EXHIBIT 10.17
AGREEMENT
This Agreement, made this 21st day of November 1995, by and between ENACT
Health Management Systems (formerly Enact Products Inc.), a California
corporation having its principal place of business at 0000 Xxxx Xx Xxxxxx Xxxx
#000, Xxxxxxxx Xxxx, XX 00000, U.S.A. (hereinafter called Enact) and Teijin
Limited, a Japanese Corporation having its principal place of business at 0-0
Xxxxxxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000, Xxxxx (hereinafter called Teijin),
WITNESSETH:
WHEREAS, both parties hereto are engaged in the design, development,
manufacture, and sale of certain health care medical equipment and its computer
systems;
WHEREAS, both parties hereto executed the MEMORANDUM dated September 21,
1995 for the cooperative development of a peak-flow monitor and its computer
systems for the Japanese market and the SECOND MEMORANDUM dated November 2, 1995
for the extension of the MEMORANDUM (hereinafter collectively called
MEMORANDUM);
WHEREAS, Teijin has paid Enact [ *
] and is conducting the Pilot Study (as hereinafter defined) in
accordance with the MEMORANDUM; and
WHEREAS, both parties hereto desire to execute a formal agreement with
respect to such equipment and its computer systems in accordance with the
MEMORANDUM;
NOW, THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereby agree as follows;
Article 1 - Definition
----------------------
1.1 As used in this Agreement, the following terms have the following
meanings respectively:
(1) "Base Product" shall mean a peak-flow monitor, its computer system
and their improvements for the U.S. market for respiratory diseases developed by
Enact as described in Exhibit A attached hereto.
(2) "Final Product" shall mean a peak-flow monitor and its computer
system for the Market (as hereinafter defined) developed by both parties based
on the Base Product as described in Exhibit B attached hereto.
(3) "Market" shall mean the market for patient monitoring in Japan in
the area of respiratory diseases including, but not limited to, asthma and
chronic obstructive pulmonary disease.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
(4) "Development" shall mean the cooperative development of the Final
Product for the Market, including, but not limited to, the Pilot Study (as
hereinafter defined) and the Clinical Trial (as hereinafter defined). It
consists of the following phases.
Phase I: the cooperative business development
Stage I: the Pilot Study
Stage II: the Clinical Trial
Phase II: the commercialization
A summary of Teijin's Initial Development plan for the Teijin Asthma
Monitoring System is attached hereto as Exhibit C.
[*]
[*]
Article 2 - Subject Matter
--------------------------
2.1 Subject to the terms and conditions of this Agreement, both parties
hereto shall collaborate with each other in carrying out the Development under
this Agreement.
Article 3 - Assignment of Teijin and Enact
-------------------------------------------
3.1 The major assignment of both parties hereto is as follows:
For Enact: 1) Supply of the Base Product for the Pilot Study
and Client Trial;
2) Supply of technology and technical support for
Teijin's modification of the Base Product
and/or Final Product as provided in Section 4.2
only for the purpose of conducting the Pilot
Study and Clinical Trial; *
3) Improvements of the peak-flow monitor of the
Base Product, which are (i) included in the
standard monitor made and marketed by Enact,
and/or (ii) improvements to the Base Product
made by Enact to comply with Japanese Telephony
standards to qualify such Base Product for use
in the Pilot Study, and/or to obtain JATE
(Japan Approvals Institute for
Telecommunications Equipment) approval for the
Base Product prior to such Pilot Study, and as
described in Exhibit B attached hereto;
4) Commercial supply of the Final Product for the
Market;
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
*Note: 5) For modification purpose, Enact agrees that
Teijin uses and modifies source code of the
computer system of the Base Product as
described in Section 9.1.
For Teijin: 6) Test and Evaluation of the Base Product and/or
Final Product;
7) Conduct of the Pilot Study and Clinical Trial;
8) Development of Teijin's monitoring services
program and modification of the computer system
based on the results from the Pilot Study for
the Japanese language, Japanese software
(database, operating system, etc.) and Market
requirements;
9) Obtaining of the Koseisho import and/or
manufacturing approval of the Base Product
and/or Final Product;
10) Application for Koseisho reimbursement of the
Final Product.
3.2 Both parties hereto shall cooperate with each other in carrying out
the Development in addition to the major assignment stipulated above.
