Exhibit 10.3
REGISTRY DEVELOPMENT AGREEMENT
THIS AGREEMENT is entered into on February 3, 1997 (the "Effective Date"),
by and between SUMMIT MEDICAL SYSTEMS, INC., a Minnesota corporation whose
principal office is located at 10900 Red Circle Drive, Suite 100, Minnetonka,
Minnesota 55434-1906 ("Summit") and ELI LILLY AND COMPANY, an Indiana
corporation whose principal office is located at Lilly Corporate Center,
Indianapolis, Indiana 46285 ("Lilly").
RECITALS
A. Summit designs, develops and markets clinical outcomes database
software products and collects, aggregates, reports and manages national
database programs for providers, manufacturers and medical societies within the
healthcare industry.
B. Lilly is a research-based corporation that develops, manufactures
and/or markets pharmaceuticals.
C. Summit desires to develop, manage and provide ongoing support for an
atherosclerosis revascularization therapies outcomes registry ("ART Registry"),
more fully described below, which will supply health care providers with
clinical data and which will supply Lilly with timely information, data analysis
and reporting regarding interventional cardiology procedures and outcomes.
D. Lilly desires to sponsor the development of a ReoPro/(R)/ outcomes
database ("ROD") as part of the ART Registry, and Summit so agrees, subject to
the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing and for other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties agree as follows:
1. DEFINITIONS
For purposes of this Agreement, the following words, terms and phrases
shall have the following meanings:
1.1 "Adverse Event" means any serious and unexpected event possibly
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related to the use of ReoPro and reportable under 21 CFR (S) 314.
1.2 "Advisory Team" means a panel of up to ten (10) physicians, nurses
and/or payor representatives selected by Lilly, who will meet periodically
during the term of this Agreement to advise the parties on issues related to the
development of ROD and its functionality.
1.3 "ART Registry" means the compilation of data related to interventional
cardiology, including certain portions of the ReoPro Outcomes Database, Summit
Software and other data collected by Summit from third parties during the Pilot
Project.
1.4 "Development Schedule" means the Development Schedule attached hereto
as Exhibit A.
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1.5 "Participant" means any end-user licensee of the Summit Software
pursuant to a Participant Agreement, who is participating in the Pilot Project.
1.6 "Participant's Data" means a Participant's own specific patient data
submitted to ROD.
1.7 "Participation Agreement" means a written agreement (in a form
substantially similar to the agreement attached hereto as Exhibit B) between
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Summit and a Participant that provides for the licensing of the Summit Software
and the Participant's participation in the Pilot Project.
1.8 "Pilot Project" means the project to design and implement ROD at ten
(10) sites, as more fully described in Section 3 below.
1.9 "Proprietary Information" means such information which is disclosed by
one party to the other orally, electronically, visually or in a document or
other tangible form, which is either identified as or should reasonably be
understood in the circumstances of its disclosure to be confidential and/or
proprietary. Proprietary Information may include the property of third parties.
1.10 "ReoPro Outcomes Database" or "ROD" means the outcomes database
developed through the Pilot Project that contains specific data elements related
to ReoPro and its use in a clinical setting and other data pertaining to
interventional cardiology procedures of a Participant whether or not ReoPro was
administered.
1.11 "Reports" means all reports distributed or made available to Lilly by
Summit, which consist of data and analysis of data from the ART Registry and
ROD.
1.12 "Summit Databases" means any and all databases developed by or for
Summit prior to, during or after the term of this Agreement, excluding ROD.
1.13 "Summit Software" means all software, algorithms, interfaces,
documentation and other materials created by Summit or its affiliated companies
prior to the Effective Date or pursuant to this Agreement, which will be used to
collect, aggregate and harvest Participant's Data, including, but not limited
to, the Crescendo! software product that is proprietary to Summit.
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1.14 "Web Site" means a specific location(s) on the World Wide Web that
Participants and the parties will be able to access in order to participate in
the Pilot Project.
2. DEVELOPMENT OF ROD
2.1 Purpose. ROD will be designed to accomplish the following three major
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objectives: (a) provide a neutral, respected outcomes database that offers
timely information, comprehensive data analysis and timely reports to
Participants and Lilly about interventional cardiology procedures and outcomes
with a focus on the clinical use of ReoPro in a clinical setting; and (b)
provide a flexible system that permits Participant's Data to be entered through
the Web Site on-line either manually or through a download from other standard
data collection systems of a Participant, such as hemodynamic equipment.
2.2 Development of ROD and Summit Software. Summit will create ROD as a
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sub-database of the ART Registry and any Summit Software necessary to implement
ROD at the Participants' sites. Lilly and the Advisory Team shall identify the
specific data elements required to be included in ROD and Summit shall ensure
the proper systems are in place to permit the collection and processing of those
data elements. Changes to data elements of ROD during the Pilot Project shall
be made only upon the mutual agreement of Lilly and Summit, which agreement
shall not be unreasonably withheld by either party. Summit will develop the
Summit Software as required hereunder to enable the Participants to input
Participant's Data into ROD.
