EXHIBIT 10.21
PHOTOELECTRON CORPORATION
CLINICAL TRIAL AGREEMENT
THIS AGREEMENT, effective this 13 day of December 1995, by and between
Photoelectron Corporation, a Massachusetts corporation having its principle
place of business at ▇▇▇-▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
U.S.A. (hereinafter called the "Company"), and Toshiba Medical Systems Co.,
Ltd., a Japanese corporation having its principal place of business at ▇▇-▇, ▇-
▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇▇-▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ (hereinafter called the "Distributor").
WHEREAS, on this date the parties are entering into the International
Distributor Sales and Service Agreement (hereinafter called the "Distribution
Agreement"), pursuant to which the Company is appointing the Distributor as the
exclusive distributor for the Photon Radiosurgery System in Japan.
WHEREAS the Company and the Distributor shall jointly conduct clinical trials
(hereinafter called "Clinical Trials") of the Photon Radiosurgery System in
Japan with the objective of obtaining all necessary legal, regulatory, or
administrative approvals to import, market, sell, and use Photon Radiosurgery
System in Japan (hereinafter called "Approvals") under Section 14 (Approval to
Import) of the Japanese Pharmaceutical Affairs Law ("PAL").
NOW THEREFORE, The parties agree as follows:
ARTICLE I DEFINITIONS
1.01 All capitalized terms used in this Agreement shall have the meanings
assigned to them in the Distribution Agreement unless otherwise defined under
this Agreement.
ARTICLE II SALES TO DISTRIBUTOR
2.01 Purchase of PRS Units for Clinical Trials
A. The Distributor agrees to purchase from the Company two complete systems
of the Photon Radiosurgery System consisting of the following items (hereinafter
called the "PRS") for use in the Clinical Trials to be conducted in Japan with
regard to the treatment of metastatic brain tumors and other agreed upon tumor
types. The purchase price for each PRS shall be U.S.$ (together with applicable
taxes and other transfer fees imposed by Japanese or
United States law), which represents a discount from the Company's current list
price. The Distributor shall pay for each system no later than thirty (30) days
after the Distributor has received and inspected each system.
1. PRS probes (2) 8. E1ectrometer
2. PRS control box 9. Ionization chamber
3. Probe adjuster 10. Dosimetry computer
4. Photodiode array 11. Dosimetry tank control electronics
5. External radiation monitor 12. Dosimetry tank
6. Sterilization tray 13. Radiochromic film reader
7. Laptop computer 14. Phantom
The Company agrees to negotiate with Radionics Inc. to sell to the Distributor
its stereotactic frame to be used with the PRSs in the Clinical Trials at a
discount price.
B. Both units of the PRS shall be sold "FOB" Boston (as such term is defined
by the International Chamber of Commerce, INCOTERMS (3d.ed. 1990)). The Company
shall use reasonable efforts to obtain, at its own expense, any export or other
official authorization and carry out or satisfy any other formalities necessary
for the transportation and exportation of the two PRS units from the United
States. The Distributor shall use reasonable efforts to obtain, at its own
expense, any authorization necessary for the importation of the two PRS units to
Japan and their use in the Clinical Trials.
C. The Company shall package the PRS in an appropriate manner for shipment to
the Distributor in Japan and in accordance with such packaging requirements as
the Distributor may reasonably request in consideration of the laws and shipping
customs of Japan.
D. The Company and the Distributor shall mutually cooperate to ensure that the
PRS complies with all local laws, standards, regulations applicable to use of
the PRS in the Clinical Trials.
E. When the Approvals have been obtained the Company shall refurbish and
upgrade the two units of the PRS to make them saleable and conform to the then
existing current models at no additional charge to the Distributor.
2.02 Warranties on Products. The Company warrants both units of the PRS and
Parts and Accessories (hereinafter called "Products") delivered to the
Distributor in accordance with the attached Schedule A (such warranty is
hereinafter referred to as the "Company Limited Warranty"). The Company Limited
Warranty is the only warranty applicable to the Products delivered in accordance
with this Agreement.
