Exhibit 10.9
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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M-6-G OPTION AGREEMENT
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Dated September 22, 2000
OPTION AGREEMENT
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THIS IS AN 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, 19,41, 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 and Technology Park, University Boulevard,
Nottingham, NG7 2TN, United Kingdom; and Innovative Drug Delivery Systems, Inc.,
a Delaware corporation, ("IDDS") with offices at 787 Seventh Avenue, New York,
New York 10019.
Background
West (directly and through its subsidiaries, including West/Nottingham)
is engaged in, among other things, the research and development of the
transmucosal delivery of pharmaceutical compounds using its patented and
proprietary drug-delivery technology. West, West/Nottingham and IDDS have
entered into a License Agreement, dated as of August 25, 2000 (the "License
Agreement") pursuant to which West and West/Nottingham have granted IDDS
exclusive worldwide rights under the Licensed Patents to make, use and sell
certain Identified Compounds for the treatment of pain in humans and animals.
West and West/Nottingham desire to grant and IDDS desires to secure an
option to include morphine-6-glucuronide ("M-6-G") as an Identified Compound
under the License Agreement, all on the terms and subject to the conditions set
forth below.
Agreement
Accordingly, intending to be legally bound, the parties agree as
follows:
1. Definitions. All capitalized terms used but not defined herein have the
same meaning ascribed to them in the License Agreement. Terms defined
parenthetically in this Agreement may be used in the singular or in the
plural, as sense shall require.
2. Grant of Option. Upon the terms and subject to the conditions set forth
herein, West and West/Nottingham hereby grant to IDDS an exclusive
option to include M-6-G as an Identified Compound under the License
Agreement, and as such exercise the rights to the Chitosan-based
Technology granted in Section 2 of the License Agreement with respect
to M-6-G, subject to the Field of Use and other terms and conditions of
the License Agreement ("the Option").
3. Duration of Option. The Option shall become exercisable on the
Effective Date and remain exercisable until 12:01 AM, December 22,
2000, (the "Option Period") when it will expire.
4. Option Consideration. In consideration of the Option, IDDS shall pay to
West within five days of the Effective Date the non-refundable amount
of *** (the "Option Fee").
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*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
5. Exercise of Option. IDDS may exercise the Option by written notice to
West in the manner set forth in Section 9.3 hereof. West must receive
such notice prior to expiration of the Option Period for IDDS to
validly exercise the Option. Upon IDDS's exercise of the Option:
5.1 IDDS shall pay to West a non-refundable license fee in the
amount of ***, payable upon execution of the License Addendum;
5.2 West, West/Nottingham and IDDS shall execute the License
Addendum attached hereto as Exhibit A (the "License
Addendum"); and
5.3 West, West/Nottingham and IDDS shall, within 45 days of the
exercise of the Option, enter into an Research and Development
and Option Agreement with respect to M-6-G, which shall
contain terms and conditions consistent with those set forth
in Schedule A hereto.
6. Failure to Exercise Option. In the event that IDDS does not exercise
the Option during the Option Period, or if prior to the expiration of
the Option Period, IDDS informs West that it will not exercise the
Option, West will as from such moment be free to license the
Chitosan-based Technology and Program IP in the Field of Use to third
Persons for use with M-6-G, and IDDS will have no further rights under
this Agreement or the License Agreement with respect to M-6-G.
7. Manner of Payment. 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
days prior to the due date thereof.
8. Term and Termination.
8.1 Term and Expiration. This Agreement shall commence on the
Effective Date and, unless terminated earlier pursuant to this
Section, shall remain in effect until expiration of the Option
Period.
8.2 Termination. This Agreement and the licenses herein granted
may be terminated as follows:
8.2.1 By mutual consent of the parties at any time.
8.2.2 By either West and West/Nottingham, on one hand, and
IDDS on the other, upon written notice to the other
party 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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*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
-2-
9. Miscellaneous Provisions.
9.1 Assignment. 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 and
be entitled to all of the rights of its assignor under this
Agreement.
9.2 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.
9.3 Notices. Any notice or other communication pursuant to this
Agreement will be deemed duly made or given: (i) when
delivered by hand; (ii) five 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:
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
-3-
9.4 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.
9.5 Entire Agreement. This Agreement, including the exhibits
hereto, which incorporated herein and made a part hereof, the
Letter of Intent, the License Agreement and the
Confidentiality Agreement among the parties entered into as of
August 25, 2000 constitute the entire agreement among 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.
9.6 Modifications. The terms and conditions of this Agreement may
be amended only by a written instrument duly executed by the
parties.
9.7 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.
9.8 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.