Article 4 - Support to Teijin by Enact
---------------------------------------
4.1 Enact shall provide the Base Product to Teijin for the Pilot Study
and/or Clinical Trial and the total quantities are one thousand (1,000) peak-
flow monitor units and one (1) computer system, provided, however, that such
quantities include ten (10) units peak-flow monitors to have been provided under
the MEMORANDUM.
4.2 Enact agrees to provide training and technical support as reasonably
requested by Teijin. Unless otherwise agreed, such training will be at Enact's
facilities. Teijin agrees to train personnel in the use and support of the Base
Product and/or Final Product on an ongoing basis in order to reduce the amount
of Enact's technical support.
Upon reasonable advance written request made by Teijin during the five (5)
year period from the date hereof, Enact will send to Teijin [ *
] of Enact for maximum [* * *] per one stay to provide Teijin with
technical support. However, such sending by Enact shall not exceed [ *
]
In the event that support to Teijin exceeds [ *
] Enact and Teijin will agree on fair compensation to
Enact, but not to exceed the equivalent of [ *
] For the purpose of this paragraph of Section 4.2, "support" shall not
include improvements and/or modifications of the defective Base Product and/or
Final Product.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
Article 5 - Progress Report
---------------------------
5.1 Each party hereto shall make and send to the other party a progress
report, within one (1) month after the end of every calendar quarter during the
term of this Agreement, stating the situation of the development made by it
during the preceding calendar quarter.
Article 6 - Alteration
----------------------
6.1 In case Teijin wishes Enact to make changes or modifications to the
basic design of the Base Product and/or Final Product in connection with the
Development, Enact and Teijin shall evaluate such change or modification and
reach agreement as to such change or modification.
6.2 With respect to any changes made or proposed by Enact which affect the
form, fit or function of the Base Product and/or Final Product, Enact agrees to
notify Teijin of all such modifications as soon as reasonably possible, but in
any case within ten (10) days of issue of a release notice to Enact's
manufacturing facility, by transmitting to Teijin the engineering drawings along
with a release notice or change order.
Article 7 - Milestone Payments and Share of Costs
-------------------------------------------------
7.1 Teijin shall make the following milestone payments for (i) the supply
of a computer system and peak-flow monitors under Section 4.1 and (ii) expenses
for the development in ENACT and (iii) the right to develop and commercialize
the Base Product and/or Final Product as described elsewhere herein.
1) First Payment: [*]
2) Second Payment: [*]
3) Third Payment: [*]
7.2 Each party hereto shall bear any cost arising from its own activities
hereunder.
7.3 As for the amount of the first and second milestone payments made by
Teijin to Enact in accordance with the MEMORANDUM and Section 7.1 hereof
(excluding the third milestone payment), Enact agrees to send to Teijin a report
which shows the details of Enact's activities and related expenses hereunder for
every calendar quarter.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
7.4 The third milestone payment to enact shall be made after the deduction
of withholding taxes duly levied in Japan on payments to the extent that the tax
credit may be obtained under the convention for the avoidance of double taxation
between the governments of U.S.A. and Japan. Teijin agrees to secure for Enact
tax receipt acceptable to U.S. tax authorities for the said tax purpose and send
it to Enact within sixty (60) days after such payment. Subject to Enact's
compliance with Section 7.3 hereof, Teijin agrees to indemnify Enact against any
deductions from the payments to Enact under Section 7.1.
Article 8 - Result and Patent
-----------------------------
ENACT has title and ownership to all intellectual property in the Base
Product. If in the course of the Development any new intellectual property is
created, the following provisions shall apply:
8.1 The result made solely by either party hereto shall be the sole and
exclusive property of such party, and the result made jointly by both parties
hereto shall be the common property of such both parties.
8.2 Both parties hereto will cooperate to file patents for any invention
solely owned by Enact in Japan and any such patents shall be filed by and in the
name of Enact.
8.3 The patent on any joint inventions (hereinafter "Joint Patent") shall
be filed by both parties hereto in any country. Any expenses to be incurred in
filing and maintaining the Joint Patent shall be born equally by both parties
hereto. If either of the parties hereto has no intention to file the Joint
Patent in a country or countries, such party (hereinafter "Non-Desiring Party")
shall notify its intentions to the other party of as soon as possible. After
receipt of such notice from the Non-Desiring Party or after failure of either
party to notify the other party of its intention to join within thirty (30) days
from the delivery of written notice by such other party expressing its desire to
file the Joint Patent in a country or countries (hereinafter "Desiring Party"),
which comes earlier, the Desiring Party has the right to file the Joint Patent
in its single name in such country or countries.