2.3 Development of Web Site. Summit will create, with design input from
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Lilly and the Advisory Team, the Web Site. The Web Site will be stored at
Summit's facilities and Summit shall establish and register its domain name.
Summit shall own all right, title and interest, including copyrights, in and to
the Web Site.
2.4 Collection and Security of Participant's Data. Collection of the
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Participant's Data to be included in ROD from Participants will be done on-line
through the Web Site, using the Summit Software. Summit will use commercially
reasonably efforts to ensure the confidentiality of all data collected through
the Web Site by use of digital signatures and encryption software. Summit will
maintain ROD at its facilities, and will use commercially reasonably efforts to
ensure that ROD is held at the C2 security level required for all secure
government systems. The parties acknowledge that the level of security Summit
can implement may be restricted by applicable export restrictions of the United
States.
2.5 Data Harvests and Reports. The data contained in ROD will be
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harvested on a monthly basis and analyzed by Summit to produce the Reports,
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which will be distributed in a timely manner to Lilly, but at least monthly.
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Summit and Lilly will define, with assistance from the Advisory Team as
described herein, the format, layout and required content for the Reports.
Lilly and the Advisory Team will work with Summit to identify the specific data
and required analysis to be included in the Reports. In addition, at Lilly's
request, Summit will prepare or have prepared any special reports containing
multi-variable regression data analysis or other advanced analysis and reporting
not provided for in the Reports ("Special Reports"). Special Reports may be
prepared at additional expense to Lilly, charged at Summit's then current fees.
All Lilly Reports shall be provided in a non-editable format, such as Adobe
Acrobat, as well as in Word for Windows format. Additionally, for audit and
documentation purposes, Summit shall be able to demonstrate how any analysis was
produced and the source of the information contained in that analysis (e.g.,
source datasets and programs used to produce the analysis); provided however,
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Summit shall not be required to provide any proprietary information of a third
party (e.g. proprietary algorithms). Summit must be able to demonstrate that
reporting programs have undergone testing to ensure accurate output from the
programs. Other reports pertinent to Participants' sites will be generated for
Participants, as provided in the Participation Agreement. Standard reports,
those which do not fall within the above definition of a Special Report, shall
be prepared for Participants on a monthly basis at no additional cost to Lilly
or Participants. Special Reports requested by Participants shall be prepared
only upon approval by Lilly and at the expense of the requesting Participant.
2.6 Adverse Event Reporting. Summit will design ROD to include an Adverse
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Event reporting system reasonably acceptable to Lilly, that provides Lilly
notification of Adverse Events related to ReoPro within forty-eight (48) hours
after such event is entered in ROD by a Participant. Summit shall contractually
obligate through the Participation Agreement and train the Participants to
immediately report to Summit all Adverse Events including, without limitation,
(i) those which involve Subject deaths, (ii) those which involve non-elective
hospitalization or extension of hospitalization of Subjects, (iii) those which
are life threatening, (iv) those which are permanently disabling, (v) a
congenital abnormality, (vi) cancer, and (vii) a drug overdose. Summit shall
capture such Adverse Events as part of ROD. Additionally, Summit shall notify
Lilly of any and all Adverse Events which meet the referenced criteria above, by
(1) telephone, immediately upon first receiving notification; and (2) facsimile,
including all relevant available data, within forty-eight (48) hours of first
receiving notification. Notwithstanding the foregoing, this reporting system
will not, and is not intended to, be a substitute for any required reporting of
Adverse Events to governmental agencies by Lilly or the Participants, and Summit
shall not assume any such responsibility on behalf of Lilly or any third party
by including the reporting system in ROD.
2.7 Use of Names and Trademarks. Neither party shall use the names and/or
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trademarks of the other party for any purpose, including, without limitation,
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advertising, press releases, or third party communication, without prior written
approval, unless otherwise agreed in writing. Summit shall be entitled to
identify Lilly as a client in client lists.
3. PILOT PROJECT
3.1 Scope. The Pilot Project will provide for the development and
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implementation of ROD in accordance with the Development Schedule. A total of
ten (10) Participants located in the U.S. will be involved in the Pilot Project.
All Participants in the Pilot Project will be selected by mutual agreement of
Summit and Lilly, with input from the Advisory Team.
3.2 Duration. The Pilot Project will begin on the Effective Date and
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shall continue until (****) of ROD data from ten (10) Participants, whichever is
later. Notwithstanding the duration of the Pilot Project, the parties shall meet
during 1997 to evaluate the possible expansion and/or continuation of ROD beyond
the term of this Agreement, under separate terms and conditions to be agreed
upon.
3.3 Fees. As compensation for the Pilot Project, Lilly shall pay to
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Summit a total fee, including, without limitation, out-of-pocket and travel
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expenses (except as otherwise expressly provided herein), of Four Hundred
Thousand Dollars ($400,000.00) in accordance with the payment schedule attached
hereto as Exhibit C.