2.03 Product Liability/Patent Indemnification
A. The Company agrees to indemnify and defend the Distributor, its parent
company, subsidiaries affiliates and Clinical Trials sites, and their respective
agents, representatives and employees (the "Distributor Group") from and
against any and all claims, proceedings, causes of action and suits
(hereinafter, collectively "Claims") (i) arising out of personal injury, death
and/or property damage in connection with the use of a Product (excluding any
uses of Products for purposes other than those approved), or (ii) which is based
on any claim that any part of the Products or the sale or use thereof by the
Distributor under this Agreement infringes any patent, any copyright, trade
secret, any trade name, any trademark or intellectual property of any third
party; subject to the Distributor giving the Company prompt written notice upon
discovery of each Claim and except to the extent such Claims occur as a result
of the negligent or willful acts or omissions of any member of the Distributor
Group. The Company shall control the defense of any such Claim and shall pay all
costs of any such defense (including the attorney's fees required to be incurred
by the Distributor Group in such action) and all judgments, awards and
settlement amounts incurred as a result of such Claims. The Distributor shall
give the Company reasonable assistance in the defense or settlement of the
Claims. It is understood that the Company shall have the sole discretion to
determine the terms of settlement of any Claim.
Notwithstanding the foregoing, the Company shall have no liability under this
Section 2.03 for any claim by a third party that the use of a Product caused
personal injury, death or property damage or infringes any patent, copyright,
trade secret or other intellectual property right in any of the following
circumstances: (i) the Product was altered or modified by any member of the
Distributor Group or any third party without prior authorization of the Company
and such alteration or modification resulted in or is the basis for the third
party claim; (ii) the Distributor or any third party used the Product in
combination with any component, apparatus or software not furnished or
authorized by the Company and such combination resulted in or is the basis for
the third party claim; (iii) the Product was used in a manner for which it was
not designed or specified or otherwise inconsistent with the clinical trial
protocol or procedures prepared by the supervisors of the Clinical Trials and
approved by the Company and the Japanese Government (hereinafter called the
"Protocols"); or (iv) any member of the Distributor Group owns an intellectual
property right or has a license which precludes it from being held responsible
for the claim of infringement.
2.04 Force Majeure. Neither party shall be liable in any manner for failure or
delay to fulfill all or part of this Agreement directly or indirectly, owing to
an act of God, governmental orders or restriction, war, threat of war, warlike
conditions, hostilities, sanctions, mobilization, blockade, embargo, detention,
revolution, riot, looting, strike, lockout, labor action, accident, or any other
causes or circumstances beyond its reasonable control.
2.05 Limit on Liability. EXCEPT TO THE EXTENT EXPRESSLY PROVIDED IN
THIS ARTICLE II, IN NO EVENT SHALL THE COMPANY BE LIABLE TO ANY
MEMBER OF THE DISTRIBUTOR GROUP FOR SPECIAL, INDIRECT OR
CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING, BUT NOT LIMITED
TO, LOSS OF PROFIT, LOSS OF BUSINESS OPPORTUNITY, LOSS OF REVENUE
OR GOODWILL ARISING FROM ANY BREACH OR OTHER FAILURE BY THE COMPANY UNDER THIS
AGREEMENT.
ARTICLE III THE CLINICAL TRIAL PROGRAM
3.01 Site of Clinical Trials. The initial site for the Clinical Trials shall be
at The Tokyo Women's Medical College in Tokyo, Japan under the supervision of
Professor Kintomo Takakura, M.D. as Principal Investigator. The Distributor
shall select the second clinical trial site taking into consideration the future
marketing strategy for the PRS in Japan and give a written notification to the
Company.
3.02 Responsibilities of the Distributor in the Clinical Trials. The
Distributor shall have the following responsibilities in the Clinical Trials to
be conducted in Japan:
A. The Distributor shall be responsible for installing and maintaining the
PRS systems to be used in the Clinical Trials and exercise reasonable efforts to
obtain all necessary legal, regulatory or administrative approvals for
conducting the Clinical Trials.
B. The Distributor shall bear the full cost to be incurred for any legal
procedures for conducting the Clinical Trials in Japan and for obtaining all
Approvals.
C. The Distributor shall use its reasonable efforts to cause the Clinical
Trials to be conducted in accordance with the Protocols.
D. The Distributor shall advise the Company concerning the requirements for
obtaining approval to import, market, sell, use and obtain reimbursement for the
PRS in Japan in accordance with the PAL and any other applicable legal,
regulatory or administrative requirements.
