056
▇▇.▇-▇▇.▇▇ February 9, 1988 April 7, 1995
------------------------------------------------------------------------------------------------------
MEXICO DDS 10367 165338
▇▇.▇-▇▇.▇▇ February 10, 1988 November 8, 1997
------------------------------------------------------------------------------------------------------
TAIWAN DDS 77100544 32616
88.P-11.TI February 10, 1987 October 7,1989
------------------------------------------------------------------------------------------------------
Intellectual Property Department March 3, 1997
Elan Pharmaceutical Research Corporation 2:39:06 PM
PANODERM ISSUED PATENTS
53
DOCKET FAMILY: P-11
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 12,889 4,678,892
▇▇.▇-▇▇.▇▇ February 10, 1987 November 7, 1989
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 430,067 5,032,109
89.P-11 ▇▇.▇▇ November 1, 1989 July 16, 1991
------------------------------------------------------------------------------------------------------
EP(10) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Sweden, Switzerland & Liechtenstein
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:30:08 PM
54
DOCKET FAMILY: P-12
[ELAN LOGO] Art = Panoderm
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 12667/88 510133
▇▇.▇-▇▇.▇▇ March 7, 1988 May 16, 1991 March 7, 1991
------------------------------------------------------------------------------------------------------
CANADA DDS 560596 1317522
▇▇.▇-▇▇.▇▇ ▇▇▇▇▇ ▇, ▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇ DDS 63041/1988 1907603
▇▇.▇-▇▇.▇▇ March 16, 1988 December 1, 1993 February 24, 1995
------------------------------------------------------------------------------------------------------
MEXICO DDS 10835 173932
▇▇.▇-▇▇.▇▇ March 10, 1988 April 11, 1994
------------------------------------------------------------------------------------------------------
TAIWAN DDS 77101547 35925
88.P-12.TI March 10, 1988 November 3, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 453,045 5,163,899
89.P-12 ▇▇.▇▇ December 12, 1989 November 17, 1992
------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
55
DOCKET FAMILY: P-13
[ELAN LOGO] Art = Panoderm
****
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
AUSTRALIA DDS 18125/88 615188
▇▇.▇-▇▇.▇▇ May 13, 1988 May 13, 1988
------------------------------------------------------------------------------------------------------
CANADA DDS 587175 1299457
▇▇.▇-▇▇.▇▇ May 10, 1989 April 28, 1992
------------------------------------------------------------------------------------------------------
EPO DDS 86108314.1 292,930 292930
88.P-13.EP(12) May 25, 1988 November 30, 1988 November 2, 1995
------------------------------------------------------------------------------------------------------
JAPAN DDS 128136/1988 1922069
▇▇.▇-▇▇.▇▇ May 25, 1989 April 7, 1995
------------------------------------------------------------------------------------------------------
SOUTH KOREA DDS 6294/88 107097
▇▇.▇-▇▇.▇▇ May 27, 1988 August 17, 1996
------------------------------------------------------------------------------------------------------
TAIWAN DDS 79202278 81218
88.P-13.TI May 16, 1989 February 11, 1991 February 11, 1991
------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
56
DOCKET FAMILY: P-13
-------------------------------------------------------------------------------------------------------
UNITED STATES DDS 438,118 5,013,293
89.P-13 ▇▇.▇▇ NOVEMBER 13, ▇▇▇▇ ▇▇▇ ▇, ▇▇▇▇
-------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 598,803 5,312,325
90.P-13 ▇▇.▇▇ OCTOBER 4, ▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇
-------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 864,544 5,326,454
92.P-13 ▇▇.▇▇ APRIL 7, 1992 JULY 12, 1994
-------------------------------------------------------------------------------------------------------
UNITED STATES DDS 864,645 5,336,168
92.P-13 ▇▇.▇▇ April 7, ▇▇▇▇ ▇▇▇▇▇▇ ▇, ▇▇▇▇
-------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 08/204,784 5,372,168
94.P-13 ▇▇.▇▇ MARCH 2, 1994 DECEMBER 13, 1994
-------------------------------------------------------------------------------------------------------
EP(12) Austria, Belgium, France, Germany, Great Britain, Italy, Luxembourg,
Netherlands, Spain, Sweden, Switzerland & Liechtenstein
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
57
DOCKET FAMILY: P-15
[ELAN LOGO] ART = OTHER
*
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 234,258 4,900,414
▇▇.▇-▇▇.▇▇ AUGUST 19, 1988 FEBRUARY 13, 1990
------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
58
DOCKET FAMILY: P-16
[ELAN LOGO] Art = Panoderm
*
COUNTRY/ ASSIGNEE/ APPLICATION NO./ PUBLICATION NUMBER/ PATENT NUMBER/
DOCKET NO. PATENTEE FILING DATE PUBLICATION DATE PATENT ISSUE DATE
------------------------------------------------------------------------------------------------------
ISRAEL DDS 100794 100794
▇▇.▇-▇▇.▇▇ JANUARY 28, ▇▇▇▇ ▇▇▇ ▇, ▇▇▇▇
------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 287,348 5,088,977
▇▇.▇-▇▇.▇▇ DECEMBER 27, 1989 FEBRUARY 16, 1992
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 823,686 5,328,453
▇▇.▇-▇▇.▇▇ FEBRUARY 12, 1992 JULY 12, 1994
------------------------------------------------------------------------------------------------------
PANODERM ISSUED PATENTS
Intellectual Property Department
Elan Pharmaceutical Research Corporation
March 3, 1997
2:39:08 PM
59
Docket Family: P-17
[ELAN LOGO]
ART=PANODERM
****
Country/ Assignee/ Application No./ Publication Number/ Patent Number/
Docket No. Patentee Filing Date Publication Date Patent Issue Date
------------------------------------------------------------------------------------------------------
UNITED STATES DDS 349,996 5,135,478
89.P-17 .US May 10, ▇▇▇▇ ▇▇▇▇▇▇ ▇, ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ DDS 08/023,463 5,328,452
93.P-17 ▇▇.▇▇ February 25, 1993 July 12, 1994
60
[ELAN LOGO]
APPENDIX D
IOMED CURRENT PRODUCT