8.4 Should either party hereto intend to withdraw or abandon its patent,
the party shall notify the other party of its intentions and provide an
opportunity for such other party to acquire the subject patent in its single
name.
Article 9 - Commercial Rights
-----------------------------
9.1 Enact hereby grants to Teijin and its subsidiaries an exclusive
license during the term of this Agreement under copyrights, trade secrets,
patents, patent applications and other intellectual property rights embodied in
the Base Product and Final Product as provided to Teijin by Enact for the Market
and only for the purpose of conducting the Pilot Study and the Clinical Trial.
Such license shall include a right to modify the source code provided by Enact
and make object code copies thereof, but only for the above purposes. An
additional license to use and sell the Base Product and Final Product for the
Market will be granted only as part of the agreement
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referenced in Sections 9.2 or 9.3. All licenses granted hereunder or in the
future are limited to the Market.
9.2 If Teijin decides to commercialize the Base Product and/or Final
Product based upon the fact that the Koseisho reimbursement will be obtained as
the result of the Clinical Trial by Teijin, both parties hereto shall enter into
a distribution agreement for the Base Product and/or Final Product in Japan.
Such an agreement shall includes the following items:
1) Royalty: principally [ * ] on
the net sales of Teijin's Final Product and
services depending upon the business forecast
which will be influenced by three factors;
reimbursement, technical advantage and market
competition
2) Transfer Price: [ * ] agreed
upon between the parties, for the commercial
sale by Teijin in Japan
3) Specification: To be agreed
4) Warranty: To be agreed
5) Maintenance: To be agreed
9.3 If Teijin decides to commercialize the Base Product and/or Final
Product before obtaining of the Koseisho reimbursement as the result of the
Clinical Trial by Teijin, both parties hereto shall negotiate an appropriate
agreement. The terms and conditions of such an agreement shall be separately
agreed upon between the parties hereto.
9.4 Teijin hereby grants to Enact a non-exclusive, worldwide right under
the copyrights, trade secrets, patents, patent applications and other
intellectual property rights embodied in any modifications to the Base Product
and/or Final Product made by Teijin during the term of this Agreement.
Article 10 - Infringement of Intellectual Property Right
--------------------------------------------------------
10.1 Enact agrees to manufacture the Base Product and/or Final Product
without knowingly infringing any third party's patent, patent application and/or
other intellectual property rights, and indemnify and save Teijin harmless from
any liability, costs and/or expenses resulting from any claim that the Base
Product and/or Final Product infringe any third party's United States patent,
patent application and/or other intellectual property rights or any claim based
upon a Japanese third party's right which is equivalent in scope to such a U.S.
right. Enact's obligation under this Section 10.1 shall not exceed one-half
(1/2) of the total amount paid by Teijin to Enact under this Agreement and a
distribution agreement separately executed by both parties hereto but excluding
the amounts of the first and second milestone payments hereunder. For such
indemnity to be effective, Enact must be promptly notified and rendered
reasonable assistance by Teijin (at Enact's expense). In the event Enact wishes
to minimize its potential liability hereunder Enact
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
may, at its option, either: (i) substitute fully equivalent non-infringing units
or the Final Product; (ii) modify the infringing Final Product so that it no
longer infringes but remains functionally equivalent; or (iii) obtain for Teijin
or its customers, at Enact's expense, the rights to continue use of such Final
Product. The indemnity shall not apply to any infringement that would not have
arisen but for modifications made by, or requested by, Teijin or that results
from the integration of the Base Product and/or Final Product with products of
the third parties.
10.2 In the event that either party hereto becomes aware of any
infringement of solely or jointly owned patent in Japan, the party becoming
aware of such situation shall promptly notify the other party in writing. If
either party hereto decides to xxx any third party for an infringement action,
the other party shall join in such actions. [*]
Article 11 - Indemnification and Liability
------------------------------------------
11.1 Except for the limitations, to which Teijin acknowledges and agrees,
in Enact's then current: (i) directions and instructions for the use of the Base
Product and/or Final Product (ii) terms and conditions of enrollment, and
standard warranty of the Base Product and/or Final Product (attached to them),
Enact shall be liable for, indemnify, defend and hold harmless Teijin from and
against any and all liabilities, damages, losses, costs and expenses (excluding
product liabilities) relating to the use, repair or replacement of, or refund of
amounts paid for, the Base Product and/or Final Product.