9.9 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 have caused this Agreement to be to be
duly executed by their respective duly authorized officers.
INNOVATIVE DRUG DELIVERY SYSTEMS, INC.
By: /s/ Mark C. Rogers
---------------------------------------------
Mark C. Rogers, M.D., Chairman
WEST PHARMACEUTICAL SERVICES, INC.
By: /s/ Donald E. Morel Jr.
---------------------------------------------
Donald E. Morel Jr., Division President,
Drug Delivery Systems
-4-
WEST PHARMACEUTICAL SERVICES DRUG DELIVERY &
CLINICAL RESEARCH CENTRE LTD.
By: /s/ Donald E. Morel Jr.
---------------------------------------------
Donald E. Morel Jr., Chairman
EXHIBIT A
---------
License Addendum
----------------
LICENSE ADDENDUM AGREEMENT
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THIS IS A LICENSE ADDENDUM AGREEMENT (the "Agreement"), dated as of
__________, 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 and Technology Park, University Boulevard,
Nottingham, NG7 2TN, United Kingdom; and Innovative Drug Delivery Systems, Inc.,
a Delaware corporation, ("IDDS") with offices at 787 Seventh Avenue, New York,
New York 10019.
Background
West, West/Nottingham and IDDS have entered into a License Agreement,
dated as of August 25, 2000 (the "License Agreement"), pursuant to which West
and West/Nottingham have granted IDDS exclusive worldwide rights under the
Licensed Patents to make, use and sell certain Identified Compounds for the
treatment of pain in humans and animals. West and West/Nottingham desire to
extend the licenses granted under the License Agreement to include, and IDDS
desires to secure such licenses including, morphine-6-glucuronide ("M-6-G") as
an Identified Compound, all on the terms and subject to the conditions set forth
below.
Agreement
Accordingly, intending to be legally bound, the parties agree as
follows:
1. Definitions. All capitalized terms used but not defined herein have the
same meaning ascribed to them in the License Agreement. Terms defined
parenthetically in this Agreement may be used in the singular or in the
plural, as sense shall require.
2. Inclusion of M-6-G. As of the Effective Date, M-6-G shall be included
as an Identified Compound according to and pursuant to the provisions
of the License Agreement, and as such IDDS may exercise the rights to
the Chitosan-based Technology granted in Section 2 of the License
Agreement with respect to M-6-G, subject to the Field of Use and other
terms and conditions of the License Agreement.
3. License Fee. Upon execution of this Agreement, IDDS shall pay to West a
non-refundable license fee of ***.
4. Effect. The provisions of this Agreement shall supersede any contrary
provision of the License Agreement, and to that extent, act as an
amendment thereto and become a part thereof. Except as otherwise set
forth herein, the License Agreement shall remain in full force and
effect in accordance with its terms.
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*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
IN WITNESS WHEREOF, the parties have caused this Agreement to be to be
duly executed by their respective duly authorized officers.
INNOVATIVE DRUG DELIVERY SYSTEMS, INC.
By:
---------------------------------------------
Mark C. Rogers, M. Chairman
WEST PHARMACEUTICAL SERVICES, INC.
By:
---------------------------------------------
Donald E. Morel Jr., Division President,
Drug Delivery Systems
WEST PHARMACEUTICAL SERVICES DRUG DELIVERY &
CLINICAL RESEARCH CENTRE LTD.
By:
---------------------------------------------
Donald E. Morel Jr., Chairman
SCHEDULE A
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Terms of M-6-G Research and Development and Option Agreement
------------------------------------------------------------
Milestone Payments: The Research and Development and Option Agreement with
respect to M-6-G shall provide for milestone payments as follows:
Completion of Phase I/II clinical trial $ ***
Start of Phase III trial ***
First NDA or similar filing ***
MDA Approval ***
Definitions respecting the Milestones will be conformed with those provided in
the Letter of Intent for other Identified Compounds requiring comparable
milestone payments.
Research and Development: The M-6-G Research and Development and Option
Agreement shall provide that West will perform pre-clinical development
services, and West shall have an option to perform the manufacture of commercial
quantities of Licensed Product containing M-6-G, all on terms and conditions
consistent with those specified in the Letter of Intent with respect to M-6-G,
provided that such R&D Agreement shall also provide that IDDS need not commence
development work on a Licensed Product containing M-6-G and chitosan until the
FDA allows (by way of a pre-Phase III meeting or otherwise) the commencement of
Phase III clinical studies with respect to a Licensed Product containing opioid
alkaloid morphine and/or a salt thereof and chitosan.
Unless separately defined herein, all capitalized terms used herein have the
same meaning as those terms used in the License Agreement.
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*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.