Exhibit 10.6
[WEST PHARMACEUTICAL SERVICES LOGO]
Certain confidential portions of this Exhibit were omitted by means of blackout
of the text (the "Mark"). This Exhibit has been filed separately with the
Secretary of the Securities and Exchange Commission without the Mark pursuant to
the Company's Application for Order Granting Confidential Treatment pursuant to
Rule 406 under the Securities Act of 1933, as amended.
WEST PHARMACEUTICAL SERVICES, INC.
And its wholly owned subsidiary
WEST PHARMACEUTICAL SERVICES DRUG DELIVERY
& CLINICAL RESEARCH CENTRE LTD.
And
INNOVATIVE DRUG DELIVERY SYSTEMS, INC.
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DEVELOPMENT MILESTONE AND OPTION AGREEMENT
(Nasal Morphine)
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Dated September 22, 2000
DEVELOPMENT MILESTONE AND OPTION AGREEMENT
THIS IS A DEVELOPMENT MILESTONE AND OPTION AGREEMENT (the "Agreement"),
dated as of September 22, 2000 (the "Effective Date"), among West Pharmaceutical
Services, Inc., a Pennsylvania corporation, ("West") with offices at 101 Gordon
Drive, Lionville, PA, 19341, its wholly owned subsidiary West Pharmaceutical
Services Drug Delivery & Clinical Research Centre Ltd., a corporation organized
under the laws of England and Wales, ("West/Nottingham") with offices at Albert
Einstein Centre, Nottingham Science & Technology Park, University Boulevard,
Nottingham, NG7 2TN, United Kingdom (West and West/Nottingham collectively being
referred to herein as the "West Group"); and Innovative Drug Delivery Systems,
Inc., a Delaware corporation, ("IDDS") with offices located at 787 Seventh
Avenue, New York, New York 10019.
Background
The West Group has completed pre-clinical development work for the
development of a product for administering morphine via the nasal mucosa using
its patented and proprietary delivery technology. The Parties have entered into
a License Agreement as of August 25, 2000 (the "License Agreement") under which
West and West/Nottingham have granted IDDS exclusive worldwide rights to exploit
such technology to make, use and sell certain Identified Products, including
morphine, for the treatment of pain in humans and animals.
IDDS desires to conduct further development work and to pay West
certain milestone payments with respect thereto, and also desires to grant West
an option to manufacture commercial quantities of the developed products, all on
the terms and conditions set forth herein.
Agreement
Accordingly, intending to be legally bound, the Parties agree as
follows:
1. Definitions. Terms defined in this Section 1 and parenthetically
elsewhere in this Agreement will throughout this Agreement have the
meanings here or there provided. Defined terms may be used in the
singular or in the plural, as sense shall require.
1.1. "Affiliate" means, with respect to any Party, an entity, over
50% of the voting securities of which are directly or
indirectly controlled by such Party, or an entity that
directly or indirectly controls over 50% of the voting
securities of such Party.
1.2. "Background IP" means know-how, knowledge, experience,
inventions, processes, technical information, trade secrets,
formulas, protocols, data and results (and any patents and
patent applications claiming any of the foregoing) arising
from or acquired outside the development activities under this
Agreement that is necessary or useful for practicing the art
covered by the Licensed Patents or the Program IP.
1.3. "Development Program" means the program of work for the
development of the Licensed Product, including milestones to
be achieved, cost estimates, relevant time schedules, etc.,
attached hereto as "Exhibit A" and as modified from time to
time by written agreement of the Parties.
1.4. "EMEA" means the European Agency for the Evaluation of Medical
Products.
1.5. "Fair Market Value" means, with respect to NLPT Securities,
the average closing bid price as quoted by the Exchange for
the 20-Business Day period that commences on the 10th Business
Day immediately preceding the date of the event that triggers
the milestone payment and ends on the 10th Business Day
immediately following such date. As used herein, a "Business
Day" is a day on which banks and the Exchange are open for the
transaction of business in New York City.
1.6. "Field of Use" means the delivery of opium alkaloid morphine
and/or a salt thereof via the nasal mucosa to humans or
animals for the treatment of pain.