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4. USE OF DATA AND OWNERSHIP
4.1 Ownership of Databases. Summit shall own all right, title and
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interest, including the copyrights, in and to the ART Registry, except that
portion related to ROD. Subject to the license granted to Summit in Section 4.2
below, Lilly shall own all right, title and interest, including copyrights, in
and to ROD.
4.2 Use of Certain ROD Data by Summit. Lilly hereby grants to Summit a
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perpetual, nonexclusive royalty-free worldwide license to use, copy, distribute
and publicly display the non-ReoPro-specific data contained within ROD into the
ART Registry and any other Summit Databases at Summit's discretion. Upon
completion of the design of ROD during the Pilot Project, the parties shall
negotiate in good faith which, if any, data elements of ROD are ReoPro-specific
and, therefore, not subject to the foregoing license.
4.3 Publication Rights. Summit and its affiliated companies shall have no
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right to publish the findings related to ReoPro and its use that result from
ROD, without the prior written permission of Lilly.
**** Confidential Treatment Requested
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5. ADDITIONAL RESPONSIBILITIES OF SUMMIT
5.1 Licensing and Installation of Summit Software. For the Participants
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in the Pilot Project, Summit shall, at no charge to the Participant, (a) license
the Summit Software to such Participants for their use in accordance with the
terms of the applicable Participation Agreement, and (b) install the Summit
Software at such Participants' locations.
5.2 Participation Agreements. Upon initial agreement between Lilly and
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Summit concerning the identity of the Participants, Summit shall enter into a
written Participation Agreement with each site which is substantially similar in
content to the template agreement attached hereto as Exhibit D.
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5.3 Training. During the Pilot Project, Summit shall provide, at no cost
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to a Participant, training in the use of the Registry for designated employees
of Participant at one (1) location of such Participant. In addition, Summit
shall also provide training in the use of the Registry to designated Lilly
representatives at one (1) location mutually selected by Summit and Lilly, at no
cost to Lilly except the travel expenses of its representatives. If requested
by Lilly, additional training during the Pilot Project will be provided to
Participants and to Lilly representatives at the cost of (****) per person
trained, plus travel expenses.
5.4 Ongoing Support. Summit shall maintain a toll-free number at its
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principal place of business for the purpose of servicing Participants and Lilly.
Summit will provide dedicated personnel experienced in the operation of ROD and
the ART Registry to answer questions regarding its use from 8:00 a.m. until 6:00
p.m. (Central Time) on weekdays, excluding any holidays.
5.5 Meetings. If requested by Lilly, Summit shall participate in bi-
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weekly meetings and/or telephone conferences with Lilly to discuss the status,
progress and interim results of the Pilot Project.
5.6 Data Processing Activities by Summit.
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(a) Data Collection and Entry. Summit shall create ROD and any
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corresponding entry, editing and processing system ("System") for the Pilot
Project in a manner that follows a documented methodology that incorporates
the concepts of computer system validation. This methodology should
include:
(1) a system of change control for both software and data;
**** Confidential Treatment Requested
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(2) development of appropriate hardware and software security
measures to ensure the integrity and accuracy of the system data and
software;
(3) a testing process that ensures the system's ability to meet
the pre-defined system requirements;
(4) a process for creation of key systems documentation,
including:
(i) a system validation plan;
(ii) system requirements and specifications listings;
(iii)system logical and physical design documents;
(iv) system testing documentation and test results;
(v) system backup and recovery and business continuity
plans;
(vi) user's and operator's guides or manuals;
(vii)relevant systems training documentation for both
software users and systems support personnel;
(5) a process for retaining the critical systems records and
documentation, listed in 5.6(a)(4) above; and
(6) a review and approval process for systems development
activities, system acceptance, and ongoing systems reviews.
Summit shall not subcontract any aspect of the development of the System
without the knowledge and consent of Lilly. Summit shall also allow a review of
any and all of the above-mentioned documentation by representatives from Lilly
or applicable regulatory authorities.
(b) Archiving. Summit shall archive all data and evidence of its
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conformance to each of the above systems requirements for fifteen (15)
years after completion or termination of the Pilot Project.
6. ADDITIONAL RESPONSIBILITIES OF LILLY
6.1 Creation of Advisory Team. Lilly shall coordinate an Advisory Team
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for the Pilot Project and shall determine the size, and the appointment of
individuals to, the Advisory Team, with input from Summit. Unless the parties
agree otherwise, Lilly shall cause the Advisory Team to meet as needed during
the term of this Agreement to provide input into the development and composition
of ROD, and to evaluate the performance of the ROD. The costs associated with
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the formation and meetings of the Advisory Team, including, but not limited to
honorariums, travel expenses and the like, shall be borne by Lilly.
7. RESPONSIBILITIES OF PARTICIPANTS
7.1 Site Preparation and Maintenance. Participants shall be responsible
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for preparing and maintaining their locations for installation of the Summit
Software, including dedicated phone lines, communication links and third party
software. Participants shall also be required to do minimal, routine systems
maintenance on those systems on which the Summit Software is installed.
