MIRAVANT MEDICAL TECHNOLOGIES/
XILLIX TECHNOLOGIES CORP.
STRATEGIC ALLIANCE AGREEMENT
June 1998
MIRAVANT MEDICAL TECHNOLOGIES/ XILLIX TECHNOLOGIES CORP.
STRATEGIC ALLIANCE AGREEMENT
Table of Contents
ARTICLE I - DEFINITIONS........................................................2
ARTICLE II - OWNERSHIP AND LICENSE.............................................5
ARTICLE III - RESEARCH, DEVELOPMENT AND FUNDING................................7
ARTICLE IV - COMMERCIAL SUPPLY.................................................9
ARTICLE V - MARKETING AND SALE OF CO-DEVELOPED DEVICES........................10
ARTICLE VI - PAYMENTS AND ACCOUNTING..........................................12
ARTICLE VII - REGULATORY RESPONSIBILITIES.....................................13
ARTICLE VIII - PATENTS........................................................14
ARTICLE IX - PUBLICATIONS AND CONFIDENTIALITY.................................15
ARTICLE X - WARRANTIES OF MRVT................................................16
ARTICLE XI - WARRANTIES OF XILLIX.............................................17
ARTICLE XII - MUTUAL WARRANTIES...............................................17
ARTICLE XIII - TERM & TERMINATION.............................................18
ARTICLE XIV - INDEMNIFICATION.................................................19
ARTICLE XV - MISCELLANEOUS....................................................20
ARTICLE XVI - BINDING EFFECT; ASSIGNMENT......................................22
ARTICLE XVII - RESOLUTION OF DISPUTES.........................................22
MIRAVANT MEDICAL TECHNOLOGIES/XILLIX TECHNOLOGIES CORP.
STRATEGIC ALLIANCE AGREEMENT
THIS MIRAVANT MEDICAL TECHNOLOGIES/XILLIX TECHNOLOGIES CORP. STRATEGIC
ALLIANCE AGREEMENT ("Agreement") entered into this ____ day of June, 1998,
between MIRAVANT MEDICAL TECHNOLOGIES, a Delaware corporation, with corporate
offices at 0000 Xxxxxxxxx Xxxxxx, Xxxxx Xxxxxxx, Xxxxxxxxxx 00000 (hereinafter
referred to as "MRVT") and XILLIX TECHNOLOGIES CORP., a British Columbia
corporation with corporate offices at #300 - 00000 Xxxxxxxx Xxxxxxx, Xxxxxxxx,
X.X. Xxxxxx X0X 0X0 (hereinafter referred to as "Xillix").
WHEREAS, MRVT is a pharmaceutical and medical device company which, using
its proprietary technology and know-how, has developed and will continue to
develop, on its own or in collaboration with third party vendors, photoreactive
drugs and devices for use in photodynamic therapy;
WHEREAS, Xillix is a medical device company which, using its proprietary
technology and know-how, has developed and will continue to develop, on its own
or in collaboration with third party vendors, Fluorescence Imaging Systems; and
WHEREAS, MRVT and Xillix desire to exclusively co-develop and commercialize
new technology and devices incorporating MRVT's Photodynamic Therapy technology
and Xillix's Fluorescence Imaging technology; and
WHEREAS, MRVT and Xillix are concurrently entering into Subscription
Agreements (the "Subscription") pursuant to which MRVT will be investing FIVE
MILLION DOLLARS ($5,000,000 U.S.) in Xillix through the combination of purchase
of Xillix common stock and issuance of MRVT common stock.
NOW, THEREFORE, in consideration of the premises and mutual covenants
exchanged herein, the parties agree as follows:
ARTICLE I - DEFINITIONS
1.01 Act. The term "Act" shall mean the Food, Drug & Cosmetic Act (21
U.S.C. ss. 301, et seq.) as such shall be amended from time to time and
regulations promulgated thereunder.
1.02 Affiliate. The term "Affiliate" shall mean, with respect to any
specified party, any company that directly or indirectly through one or more
intermediaries, controls, or is controlled by, or is under common control with,
the party specified. For purposes of this definition, "control" including with
correlative meanings, the terms "controlled by" and "under common control with"
means ownership directly or indirectly of more than fifty percent (50%) of the
equity capital having the right to vote for election of directors (or in the
case of an entity other than a corporation, the equivalent management
authority).
1.03 Clinical Evaluations. The term "Clinical Evaluations" shall mean any
tests performed by Xillix on Co-Developed Devices not reportable in regulatory
submissions.
1.04 Clinical Device. The term "Clinical Device" shall mean any
Co-Developed Device or MRVT Component or Xillix Component used in the
Preclinical Tests and Clinical Trials necessary for the support of regulatory
submissions as defined in writing by the Operating Committee.
1.05 Clinical Trials. The term "Clinical Trials" shall mean any tests
performed on humans in preparation and support of regulatory submissions.
1.06 Co-Developed Device. The term "Co-Developed Device" shall mean any new
instrument, device or product, or any functionally separable component thereof,
that embodies, incorporates, is comprised of, functions or is produced by means
of, or derives its utility from, any Co-Developed Technology. This term does not
include the existing MRVT Components and Xillix Components.
1.07 Co-Developed Technology. The term "Co-Developed Technology" shall mean
all new technology or systems developed that incorporates a combination of MRVT
Technology and Xillix Technology. This term does not include MRVT Technology and
Xillix Technology.
1.08 Fluorescence Imaging. The term "Fluorescence Imaging" shall mean the
use of fluorescence/reflectance spectroscopy and/or imaging for the purpose of
detection, diagnosis and dosimetry.
1.09 Effective Date. The "Effective Date" of this Agreement shall be the
date first written hereinabove upon the execution of this Agreement by the last
of the parties to sign.
1.10 FDA. The term "FDA" shall mean the United States Food and Drug
Administration or any successor agency having the administrative authority to
regulate the approval for testing or marketing of human pharmaceutical,
biological medical or medical device products in the United States (or, where
appropriate, the equivalent governmental authority in any foreign country).