E. The Distributor shall provide such assistance to the hospitals and
physicians conducting the Clinical Trials in Japan as they or the Company may
reasonably request from time to time. Such assistance shall include the
collection and analysis of clinical data in compliance with the PAL and U.S.
Food and Drug Administration requirements.
3.03 Responsibilities of the Company in the Clinical Trials. The Company shall
have the following responsibilities in the Clinical Trials to be conducted in
Japan:
A. Prior to commencement of and during the Clinical Trials the Company shall
provide at no charge reasonable training at the Company's headquarters to the
Distributor's personnel with respect to the installation, operation and
maintenance of the PRS. The Distributor shall be responsible for all out of
pocket travel expenses (meals, airfare, hotel, local transportation, etc.)
incurred by its representatives in connection with such training.
B. The Company shall provide at no charge all technical information
including, but not limited to, the following, to the extent necessary to comply
with the requirements of PAL:
(1) technical information detailing the development of the PRS;
(2) technical information concerning shape (size), structure, and composition
materials of the PRS;
(3) technical information concerning the manufacture and testing of the PRS;
(4) technical information concerning the performance and effectiveness of the
PRS;
(5) technical information concerning the operation and use of the PRS;
(6) technical information concerning the stability and safety (as mechanically,
electronically, biologically, radioactivity wise) of the PRS;
(7) technical information concerning the status of clinical trials in the U.S.
or other countries;
(8) installation and operation manuals; and
(9) other documents required by the Japanese Ministry of Health and Welfare;
and other assistance as the Distributor may reasonably request, which shall
include sending appropriate engineering personnel to Japan if the Company deems
such action necessary. The Company shall be responsible for all out of pocket
travel expenses (meals, airfare, hotel, local transportation, etc.) incurred by
its representatives in providing such assistance.
C. The Company shall provide on-site installation supervision and training at
no charge at the first clinical trial site and the second clinical trial site,
if reasonably requested by the Distributor. The Company shall be responsible for
all out of pocket travel expenses (meals, airfare, hotel, local transportation,
etc.) incurred by its representatives in providing such assistance.
D. The Company will also provide the Distributor with all necessary spare
parts for the PRS during the Clinical Trials. For the Clinical Trials to be
conducted smoothly, the Company agrees to consign to the Distributor a
reasonable amount of accessories, supplies and spare parts. At the time when the
Clinical Trials are completed, both parties agree to discuss what to do with the
unused portion of the accessories, supplies and spare parts.
E. The Company shall be responsible for approving all Protocols to be
utilized in connection with the Clinical Trials.
F. The Company shall be responsible for and bear the full cost to be incurred
in any necessary modifications of the PRS for successfully concluding the
Clinical Trials and for obtaining the Approvals.
3.04 Trademarks and Service Marks
A. The Company or its affiliated companies are the exclusive owners of the
various trademarks, service marks, names, and designs (herein called "Marks")
used in connection with the Products.
B. The Distributor is granted the non-exclusive right of displaying the Marks
in Japan in connection with performing its obligations under this Agreement. The
Marks may be used as part of the name under which the Distributor's business is
conducted only with the prior written approval of the Company. The Distributor
will change or discontinue the use of any ▇▇▇▇ upon the written request of the
Company. No member of the Distributor Group may use any ▇▇▇▇ or Product name
without the Company's prior written permission.
C. Upon termination of this Agreement, unless allowed by the Distribution
Agreement, the Distributor will immediately discontinue or cause to be
discontinued at its expense, all use of Marks. Thereafter, the Distributor will
not use, either directly or indirectly, any Marks or any other confusingly
similar marks in a manner likely to cause confusion or mistake or to deceive the
public.
3.05 Proprietary Information. Unless superseded or continued by terms of the
Distribution Agreement, during the term of this Agreement and four (4) years
thereafter, the Distributor shall receive and keep in confidence all proprietary
information concerning the Products and the Company's business including, but
not limited to, trade secrets, business and marketing plans and other
specialized information which might be disclosed to or learned by the
Distributor. After the termination of this Agreement, the Distributor shall
return all property belonging to the Company and shall keep all proprietary
information in confidence and shall not use or disclose any such information for
its own purposes or for the benefit of any third party without the prior
written consent of the Company.