7.2 Data Entry. Participants shall be responsible for entering, and
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verifying the accuracy of, their Participant's Data entered into ROD via the Web
Site. Intra and/or inter field validation will be incorporated into the Summit
Software by Summit to facilitate this process.
7.3 Feedback. Participants involved in the Pilot Project shall be
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required to participate in user group meetings and to provide ongoing feedback
to Summit regarding ROD and the ART Registry, its functionality, implementation
and training.
7.4 Required Consents. Summit shall include in the Participation
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Agreement a contractual requirement that Participants (i) obtain all consents
required by law from its patients to enable the data related to such patients to
be included in and used in ROD and the ART Registry, and (ii) indemnify and hold
harmless Summit and Lilly from any failure by Participants to do so.
8. CONFIDENTIALITY
8.1 Non-Disclosure of Data. Except as otherwise provided in Section 4,
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Summit will hold and maintain as confidential and shall not disclose to third
parties the actual data contained in ROD or the Reports, and will protect such
data from use for any purpose other than the design, development, implementation
and maintenance of ROD and the Reports as contemplated hereunder or as expressly
permitted in this Agreement. ROD will be maintained in an access-controlled
computer system, with access limited to employees or agents of Summit who are
directly involved in the management and/or analysis of the data contained
therein.
8.2 Non-Disclosure of Summit Software. Lilly shall not, during the term
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of this Agreement or after termination hereof for any reason, disclose or
directly or indirectly make available to any third party the Summit Software,
without Summit's express prior written approval, and shall not use such Summit
Software except as expressly contemplated hereunder. Lilly shall maintain in
confidence the
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Summit Software by using at least the same physical and other security measures
as are used for its own confidential proprietary information and documentation.
8.3 Non-Use and Non-Disclosure of Proprietary Information. In addition to
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the parties' respective obligations under Sections 8.1 and 8.2, all Proprietary
Information shall be deemed confidential and proprietary to the party disclosing
such information hereunder. Each party may use the Proprietary Information of
the other party during the term of this Agreement only as permitted or required
for the receiving party's performance hereunder. The receiving party shall not
disclose or provide any Proprietary Information to any third party and shall
take reasonable measures to prevent any unauthorized disclosure by its
employees, agents, contractors or consultants during the term hereof including
appropriate individual nondisclosure agreements. All software, algorithms,
interfaces, protocols and other information related to the collection of data
via the Internet, and the development, design, and implementation of databases
or registries (such as the ART Registry), or the like, shall be Proprietary
Information of Summit; provided, however, that Lilly shall have the right to use
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such Proprietary Information for Lilly or its affiliates' research purposes.
8.4 Exclusions. The following shall not be considered Proprietary
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Information for purposes of this Agreement:
(a) Information which is or becomes in the public domain through no
fault or act of the receiving party;
(b) Information which was independently developed by the receiving
party without the use of or reliance on the disclosing party's Proprietary
Information;
(c) Information which was provided to receiving party by a third party
under no duty of confidentiality to the disclosing party; or
(d) Information which is required to be disclosed by law, provided,
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however, prompt prior notice thereof shall be given to the party whose
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Proprietary Information is involved.
8.5 Survival. Except as otherwise indicated, the provisions of this
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Section 8 shall survive any termination of this Agreement.
9. INVENTIONS
If as a result of the Pilot Project, Summit conceives or actually reduces
to practice any new invention or use involving ReoPro, Summit will promptly
notify Lilly, and such new invention or use shall be the sole property of and
shall be
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assigned to Lilly. Notwithstanding the foregoing, Lilly shall not own any
rights, and hereby assigns to Summit all rights (including copyrights) it may
have, in any computer software, algorithms, interfaces, protocols, information
related to development of databases, registries (i.e. the ART Registry) or the
collection of data via the Internet, or the like, developed in connection with
the Pilot Project whether by Summit alone or in conjunction with Lilly or any
other party, and all such inventions and information shall be owned by Summit;
provided, however, that Lilly shall have a right to use such inventions or
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information for Lilly or its affiliates' research purposes.
10. INDEMNIFICATION
Summit shall indemnity, defend and hold harmless Lilly from and against
loss, damage, cost and expense of claims and suits (including reasonable
attorneys fees) resulting from the provision, use or application of information
to or from ROD or the ART Registry by Participants and/or Summit. Summit's
obligations of indemnification shall not extend to any loss, damage or expense
arising from the misconduct by Lilly. Lilly shall indemnify, defend and hold
Summit harmless from and against any and all Claims resulting from or arising
out of the use or inclusion of data, or the release of such data from ROD or the
ART Registry by Lilly, provided that such Claim results from or arises solely
from Lilly's willful misconduct.
11. WARRANTIES AND LIMITATION OF LIABILITY
11.1 Warranties.
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(a) Use and Development. Summit will warrant the Summit Software to
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Participants in accordance with Summit's then standard end user warranties.