1.11 Field. The term "Field" shall mean the Field of Oncology and other
fields added by majority vote of the Operating Committee.
1.12 GCP. The term "GCP" shall mean the applicable current good clinical
practices promulgated from time to time by the FDA in accordance with the Act,
and which may be amended from time to time (or the equivalent in any foreign
country).
1.13 GLP. The term "GLP" shall mean the applicable current good laboratory
practices promulgated from time to time by the FDA in accordance with the Act,
and which may be amended from time to time (or the equivalent in any foreign
country).
1.14 GMP. The term "GMP" shall mean the applicable current good
manufacturing practices promulgated from time to time by the FDA in accordance
with the Act, and which may be amended from time to time (or the equivalent in
any foreign country).
1.15 Gross Sales. The term "Gross Sales" shall mean the final gross
invoiced price from the sale of Co-Developed Devices by the seller (and its
Affiliates, sublicensees or marketing partners). In the event of a sale of a
Co-Developed Device to an Affiliate or sublicensee, and the subsequent resale by
such Affiliate or sublicensee, Gross Sales shall be computed on the basis of
such subsequent resale.
1.16 IDE. The term "IDE" shall mean an "investigational device exemption"
application or any other application submitted to the FDA for the purpose of
conducting clinical investigations of a device, and any supplement or
abbreviated application thereof (or the equivalent in any foreign country).
1.17 IND. The term "IND" shall mean an "investigational new drug"
application or any other application submitted to the FDA in accordance with the
Act for the purpose of conducting clinical investigations of a drug and any
supplement or abbreviated application thereof (or the equivalent in any foreign
country).
1.18 Know-How. The term "Know-How" shall mean all ideas, concepts,
inventions (whether or not patentable), discoveries, improvements, unpublished
research and development information, information disclosed (whether or not
claimed) in Patent applications or in issued Patents, trade secrets, technical
and other information and data, including, without limitation, apparatus;
compositions; methods; processes; techniques; controls; routines; systems
(including quality assurance systems); procedures; reports; operating, test and
performance data; and process, mechanical, material and product specifications.
1.19 Manufacturing Partner. The term "Manufacturing Partner" shall mean the
party who manufactures the Co-Developed Device from time to time selected by the
Operating Committee.
1.20 Marketing Partner. The term "Marketing Partner" shall mean the
marketing partner from time to time selected by the Operating Committee to
market the Co-Developed Device.
1.21 MRVT Component. The term "MRVT Component" shall mean any subassembly
or other part or device used for the delivery of light through a Co-Developed
Device, whether proprietary to MRVT or not, developed, manufactured, licensed,
or otherwise capable of being provided by MRVT for incorporation into and
manufacture of Co-Developed Devices.
1.22 MRVT Drug. The term "MRVT Drug" shall mean any Photodynamic Therapy
compound conceived by, owned by or licensed to MRVT or any of its Affiliates, to
the extent that MRVT has the right to use, make, sell or license such compound.
1.23 MRVT Technology. The term "MRVT Technology" shall mean MRVT's
proprietary pharmaceutical and medical device products (trademarked
"PhotoPoint"), using the principles of Photodynamic Therapy.
1.24 NDA. The term "NDA" shall mean a New Drug Application or other
premarket approval application for a MRVT Drug, and any supplement or
abbreviated application relating thereto, submitted to the FDA (or the
equivalent in any foreign country).
1.25 Net Sales. The term "Net Sales" shall mean Gross Sales less the
following: tariffs, import or export duties, excise, value-added and sales
taxes, where such tariffs, duties or taxes are separately stated as part of the
sales price; customary trade, distributor, quantity and cash discounts actually
given; rebates and adjustments required by governmental entities and made
pursuant to governmental or private third-party health or medical insurance
programs; allowances or credits for returns or rejections. In the event of a
sale to an Affiliate or a sublicensee, and the subsequent resale by such
Affiliate or sublicensee, Net Sales shall be computed on the basis of such
subsequent resale. In the event that any Co-Developed Device is sold as a
component of another product, "Net Sales" shall mean the portion of such other
product's invoice price that is allocable to the Co-Developed Device based on
the customary price of the Co-Developed Device when sold separately or, in the
absence of such customary price, on the ratio of the cost of the Co-Developed
Device to the total cost of such other product.
1.26 Patents. The term "Patents" shall mean all United States and foreign
patents, including improvement patents, patents of addition, patents of
importation, certificates of invention, utility model and design patents, method
patents, and all reissues, renewals and extensions thereof; and all United
States and foreign patent applications, including original, divisional,
continuation and continuation-in-part applications pending before any patent
office.
1.27 Photodynamic Therapy. The term "Photodynamic Therapy" shall mean the
technique of diagnosis and/or treatment of abnormal or normal biological or
medical conditions, either in-vivo or ex-vivo, through the use of drugs
activated by any type of electromagnetic radiation or magnetic field, including
PhotoPoint.
1.28 PMA. The term "PMA" shall mean a Pre-Market Approval Application,
510(k) Application or any other application for regulatory approval of a device,
and any supplement or abbreviated application relating thereto, submitted to the
FDA (or the equivalent in any foreign country).
1.29 Preclinical Tests. The term "Preclinical Tests" shall mean any
nonhuman or human tests performed as part of the Co-Development research and
development activity, prior to preparation and support of a regulatory
submission.
1.30 Xillix Component. The term "Xillix Component" shall mean any
subassembly, part or device, whether proprietary to Xillix or not, developed,
manufactured, licensed, or otherwise capable of being provided by Xillix for
incorporation into and manufacture of Co-Developed Devices.
1.31 Xillix Technology. The term "Xillix Technology" shall mean Xillix's
proprietary Fluorescence Imaging systems, including LIFE-Lung and LIFE-GI, using
the principles of Fluorescence Imaging.
