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EXHIBIT 10.1
MASTER AGREEMENT FOR TECHNOLOGY EVALUATION
This Agreement, effective as of _____________, 1996 (the "Effective
Date"), is entered into between The University of Xxxxxxxxx, Xxxxxxx Xxxx,
Xxxxxxxxx X00 0XX, Xxxxxxx ("University") and Medical Science Systems, Inc.,
0000 XxxXxxxxx Xxxx., Xxxxx 000, Xxxxxxx Xxxxx, Xxxxxxxxxx 00000 ("MSS").
RECITALS
A. The University possesses scientific expertise in genetics and other
scientific disciplines, and has laboratories and other facilities, staff and
clinical investigators for creating and developing proprietary information and
technologies in such disciplines.
B. MSS has experience in product discovery and development and
technology transfer, including evaluation of market and clinical utility of
technologies, patent and regulatory strategy, design, implementation, management
and monitoring of clinical trials, identification of and negotiation with
product development partners and the use of proprietarty research systems and
technologies supporting product discovery and development, and scientific
expertise in microbiology, periodontitis, inflammatory diseases and other
scientific disciplines.
C. The University and MSS desire to establish a joint cooperative
relationship pursuant to which various technologies can be developed and
products based thereon can be commercialized. It is expected that University
will take the lead in conducting fundamental discovery research and laboratory
development of such technologies, and MSS will take the lead in commercializing
products based upon such technologies and related product development.
D. The parties desire to establish in this Agreement a procedure
pursuant to which either party may submit ideas, inventions and proposed
products to the other for evaluation for potential joint development and
commercialization. If, based on such evaluation procedure, the parties mutually
agree to embark on a project to develop and commercialize particular
technologies and/or products, the parties will enter into a specific project
agreement defining their respective obligations and rights with respect to such
project. This Agreement is intended to define the basic structure that the
specific project agreements will take.
NOW, THEREFORE, in consideration of the foregoing premises and of the covenants
and conditions set forth herein, the parties agree as follows:
1. DEFINITIONS
1.1 "Confidential Information" consists of (i) any information
designated by a disclosing party as confidential, (ii) information contained in
or disclosed in connection with an Evaluation Proposal submitted by one of the
parties hereunder, and (iii) any non-public information relating to the product
plans, product designs, product costs, product prices, product
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* Confidential Treatment requested.
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names, finances, marketing plans, business opportunities, personnel, industry
contacts, research, development or know-how of University or MSS (as the case
may be). "Confidential Information" shall not include, however, any information
that (i) is already rightfully known to the receiving party at the time of
disclosure by the disclosing party, (ii) has become publicly known through no
wrongful act of the receiving party, (iii) has been rightfully received from a
third party authorized to make such disclosure without restriction, (iv) has
been independently developed by the receiving party or (v) has been approved for
release by written authorization of the disclosing party.
1.2 "Department" means any department at the University.
1.3 "Evaluation Proposal" means a written confidential proposal for the
potential joint development and/or commercialization of one or more Technologies
and/or one or more Products based thereon which is submitted by one party to the
other pursuant to the provisions of Section 2 below.
1.4 "Products" means commercial products based upon one or more
Technologies developed pursuant to a Project Agreement.
1.5 "Project" means a project for the joint development and/or
commercialization of one or more Technologies and/or one or more Products based
thereon that the parties mutually agree to undertake after submission and
evaluation of an Evaluation Proposal in accordance with the procedures set forth
in Section 2 below.
1.6 "Project Agreement" means a separate written agreement between the
parties that defines the precise scope of a Project and the respective
obligations and rights of the parties with respect thereto.
1.7 "SMM" means The Section of Molecular Medicine of the University's
Department of Medicine and Pharmacology.
1.8 "Summary Proposal" means a written confidential memorandum
describing the general nature and subject matter of an Evaluation Proposal that
one party proposes to submit to the other for full evaluation pursuant to the
provisions of Section 2 below.
1.9 "Technologies" means ideas, inventions, apparatus, systems, data,
discoveries, methods, processes, test procedures, diagnostic procedures,
therapeutic procedures and works of authorship.