Unless superseded or continued by terms of the Distribution Agreement, during
the term of this Agreement and four (4) years thereafter, the Company shall
receive and keep in confidence all proprietary information concerning the
Distributor's products and business including, but not limited to, trade
secrets, business and marketing plans and other specialized information which
might be disclosed to or learned by the Company. After termination of this
Agreement, the Company shall return all property belonging to the Distributor
and shall keep all proprietary information in confidence and shall not use or
disclose any such information for its own purposes or for the benefit of any
third party without the prior written consent of the Distributor.
ARTICLE IV TECHNICAL RIGHTS
4.01 No License Granted to Distributor. Nothing in this Agreement shall be
deemed or construed to create or grant to the Distributor any license or other
rights in or to the PRS, any other Product or any component thereof except as
expressly set forth in this Agreement.
4.02 Ownership of Improvements; Fixtures. All improvements, upgrades or
modifications to the PRS, any other Product or any component thereof developed
by the Distributor by the use of proprietary information of the Company which is
made available to the Distributor under this Agreement or the Distribution
Agreement, shall be solely owned by the Company, and the Distributor agrees to
execute or to cause to be executed such documents and to take or to cause to be
taken such other actions as the Company may deem necessary or desirable to
confirm its ownership of such improvements, upgrades or modifications. All
improvements, upgrades or modifications developed by the Distributor in a manner
other than described in the preceding sentence, including any interfacing
fixture, between the PRS and the frame or any other device for use with the PRS,
shall be solely owned by the Distributor. The Distributor will promptly notify
the Company in the event the Distributor or any of its affiliated companies
develop any improvements, upgrades or modifications to the PRS, any other
Product or any component thereof. The Distributor will grant to the Company a
worldwide, non-exclusive license to utilize any such improvements, upgrades or
modifications developed by the Distributor in connection with the PRS outside
the Territory at a commercially reasonable royalty.
ARTICLE V TERMINATION
5.01. Termination of Agreement
A. The initial term of this Agreement shall commence on the execution of this
Agreement and shall expire on the date when (i) the Distributor has obtained all
necessary Approvals, (ii) it is decided after every reasonable effort has been
made by both parties that the Clinical Trials cannot be successfully completed,
or as otherwise agreed to by the parties. This Agreement may also be canceled at
any time by either party upon thirty (30) days prior written notice upon breach
of any material term or condition of this Agreement, and this Agreement shall be
deemed terminated at the end of such thirty (30) day period if such breach is
not cured before such date.
B. The parties expressly acknowledge that no franchise, partnership or joint
venture relationship exists or is intended to exist between the parties hereto
during the term of this Agreement.
C. Termination of this Agreement will not release the Distributor or the
Company from the obligation to pay any amounts owing the other.
D. In case of termination pursuant to Section 5.01 A (ii) above, the
Distributor may at its own discretion, request that the Company make a
reasonable effort to resell to another customer, for the US $______ paid by the
Distributor, the two (2) sets of the PRS used in the Clinical Trials.
ARTICLE VI GENERAL PROVISIONS
6.01 No Agent or Legal Representative Status. This Agreement does not make
either party the agent or legal representative of the other for any purpose
whatsoever, nor does it grant either
party any authority to assume or to create any obligation on behalf of or in the
name of the other. Neither party owes the other any fiduciary obligation.
6.02 Distributor's Responsibility for Its Operation. Except as provided
otherwise in this Agreement, the Company has no liability in connection with the
establishment or conduct of the Distributor's expenditures, liabilities and
obligations incurred or assumed by the Distributor in connection with the
Distributor's responsibilities under this Agreement.
6.03 Taxes. The Distributor will pay all Japanese taxes and will file required
tax returns related to the purchase of the PRS under this Agreement and will
hold the Company harmless from any claims or demands made by any taxing
authority with respect thereto.
6.04 Notices. Any notice, demand or request required or permitted to be given
hereunder shall be in writing, shall be in English, shall be sent to the address
or facsimile number set forth below, and shall be given by registered or
certified mail, internationally recognized courier service (e.g. Federal
Express, DHL), or by facsimile. Any such notice, demand or request shall be
deemed effective (i) five (5) days after having been deposited in the mail,
first class airmail postage prepaid for overseas notice, three (3) days for
domestic notices, (ii) three (3) days after deposit with an internationally
recognized courier service, or (iii) upon receipt if delivered by facsimile.