ARTICLE II - OWNERSHIP AND LICENSE
2.01 Ownership of Technology.
MRVT retains all right, title and interest in and to all MRVT Technology,
MRVT Components and MRVT Drugs. Xillix retains all right, title and interest in
and to all Xillix Technology and Xillix Components. All right, title and
interest in and to the Co-Developed Technology and Co-Developed Device shall be
owned by the parties as follows unless otherwise agreed to in writing by the
parties:
MRVT *****
Xillix *****
2.02 Distribution Rights to Marketing Partner.
Subject to the terms of this Agreement, MRVT and Xillix hereby (i) grants
to the Marketing Partner an exclusive, worldwide distribution right under the
Co-Developed Technology to use, distribute, and sell Co-Developed Devices in the
Field, (ii) MRVT grants to the Marketing Partner an exclusive, worldwide
distribution right under the MRVT Technology to use, distribute and sell the
MRVT Components in the Field, but only when such MRVT Components are components
of Co-Developed Devices, and (iii) Xillix grants to the Marketing Partner an
exclusive, worldwide distribution right under the Xillix Technology to use,
distribute and sell the Xillix Components in the Field, but only when such
Xillix Components are components of Co-Developed Devices. The Marketing Partner
may subdistribute, totally or in part, the distribution rights granted to it
under this Section 2.02, or may appoint one or more third parties to
subdistribute Co-Developed Devices (including the Xillix Components and MRVT
Components as described in (ii) and (iii) above); provided, however, that (a)
the Marketing Partner must notify the parties in writing of each such
subdistributor at least thirty (30) days in advance; (b) the Marketing Partner
remains responsible to the parties for all contractual obligations of the
subdistributor, including, but not limited to, keeping of records, reporting of
sales and payment of invoices, as if the subdistributor's sales were the
Marketing Partner's sales and (c) the subdistributor agrees to be bound by the
terms of this Agreement to the same extent as the Marketing Partner.
2.03 Manufacturing Partner.
Subject to the terms of this Agreement, MRVT and Xillix hereby grants to
the Manufacturing Partner an exclusive, worldwide, manufacture right under the
Co-Developed Technology to make and manufacture, the Co-Developed Devices in the
Field solely for sale to the Marketing Partner. The Manufacturing Partner may
subcontract, totally or in part, the manufacture rights granted to it under this
Section 2.03; provided, however, that (a) the Manufacturing Partner must notify
the parties in writing of each such subcontractor at least thirty (30) days in
advance; (b) the Manufacturing Partner remains responsible to the parties for
all contractual obligations of the subcontractor, including, but not limited to,
keeping of records, reporting and payment of invoices, as if the subcontractor's
responsibilities were the Manufacturing Partner's responsibilities and (c) the
subcontractor agrees to be bound by the terms of this Agreement to the same
extent as the Manufacturing Partner.
***** Confidential Treatment Requested
2.04 Exclusivity.
During the term of this Agreement, or as otherwise agreed to in writing by
the parties: (i) neither party shall, directly or indirectly, grant any rights
in, to or under the Co-Developed Technology to any third party, whether in the
Field or not, except as provided in Sections 2.02 and 2.03 hereof; (ii) neither
the Marketing Partner nor the Manufacturing Partner shall, directly or
indirectly, make, use, distribute or sell Xillix Components or MRVT Components
apart from the Co-Developed Technology or purchase Xillix Components or MRVT
Components from a third party; (iii) neither the Marketing Partner nor the
Manufacturing Partner, nor Xillix or MRVT, shall directly or indirectly make,
use, sell, distribute or license Co-Developed Devices outside the Field; (iv)
neither Xillix or MRVT, nor the Marketing Partner or the Manufacturing Partner
shall, directly or indirectly, make, use, sell, distribute or license any
Co-Developed Device with any Photodynamic Therapy drug other than MRVT Drugs;
and (v) neither MRVT nor Xillix will engage in any activity with any third party
in the area of Photodynamic Therapy, in the case of Xillix, and in the area of
Fluorescence Imaging, in the case of MRVT, during the term of this Agreement and
for a period of ***** after termination of this Agreement. In the event of any
such termination of this Agreement for material breach, the non-breaching party
shall not be subject to the ***** period described in
the prior sentence.
2.05 *****
ARTICLE III - RESEARCH, DEVELOPMENT AND FUNDING
3.01 Co-Development.
MRVT and Xillix agree to use reasonable efforts to cooperate in the joint
development of Co-Developed Technology and Co-Developed Devices. Unless
otherwise agreed to in writing by the parties, the parties will pay for the
development and clinical trial costs in accordance with Article VI, and (i) MRVT
shall provide, during the development and Clinical Trial period, without charge,
MRVT Components for incorporation into and manufacture of Co-Developed Devices;
and (ii) Xillix shall provide, during the development and Clinical Trial period,
without charge, Xillix Components for incorporation into and manufacture of
Co-Developed Devices. In addition, each party will provide facilities and
technical support without charge to the other party. Except as otherwise
provided herein, the joint development of the Co-Developed Technology and
Co-Developed Devices and the provision of the MRVT Components and the Xillix
Components shall be coordinated by an "Operating Committee" as set forth in
Section 3.02, provided, however, that MRVT shall solely determine the
appropriate MRVT Drugs.
3.02 Operating Committee.
Unless otherwise agreed to in writing by the parties, within thirty (30)
days after the Effective Date the parties shall establish an operating committee
(the "Operating Committee") consisting of four (4) members. The Operating
Committee shall direct and monitor the research and development collaboration
between MRVT and Xillix. MRVT and Xillix shall each appoint two (2)
representatives to the Operating Committee and the Operating Committee will
select one member as Chairman. The number of members of the Operating Committee
may be expanded at any time, provided all members agree to do so in writing and
so long as each party has an equal number of representatives. Responsibilities
of the Operating Committee shall include, but are not limited to, development
and approval of Co-Developed Device specifications, identification and pricing
of MRVT Components and Xillix Components, defining Clinical Devices,
establishing prices for the Co-Developed Devices, testing protocols, schedules
and budgets, selection of the Marketing Partner and the Manufacturing Partner,
and review and approval of publications and presentations related to
Co-Developed Technology and Co-Developed Devices. Each member of the Operating
Committee shall have one (1) vote and all decisions of the Operating Committee
shall require a majority vote. In the event of a tie vote of the Operating
Committee, the matter shall be resolved in accordance with Article 17 hereof.
