Exhibit 10.1
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
February 20, 1998
The ▇.▇. ▇▇▇▇▇▇▇ Pharmaceutical Research Institute
Welsh and ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Dear Sirs:
This Letter Agreement ("Agreement") sets forth the terms and conditions under
which The ▇.▇. ▇▇▇▇▇▇▇ Pharmaceutical Research Institute, a division of Ortho-
▇▇▇▇▇▇ Pharmaceutical, Inc. (PRI) and DepoMed, Inc. ("DepoMed") will collaborate
in a joint research project (the "Research") to determine optimal conditions for
the production of a product (the "Product") consisting of formulations of the
chemical compound known as [* *] incorporated in the DepoMed Gastric Retentive
System (the "GR System"). The specific terms and conditions of this Agreement
are as follows:
I. THE RESEARCH
A. DepoMed agrees to use its diligent efforts to implement and complete
the Research Plan attached herewith and fully incorporated herein as Appendix A.
Elements of this plan may be modified, but only by mutual written agreement of
PRI and DepoMed (the "Parties") at any time during the term of this Agreement.
B. PRI agrees to collaborate with and assist DepoMed in the
implementation and completion of the Research Plan set forth in Appendix A by
providing to DepoMed:
1. Bulk [* *] in sufficient quantities to perform the Research Plan;
2. Appropriate analytical and handling procedures for [* *]; and
CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
3. Such other technology and expertise possessed by PRI which may be
deemed necessary, by subsequent mutual agreement of the Parties, to achieve the
objectives of this Agreement.
C. All [* *], including work in process, shall remain the sole property of
PRI. DepoMed agrees not to make any modifications of the [* *] provided by PRI
hereunder, except as required in the performance of the Research Plan.
D. The [* *] shall be used solely to conduct the Research Plan, and not
for any other purpose. The [* *] shall not be made available to anyone other
than employees of DepoMed working in furtherance of the Research Plan, shall not
be transferred to any other persons outside of DepoMed for any purpose, and
shall not be transferred to another institution or company without the prior
written consent of PRI.
E Nothing herein shall create or imply any license in intellectual
property rights related to [* *] owned or controlled by PRI to DepoMed, except
for the non-exclusive license to DepoMed to use the [* *] for the research
purposes expressly set forth herein. Similarly, nothing herein shall create or
imply any license in intellectual property rights related to the GR System to
PRI.
F. Upon conclusion of the Research Plan, or termination of this Agreement,
DepoMed shall discontinue use of the [* *] and will arrange for the return to
PRI of all unused [* *] and work in progress.
G. DepoMed will take appropriate steps to inform all Research Plan
personnel of their obligations under this Agreement and to obtain their
agreement to abide by the terms and conditions of this Agreement in the same
manner as DepoMed.
H. In the performance of the activities contemplated hereunder, the
parties including employees and agents of each, shall be that of independent
contractors, and not as employees, agents or fiduciaries of the other party, and
neither party shall have the right to make commitments for or on behalf of the
other party.
II. TERM
A. This Agreement is effective as of February 20, 1998, and shall continue
in effect for the time period necessary for DepoMed to complete the Research
Plan set forth in Appendix A, as estimated therein, or until DepoMed notifies
PRI in writing that the Research Plan has been completed, or that the Research
Plan is not likely to be successfully completed, if earlier.
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
B. The term of this Agreement may be extended by an amendment in writing
executed by both Parties.
III. COSTS/PAYMENTS
A. DepoMed agrees to use diligent efforts to complete the Research Plan
within the estimated cost figures provided in the Research Plan. However, PRI
acknowledges that the actual costs may exceed the estimates. DepoMed will
invoice PRI on a monthly basis for work completed on the Research Plan, and PRI
agrees to pay such invoices within 45 days.
B. PRI and DepoMed understand that developments, unforeseen circumstances
beyond the reasonable control of DepoMed or changes in the scope of the Research
or DepoMed's responsibilities for the Research may increase the funding
requirements for the Research. In such event, PRI and DepoMed agree to discuss
appropriate revisions in the Research Plan and estimated costs for further work
under the Research Plan.
C. PRI is under no obligation to make payments to DepoMed or to agree to
funding increases beyond the amount set forth in Appendix A.
D. DepoMed will maintain complete and accurate records which are relevant
to its execution of the Research Plan. DepoMed shall maintain such records,
including raw data, in good order. Such records shall be open during regular
business hours upon reasonable notice for a period of two (2) years from
creation of individual records for examination at PRI's expense.
IV. PROGRESS REPORTS/JOINT MEETINGS
DepoMed agrees to keep PRI informed through mutually agreeable means as
significant tasks of the Research Plan are completed. DepoMed shall furnish to
PRI appropriate technical information and reports describing the results
obtained in performance of the Research Plan. Upon completion DepoMed shall
provide PRI with a final written report on the results.