2. SUBMISSION AND EVALUATION PROCEDURES
2.1 Notice of a Proposed Project. If MSS or any Section of the
University desires to propose a Project to the other party, it will notify the
other party of its intention, and the other party will have fourteen (14) days
to decide whether it wishes to first receive a Summary Proposal of the proposed
Project on a confidential basis. If so, the proposing party (the
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"Submitter") will then submit a Summary Proposal of the proposed Project to the
other party (the "Recipient"). The Recipient will notify the Submitter within
ten (10) business days of receipt of the Summary Proposal whether the Recipient
wishes to receive an Evaluation Proposal with respect to such Project. All
Projects submitted by or to any Section of the University hereunder will be
processed through the SMM under the supervision and direction of Professor
Xxxxxx Xxxx.
2.2 Inital Review of Evaluation Proposal. A Recipient will have a period
of one (1) month to conduct an initial review of an Evaluation Proposal for a
proposed Project submitted by the other party hereunder, during which time the
Submitter agrees to provide reasonable information regarding the proposed
Project and any Technologies associated therewith. The Recipient will notify the
Submitter on or before expiration of the initial review period whether or not it
wishes to engage in a formal evaluation of the proposed Project. If the
Recipient does not notify the Submitter of its desire to proceed with a formal
evaluation of the proposed Project, then the Recipient will be deemed to have
decided not to proceed with a formal evaluation. If the Recipient decides not to
proceed with a formal evaluation, the Submitter will be free to publish,
develop, commercialize, and submit the proposed Project to other third parties.
2.3 Formal Evaluation of a Proposed Project. If the Recipient decides to
conduct a formal evaluation of a proposed Project, it will use all good faith
and reasonable efforts to complete the evaluation as efficiently and
expeditiously as possible. Unless otherwise agreed, such formal evaluation will
be completed within three (3) months of Recipient's determination to conduct the
formal evaluation. The Submitter agrees to provide all reasonable information,
cooperation and consultation with respect to the proposed Project at its cost to
assist the Recipient's evaluation. At the conclusion of the Recipient's formal
evaluation of the proposed Project, the Recipient will notify the Submitter in
writing of its decision to accept or reject the proposed Project for further
development and/or commercialization. If the Recipient does not notify the
Submitter of its desire to proceed with the proposed Project before the
expiration of the formal evaluation period, then the Recipient will be deemed to
have decided not to proceed with the proposed Project. If the Recipient decides
not to proceed with the proposed Project, the Submitter will be free to publish,
develop, commercialize, and submit the Project to other third parties. If the
Recipient decides to proceed with the proposed Project, the parties will
negotiate in good faith a Project Agreement for the Project, and will use all
good faith reasonable efforts to enter into such a Project Agreement within two
(2) months after the Recipient's decision to proceed with the proposed Project.
The Project Agreement will incorporate at a minimum the structure and provisions
described in Section 3 below.
2.4 Exclusivity.
(a) Right of First Offer. MSS agrees that it will submit any
proposed Project with respect to which research and/or development could be
adequately performed on a timely and cost effective basis with sufficient
qualified faculty and staff within the laboratories and other facilities of The
Section of Molecular Medicine at the University under the supervision and
direction of Prof. Xxxxxx Xxxx (a "Qualified Project") to SMM first for
evaluation in accordance with the procedures of this Section 2 before offering
any such proposed Project to any other third party. SMM agrees that it will
submit any proposed Project for the commercialization of and/or
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development and marketing of Products based upon one or more Technologies
developed by SMM to MSS first for evaluation in accordance with the procedures
of this Section 2 before offering any such proposed Project to any other third
party. Notwithstanding the preceding two sentences, neither party will have an
obligation to submit any proposed Project to the other (i) which would create a
conflict of interest with a preexisting client or business partner or (ii) which
comprises or would require use of research funded by a third party, the data or
results of which the proposing party hereunder does not own or have license
rights sufficient to utilize in a Project with the other party hereunder. Each
party shall be free to determine in its sole discretion whether or not to submit
to the other party any proposed Project that is not a Qualified Project.