Summit also warrants to Lilly that the Summit Software and ROD shall be
developed and implemented in accordance with prevailing professional
standards and using current state-of-the-art technology and security
systems.
(b) Rights. Summit represents and warrants that it has the right to
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grant Participants a license to use the Summit Software as set forth in
this Agreement without violating the rights of any third party, and there
is no actual or, to the best of its knowledge, threatened suit by any such
third party based on alleged violation of such rights by Summit. To the
extent Summit incorporates third party software into the Summit Software,
Summit shall have obtained the rights from those third parties to vest in
or grant to Participants the various license rights necessary under this
Agreement.
(c) Media. Summit represents and warrants that any media upon which
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the Summit Software is delivered to Participants shall be free from all
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defects) provided that the sole remedy for any defective media shall be
that it is promptly replaced by Summit at no expense to Lilly or
Participants.
(d) Content of the Summit Software. Summit represents and warrants to
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Lilly that all delivered components of the Summit Software will be the
latest available releases, and that future releases and engineering changes
to the Summit Software or its components will not degrade performance or
remove functionality. Summit represents and warrants that the Summit
Software as delivered to Participants neither contains nor shall contain
any "Disabling Code," "Unauthorized Code," or "Marketing Code." As used in
this paragraph the term "Disabling Code" means any code, routine, or
procedure that has the effect of terminating or disabling execution of the
Summit Software. As used in this paragraph, the term "Unauthorized Code"
means any virus, Trojan horse, worm, or other code, routine, or procedure
that (i) permits unauthorized access to data, software, or systems; or (ii)
disables, erases, or otherwise damages software, hardware, or data. As
used in this paragraph, "Marketing Code" means any code, routine, or
procedure not expressly authorized by Lilly that has the effect of
promoting or advertising any goods or services of Summit or other third
parties; provided however, that Internet hyperlinks shall not be deemed MC.
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11.2 Disclaimer of Warranties. EXCEPT AS PROVIDED IN SECTION 11.1, SUMMIT
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MAKES NO WARRANTIES OF ANY KIND WHATSOEVER WITH RESPECT TO THE SUMMIT SOFTWARE
OR THE ART REGISTRY, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. SUMMIT
DOES NOT WARRANT THAT OPERATION OF THE SUMMIT SOFTWARE OR THE ART REGISTRY WILL
BE UNINTERRUPTED OR ERROR- FREE.
11.3 Limitation on Liability. IN NO EVENT SHALL SUMMIT OR LILLY BE LIABLE
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FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES UNDER THIS
AGREEMENT, INCLUDING LOSS OF PROFITS, REVENUE, DATA, OR USE, INCURRED BY THE
OTHER PARTY OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR TORT OR
BASED ON A WARRANTY, WHETHER OR NOT THE OTHER PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
11.4 Survival. The provisions of this Section 11 will survive any
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termination of this Agreement.
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12. TERMINATION
12.1 Method of Termination. Lilly may terminate this Agreement at any time
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upon (****) written notice to Summit. Summit may terminate this Agreement in the
event Lilly:
(a) files a petition of any type as to its bankruptcy, is declared
bankrupt, becomes insolvent, makes an assignment for the benefit of
creditors, goes into liquidation or receivership, or otherwise loses legal
control of its business involuntarily, effective immediately upon written
notice to the bankruptcy party; or
(b) is in material breach of this Agreement and has failed to cure
such breach within thirty (30) days of receipt of written notice thereof
from Summit.
12.2 Effect of Termination. In the event of termination or expiration of
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this Agreement for reasons other than breach by Summit, (****). Additionally,
within thirty (30) days of the effective date of termination, Summit shall
deliver to Lilly a complete copy of the ReoPro-specific data in ROD in an ASCII
comma delimited data file format suitable for processing under commercially
reasonable standards with other (non-Summit) commercially available database
software with relevant open standards for database creation (so that the data is
susceptible of query) plus a human-readable copy of the same.
12.3 Survival. The parties' respective rights and obligations under
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Sections 4 [Use of Data and Ownership], 8 [Confidentiality], 11 [Summit's
Warranties], 13 [Dispute Resolution] and 14 [Miscellaneous] shall survive
termination or expiration of this Agreement.
13. DISPUTE RESOLUTION
13.1 Dispute Resolution. Summit and Lilly shall each use its best efforts
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to resolve any dispute between them promptly and amicably and without resort to
any legal process if feasible within thirty (30) days of receipt of a written
notice by one party to the other party of the existence of such dispute. No
further action may be taken under this Section 13 unless and until authorized
representatives of Summit and Lilly have met in good faith to discuss and settle
such dispute. The foregoing requirement in this Section 13.1 shall be without
prejudice to either party's rights, if applicable, to terminate this Agreement
under Section 12 above.
**** Confidential Treatment Requested
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13.2 Litigation Rights Reserved. If any dispute arises with regard to the
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unauthorized use, disclosure or infringement of Proprietary Information by the
either party, the other party may seek any available remedy at law or in equity
from a court of competent jurisdiction.