***** Confidential Treatment Requested
3.03 Research & Development and Clinical Evaluations.
The Operating Committee will be responsible for all research and
development activities as well as Clinical Evaluations. Unless otherwise agreed
to in writing by the parties, MRVT shall contribute MRVT Components and MRVT
Drugs and Xillix shall contribute Xillix Components and Co-Developed Devices for
use in such Clinical Evaluations and tests, each at no cost to the other. Also,
each party will provide facilities and technical support without charge to the
other party. All other actual costs of all research, development and Clinical
Evaluations of Co-Developed Devices shall be shared ***** percent ***** by MRVT
and ***** percent ***** by Xillix unless otherwise agreed to in writing by the
parties.
3.04 Preclinical Tests of Co-Developed Devices.
Unless otherwise agreed to in writing by the parties, (i) MRVT shall
conduct or arrange for a third party to conduct, all reasonably necessary
Preclinical Tests of Co-Developed Devices, and (ii) MRVT shall contribute MRVT
Components and MRVT Drugs and Xillix shall contribute Xillix Components and
Co-Developed Devices, each at no cost to the other. Also, each party will
provide facilities and technical support without charge to the other party. All
actual costs of Preclinical Tests shall be shared ***** percent ***** by MRVT
and ***** percent ***** by Xillix unless otherwise agreed to in writing by the
parties.
3.05 Clinical Trials.
Unless otherwise agreed to in writing by the parties, (i) MRVT shall
conduct or arrange for a third party to conduct, all reasonably necessary
Clinical Trials of Co-Developed Devices, and (ii) MRVT shall contribute MRVT
Components and MRVT Drugs and Xillix shall contribute Xillix Components and
Co-Developed Devices, each at no cost to the other. Also, each party will
provide facilities and technical support without charge to the other party. All
other actual costs shall be paid by MRVT unless otherwise agreed to in writing
by the parties.
3.06 Regulatory Submissions.
MRVT shall prepare and submit, or arrange for a third party to prepare and
submit, in the name of MRVT, any applicable regulatory submissions covering
Co-Developed Devices, including any IDE or IND applications which may be
necessary for conducting Clinical Trials of Co-Developed Devices. The actual
costs of regulatory submissions for Co-Developed Devices shall be paid by MRVT.
Unless otherwise agreed to in writing by the parties, MRVT shall be responsible
for securing government or private price approvals and reimbursement
qualifications in preparation for product launch of Co-Developed Devices in the
Fields. MRVT and Xillix agree to provide each other with access to information
or data relating to Co-Developed Devices which the other may need for regulatory
submissions or compliance. If necessary, Xillix will file any amendments to its
existing FDA filings consistent with MRVT's regulatory filing and strategy.
***** Confidential Treatment Requested
ARTICLE IV - COMMERCIAL SUPPLY
4.01 Supply of Components.
Each party shall provide all requirements of the Manufacturing Partner for
MRVT Components or Xillix Components for use in manufacturing Co-Developed
Devices for commercial sale in the Field. Each party shall sell MRVT Components
or Xillix Components to the Manufacturing Partner at transfer prices to be
determined by the Operating Committee, but not to exceed prices granted by the
parties to other customers for similar quantities. If a party determines not to
provide a certain component to the Manufacturing Partner for use in
manufacturing a Co-Developed Device for commercial sale in the Field, or cannot
supply such component to the Manufacturing Partner, in either case for a period
of six (6) months, then the parties, through mutual discussion in good faith,
shall negotiate a license for the Manufacturing Partner and the non-defaulting
party (the "Non-Defaulting Party") to manufacture or have manufactured such
unavailable or non-supplied components, at the Non-Defaulting Party's own cost
and solely for use as a component in a Co-Developed Device in the Field. Such
license shall include a royalty on commercially reasonable terms and conditions,
taking into account the respective performance of the parties under the
Agreement and the relative investment of the parties in the Xillix Technology or
the MRVT Technology, as the case may be. In the case where a party determines
not to provide a component which it is then providing to the Manufacturing
Partner, such party shall use reasonable efforts to continue to supply such
component to the Manufacturing Partner or the other party for a period of nine
(9) months or until the Manufacturing Partner or the other party determines it
is able to supply such component, whichever is sooner.
4.02 Manufacture of Co-Developed Devices.
The Manufacturing Partner shall have the exclusive right under the
Co-Developed Technology to manufacture Co-Developed Devices for commercial sale
in the Field, but only to the Marketing Partner. In the event the Manufacturing
Partner determines, for any reason, not to manufacture a Co-Developed Device,
for a period of six (6) months or longer, then the Manufacturing Partner's
rights shall terminate. In such an event, the Manufacturing Partner shall use
reasonable efforts to continue to supply Co-Developed Devices to the Marketing
Partner, at transfer prices to be determined by mutual agreement in writing by
the parties, but not to exceed prices granted by the Manufacturing Partner to
the Marketing Partner for similar quantities, for a period of nine (9) months or
until MRVT and Xillix have appointed a new Manufacturing Partner and are able to
supply Co-Developed Devices, whichever is sooner.
4.03 Initial Forecast Requirements.
At least six (6) months prior to any anticipated FDA approval of
Co-Developed Devices, the Manufacturing Partner shall provide to MRVT and Xillix
a written forecast of its requirements for MRVT Components and Xillix Components
for the period extending from that forecast date through the first full quarter
following such FDA approval. This is the "Initial Forecast" for MRVT Components
and the Xillix Components. The MRVT Components and the Xillix Components shown
in the Initial Forecast shall be considered a firm purchase order by the
Manufacturing Partner.