V. CONFIDENTIAL INFORMATION
A. During the term of Agreement and at such times as the parties shall
agree, each party shall disclose to the other, in confidence subject to this
Section V, relevant proprietary information useful to the activities of the
Research Plan which it considers confidential ("Confidential Information").
Such Confidential Information as well as all information generated in
performance of the Research Plan ("Plan Information") shall be
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
maintained in confidence by the other party and shall not be disclosed or
otherwise communicated to others, or used for any purpose, except pursuant to
and in order to carry out the terms and objectives of this Agreement, or the
performance of any future Development and/or license agreement entered into by
the parties under Section VI hereof. Each party hereby agrees to exercise
reasonable precautions to prevent the unauthorized disclosure of such
Confidential Information and Plan Information.
B. Section V.A. shall not apply to the extent such Confidential
Information or Plan Information:
(a) was known or used by the receiving party prior to its date of
disclosure to the receiving party as evidenced by the prior written records of
the receiving party; or
(b) either before or after the date of the disclosure to the
receiving party is lawfully disclosed to the receiving party by sources other
than the disclosing party rightfully in possession of the Confidential
Information or Plan Information; or
(c) either before or after the date of the disclosure to the
receiving party becomes published or generally known to the public, other than
through the sale of Products in the ordinary course of business through no fault
or omission on the part of the receiving party or an Affiliate; or
(d) is required to be disclosed by the receiving party to comply with
applicable laws, to defend or prosecute litigation or to comply with
governmental regulations, provided that the receiving party provides prior
written notice of such disclosure to the other party and takes reasonable and
lawful actions to avoid and/or minimize the degree of such disclosure.
C. Notwithstanding the foregoing, each party may disclose the other's
Confidential Information and Plan Information to its Affiliates, agents and
consultants who have a need to know and who are under an obligation of
confidentiality and non-use substantially equivalent to the obligations under
this Section V.
D. The provisions of this Section V shall supersede the Confidentiality
Agreement between the parties executed November 18, 1997 and shall survive
termination of this Agreement, but each party shall be released from the
obligations under this Section V after a period of fifteen (15) years from the
date of expiration or termination of this Agreement.
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
VI. FUTURE DEVELOPMENT
The decision as to whether to proceed with the preclinical and clinical
development and marketing of any Product containing formulations of [* *]
developed pursuant to this Agreement shall be in the sole discretion of PRI. At
the conclusion of Stage 1 of the Research Plan, and prior to commencing work on
Stage 2, the parties shall meet to negotiate the basic terms of a definitive
Development Agreement and License, which will provide, inter alia, for an
exclusive worldwide license to PRI and mutually agreeable development payments,
milestone payments and/or royalties payable to DepoMed on net sales by PRI, its
affiliates and sublicensees of any such product containing formulations of [* *]
utilizing the GR System. Provided the parties can agree upon such basic terms,
DepoMed will proceed with Stage 2 of the Research Plan hereunder, and the
parties will negotiate and execute a definitive Development and License
agreement incorporating such basic terms. Notwithstanding the foregoing, PRI
may decide to terminate negotiations under this Article at any time without any
resulting obligation or liability to DepoMed.
VII. PROPRIETARY RIGHTS
A. All rights, title and interest to inventions, discoveries or
improvements first conceived or made as a result of the performance of the
Research Plan ("Inventions") that relate solely to the GR System, shall belong
to DepoMed. All inventions that relate solely to [* *] shall belong to PRI.
B. DepoMed represents and warrants to PRI that any Inventions that may be
made by its employees in the performance of the Research Plan are owned by and
shall be assigned to DepoMed, wholly and completely.
C. DepoMed will promptly notify PRI in writing of any Inventions that
relate solely to [* *], conceived and/or made by DepoMed as a result of the
performance of the Research Plan. Such notice shall describe the substance of
any such Invention in writing in sufficient detail so as to enable PRI to
determine if a patentable Invention has been made.
VIII. PUBLICITY
A. Neither PRI nor DepoMed shall disclose the existence of or any terms of
this Agreement or any of the information contained in the Appendix to this
Agreement to any third party other than their professional advisors without the
prior written permission of the other Party, except where such disclosure is
required by law.
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
B. Neither PRI nor DepoMed shall use the name of the other Party in any
advertising or promotional context in any medium, except that a mutually
acceptable press release may be made by the parties.
IX. COVENANT AND WARRANTY
Each Party hereby warrants, as of the date hereof, and covenants that (a) it has
full right and authority to enter into this Agreement and to perform its
obligations hereunder and (b) it has not entered into and during the term of the
Agreement will not enter into any other agreement in conflict with this
Agreement.
