Exhibit 10.8
Certain confidential portions of this Exhibit were omitted by means of blackout
of the text (the "Xxxx"). This Exhibit has been filed separately with the
Secretary of the Securities and Exchange Commission without the Xxxx 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 LOGO]
WEST PHARMACEUTICAL SERVICES, INC.
And its wholly owned subsidiary
WEST PHARMACEUTICAL SERVICES DRUG DELIVERY
& CLINICAL RESEARCH CENTRE LTD.
and
INNOVATIVE DRUG DELIVERY SYSTEMS, INC.
RESEARCH AND DEVELOPMENT AND OPTION
AGREEMENT
(Nasal Fentanyl)
Dated October 24, 2000
RESEARCH AND DEVELOPMENT AND OPTION AGREEMENT
THIS IS A RESEARCH AND DEVELOPMENT AND OPTION AGREEMENT (the
"Agreement"), dated as of October 24, 2000 (the "Effective Date"), among West
Pharmaceutical Services, Inc., a Pennsylvania corporation, ("West") with offices
at 000 Xxxxxx Xxxxx, Xxxxxxxxx, XX, 00000, 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 Xxxxxx Xxxxxxxx Centre, Nottingham Science & Technology Park,
Xxxxxxxxxx Xxxxxxxxx, Xxxxxxxxxx, XX0 0XX, Xxxxxx Xxxxxxx (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 000 Xxxxxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000.
Background
West (directly and through its subsidiaries, including West/Nottingham)
is engaged in, among other things, the research and development of delivering
pharmaceutical compounds using its patented and proprietary drug-delivery
technology. West/Nottingham is the owner of the entire right, title and interest
in certain issued letters patent and pending patent applications relating to the
use of chitosan for the transmucosal delivery of pharmaceutical compounds,
including the delivery of morphine via the nasal mucosa. West, West/Nottingham
and IDDS have entered into a License Agreement as of August 25, 2000 (the
"License Agreement") under which West and West/Nottingham have granted IDDS an
exclusive worldwide license to make, use and sell products including fentanyl
covered by such patents for the treatment of pain in humans and animals.
IDDS desires that the West Group to perform certain work for the
development of a product for administering fentanyl via the nasal mucosa, and to
itself 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 fentanyl 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 fentanyl,
including all continuations, continuations-in-part,
divisionals, reissues and reexaminations thereof.
1.12. "Licensed Product" means fentanyl 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.
2
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.
1.14. "NLPT Securities" means equity securities of IDDS or an
Affiliate 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.
1.20. Successful Completion" means, with respect to a Phase I
clinical study, results that would be considered commercially
reasonable grounds for deciding to immediately proceed with
further Phase II or Phase III clinical studies.
2. Development Activities.
2.1. Conduct of Development Program; Condition to Commencement of
Work.
2.1.1. Each Party will undertake development of the Licensed
Product in accordance with a written Development
Program agreed to by the West Group, on the one hand,
and IDDS, on the other hand, as set forth in Exhibit
A hereto. The Development Program may be modified
only by written agreement of the Parties. Each Party
will make every reasonable effort to complete its
responsibilities under the Development Program within
the timetables set out therein but if some cause
beyond the reasonable control or foresight of such
Party shall interrupt the progress of the Development
Program then the other Parties shall allow a
reasonable additional period of time to complete the
Development Program.
3
2.1.2. IDDS need not commence development work on a Licensed
Product containing fentanyl 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 product containing opioid
alkaloid morphine and/or a salt thereof and chitosan.
2.2. Project Team.
2.2.1. Promptly following the Effective Date, the Parties
shall form a Project Team, which shall be chaired by
a representative of IDDS and include representatives
of West and West/Nottingham. The Project Team shall
initially consist of those Persons listed on Schedule
A hereto.