4.04 Order Forecasts.
Each quarter, beginning six (6) months prior to any anticipated FDA
approval of Co-Developed Devices, the Manufacturing Partner shall provide MRVT
and Xillix written forecasts of the Manufacturing Partner's quarterly
requirements for Components for the next twelve (12) month period (the "Rolling
Forecast"). Such Rolling Forecasts shall be for the purpose of assisting MRVT
and Xillix in its planning. In each quarter, unless otherwise agreed to by MRVT
and Xillix, the quantities of MRVT Components and Xillix Components purchased by
the Manufacturing Partner shall not vary from the forecasted quantity by more
than fifteen percent (15%).
4.05 Purchase Orders and Shipment.
The Manufacturing Partner shall order MRVT Components and Xillix Components
from MRVT and Xillix by submitting written, non-cancelable purchase orders to
MRVT and Xillix identifying the quantity, the MRVT Components and the Xillix
Components ordered, shipping instructions, including the common carrier to be
used and the place to which the goods should be delivered, and the requested
delivery date. No later than ten (10) business days after receipt of the
purchase order, MRVT and Xillix shall provide the Manufacturing Partner with the
shipping date. MRVT Components and Xillix Components shall be shipped in the
manner and to the location specified by the Manufacturing Partner.
ARTICLE V - MARKETING AND SALE OF CO-DEVELOPED DEVICES
5.01 (i) Marketing and Sale of Co-Developed Devices.
Subject to the terms and conditions hereof, the Marketing Partner selected
by the parties shall use its best reasonable efforts to market the Co-Developed
Technology and shall provide all necessary customer or other service, shipping
and receiving and invoicing services in support of the sales of Co-Developed
Devices.
5.01 (ii) Marketing and Sale of MRVT Drugs.
Subject to the terms and conditions hereof, MRVT, or a marketing partner
selected by MRVT, shall use its best reasonable efforts to market the MRVT Drugs
in connection with the Co-Developed Devices and shall provide all necessary
customer or other service, shipping and receiving and invoicing services in
support of the sales of MRVT Drugs sold in connection with the Co-Developed
Technology by the Marketing Partner, and MRVT shall pay to Xillix royalties on
the sale of MRVT Drugs as follows:
(a) *****
(b) *****
5.02 Ownership of Trademarks.
(a) The registration, maintenance and protection of all trademarks, logos
and/or trade dress owned by Xillix for use in connection with the Xillix
Components shall be the responsibility of Xillix. The registration, maintenance
and protection of all trademarks, logos and/or trade dress owned by MRVT for use
in connection with the MRVT Components and the MRVT Drugs shall be the
responsibility of MRVT. Ownership of trademarks of Co-Developed Devices shall be
owned by the parties as follows, unless otherwise agreed to in writing by the
parties: MRVT *****, Xillix *****. The Co-Developed Device will be labeled with
a MRVT Trademark if requested by MRVT.
(b) Each party acknowledges that the other party owns all right, title and
interest in their respective corporate names, logos and are the owners of
certain other trademarks, service marks, and tradenames; and that each party
will not acquire any interest in any of these trademarks, service marks or
tradenames of the other party by virtue of this Agreement or the activities
under it.
(c) During the term of this Agreement, each party may indicate to the
public and the trade that they have a business relationship with the other and
will be developing the Co-Developed Devices and Co-Developed Technology. With
the other party's prior written approval, either party may also use the
trademarks and tradenames of the other party to promote and solicit sales of the
Co-Developed Devices and Co-Developed Technology if they strictly comply with
the other party's instructions regarding that use. Both parties agree not to
adopt or use those trademarks or tradenames of the other party, or any
confusingly similar word or symbol, as part of its company name or (to the
extent they have power to prevent such use) allow such names or marks to be used
by others.
(d) At the expiration or termination of this Agreement, both parties agree
to immediately discontinue any use of the corporate name and all trademarks,
tradenames and service marks of the other party, as well as any other
combination of words, designs, trademarks or tradenames that would indicate that
such party has a business relationship with the other party.
***** Confidential Treatment Requested
ARTICLE VI - PAYMENTS AND ACCOUNTING
6.01 Payment of Research and Development, Clinical Evaluations and
Preclinical Costs.
Unless otherwise agreed in writing, during Research and Development,
Clinical Evaluations and Preclinical Tests, each party shall pay the expenses
thereof, excluding MRVT Components, Xillix Components, MRVT Drugs and
Co-Developed Devices, as follows:
MRVT *****
Xillix *****
All requests for expense reimbursement shall be made quarterly within sixty
(60) days of the end of each quarter. Reimbursement will be made within thirty
(30) days of the receipt of an invoice. A party who receives an invoice may pay
the invoice by setting off sums owed to that party by the submitting party,
excluding MRVT Components and Xillix Components.
6.02 Payment of Clinical Trial Costs.
During Clinical Trials, excluding MRVT Components, Xillix Components and
the Co-Developed Device, MRVT will pay all Clinical Trial costs unless otherwise
agreed in writing.
6.03 Payment for MRVT Components and Xillix Components.
Once Co-Developed Devices are in commercial distribution, each party shall
submit invoices to the Manufacturing Partner upon shipment of components. The
Manufacturing Partner shall pay all invoices, plus all applicable taxes or
freight and other transportation charges stated thereon, within thirty (30) days
after date of invoice.
6.04 Payment of Royalties.
The royalties due under this Agreement shall be paid quarterly within
thirty (30) days after March 31, June 30, September 30 and December 31. Each
payment shall be accompanied by a report containing sufficient information to
enable the other party to verify the accuracy of the calculation of Net Sales on
which such payment was based during the royalty period, including a statement of
Gross Sales and Net Sales and a reconciliation of the credits, allowances and
rebates used to calculate Net Sales from Gross Sales.