14. MISCELLANEOUS
14.1 Notices. All notice and demands of any kind or nature which either
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party to this Agreement may be required or may desire to serve upon the other in
connection with this Agreement will be in writing and may be served personally,
by registered or United States mail, or by overnight courier (e.g., Federal
Express or DHL) to the following addresses:
If to Summit: Kevin R. Green
President and Chief Executive Officer
Summit Medical Systems, Inc.
10900 Red Circle Drive, Suite 100,
Minnetonka, Minnesota 55434-1906
with a copy to: Nelson Dong, Esq.
Dorsey & Whitney
220 South Sixth Street
Minneapolis, Minnesota 55402
If to Lilly: Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
Attention: Lee Bowman
Neal Fowler
Service of such notice or demand so made will be deemed complete on the day
of the actual delivery. Any party hereto may, from time to time, by notice in
writing served upon the other party as aforesaid, designate a different mailing
address or a different person to which all further notices or demands will
thereafter be addressed.
14.2 Headings. The headings of the various Sections hereof are intended
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solely for the convenience of reference and are not intended for any purpose
whatsoever to explain, modify, or place any construction upon any of the
provisions of this Agreement.
14.3 Assignment. This Agreement may not be assigned by either party
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without the express written approval of the other party; provided, however, that
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Summit may assign its rights or obligations hereunder without such consent to
any
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affiliated company or in the event of a merger, acquisition or sale of
substantially all of its assets.
14.4 Relationship of Parties. The relationship of the parties to this
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Agreement is that of independent contractors and not that of a master and
servant, principal and agent, employer and employee, or partners or joint
venturers.
14.5 Counterparts. This Agreement may be executed in one or more
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counterparts, each which will be deemed an original and all of which taken
together will constitute one and the same instrument.
14.6 Waiver. A waiver, by either party to this Agreement, of any of its
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items or conditions in any one instance will not be deemed or construed to be a
general waiver of such term or condition or a waiver of any subsequent breach.
14.7 Severability. All provisions of this Agreement are severable. If any
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provision or portion hereof is determined to be unenforceable by a court of
competent jurisdiction, then the rest of the Agreement will remain in full
effect, provided that its general purposes remain reasonably capable of being
effected.
14.8 Entire Agreement, Amendments. This Agreement constitutes the entire
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agreement of the parties with respect to the subject matter hereof and
supersedes all proposals, oral or written, and all negotiations, conversations,
discussions, or agreements heretofore between the parties. No modification or
amendment of this Agreement shall be effective unless in writing duly executed
by both parties and indicating on its face that it is intended to be an
amendment to this Agreement.
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement on
the Effective Date.
ELI LILLY AND COMPANY SUMMIT MEDICAL SYSTEMS, INC.
By: /s/Alan S. Clark By:/s/Dave Teckman
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Alan S. Clark, Dave Teckman,
President Vice President
U.S. Operations Sales and Marketing
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EXHIBIT A
DEVELOPMENT SCHEDULE
FOR THE PILOT PROJECT
Target Date Benchmark
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(****) Establish the Advisory Team (Lilly, with input from Summit)
(****) Design the ReoPro Outcomes Database and Web Site
(****) Design the Adverse Event Reporting Mechanism into the Registry
(****) Implement the ART Registry at the locations of the 10
Participants in the Pilot Project
(****) Complete the training program for the Participants in the
Pilot Project and appropriate Lilly representatives
(****) Aggregate the Participant's Data into the Registry
(****) Provide Reports on a monthly basis
(****) Identify additional reports desired upon completion of the
Pilot Project
**** Confidential Treatment Requested
EXHIBIT B
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REOPRO OUTCOME DATABASE
PARTICIPATION AGREEMENT
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DATABASE:
THIS AGREEMENT is effective as of the ____day of _________________, 199__
by and between SUMMIT MEDICAL SYSTEMS, INC., a Minnesota corporation with its
principal place of business at 10900 Red Circle Drive, Minnetonka, MN 55343-9106
("Summit") and ______________ ("Participant") an individual cardiologist or
group of cardiologists whose members are identified in Schedule A of the Summit
License Agreement between Summit and Participant, dated ____________ ("License
Agreement") and whose business address is at: __________________________________
IT IS AGREED:
1. Participation.
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1.1 Participant hereby agrees to participate in the ReoPro Outcomes
Database ("ROD") sponsored by Eli Lilly and Company ("Lilly") in accordance with
this Agreement. Unless otherwise provided in the License Agreement, Participant
will provide Summit with the Patient Information required for the ROD via the
Summit Web Site on a monthly basis. Participant will use reasonable efforts to
ensure that data is entered into ROD within 30 days of a patients' procedure or
visit PARTICIPANT WARRANTS THAT ALL PATENT INFORMATION SHALL BE ACCURATE AND
COMPLETE, AND THAT PARTICIPANT HAS RECEIVED ALL PERMISSIONS OR LICENSES REQUIRED
IN ORDER FOR SUMMIT TO USE SUCH PATIENT INFORMATION AS PROVIDED IN THIS
AGREEMENT AND TO SUPPLY AGGREGATE DATABASE REPORTS FROM ROD TO LILLY AND/OR
THIRD PARTIES. PARTICIPANT FURTHER WARRANTS THAT DATA PERTAINING TO ADVERSE
EVENTS WILL BE PROVIDED AS OUTLINED IN SECTION 2 OF THIS AGREEMENT. Any Data
Collection Forms provided in conjunction with ROD shall be used by Participant
only for collecting the Patient Information.