2.2.2. The purpose of the Project Team shall be to manage
the Development Program. The Project Team shall meet
monthly. Meetings may be held either in person or by
tele-conference or video-conference. The West Group
or IDDS, as applicable, shall prepare and circulate
written progress summaries of the Development Program
for the Project Team prior to each meeting, in such
form, content and detail as reasonably required by
the Project Team.
2.3. Payments for Development Work.
2.3.1. IDDS shall pay to West the costs of the Development
Program work performed by or for West in the amounts
and according to the timetable as set forth in
Exhibit A. The Parties acknowledge that such cost may
vary by up to 10%, and West may revise any such
amount up or down by up to 10% by showing reasonable
justification therefor.
2.3.2. IDDS shall have the right to select alternative
suppliers should West be unable to provide
competitive cost bids on any or all subprojects
listed in Exhibit A.
2.3.3. IDDS shall have the right to select alternative
suppliers should West be unable complete any
subprojects listed in Exhibit A within a reasonable
projected timeframe.
4
2.3.4. Payment Schedule. IDDS shall pay to West the costs
and fees for the subprojects listed in Exhibit A as
follows:
(a) 40% of the total subproject cost upon order
to commence;
(b) 30% of the total subproject cost invoiced
monthly in evenly divided amounts over the
duration of the subproject; and
(c) 30% of the total subproject cost upon
completion of the subproject.
(d) Other than payments due upon order, payments
shall be due upon invoicing.
2.4. IDDS's Development and Commercialization Obligations. IDDS
shall, at its cost and expense, conduct the following
activities:
2.4.1. IDDS shall perform the work set forth in and in
accordance with the Development Program.
2.4.2. Diligently perform all activities necessary or
appropriate to obtain and maintain in full force and
effect Regulatory Agency approval in the U.S. and
each Major Market Country for the marketing of the
Licensed Product in the Field of Use; provided, that
IDDS shall not be 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.
2.4.3. 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, and
2.4.4. Use all reasonable commercial efforts to Launch the
Licensed Product within 90 days after receiving all
necessary approvals in each such country.
2.4.5. IDDS shall maintain insurance covering 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. Such policies shall, at a minimum,
provide for:
5
(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.
2.5. West's Obligations.
2.5.1. 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.
2.5.2. West shall perform the work set forth as West's
responsibilities in and in accordance with the
Development Program.
2.6. 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 of West under Section 2.5.1 shall survive any
termination of this Agreement for any reason whatsoever,
including without limitation by reason of breach by West or
West/Nottingham.
3. Milestone 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:
3.1.1. Within thirty (30) days following successful
completion of proof-of-principle in vitro and in vivo
animal studies demonstrating the absorption,
distribution, metabolism, excretion (ADME), safety,
tolerability and efficacy of transnasal delivery of
fentanyl, the amount of U.S.$500,000;
3.1.2. Within thirty (30) days following the successful
completion of the first Phase I trial for a Licensed
Product that is under development through an
IDDS-sponsored or West-sponsored IND, the amount of
U.S.$***.
*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
6
(a) For the purposes of this Section, "Phase
I trial" means an initial Phase I clinical
trial in normal volunteers or an initial
Phase I/II clinical trial in less than fifty
(50) patients suffering from pain, as
determined by IDDS in accordance with the
Development Program.
3.1.3. 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 $***;
3.1.4. 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
3.1.5. 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
3.1.4 and 3.1.5 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 days prior 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 3.1.4 and/or 3.1.5 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%.
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.
*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
7
3.4.3. Any NLPT Securities issued pursuant to his 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 eighteen (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.
8
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 5 Business Days in the event of
default under Section 3) after receipt of
written notice of such default from the
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.
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.
9
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.
10
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:
11
If to West or West/Nottingham to:
West Pharmaceutical Services, Inc.
000 Xxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: Division President, Drug Delivery Systems
Telecopier: 000 000-0000
With a required copy to:
West Pharmaceutical Services, Inc.
000 Xxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxx 00000
Attention: General Counsel
Telecopier: 000 000-0000
If to IDDS to:
Innovative Drug Delivery Systems, Inc.