6.05 Payment of Monies.
All payments made pursuant to this Agreement by one party to the other
shall be made in U.S. dollars.
***** Confidential Treatment Requested
6.06 Late Payments.
In the event any payment due pursuant to this Agreement is not paid within
the time specified, in addition to remitting the amount of the payment as
required by this Agreement, the late paying party shall pay the other party
interest on such amount at the prime rate per annum, as published from time to
time in the Wall Street Journal; such interest being payable on demand together
with all costs incurred by the collecting party to collect the amounts due
hereunder, including, but not limited to, reasonable attorney fees and
disbursements.
6.07 Books and Records.
Each of MRVT and Xillix shall keep, and shall cause their Affiliates and
the Manufacturing Partner and Marketing Partner and sublicensees to keep, full,
true and accurate books of accounts and other records, for a period of five (5)
years, containing sufficient detail as may be necessary for the other party to
properly ascertain and verify the costs and royalties payable to it hereunder in
accordance with generally accepted accounting principles. Upon either MRVT's or
Xillix's request, the other party shall permit an employee of the requesting
party or an independent certified accountant selected by the requesting party
(except one to whom the other has reasonable objection) to have access once each
year during ordinary business hours to such records as may be necessary to
determine the correctness of any report and payment made under this Agreement.
If an audit shows that either party has overstated costs or underpaid royalties
by ten percent (10%) or more, for any financial period covered by the audit,
that party shall, in addition to immediately remitting the amount of cost
overstatement or royalty underpayment, pay for the cost of such audit.
ARTICLE VII - REGULATORY RESPONSIBILITIES
7.01 Compliance With Applicable Law.
In exercising the rights, and in carrying out the duties and obligations
set forth in this Agreement, each party represents and warrants that it shall
comply with all applicable state, federal and other laws or rules. Each party
further represents and warrants that it shall comply to the extent of its duties
hereunder with all applicable state, federal or other rules and regulations
governing the manufacture, records, distribution, promotion, marketing and sale
of Co-Developed Devices, MRVT Components or Xillix Components, as the case may
be, and that it shall specifically comply with GCPs, GLPs, GMPs or other
equivalent regulatory requirements of any country.
7.02 Notification of FDA Action.
MRVT and Xillix shall promptly notify each other of, and shall provide
copies of, any correspondence and other documentation received or prepared in
connection with any FDA action or notification regarding Co-Developed Devices.
MRVT and Xillix shall jointly determine whether a recall, field action, or other
regulatory action is warranted. In the event of a total or partial recall of
Co-Developed Devices, whether voluntary or mandated by law, MRVT and Xillix
agree to cooperate fully with each other to effect such recall. In the event a
recall results from the gross negligence or willful misconduct of either party,
then that party, whether MRVT or Xillix, shall bear the expenses associated with
such recall. In the event a recall results from the gross negligence or willful
misconduct of both MRVT and Xillix, then the parties shall equitably share the
expenses associated with such recall, to the extent that each party is
responsible.
ARTICLE VIII - PATENTS
8.01 Patents.
If a patentable invention embodying Co-Developed Technology, or related to
Co-Developed Devices or to the Field, is conceived in the course of this
Agreement and reduced to practice during the term of this Agreement and for a
period of two (2) years after its termination, MRVT and Xillix shall together
determine whether to file patent applications covering the invention. Both
parties agree to begin application and prosecution in a timely manner once
patentable inventions are identified and disclosed. Any such patent applications
shall be prepared by the parties and filed in the name of the parties as defined
in Section 2.01. Xillix and MRVT shall prepare, prosecute and maintain any and
all of their respective Patents embodying Co-Developed Technology or related to
Co-Developed Devices for the Field. The reasonable costs thereof shall be the
responsibility of each party separately or shared according to the ownership
thereof, as defined in Section 2.01, and any rights hereunder shall be owned in
the same proportions. If either party elects not to prepare, prosecute or
maintain any such Patent, then the other party shall have the right, but not the
obligation, to do so in its own name, at its own expense and for its own benefit
and assignment of rights in such Patent. If MRVT and Xillix mutually agree in
writing to allow either party to utilize any Patent outside the Field, such
agreement shall include, at a minimum, terms as to the development, manufacture
and royalty obligations of the parties.
8.02 Patent Infringement by Third Parties.
If, during the term of this Agreement, either MRVT or Xillix shall acquire
knowledge or have reasonable cause to believe that any patent rights covering
Co-Developed Devices, Co-Developed Technology shall be infringed or used without
authorization by any third party, either MRVT or Xillix shall promptly notify
the other of such knowledge. MRVT and Xillix agree to cooperate in making prompt
investigation of such possible infringement.
8.03 Initiation of Action by MRVT or Xillix.
If MRVT and Xillix determine to jointly institute any action described in
Section 8.02, then MRVT and Xillix shall share in the costs of such action
according to the ownership as defined thereof, in Section 2.01 and in the full
recovery of any money or other property collected by way of judgment, settlement
(whether prior to or after the institution of any action or proceeding) or
otherwise on any action initiated jointly by the parties. If either MRVT or
Xillix determines not to be involved in any such action, then it will execute an
assignment of its rights to the other party, and the other party may take all
steps in the name of both parties which are necessary or advisable including,
without limitation, the institution of any action or proceeding for the
obtaining of damages or the enjoinment of any such infringement and to
prosecute, settle, compromise or otherwise dispose of the same. That party,
whether MRVT or Xillix, shall pay all costs taken pursuant to this Section 8.03
and shall be entitled to the full recovery of any money or other property
collected by way of judgment, settlement (whether prior to or after the
institution of any action or proceeding) or otherwise on any action initiated by
the party.