Except for the matters covered by the above paragraph of this Section 11.1,
Enact shall be liable for, indemnify, defend and hold harmless Teijin from and
against any and all liabilities, injuries, damages, losses, claims, suits, costs
and expenses (including attorney's fees) caused by a defect of the Base Product
and/or Final Product supplied by Enact. Enact's obligation shall be limited to
the amount stipulated in Section 10.1 hereof.
11.2 Teijin shall indemnify, hold harmless and defend Enact from and
against any and all claims or losses and the associated costs and expenses
(including attorney's fees), which it may incur or become responsible for in
connection with the Pilot Study, Clinical Trial or other activity conducted by
Teijin with respect to the Base Product or Final Product. Such indemnity shall
not cover matters covered under Sections 10.1 and 11.1.
11.3 If it is not obvious that which party may become responsible for
claims, losses, costs and/or expenses in connection with the activities
hereunder, Enact and Teijin shall negotiate a treatment about such claims,
losses, costs and/or expenses in good faith.
11.4 Each party agrees that any indemnity under this Agreement shall be
conditioned upon the indemnifying party receiving prompt notice and reasonable
assistance from the indemnified party (at the indemnified party's expense) of
the matter in question. Each party agrees that it shall not settle any
indemnified mater with any third party without the consent of the other party.
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Article 12 - Development with Any Third Party
---------------------------------------------
12.1 Neither party hereto may cooperate with any third party during the
term of this Agreement, in any field concerning the Development for the Market
or any development for the same purpose as described herein; provided, however,
that each party hereto may develop and commercialize any product and/or service
not to be based upon the other party's technology disclosed to it hereunder but
to be based upon its own technology to be developed independently. Such product
and/or service shall not directly compete with the Base Product and/or Final
Product.
Article 13 - Termination
------------------------
13.1 Teijin has the right to evaluate the progress and result of the
Development at any milestone stipulated in Section 7.1 hereof. If such progress
and/or result are unsatisfactory to Teijin, Teijin may terminate this Agreement
at any time. Thereafter, Teijin will have no obligation to pay the remainder of
the milestone payments stipulated in Section 7.1 hereof.
13.2 Enact may terminate this Agreement at any time in the event that; (i)
Teijin has neither obtained the Koseisho approval by October 31, 2000, nor come
to an agreement with Enact under Section 9.3 which is satisfactory to Enact, or
(ii) Teijin breaches the scope of the license under Section 9.1 or the
confidentiality provisions under Article 14. Thereafter, all Teijin's rights
hereunder shall terminate immediately, and Teijin shall return to Enact the
source code and all other confidential information provided by Enact in any
form.
13.3 In the event that either party hereto, at any time during the term of
this Agreement, commits the material breach of any provision hereunder, and
fails to rectify such breach within sixty (60) days from the receipt of written
notice from the other party, such other party may terminate this Agreement
forthwith by notice in writing to the breaching party, and then any right of
such breaching party under this Agreement shall cease forthwith. Any termination
as provided hereunder shall not prejudice any cause of action or claim of the
other party.
13.4 Should either party hereto become insolvent or make an assignment for
the benefit of creditors, or should proceedings in voluntary or involuntary
bankruptcy be instituted on behalf or against either party, or should a receiver
or trustee of either party's property be appointed, then the other party has the
right to terminate this Agreement forthwith.
Article 14 - Confidentiality
----------------------------
14.1 Either party hereto shall keep secret and confidential any and all
information and data disclosed by the other party hereunder and any result
arising from the Development, and shall not disclose the same to any third party
excluding its subsidiaries. However, such information, data and/or result may
be disclosed insofar as such disclosure is necessary for purposes hereof.
Unless otherwise agreed upon between the parties hereto, either party hereto
shall not use such information, data and/or result for any purpose other than
specifically provided herein. The foregoing shall not, however, apply to any
information, data and/or result which:
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(a) is or becomes public knowledge other than by default on the part
of the receiving party;
(b) can be established by competent proof to have been in the
possession of the receiving party at the time of disclosure to it, or
(c) is received from bona fide third party having free right of
disposal thereof.
This secrecy and non-use obligations shall remain in effect for a period of
five (5) years after expiration or earlier termination of this Agreement.
14.2 Teijin agrees that it shall protect and cause its subsidiaries to
protect all information provided by Enact in the same manner as they would
protect their own information of similar type. In particular, Teijin and its
subsidiaries shall allow access to such information only to their employees and
contractors who are under legal obligations to protect the secrecy of such
information. Source code shall in all cases be kept in locked, restricted access
room and be treated as confidential. Source code may not be copied and shall be
provided only to Teijin's and it subsidiaries' employees with a need to access
to such software for purposes hereof. All modifications can be made except for
the purposes of this Agreement. Enact agrees to comply with similar restrictions
in the event that source code or similar confidential information is provided to
it by Teijin.