X. ASSIGNMENT
This Agreement may not be assigned by either party without the prior written
consent of the other Party, except that PRI may assign its rights and/or
obligations hereunder to any affiliate owned or controlled by, or under common
ownership or control, or which owns or controls PRI. This Agreement shall be
binding upon and inure to the benefit of and be enforceable by the Parties
hereto and their respective heirs, legal and personal representatives, successor
and permitted assigns.
XI. NOTICES
All notices permitted or required under this Agreement shall be deemed effective
upon receipt by the Party to whom it is addressed, if made in writing and
deposited, postage prepaid in a facility for the collection of mail maintained
by the United States Post Office or if deposited with Federal Express or any
other generally recognized expedited delivery service, or if personally
delivered, or if transmitted by fax, addressed as follows:
To PRI:
Chairman
The ▇.▇. ▇▇▇▇▇▇▇ Pharmaceutical Research Institute
Welsh and ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
FAX: (▇▇▇) ▇▇▇-▇▇▇▇
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
To DepoMed:
▇▇. ▇▇▇▇ ▇. ▇▇▇▇▇
Chairman and Chief Scientific Officer
DepoMed, Inc.
▇▇▇▇ ▇ ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
FAX: (▇▇▇) ▇▇▇-▇▇▇▇
XII. GOVERNING LAW
This Agreement shall be governed by and construed in accordance with the laws of
the State of New Jersey. Caption and paragraph headings are for convenience
only and shall not form an interpretive part of this Agreement. This Agreement
shall not be strictly construed against either Party hereto.
XIII. TERMINATION
A. This Agreement may be terminated by PRI with or without cause at any
time, including but not limited to the completion of Phase I, upon thirty days
written notice to DepoMed.
B. Upon any material breach by a party to the Agreement, the other party
may terminate this Agreement by thirty days written notice to the breaching
party, specifying the material breach, default or other defect. The termination
becomes effective, at the option of the non-breaching party, at the end of the
thirty days period unless the breaching party cures the breach during the thirty
day period.
C. Upon expiration or termination of this Agreement, the provisions of
Articles I.F, V, VI, VII, VIII, IX and XII shall continue in full force and
effect, as well as any other provision herein which, by its intent or meaning,
is intended to survive such expiration or termination.
D. Any expiration or early termination of this Agreement shall not
affect the rights and obligations of the Parties accruing under this Agreement
prior to the effective date of such expiration or termination, including, but
not limited to, any rights and obligations accruing under Articles I.F, V, VI,
VII, VIII, IX and XII.
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
XIV. SEVERABILITY
The provisions of this Agreement are severable. If any item or provision of
this Agreement shall to any extent be invalid or unenforceable, the remainder of
this agreement shall not be affected thereby, and each term and provision of
this Agreement shall be valid and shall be enforced to the fullest extent
permitted by law.
XV. ENTIRE AGREEMENT
This Agreement constitutes the entire agreement between PRI and DepoMed with
respect to the subject matter hereof and supersedes any and all previous
understandings or agreements between the Parties, whether written or verbal. No
terms or provisions of this Agreement may be varied or modified by the Parties
hereto except by a written instrument specifically referring to and executed in
the same manner as this Agreement. No provision of this Agreement may be waived
by any act, omission or knowledge of a Party or its agents or employees, except
by a writing expressly waiving such provision and signed by the waiving Party.
The failure of a Party at any time or times to require performance of any
provision hereof shall in no manner affect its rights at a later time to enforce
the same. No waiver by a Party of any condition, remedy or term in any one or
more instance shall be construed as a continuing waiver of such condition,
remedy or term or any other condition, remedy or term on any successive
occasion. Any inconsistency between the terms of this Agreement and any
Appendix shall be resolved in favor of the text of this Agreement.
If this Letter Agreement correctly sets for the terms and conditions of our
agreement, please indicate the acceptance thereof by PRI in the space provided
below and return an original counterpart of this Agreement to the address first
shown above. The other original counterpart should be retained in your files.
Thank you.
Sincerely,
DepoMed, Inc.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇
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▇▇▇▇ ▇. ▇▇▇▇▇, Ph.D.
Title: Chairman and Chief Scientific Officer
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Exhibit 10.1
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CONFIDENTIAL TREATMENT REQUESTED
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
Accepted and agreed this 20th
Day of February, 1998
The ▇.▇. ▇▇▇▇▇▇▇ Pharmaceutical Research Institute,
a division of Ortho-▇▇▇▇▇▇ Pharmaceutical, Inc.
By:___________________________
Title:________________________
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APPENDIX A
THE SYMBOL "[* *]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
[* *]