1.7. "FDA" means the U.S. Food and Drug Administration.
1.8. "IND" means an Investigational New Drug Application.
1.9. "Launch" means commencement of commercial sale of the Licensed
Product following receipt of all necessary Regulatory Agency
approvals
1.10. "Launch Date" means the date of the first such commercial sale
following the Launch.
1.11. "Licensed Patents" means the letters patent and letters patent
that may issue from patent applications listed in Schedule 1
of the License Agreement which relate to nasal morphine,
including all continuations, continuations-in-part,
divisionals, reissues and reexaminations thereof
1.12. "Licensed Product" means opium alkaloid morphine and/or a salt
thereof combined with chitosan or a chitosan derivative or
salt for administration to humans and animals via the nasal
mucosa and which is covered by one or more claims of the
Licensed Patents.
1.13. "Major Market Country" means the United States, Japan, or any
European Union nation party to the EMEA Mutual Recognition
guidelines for pharmaceutical products.
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1.14. "NLPT Securities" means equity securities of IDDS or an
Affiliate of IDDS that are listed on any of the New York Stock
Exchange, NASDAQ National Market System, NASDAQ Small-Cap
Market or American Stock Exchange (each, an "Exchange") and
that meet the continuing listing requirements of such Exchange
at the time the securities are issued.
1.15. "NDA" means a New Drug Application in the U.S., or the
analogous process as defined in applicable laws and
regulations by which application is made with the appropriate
Regulatory Agency of a given country for approval to market a
drug in that country.
1.16. "Party" means a party to this Agreement.
1.17. "Person" means an individual, partnership, limited liability
company, corporation, trust or unincorporated organization or
other business entity, and a government or agency or political
subdivision thereof
1.18. "Program IP" means know-how, knowledge, experience,
inventions, processes, technical information, trade secrets,
formulas, protocols, data and results (and any patents and
patent applications claiming any of the foregoing), arising
from or acquired specifically in the course of the development
activities covered by this Agreement that relate specifically
to the Licensed Product within the Field of Use.
1.19. "Regulatory Agency" means any governmental regulatory
authority responsible for granting health or pricing
approvals, registrations, import permits and other approvals
required before the Licensed Product may be tested or marketed
in any country. Regulatory Agency shall include the FDA, EMEA
and any analogous agency in any other country or region.
2. Development Activities.
2.1. IDDS's Development and Commercialization Obligations. IDDS
shall, at its cost and expense, conduct the following
activities:
2.1.1. Perform the work set forth in and in accordance with
the Development Program in cooperation with West;
2.1.2. Diligently perform all activities necessary or
appropriate to obtain and maintain in full force and
effect Regulatory Agency approval in the U.S. and,
following U.S. approval, each Major Market Country
for the marketing of the Licensed Product in the
Field of Use; provided, that IDDS shall not We
required to pursue such Regulatory Agency approvals
in multiple Major Market Countries simultaneously and
IDDS may pursue such Regulatory Agency approvals in
such order as it decides consistent with a
commercially reasonable regulatory strategy;
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2.1.3. At the earliest possible time, consistent with sound
scientific and business principles, file applications
for, and use its best commercial efforts to pursue
Regulatory Agency approval to sell, the Licensed
Product in each Major Market Country and, either
directly or through sublicensees under the License
Agreement, in other countries where a reasonable
market opportunity exists;
2.1.4. Use all reasonable commercial efforts to Launch the
Licensed Product within 90 days after receiving all
necessary approvals in each such country; and
2.1.5. Maintain in full force and effect one or more
policies of insurance providing continuous coverage
of all of its development activities (including
without limitation insurance covering clinical
trials) hereunder in such amounts and against such
risks as is customary by companies engaged in the
same or similar business and similarly located, and
shall, upon West's request, furnish evidence
reasonably satisfactory to West of such insurance.
IDDS shall use its best efforts to ensure that such
policies shall, at a minimum, provide for:
(a) no less than $*** professional clinical trial
insurance coverage, including products and
complete operations coverage; and
(b) no less than 30 days advance notice to West
from the insurer or broker of any change or
cancellation of such coverage.