8.04 Claims Against MRVT or Xillix.
If any claim is made or action brought against MRVT or Xillix based on the
claim that MRVT or Xillix is infringing any third party patent rights by virtue
of the manufacture, use or sale of Co-Developed Devices or Co-Developed
Technology hereunder, MRVT or Xillix shall promptly so notify the other. The
parties shall then consult with each other as to the course of action to take
relative to such third party claim. Unless otherwise agreed to in writing by the
parties, each party hereto shall pay its own expenses in defending any such
third party claim and if they cannot agree, then it shall be resolved in
accordance with Article 17 hereof. MRVT shall be solely responsible for any
infringement claims related to MRVT's trademarks, Patents or other intellectual
property, including the MRVT Technology or the MRVT Components, and for all
damages related thereto. Xillix shall be solely responsible for any infringement
claims related to Xillix's trademarks, Patents or other intellectual property,
including the Xillix Technology or the Xillix Components, and for all damages
related thereto.
8.05 Damages to Third Party.
If, in any such action described in Section 8.04, a court of competent
jurisdiction determines that MRVT or Xillix is obligated to pay damages to any
third person because the manufacture, use, sale, distribution or licensing of
the Co-Developed Technology or Co-Developed Devices was held to be an
infringement of a third party right, the parties shall be responsible for any
damages and associated costs related thereto in accordance with the ownership
thereof, as defined in Section 2.01.
ARTICLE IX - PUBLICATIONS AND CONFIDENTIALITY
9.01 Publication.
(a) At least thirty (30) days prior to the time either party submits any
data or articles related to Co-Developed Technology or Co-Developed Devices for
publication or presentation, the proposed publication or presentation must be
sent to the Operating Committee for review and approval. If the Operating
Committee so decides, such publication or presentation can be delayed as long as
necessary to preserve U.S. or foreign patent or other property rights.
(b) The parties agree that neither of them will make any public
announcements or issue any press release arising out of or in connection with
this Agreement without consulting with the other party prior to making any
announcement or press release and the parties will use all reasonable effort,
acting expeditiously and in good faith, to agree upon a text for such
announcement or release which is satisfactory to each of them. If the parties
fail to agree upon such text, the party making the disclosure will make only
such public announcement or release as its counsel advises in writing is legally
required to be made.
9.02 Confidential Information.
Unless otherwise agreed to in writing by the parties, the parties agree to
maintain in confidence information relating to MRVT Technology, Xillix
Technology, Co-Developed Technology or Co-Developed Devices (including without
limitation, information developed in Preclinical Tests and Clinical Trials), and
licenses, Patents, patent applications, technology or processes and business
plans of the other party, including, without limitation, information designated
as confidential in writing from one party to another (all of the foregoing
hereinafter referred to as "Confidential Information"), disclosed to the other
and shall not, during the term of this Agreement and for a period of five (5)
years thereafter, use such Confidential Information, except as permitted by this
Agreement or disclose the same to anyone other than those of its officers,
directors, employees, Affiliates and sublicensees as are necessary in connection
with either parties' activities as contemplated in this Agreement, provided that
these disclosees agree in writing to be similarly bound.
9.03 Limitations on Confidentiality.
The obligation of confidentiality in Section 9.02 shall not apply to the
extent that (i) a party is required to disclose information by applicable law,
such as pursuant to Securities and Exchange Commission rules and regulations, or
by order of a governmental agency or a court of competent jurisdiction; (ii) a
party can demonstrate that the disclosed information was, at the time of
disclosure, already in the public domain other than as a result of actions or
failure to act of a party, its officers, directors, employees, Affiliates and
sublicensees in violation hereof; (iii) the disclosed information was rightfully
known by a party or its Affiliates or sublicensees (as shown by its written
records) prior to the date of disclosure to the other party in connection with
this Agreement; or (iv) a party can demonstrate that the disclosed information
was received by a party or its Affiliates or sublicensees on an unrestricted
basis from a third party which is not the other party or an Affiliate of the
other party and not under a duty of confidentiality, and which was rightfully
known to said source.
ARTICLE X - WARRANTIES OF MRVT
10.01 Warranty.
MRVT represents and warrants that MRVT Components and Co-Developed Devices,
at the time of shipment to Xillix, shall not have been misbranded or adulterated
within the meaning of the Act, or of any applicable state or local law. MRVT
further represents and warrants that MRVT Components sold to Xillix hereunder
shall have been manufactured, packaged, labeled, stored and shipped in
conformity with all applicable GMP requirements.
10.02 No Other Product Warranties.
Except as expressly provided for in this Article X, MRVT makes no
representations or warranties of any nature whatsoever with respect to the MRVT
Components, the MRVT Technology the Co-Developed Technology and the Co-Developed
Devices, and ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY
DISCLAIMED BY MRVT AND ITS AFFILIATES.
10.03 Product Liability Insurance.
Upon commencement of Clinical Trials, MRVT shall obtain product liability
insurance in such reasonable amounts as is customary for pharmaceutical
companies in the United States and shall name Xillix as an additional named
insured on its policy of product liability insurance. MRVT shall not cancel the
insurance policy or fail to renew it without providing Xillix with sixty (60)
days notice in advance of such cancellation or non-renewal.
10.04 Limitation on Liabilities.
MRVT will not be responsible to Xillix or any third party for
consequential, extraordinary or punitive damages. MRVT's total liability for
damages to Xillix under this Agreement, excluding any liability for direct
damages, lost profits and reasonable attorneys' fees, shall not exceed
$2,000,000.00, regardless of the form of action.
ARTICLE XI - WARRANTIES OF XILLIX
11.01 Warranty.
Xillix represents and warrants that Xillix Components shall not have been
misbranded or adulterated within the meaning of the Act, or of any applicable
state or local law. Xillix further represents and warrants that the Xillix
Components shall have been manufactured, packaged, labeled, stored and shipped
in conformity with all applicable GMP requirements.
11.02 No Other Product Warranties.
Except as expressly provided for in this Article XI, Xillix makes no
representations or warranties of any nature whatsoever with respect to the
Xillix Components or the Xillix Technology, and ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY XILLIX AND ITS AFFILIATES.