(b) Forbearance During the Evaluation Period. In order to provide
the Recipient sufficient incentive to devote its resources to review and
evaluation of proposed Projects, the Submitter agrees not to publish, license or
assign any Technologies associated therewith, or enter into any agreements with
third parties for the development or commercialization thereof, unless and until
the Recipient determines not to proceed with the proposed Project.
(c) Exclusivity With Respect to the Scope of the Project. Upon
mutual determination to proceed with a Project, the Project Agreement will
provide that the parties' relationship with respect to the research and
development and/or commercialization of Products within the scope of the Project
defined in the Project Agreement will be exclusive, unless otherwise mutually
agreed by the parties.
3. STRUCTURE OF PROJECT AGREEMENTS
3.1 Responsibilities and Schedule. Project responsibilities and initial
milestones will be set forth in the applicable Project Agreement.
3.2 Cost and Expenses. Costs and expenses to be incurred by the parties
in connection with their responsibilities under a Project will be allocated in
the Project Agreement on a case-by-case basis, and will be a factor in
determining the appropriate allocation of proceeds from commercialization.
Unless otherwise mutually agreed, each party will be responsible for its costs
of any travel incurred in connection with a Project, and the parties will share
the legal fees incurred in connection with a business transaction with a
commercial partner, and all legal fees and costs (including filing fees and
translation costs) associated with international patent filings and prosecution.
3.3 Research Funding. All research funding provided by third parties
relating to a Project or the results thereof will be allocated between the
parties in proportion to the allocation of responsibilities for such research.
Where allocation of responsibilities is not determinable, funds will be divided
using the same allocation as applies to proceeds from sale, license or other
disposition of Products.
3.4 Status Reports. The Project Agreement will provide for a Steering
Committee which will manage and make joint decisions for the Project. In
addition, there will be at least
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two in-person meetings between the parties regarding Project status annually,
which could be combined with or incorporate the Steering Committee meetings set
forth in any Project.
3.5 Proceeds/Net Profits of Commercialization. The distribution of
proceeds/net profits from the sale, license or other disposition of Products or
Technologies developed or commercialized under a Project Agreement will be
determined on a case-by-case basis using the following factors: (a) relative
development efforts preceding the Project Agreement; (b) anticipated research
and development responsibilities for the Project; (c) anticipated
commercialization responsibility; and (d) source and nature of original
submission. Each party will be responsible for allocation and distribution of
its portion of the proceeds to its faculty, employees or other persons or
entities to which it may be obligated, provided, however, that a Project
Agreement may provide that MSS may pay directly to [ * ] any portion
of the University's share of such proceeds/net profits to which [ * ] is
entitled. Each Project Agreement may contain a change of scope clause providing
that the distribution of the proceeds/net profits from the sale, license or
other disposition of Products or Technologies may chage in the event the scope
of one party's responsibilities under the Project change.
4. INTELLECTUAL PROPERTY
4.1 Pre-existing and Individually-Developed Technology. During the
period of evaluation of a proposed Project, each party will retain all rights in
pre-existing or independently-developed Technologies.
4.2 Ownership of Technologies and Products. Upon mutual agreement to
proceed with the Project for further development and/or commercialization, the
parties will, as part of the Project Agreement, define their respective rights
with respect to ownership and exploitation of Technologies and Products within
the scope of the Project.
4.3 Patent Prosecution and Enforcement of Intellectual Property Rights.
The Project Agreement will specify and allocate responsibility for prosecution
of patents and enforcement of intellectual property rights with respect to
Technologies and Products within the scope of the Project.
4.4 Personnel. The Project Agreement will provide that each party will
cause its respective employees, faculty, consultants and staff to execute such
agreements, assignments, applications and other documents as necessary to
perfect and protect each party's rights in the Technologies and Products within
the scope of the Project.