2.2. West's Obligations.
2.2.1. West shall, at its cost and expense, reasonably
cooperate with IDDS and provide IDDS with such
information and documentation in West's possession,
including without limitation data, graphs, figures
and specifications, as may be reasonably required for
IDDS to perform its development and commercialization
obligations hereunder (including without limitation
the necessary U.S. and foreign regulatory filings);
provided that this Section shall not be construed to
require West to perform any studies, trials or other
development or commercialization work.
2.2.2. West shall, at its cost and expense, perform the work
set forth as West's responsibilities in and in
accordance with the Development Program.
2.3. Survival of Obligations. Notwithstanding any other provision
of this Agreement, so long as the License Agreement remains in
effect, the obligations of IDDS under this Section 2 and the
obligations to West under Section 2.2.1 shall survive any
termination of this Agreement for any reason whatsoever,
including without limitation by reason of breach by West or
West/Nottingham.
*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
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2.4. IDDS IND Filing. IDDS shall have the right, in its sole
discretion, to cross-file in the name of IDDS, the IND held by
West for the Licensed Product.
3. Payments.
3.1. Milestone Payments. In consideration of the obligations
undertaken by West and West/Nottingham and the rights granted
to IDDS under this Agreement and the License Agreement, IDDS
shall pay to West:
3.1.2 Within 30 days following the administration of the
first dose in the first pivotal Phase III trial for a
Licensed Product that is under development through a
West-sponsored or IDDS-sponsored IND (or other
equivalent regulatory filing such as a CTX), the
amount of $***;
3.1.3 Within 60 days following the first filing of an NDA
with a Regulatory Agency in a Major Market Country
for the Licensed Product, the amount of $***;
and
3.1.4 Within 60 days following the date of the receipt of
the first approvable letter from a Regulatory Agency
of an NDA in a Major Market Country for a Licensed
Product, the amount of $***.
3.2 Extended Payment Date and Interest Thereon. Notwithstanding
the foregoing, IDDS may pay the amounts due under Sections
3.1.3 and 3.1.4 hereof up to an additional 30 days following
the applicable due date (i.e., up to 90 days after such due
date) without being in violation of this Agreement, provided
that any amounts remaining unpaid after 60 days from the due
date shall bear interest at the U.S. prime interest rate for
short-term funds plus two percentage points from such due date
until the date it is received. The interest will be calculated
on a daily average basis.
3.3 Manner of Payment. Except as provided in Section 3.4 hereof,
all amounts payable under this Agreement shall be in United
States dollars by wire transfer of immediately available funds
to an account or accounts specified in writing by West at
least five d&ys pnor to the due date thereof.
3.4 Payment By Issuance of NLPT Securities.
3.4.1 If the Parties mutually agree, some or all of the
amounts due under Sections 3.1.3 and/or 3.1.4 hereof
may be paid by issuance to West of a number of shares
of NLPT Securities equal to the applicable payment
amount divided by the Fair Market Value; provided
that at the time the NLPT Securities are issued, the
aggregate percentage of the total outstanding
securities of the issuing company (the "Issuer") held
by West shall not exceed 19.9%.
*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
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3.4.2 The Parties shall use their best efforts
approximately 60 days prior to the estimated date of
achievement of a milestone event to meet and discuss
the option of taking payment in NLPT Securities in
lieu of cash.
3.4.3 Any NLPT Securities issued pursuant to this Section
3.4 shall be subject to the Securities Issuance and
Registration Rights Agreement between West and IDDS
entered into as of September 22,2000.
3.5 Survival of Obligation to Make Milestone Payments.
Notwithstanding any other provision of this Agreement, so long
as the License Agreement remains in effect, the obligations of
IDDS under this Section 3 shall survive any termination of
this Agreement for any reason whatsoever, including without
limitation by reason of breach by any member of the West
Group.