1.2. Summit will collect Participant's Patient Information on-line through
the Summit Web Site, using Summit Software. Summit will use commercially
reasonable efforts to ensure the confidentiality of the Participant's Patient
Information collected through the Web Site, and ensure that such individual data
are held at the C2 security level required for all government systems, by use of
digital signatures, and encryption software as commercially reasonable under
burdens imposed by applicable governmental export licensing restrictions.
1.3 Summit will review the Patient Information received from Participant
for completeness by performing key field data analyses. If Summit reasonably
concludes that the Patient Information is incomplete, then Summit shall request
additional data, and Participant shall provide the data to Summit within fifteen
(15) days. If Participant does not supply complete Patient Information for any
three consecutive calendar months, then Summit may withhold any and all reports
to which Participant is otherwise entitled pursuant to this Paragraph 4, and may
terminate this Agreement as provided in Paragraph 5. Upon Summit's receipt of
complete Patient Information, it shall merge that information into ROD, as
applicable.
1.4 Summit will provide the Participant with standard reports from ROD on
a monthly basis. The Participant agrees to use these reports and the aggregate
data from ROD only for Participant's internal purposes, unless Participant
receives Summit's prior written consent to otherwise use such data. Special
reports including multi-variable regression analysis not included in the
standard report package may be purchased by the Participant.
1.5 Participant understands and agrees that Participant's data in
aggregate are being collected as part of larger databases which shall be owned
by Summit and/or Lilly and used by any or all of the following: Summit, Lilly,
third parties or other Participants for the study of cardiology and/or cardiac
surgery.
2. Adverse Event Reporting. ROD and the collection of data for ROD is a
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prospective data collection project. Treatment and care of patients are within
the sole control and discretion of the investigator/physician. Accordingly when
addressing safety concerns, if any, that arise during the collection of data for
ROD, Participants and other physicians should use whatever methods of care are
usual and customary in their practices. The collection of data for ROD is not
intended to in any way affect or interfere with the Participant's/physician's
standard treatment or care of patients.
Because this project involves a marketed drug, only serious and unexpected
adverse events possibly associated with the use of ReoPro should be reported via
the Web Site to Lilly.
A serious adverse event would include an event that:
. Results in death
. Results in initial or prolonged inpatient hospitalization
. Is life-threatening
. Results in severe or permanent disability
. Results in cancer
. Results in a congenital anomaly
. Results in a drug overdose
. Is significant for any other reason
An unexpected event would include those events which are not listed in the
product labeling or package insert. Notwithstanding the foregoing, adverse
reporting using ROD or the Summit Web Site will not, and is not intended to, be
a substitute for any reporting of Adverse Events to governmental agencies by the
Participants (or Lilly) and Summit shall not assume any such responsibility on
behalf of Lilly or any third party by including the reporting system in ROD.
3. Confidentiality. Summit will hold and maintain as confidential and
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shall not disclose to third parties the individual Patient Information contained
in ROD or the Reports, and will protect such data from use for any purpose other
than the design, development, implementation and maintenance of ROD and larger
databases and the reports thereon or as expressly permitted in this Agreement.
Patient and physician identifying information ("Identifiers") within the Patient
Information will not be incorporated into the Databases. ROD will be maintained
in an access-controlled computer system, with access limited to employees or
agents of Summit who are directly involved in the management and/or analysis of
the data contained therein.
Participant shall hold and maintain as confidential, and not use or
disclose except as expressly permitted hereunder, any of the following: the
software, algorithms, interfaces, protocols, user documentation, data collection
forms and other information related to the collection of data via ROD and the
Internet. All software, algorithms, interfaces, protocols and other information
related to the collection of data via the Internet, and the development, design;
and implementation of ROD or the like, shall be proprietary information of
Summit.
This provision shall not apply to information which (i) is or becomes a
part of the public domain through no act or omission of the other party; (ii)
was in the other party's lawful possession prior to such access to or the
disclosure of same and had not been obtained by such other party either directly
or indirectly from the party hereto granting such access or making such
disclosure; (iii) is lawfully disclosed to the other party by a third party
having a legal right to so disclose without restriction on such disclosure.
Except as otherwise indicated, the provisions of this Paragraph 3 shall survive
any termination of this Agreement.