5. CONFIDENTIALITY
5.1 Confidential Information. Each party shall use Confidential
Information of the other solely for implementing its respective rights and
obligations under this Agreement or any Project Agreement. Neither party will
use or disclose Confidential Information of the other except as expressly
permitted under this Agreement or any Project Agreement. Any such
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Confidential Information shall be protected by the recipient from disclosure to
others with at least the same degree of care as that which is accorded to its
own proprietary information, but in no event with less than reasonable care. The
obligations of this Section 5.1 will survive for a period of five (5) years from
disclosure (or, with respect to Confidential Information relating to a Project
Agreement, the later of such time or two (2) years from termination of such
Project Agreement), notwithstanding any earlier termination or expiration of
this Agreement or any Project Agreement.
5.2 Publication.
(a) Each party recognizes that publication of research results is
an important part of the mission of the University and is important to
scientific researchers at the University and at MSS. However, the parties
acknowledge the intent of this Agreement is to maximize the commercialization
potential of Project Technologies and Products, and that publication should not
unduly interfere with that goal. Consequently, the parties agree that
publication issues will be determined mutually in good faith in recognition of
these interests. In particular, the parties will submit in advance and review
jointly proposals for publishing any information relating to any Project
Technologies or Products and determine whether in each instance publication is
in the best interests of the parties and the scope, authorship (e.g., individual
or joint) and timing of such publication. The Project Agreements may further
define procedures for the clearance of such publications with respect to any
particular Project. Neither party, nor any person who participated in the
development of Project Technologies or Products shall submit for publication,
submit abstracts of, publish or present at any academic seminar, professional
society meeting or similar event any Project Technologies or Products unless it
has complied with the provisions of this Section 5.2 and any applicable
provisions in the relevant Project Agreement.
(b) Assuming publication has been agreed to by the parties, all
publications and presentations at meetings will, unless otherwise agreed in a
particular Project Agreement, comply with the following procedures. All persons
wishing to publish an article shall provide to a designated person of the other
party advance copies of all abstracts and articles proposed to be submitted for
publication at least ninety (90) days prior to intended publication or
disclosure. For presentations at meetings where written papers will not be
available, the person intending to make such presentation will inform a
designated person of the other party of such intent and the contents of the
intended presentation in writing at least ninety (90) days prior to the
presentation. Each party will use its reasonable best efforts to review such
information within thirty (30) days after submission to the designated person of
such party and provide the person intending to make such publication or
disclosure comments on such disclosure based on the protection of intellectual
property rights in the information to be published or disclosed and the
maximization of commercialization potential of Project Technologies and
Products. The parties will agree in good faith on appropriate modifications, if
any, to be made. In addition, each party will use its reasonable best efforts to
cooperate with the other in the filing of any patent applications prior to the
date of actual publication or disclosure. Each party will ensure that its
faculty, staff, students, employees and consultants comply with the requirements
of this Section 5.2
6. TERM AND TERMINATION
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6.1 Term. This Agreement will continue in effect for a period of ten
(10) years from the Effective Date, unless terminated earlier in accordance with
this section.
6.2 Termination for Cause. Either party may terminate this Agreement
upon written notice in the event: (a) the other party breaches a material term
of the Agreement, and fails to cure such breach within thirty (30) days
following notice of such breach from the non-breaching party; or (b) the other
party ceases to do business in the ordinary course, or files or has filed
against it a petition for bankruptcy, and such petition is not dismissed within
sixty (60) days of filing.
6.3 Termination Without Cause. Either party may terminate this Agreement
at any time with or without cause on not less than six (6) months notice. Such
termination, however, shall not apply to, and the Agreement will continue with
respect to, any proposed Projects which are, as of the effective date of
termination, under review or evaluation or approved for development and/or
commercialization.
6.4 Effect of Termination. In the event of any expiration or termination
of this Agreement, each party shall retain all of its rights in pre-existing or
independently developed Technologies not yet subject to a Project Agreement.
Rights with respect to Technologies and/or Products that are the subject of a
Project Agreement shall survive as provided in the applicable Project Agreement.