4. Option to Manufacture. IDDS hereby grants to West an option to first
negotiate with IDDS for the right to manufacture and/or package
commercial quantities of the Licensed Product (the "Manufacturing
Rights Option"), as follows:
4.1. No later than 18 months prior to the estimated Launch Date,
IDDS shall notify West of its anticipated need for commercial
quantities of Licensed Product. Such notice shall include
reasonable details of its requirements, including first-year
volume forecast, target pricing and other information
reasonably available to IDDS that shall have a bearing on
West's decision to exercise the Manufacturing Rights Option.
4.2. Within 15 days following receipt of IDDS's notice under
Section 4.1 hereof, West shall notify IDDS of its intent to
exercise or not exercise the Manufacturing Rights Option.
4.3. If West exercises its Manufacturing Rights Option, West and
IDDS shall promptly commence and diligently pursue for the
next 45 days good-faith negotiations towards agreement to, and
execution of, a definitive supply agreement with respect
thereto. The definitive agreement shall contain terms and
conditions that are usual and customary for supply agreements
of similar type for goods of similar kind and quantity in the
U.S.
4.4. If West fails to exercise its Manufacturing Rights Option
within the time period set forth in Section 4.2 hereof, or
West and IDDS fail to conclude agreement on the terms of such
agreement within the time period set forth in Section 4.3
hereof, then IDDS shall be free to negotiate with and conclude
agreements with third Persons for manufacturing and/or
packaging of the Licensed Product, provided that no such
agreement (i) shall contain price terms or other terms and
conditions that, in the aggregate, are less favorable to IDDS
than the West's last proposal or (ii) shall contain any
material terms and conditions that are more favorable to the
third Person than the terms and conditions set forth in
IDDS's notice to West under Section 4.1 hereof
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5. Intellectual Property Rights.
5.1 Each Party shall own all intellectual property developed by
its independent research and development projects.
5.2 West and West/Nottingham own and shall own all Background IP.
5.3 IDDS shall own all Program IP developed by the IDDS-funded
portions of the Development Program, provided that West shall
have a non-exclusive, worldwide, fully paid-up, royalty-free,
perpetual license (with right to sublicense) to all such
Program IP relating in any way to manufacturing, scale-up and
production processes, techniques, inventions and know-how,
including without limitation clinical- and production-scale
manufacturing processes.
6. Term and Termination.
6.1 Term and Expiration. This Agreement shall become effective as
of the Effective Date and, unless terminated earlier pursuant
to this Section 6, shall remain in effect until the last to
occur Launch Date after the Licensed Product has been Launched
in all Major Market Countries.
6.2 Termination. This Agreement may be terminated as follows:
6.2.1 By mutual consent of the Parties at any time.
6.2.2 By either West or IDDS upon written notice to the
other:
(a) in the event of a default by the other Party
in the due observance or performance of any
covenant, condition or limitation of this
Agreement or the License Agreement, but only
if the defaulting Party will not have
remedied its default within 30 days (or
within five Business Days in the event of
default under Section 3) after receipt of
written notice of such default from
th~non-defaulting party; or
(b) if the other Party is adjudicated a
bankrupt, if insolvency, bankruptcy,
reorganization, debt adjustment or
liquidation proceedings are instituted
against such Party and not dismissed within
60 days after the institution thereof, if a
receiver or trustee is appointed for such
party and its assets, or if such Party makes a
general assignment for the benefit of its
creditors.
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6.3 Survival. Notwithstanding the termination of this Agreement,
all rights and obligations that by their terms survive
termination shall remain unaffected until the complete
satisfaction or expiration thereof
7. Representations and Disclaimer.
7.1 Representations by West and West/Nottingham. Each of West and
West/Nottingham represents and warrants to IDDS:
7.1.1 It has the full legal right, power and authority to
enter in this Agreement.
7.1.2 It has not entered, and will not enter, into any
agreement that conflicts with the provisions of this
Agreement.
7.2 Representations by IDDS. IDDS represents and warrants to West
and West/Nottingham:
7.2.1 It has the full legal right, power and authority to
enter in this Agreement.
7.2.2 It has not entered, and will not enter, into any
agreement that conflicts with the provisions of this
Agreement.