000 Xxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxxx
Telecopier: 000 000-0000
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.
12
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 counterparts,
each of
13
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 instrument to be
executed in duplicate by their respective duly authorized officers.
INNOVATIVE DRUG DELIVERY SYSTEMS, INC.
By: /s/ Xxxx X. Xxxxxx
---------------------------------
Xxxx X. Xxxxxx, M.D., Chairman
WEST PHARMACEUTICAL SERVICES, INC.
By: /s/ Xxxxxx X. Xxxxx Xx.
---------------------------------
Xxxxxx X. Xxxxx Xx., Division President, Drug Delivery Systems
WEST PHARMACEUTICAL SERVICES DRUG DELIVERY &
CLINICAL RESEARCH CENTRE, LTD.
By: /s/ Xxxxxx X. Xxxxx Xx.
---------------------------------
Xxxxxx X. Xxxxx Xx., Chairman
14
EXHIBIT A
Scope of Development Project
EXHIBIT A
Nasal Fentanyl Development Program - Work to be Performed by IDDS
Project/Activity Responsibility
---------------- --------------
IND Filing IDDS To be completed within
*** from initiation
of project To be
initiated *** filing
fof IND
Phase I Clinical Trials
Prepare clinical supplies IDDS
Active trial IDDS
Analysis of plasma samples IDDS
PK analysis of plasma data IDDS
Write/issue clin/stat report phase 1 IDDS
Additional Phase I Study (If Needed)
PK-PD Study
Prepare clinical supplies IDDS
Active trial IDDS
Analysis of plasma samples IDDS
PK analysis & report IDDS
Write/issue clin/stat report phase 1 IDDS
Phase II Clinical Trials To be initiated within
Phase 2 trial in patients with breakthrough or incident *** of IND filing
pain (first trial in target population)
Prepare clinical supplies IDDS
Active trial IDDS
Analysis of plasma samples IDDS
Write/issue clin/stat report phase 2 IDDS
Phase III Clinical Trials To be initiated within
First pivotal efficacy trial in breakthrough or incident pain *** of IND filing
Prepare clinical supplies IDDS
Active trial IDDS
Analysis of plasma samples IDDS
PK analysis of plasma data IDDS
Write/issue clin/stat report phase 3 IDDS
Second pivotal efficacy trial in breakthrough or incident pain
Prepare clinical supplies IDDS
Active trial IDDS
Analysis of plasma samples IDDS
PK analysis of plasma data IDDS
Write/issue clin/stat report phase 3 IDDS
Pilot/Process Evaluation Batch Manufacture
Tech Transfer to mfg site IDDS
Complete production validation IDDS
3 consecutive scale-up batches for NDA filing IDDS
Pre-approval inspection IDDS
Registration To be filed within
End of Phase II Report IDDS *** of IND filing
Annual IND Updates IDDS
NDA Submission & Approval
NDA packages for CMC, Toxicology and PK IDDS
*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
EXHIBIT A
Nasal Fentanyl Development Program - Work to be Performed by WPS
$(000)
Description Total
----------- -----
Formulation Development & Optimization $ ***
Proof of Principle
*** Feasibility Study (***) $ ***
Including analytical & report
Initial Human Volunteer Trial $ ***
(*** subjects)
Including analytical & report
Analytical Method Development $ ***
and Stability Testing
Subchronic
GLP Toxicology Studies (***) $ ***
Manufacturing of Phase I
Clinical Supplies (up to 3,000 units) $ ***
IND Package for
Submission (CMC, Clinical, PK & Tox) $ ***
U.S. Phase I Clinical Trial $ ***
Approx. 20 normal volunteers (not to exceed 50)
Selected single formulation & package
Including analytical & report ____________
Total $ ***
* Fixed Fee Projects
** Non-IND Study
*** Represents material which has been omitted pursuant to an Application for
Order Granting Confidential Treatment and filed separately with the
Commission.