Article 15 - Survival Rights and Obligations
--------------------------------------------
15.1 Articles 9 (Result and Patent), 10 (Infringement of Intellectual
Property Rights), 11 (Indemnification and Liability), 14 (Confidentiality), 19
(Governing Law), 20 (Arbitration) and 21 (Notice) shall remain in effect as long
as necessary after expiration or earlier termination of this Agreement.
15.2 In case of any termination of this Agreement based upon a breach by
either party, the parties shall negotiate in good faith a right and license
under solely owned result by either party hereunder respectively. However,
neither party shall be obliged to enter into such an agreement.
Article 16 - Assignment to Any Third Party
------------------------------------------
16.1 Neither party hereto shall assign this Agreement nor any of the
rights and obligation arising hereunder in whole or in part to any third party
excluding it subsidiaries without the prior written consent of the other party,
and any attempted assignment in violation of this Article shall be void provided
that Enact may assign this Agreement to any party which acquires the business of
Enact which is the subject of this Agreement.
Article 17 - Force Majeure
--------------------------
17.1 Neither party hereto shall be liable for failure to perform its
obligation hereunder due to riot, explosion, war, fire, flood, earthquake, acts
of God, strike, lockout or other labor troubles, acts or non-acts of the
government or any other causes beyond the control of the party,
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and the performance of its obligation hereunder shall be suspended during the
existence of such causes, provided, however, that if such suspension exceeds
three (3) months, the other party has the right to terminate this Agreement by
at least thirty (30) days' notice in writing to the party suspending the
performance of the obligation.
Article 18 - Term
-----------------
18.1 This Agreement shall become effective on the date first above written
and shall continue in full force for a period of ten (10) years, unless earlier
terminated under this Agreement. The term of this Agreement may be extended by
prior mutual agreement in writing of both parties hereto for a mutually agreed
period.
Article 19 - Governing Law
--------------------------
19.1 This Agreement shall be governed by and construed in accordance with
the laws of the State of California, U.S.A.
Article 20 - Arbitration
------------------------
20.1 All disputes, controversies or differences which may arise between
the parties hereto, in connection with this Agreement, or for the breach
thereof, shall be finally settled by arbitration in accordance with the rules of
the Conciliation and Arbitration of the International Chamber of Commerce. The
arbitration shall be held in Honolulu, U.S.A.
Article 21 - Notice
-------------------
21.1 All notices and other communications required or permitted to be
given hereunder shall be in writing and in the English language and shall be
deemed given seven (7) days after they are dispatched by postage prepaid and
registered airmail, addressed as follows:
To Teijin: 0-0, Xxxxxxxxxxxxx 0-xxxxx, Xxxxxxx-xx,
Xxxxx 000, Xxxxx
Attn: General Manager of Home Health Care Planning
Department
To Enact: 0000 Xxxx Xx Xxxxxx Xxxx #000
Xxxxxxxx Xxxx, XX 00000
Attn: Chief Financial Officer
Article 22 - Damages
--------------------
22.1 NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR SPECIAL OR
CONSEQUENTIAL DAMAGES OR LOST PROFITS FOR ANY REASON OR CAUSE OF ACTION.
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Article 23 - Another Collaboration
----------------------------------
23.1 Both parties hereto shall use their reasonable efforts to find a
chance of another collaboration in addition to the Development.
Article 24 - Public Releases
----------------------------
24.1 Neither party shall make a public release relating to the execution
of this Agreement or the terms thereof without the prior written consent of the
other party; provided, however, that with respect to any required release of
information to the U.S. Securities and Exchange Commission, the filing party
need only provide the non-filing party with a reasonable prior opportunity to
review the release.
IN WITNESS HEREOF, the parties hereto have caused this Agreement to be
signed by their respective duly authorized representatives as of the day and
year first above written.
Enact Health Management Systems Teijin Limited
By:______________________________________ By:______________________________
Xxxxxxx Xxxxxxx Xxxxx Xxxxxxxxx
Title: President Title: Senior Managing Director
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EXHIBIT B: FINAL PRODUCT
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EXHIBIT C: TEIJIN'S INITIAL DEVELOPMENT PLAN
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