If to the Company:
Address: ▇▇▇-▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇.▇.▇. ▇▇▇▇▇
Attention: President
Facsimile Number: ▇▇▇-▇▇▇-▇▇▇▇
If to the Distributor:
Address: 26-5, 3-Chome, Hongo, Bunkyo-ku
Tokyo ▇▇▇ ▇▇▇▇▇
Attention: President
Facsimile Number: 03 (3813) 7625
6.05 No Implied Waivers. The failure of either party to require performance by
the other party of any provisions hereof will in no way effect the right to
require such performance at any time thereafter, nor will the waiver by either
party of a breach of any provisions hereof.
6.06 Assignment of Rights or Delegation of Duties. Neither this Agreement, nor
the rights or obligation of either party hereunder, may be sold, assigned or
otherwise transferred without the prior written approval of the other party.
6.07 Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of The Commonwealth of Massachusetts, U.S.A. applicable
to contracts made, accepted and performed wholly within The Commonwealth of
Massachusetts, without application of principles of conflicts of laws. The
parties agree to submit to the jurisdiction of the courts of The Commonwealth of
Massachusetts should any dispute arise with respect to the interpretation or
enforcement of this Agreement.
6.08 Official Language. The official language of this Agreement shall be in
English, provided, however, that a Japanese translation of this Agreement shall
be prepared for the Distributor's reference.
6.09 Sole Agreement of Parties. Except as otherwise provided or referred to
herein, neither party has made any promises to the other, and there are no other
agreements or understandings, either oral or in writing, between the parties
affecting this Agreement or relating to the subject matter covered by this
Agreement. This Agreement cancels and supersedes all previous agreements
between the parties that relate to any matters covered herein.
6.10 Amendments. No agreement between the Company and the Distributor which
relates to matters covered herein, and no change, addition to (except the
filling in of blank lines) or deletion of any printed portion of this Agreement,
will be binding unless it is approved in writing and signed by the duly
authorized representatives of both parties.
IN WITNESS WHEREOF, the parties hereto through their respective duly authorized
representatives have executed and delivered the Agreement as of the date first
above written.
TOSHIBA MEDICAL SYSTEMS PHOTOELECTRON CORPORATION
CO., LTD.
[SIGNATURE APPEARS HERE] [SIGNATURE APPEARS HERE]
By:-------------------- By:----------------------
Title: President Title: President & CEO
Dec 22, 1995 Dec 26, 1995
----------------------- -------------------------
Date Date
SCHEDULE A
COMPANY'S LIMITED WARRANTY
--------------------------
The Company warrants to the Distributor that during the Clinical Trials, the
Company shall, at its option, either repair any defective Product or provide
without charge to the Distributor all replacement Parts necessary to correct any
such Product which proves to be defective and shall pay all shipping and labor
expenses associated with such replacement.
THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, AND THE COMPANY EXPRESSLY DISCLAIMS ANY OTHER WARRANTIES.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER OR TO ANY THIRD PARTY, UNDER ANY
CIRCUMSTANCES, FOR ANY SPECIAL, PUNITIVE, CONSEQUENTIAL OR INCIDENTAL DAMAGES
WHATSOEVER, INCLUDING ANY COSTS, EXPENSES, LOST PROFITS OR ANY OTHER CLAIMED
LOSSES HOWEVER DESIGNATED.
[SIGNATURE APPEARS HERE]
[PEC PHOTOELECTRON CORPORATION LETTERHEAD APPEARS HERE]
December 13, 1995
▇▇. ▇▇▇▇▇▇▇▇▇ Kurihara
President
Toshiba Medical Systems Co., Ltd.
▇▇-▇, ▇-▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇-▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇
Dear ▇▇. ▇▇▇▇▇▇▇▇:
Schedule C to The International Distributor Sales and Service Agreement between
Photoelectron Corporation and Toshiba Medical Systems Co., Ltd. provides that
the discount rate on the sale of Products by Photoelectron to Toshiba Medical
shall be negotiated "at the proper time".
We hereby confirm to you that the minimum discount rate to be provided to
Toshiba Medical with respect to its purchases of the PRS and other Products will
be below Photoelectron's US retail list price. The actual amount of the discount
will be _____________ established in future negotiations between us.
Sincerely,
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
President and Chief Executive Officer
Photoelectron Corporation
as confirmed by,
/s/ Shigeyasu Kurihara
Shigeyasu Kurihara
President
Toshiba Medical Systems Company, Ltd