7.3 Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH IN THIS AGREEMENT, NEITHER WEST NOR WEST/NOTTINGHAM
MAKES ANY REPRESENTATION, GUARANTEE OR WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO
REPRESENTATIONS OR WARRANTIES TO THE SUCCESS OF ANY
DEVELOPMENT EFFORTS TO BE TAKEN HEREUNDER OR THE RESULTS TO BE
EXPECTED FROM IDDS'S USE OF ANY LICENSED PRODUCT OR FROM THE
MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCT AND NO RIGHTS
IMPLIED OR OTHERWISE ARE GRANTED. NEITHER WEST,
WEST/NOTTINGHAM NOR ANY AFFILIATE OF ANY OF THEM SHALL HAVE
ANY RESPONSIBILITY TO IDDS OR OTHERS UNDER ANY LEGAL PRINCIPLE
FOR THE ABILITY OF IDDS OR THE QUALITY OR PERFORMANCE OF ANY
LICENSED PRODUCT DEVELOPED HEREUNDER; FOR CLAIMS OF THIRD
PERSONS RELATING TO ANY LICENSED PRODUCT MANUFACTURED OR SOLD
BY IDDS OR ANY OF ITS AFFILIATES OR SUBLICENSEES, OR FOR ANY
FAILURE IN LICENSED PRODUCTION, DESIGN OR OPERATION OF ANY
LICENSED PRODUCT MANUFACTURED OR SOLD BY ANY OF THEM. WEST AND
WEST/NOTTINGHAM DISCLAIM ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR USE. IN NO EVENT SHALL WEST,
WEST/NOTTINGHAM OR ANY AFFILIATE OF ANY OF THEM BE LIABLE TO
IDDS OR ANY AFFILIATE OR SUBLICENSEE FOR INDIRECT, SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES UNDER THIS AGREEMENT OR
OTHERWISE, REGARDLESS OF WHETHER WEST, WEST/NOTTINGHAM OR ANY
AFFILIATE OF ANY OF THEM KNEW OR HAD REASON TO KNOW OF THE
POSSIBILITY OF SUCH DAMAGES.
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8. Miscellaneous Provisions.
8.1 Force Majeure. No Party hereto shall be held liable or
responsible to any other Party nor be deemed to have defaulted
under or breached this Agreement for failure or delay in
fulfilling or performing any term of the Agreement when such
failure or delay is caused by or results from causes beyond
the reasonable control of the Party failing to perform or
delayed in performing including, but not limited to, fire,
floods, embargoes, war, acts of war (whether war be declared
or not), insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or
the other Party.
8.2 Assignment. This Agreement may not be assigned or otherwise
transferred by any Party without the consent of the other
parties; provided, however, that either Party may, without
such consent, assign this Agreement and its rights and
obligations hereunder to its Affiliates or in connection with
the transfer or sale of all or substantially all of its
business, or in the event of its merger or consolidation or
change in control or similar transaction. Any purported
assignment in violation of the preceding sentence shall be
void. Any permitted assignee shall assume all obligations of
its assignor under this Agreement.
8.3 Severability. In the event any one or more of the provisions
contained in this Agreement should be held invalid, illegal or
unenforceable in any respect, the validity, legality and
enforceability of the remaining provisions contained herein
shall not in any way be affected or impaired thereby, unless
the absence of the invalidated provision(s) adversely affect
the substantive rights of the parties. The parties shall in
such an instance use reasonable efforts to replace the
invalid, illegal or unenforceable provision(s) with valid,
legal and enforceable provision(s) which, insofar as
practical, implement the purposes of this Agreement.
8.4 Notices Any notice or other communication pursuant to this
Agreement will be deemed duly made or given: (i) when
delivered by hand; (ii) 10 business days after it is mailed,
certified or return receipt request, with postage prepaid;
(iii) when sent, if sent by telecopy (with receipt confirmed)
or (iv) when receipt is signed for when sent by Federal
Express, DHL or other express delivery service. Notices will
be addressed as follows:
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If to West or West/Nottingham to:
West Pharmaceutical Services, Inc.