4. Data and Copyright Ownership.
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Participant shall be deemed the owner with respect to all individual
Patient Information provided to Summit by Participant hereunder prior to its
inclusion in ROD or other larger databases. Pursuant to Section 1.5,
Participant hereby grants permission for Participant's Patient Information (with
the exception of patient and physician identifying information) to be
incorporated into ROD and larger databases and all reports based thereon. The
Participant shall have no rights whatsoever with respect to ROD and the larger
databases or to the software, documentation, and other materials created or
supplied pursuant to this Agreement, including all associated source code and
Web Site designs.
5. Access to Records. For audit and documentation purposes, Summit may
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provide access to source data sets and programs used to produce reports in order
to demonstrate how any report was produced and the source of the information
contained in that report; unless such information is proprietary information of
a third party (e.g. a proprietary algorithm.) Summit may provide access to data
pertaining to adverse events to the Federal Food and Drug Administration upon
their request or upon the request of Lilly. Digital signatures and encryption
will be maintained throughout any review.
6. Limitation of Liability. Participant acknowledges that Lilly is a
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only a sponsor of ROD and is not responsible for the operation or management of
ROD, and hereby waives, and covenants not to sue Lilly for, any and all possible
claims that it might have against Lilly arising out of, or resulting from, any
aspect of this Agreement. Moreover, in no event shall Summit be liable for any
indirect, incidental, special or consequential damages under this Agreement,
whether in an action in contract or tort or based on a warranty, whether or not
Summit or any other person has been advised of the possibility of such damages.
Summit's liability for damages under this agreement shall in no event exceed the
amount of the fee paid by Participant under this Agreement, and if such damages
result from Participant's use of the Web Site or other Summit products, such
liability shall be limited to the fee paid during such year. Some states and
jurisdictions outside of the United States do not allow the limitation or
exclusion of implied warranties, or liability for incidental or consequential
damages, so the above limitation or exclusion may not apply. The provisions of
this paragraph 3 shall survive any termination of this agreement.
7. Notices. All notices and demands of any kind in connection with this
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Agreement shall be in writing to the addresses appearing at the preamble to this
Agreement, and, in the case of Summit directed to the attention of its
Contracting Officer. Service of such notice or demand shall be deemed complete
on the day of actual delivery. A party may designate a different mailing
address or a different person to which all further notice or demands shall
thereafter be addressed with written notice to the other party.
8. Price. Pricing, terms and conditions are outlined in the License
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Agreement; provided, however, that there will be no charge to Participant
throughout the term of the Pilot Study except for any Special Reports requested
by the Participant.
9. Term and Termination. This Agreement is effective during the time
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period listed in the License Agreement.
10. Assignment. This Agreement may not be assigned by Participant without
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the express written consent of Summit. Any attempted assignment without such
consent shall be void. Any permitted assignment or transfer of this
Agreement shall be binding upon, and inure to the benefit of, the successors,
executors, heirs.
11. Relationships of Parties. The relationships of the parties to this
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Agreement are those of independent contractors and not those of master and
servant, principal and agent, employer and employee, or partners or joint
ventures.
12. Waiver. A waiver by either party of any of the terms or conditions of
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this Agreement in any one instance shall not be deemed or construed to be a
general waiver of such term or condition or a waiver of any subsequent breach.
13. Governing Law. This Agreement shall be construed and enforced in
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accordance with federal law and the laws of the State of Minnesota (excluding
its choice of law rules and the U.N. Convention on the International Sale of
Goods).
14. Severability. If any provision or portion hereof is determined to be
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unenforceable by a court or competent jurisdiction, then the rest of the
Agreement shall remain in full effect, provided that its general purposes remain
reasonably capable of being effected.
15. Authority. If participant is a group of cardiologists, then the
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individual executing this Agreement on behalf of Participant below presents and
warrants that he or she has been expressly authorized to bind each member of the
group identified in Schedule A attached hereto to the terms and conditions of
this Agreement, and that he or she shall be so authorized with respect to each
new member of Participant to whom any benefits of this Agreement are provided in
the future.
16. Survival. The provisions of Paragraphs 1.5, 3, 4, 5 and 6 shall
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survive this Agreement.
17. Entire Agreement. This Agreement (a) constitutes the entire Agreement
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between the parties hereto with respect to the subject matter hereof, (b)
supersedes and replaces all prior Agreements, oral or written, between the
parties relating to the subject matter hereof, and (c) except as otherwise
indicated herein, may not be modified, amended or otherwise changed in any
manner except by a written instrument executed by the party against whom
enforcement is sought.
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement on
the date and year first above written.
SUMMIT MEDICAL SYSTEMS, INC. PARTICIPANT
By By
Title Title
Date Date
EXHIBIT C
SPONSORSHIP FEE
PAYMENT SCHEDULE
Lilly shall pay to Summit a Fee for the Pilot Study of $400,000 payable as
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follows:
(****) Upon the Effective Date of the Definitive Agreement
To begin Software, Database and Web-Site Design
(****) Upon completion of Software, Database and Web-Site Design
(****) Upon implementation of ROD in 10 Pilot Sites
(****) Upon aggregation of Participants' Data and initial report
generation to Lilly and Participants
**** Confidential Treatment Requested