Termination or expiration of this Agreement will not affect the continued
enforceability of any Project Agreement or any rights governing Technologies
and/or Products subject to such Project Agreement. The provisions of Sections
5.1, 6.4, 7 and 8 of this Agreement will survive any termination or expiration.
7. DISCLAIMERS OF WARRANTY AND LIABILITY
7.1 Disclaimer of Warranties. EXCEPT AS EXPRESSLY SET FORTH IN A PROJECT
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY, EXPRESS OR IMPLIED, RELATING TO
THIS AGREEMENT, ANY PROJECT AGREEMENT OR ANY TECHNOLOGIES OR PRODUCTS, INCLUDING
BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON-INFRINGEMENT.
7.2 Limitation of Liability. EXCEPT FOR ANY WILLFUL BREACH OF SECTION 5,
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT, SPECIAL,
CONSEQUENTIAL OR INCIDENTAL DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY, ARISING OUT OF THIS AGREEMENT OR ANY PROJECT AGREEMENT.
8. GENERAL PROVISIONS
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8.1 Governing Law. This Agreement and any Project Agreement will be
governed by and construed in accordance with the substantive laws of the United
States and the State of California, without regard to or application of choice
of law rules or principles.
8.2 Waiver and Modification. Failure by either party to enforce any
provision of this Agreement or any Project Agreement will not be deemed a waiver
of future enforcement of that or any other provision. Any waiver, amendment or
other modification of any provision of this Agreement or any Project Agreement
will be effective only if in writing and signed by the parties.
8.3 Severability. If for any reason a court of competent jurisdiction
finds any provision or portion of this Agreement or any Project Agreement to be
unenforceable, that provision of the Agreement or Project Agreement will be
enforced to the maximum extent permissible so as to effect the intent of the
parties, and the remainder of this Agreement or Project Agreement will continue
in full force and effect.
8.4 Notices. All notices required or permitted under this Agreement or
any Project Agreement will be in writing, will reference this Agreement or
Project Agreement and will be deemed given: (i) when sent by confirmed
facsimile; (ii) ten (10) working days after having been sent by registered or
certified mail, return receipt requested, postage prepaid; or (iii) five (5)
working day after deposit with a commercial overnight carrier, with written
verification of receipt. All communications will be sent to the addresses set
forth below or to such other address as may be designated by a party by giving
written notice to the other party pursuant to this section:
To MSS:
Xxxx X. Xxxxx
President and CEO
Medical Science Systems, Inc.
0000 XxXxxxxx Xxxx., Xxxxx 000
Xxxxxxx Xxxxx, XX 00000
U.S.A.
To the University:
[ * ]
with a copy to:
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[ * ]
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[ * ]
8.5 Delays Beyond Control. Neither party will be liable to the other
party for any failure or delay in performance caused by reasons beyond such
party's reasonable control, and such failure or delay will not constitute a
material breach of this Agreement or any Project Agreement.
8.6 Assignment. Neither party may assign its rights or obligations
hereunder or under any Project Agreement, by operation of law or otherwise,
without express written consent of the other party, which consent will not be
unreasonably withheld. Any attempted assignment without such consent shall be
void. Subject to the foregoing, this Agreement and any Project Agreement will
benefit and bind the successors and assigns of the parties.
8.7 No Third Party Beneficiaries; No Agency. Except as expressly
provided herein to the contrary, no provision of this Agreement or any Project
Agreement, express or implied, is intended or will be construed to confer
rights, remedies or other benefits to any third party under or by reason of this
Agreement or any Project Agreement. This Agreement or any Project Agreement will
not be construed as creating an agency, partnership or any other form of legal
association (other than as expressly set forth herein) between the parties.
8.8 Entire Agreement. This Agreement, including all exhibits,
constitutes the entire agreement between the parties with respect to the subject
matter hereof, and supersedes and replaces all prior or contemporaneous
understandings or agreements, written or oral, regarding such subject matter.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement through
their duly authorized representatives as set forth below.
THE UNIVERSITY OF SHEFFIELD MEDICAL SCIENCE SYSTEMS, INC.
By: By:
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Printed Name: Printed Name:
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Title: Title:
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