101 Gordon Drive
Lionville, Pennsylvania 19341
Attention: Division President, Drug Delivery Systems
Telecopier: 610 594-3013
With a required copy to:
West Pharmaceutical Services, Inc.
101 Gordon Drive
Lionville, Pennsylvania 19341
Attention: General Counsel
Telecopier: 610 594-3013
If to IDDS to:
Innovative Drug Delivery Systems, Inc.
787 Seventh Avenue
New York, NY 10019
Attention: David M. Tanen
Telecopier: 212 554-4355
8.5. Governing Law/Jurisdiction. This Agreement is acknowledged to have been
made in and shall be construed, governed, interpreted and applied in
accordance with the federal patent laws and the laws of the
Commonwealth of Pennsylvania, without giving effect to its conflict of
laws provisions. The state and federal courts in Pennsylvania shall
have exclusive jurisdiction over any litigation arising under this
Agreement.
8.6. Arbitration Clause. Any controversy or claim arising out of or relating
to this Agreement or the breach thereof, which remains unsettled
following diligent efforts by each Party to reach a mutually acceptable
resolution of such claim or controversy, shall be settled by
arbitration administered by the American Arbitration Association and
judgment on the award rendered by the arbitrator(s) may be entered in
any court having jurisdiction thereof This Section shall not prevent
any Party from seeking equitable relief
8.7. Entire Agreement. This Agreement, the License Agreement, and the
Confidentiality Agreement among the Parties entered into as of August
25, 2000 constitute the entire Agreement between the parties with
respect to the subject matter hereof, and supersede all proposals, oral
or written, purchase orders, confidentiality agreements and all other
communications between the parties with respect to such subject matter.
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8.8. Modifications The terms and conditions of this Agreement may be amended
only by a written instrument duly executed by the Parties.
8.9. Headings. The headings and captions preceding the Sections hereof are
inserted solely for convenience of reference, and will not constitute
part of this Agreement, nor will they affect its meaning, construction
or effect.
8.10. Independent Contractors. It is expressly agreed that West and
West/Nottingham, on one hand, and IDDS, on the other hand, are
independent contractors with respect to this Agreement and that the
relationship between them created by this Agreement shall not
constitute a partnership, joint venture or agency. No Party hereto
shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding
on any other Party, without the prior consent of the Party to do so.
8.11. Waiver. The waiver by any Party of any right hereunder or the failure
to perform or of a breach by any other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure
by said other Party whether of a similar nature or otherwise.
8.12. Counterparts. The Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be the
subject matter hereof, and supersede all proposals, oral or written, purchase
orders, confidentiality agreements and all other communications between the
parties with respect to such subject matter.
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8.8. Modifications The terms and conditions of this Agreement may be amended
only by a written instrument duly executed by the Parties.
8.9. Headings. The headings and captions preceding the Sections hereof are
inserted solely for convenience of reference, and will not constitute
part of this Agreement, nor will they affect its meaning, construction
or effect.
8.10. Independent Contractors. It is expressly agreed that West and
West/Nottingham, on one hand, and IDDS, on the other hand, are
independent contractors with respect to this Agreement and that the
relationship between them created by this Agreement shall not
constitute a partnership, joint venture or agency. No Party hereto
shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding
on any other Party, without the prior consent of the Party to do so.
8.11. Waiver. The waiver by any Party of any right hereunder or the failure
to perform or of a breach by any other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure
by said other Party whether of a similar nature or otherwise.
8.12. Counterparts. The Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
duly executed by their respective duly authorized officers.
INNOVATIVE DRUG DELIVERY SYSTEMS, INC.
By: /s/ Mark C. Rogers
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Mark C. Rogers, M.D., Chairman
WEST PHARMACEUTICAL SERVICES, INC.
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WEST PHARMACEUTICAL SERVICES, INC.
By: /s/ Donald B. Morel Jr.
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Donald B. Morel Jr.,
Division President,
Drug Delivery Systems
WEST PHARMACEUTICAL SERVICES DRUG DELIVERY
& CLINICAL RESEARCH CENTRE LTD.
By: /s/ Donald B. Morel Jr.
----------------------------------
Donald E. Morel Jr, Chairman
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