11.03 Product Liability Insurance.
Upon commencement of Clinical Trials, Xillix shall obtain product liability
insurance in such reasonable amounts as is customary for medical device
companies in Canada and shall name MRVT as an additional named insured on its
policy of product liability insurance. Xillix shall not cancel the insurance
policy or fail to renew it without providing MRVT with sixty (60) days notice in
advance of such cancellation or non-renewal.
11.04 Limitation on Liabilities.
Xillix will not be responsible to MRVT or any third party for
consequential, extraordinary or punitive damages. Xillix's total liability for
damages to MRVT under this Agreement, excluding any liability for direct
damages, lost profits and reasonable attorneys' fees, shall not exceed
$2,000,000.00, regardless of the form of action.
ARTICLE XII - MUTUAL WARRANTIES
12.01 Right, Power and Authority to Execute.
Each party hereby represents and warrants to the other party that it has
full right, power and authority to enter into this Agreement and that the
Agreement has been duly authorized by all necessary actions of its directors and
shareholders and constitutes a valid and binding obligation.
12.02 Corporate Good Standing.
Each party represents and warrants to the other party that it is a
corporation duly organized and validly existing and in good standing under the
laws of its respective jurisdiction of incorporation and that no governmental
approval or consent of any third party is necessary for the execution or
delivery by such party of this Agreement or for the legality, validity or
enforceability of this Agreement as to such party.
12.03 Duration of Representations and Warranties.
Each party represents and warrants to the other party that the
representations and warranties set forth in Articles X, XI, and XII shall be
true as of the Effective Date of this Agreement.
ARTICLE XIII - TERM & TERMINATION
13.01 Term of Agreement.
This Agreement shall be effective as of the date first set forth
hereinabove ("Effective Date"), and shall continue in full force and effect for
seven (7) years from the date of first NDA approval for commercial sale of
Co-Developed Devices. If an NDA is not approved by December 31, 2003, then this
Agreement shall continue for an additional period of one year, which shall renew
automatically for additional periods of one year, unless either party decides to
terminate this Agreement upon thirty (30) days prior written notice. Provided
that both parties agree in writing, at least one hundred eighty (180) days prior
to the expiration of the then-existing term, MRVT and Xillix may have the option
to extend the term of this Agreement by successive two (2) year periods. Subject
to the other terms and conditions of this Agreement, royalty payments payable
hereunder shall continue for the life of the Co-Developed products.
13.02 Termination for Material Breach.
Either party may terminate this Agreement in the event of a material breach
by the other, provided that the party asserting such breach first serves written
notice of the alleged material breach on the offending party and such alleged
breach is not cured within thirty (30) days of said notice, unless such material
breach cannot reasonably be cured within said period, in which case the cure
period will be extended ninety (90) days if the offending party has commenced to
cure the material breach within the thirty (30) day period and continues to
diligently effect such cure. The nondefaulting party can, at its option, waive
the right to terminate the Agreement and specifically enforce this Agreement. A
material breach of the Subscription Agreement will be deemed a material breach
of this Agreement.
13.03 Termination for Insolvency.
In the event that either party becomes insolvent or shall suspend its
business, or shall file a voluntary petition or any answer admitting the
jurisdiction of the court and the material allegations of, or shall consent to,
an involuntary petition pursuant to or purporting to be pursuant to any
reorganization or insolvency law of any jurisdiction, or shall make an
assignment for the benefit of creditors, or shall apply for or consent to the
appointment of a receiver or trustee of all or a substantial part of its
property (such party, upon the occurrence of any such event, a "Bankrupt
Party"), and if such proceeding is not terminated within sixty (60) days of such
a filing, then to the extent permitted by the law another party hereto may
thereafter immediately terminate this Agreement by giving written notice of
termination to the Bankrupt Party.
13.04 Effect of Expiration or Termination.
Expiration or earlier termination of this Agreement shall not extinguish
rights or obligations previously accrued or vested, and Sections 2.04, 2.05,
4.01, 5.01(ii), 5.02, 6.07, 8.01, 8.02, 8.03, 8.04, 8.05, 9.02, 10.01, 10.02,
10.03, 10.04, 11.01, 11.02, 11.03, 11.04, 14.01, 14.02, 14.03, 15.03, 17.01 and
17.02 hereof shall survive the termination of this Agreement.
ARTICLE XIV - INDEMNIFICATION
14.01 MRVT Indemnity.
MRVT agrees to indemnify, protect and defend Xillix and hold Xillix
harmless from and against any claims, damages, liability, harm, loss, costs,
penalties, lawsuits, threats of lawsuit, recalls or other governmental action,
including reasonable attorneys' fees, brought or claimed by any third party
which (i) arise as the result of MRVT's breach of this Agreement or of any
warranty or representation made by MRVT under this Agreement; (ii) result from
the negligent acts or willful malfeasance on the part of MRVT or its employees
or agents, or (iii) result from any claim made against Xillix in connection with
MRVT's manufacture or sale of defective MRVT Components or Co-Developed Devices.
Upon the filing of any such legal claim or lawsuit against Xillix, Xillix shall
promptly notify MRVT, in writing, of any such claim and MRVT shall, at its
expense, with attorneys reasonably acceptable to Xillix, handle, defend and
control such claim or lawsuit.
14.02 Xillix Indemnity.
Xillix agrees to indemnify, protect, and defend MRVT and hold MRVT harmless
from and against any claims, damages, liabilities, harm, loss, costs, penalties,
lawsuits, threats of lawsuit, recalls or other governmental action, including
reasonable attorneys' fees, brought or claimed by any third party, which (i)
arise as a result of Xillix's breach of this Agreement or of any warranty or
representation by Xillix under this Agreement; or, (ii) result from the
negligent acts or willful malfeasance on the part of Xillix or its employees or
agents, or (iii) result from any claim made against MRVT in connection with
Xillix's manufacture or sale of defective Components or the Co-Developed
Devices. Upon the filing of any such legal claim or lawsuit against MRVT, MRVT
shall promptly notify Xillix, in writing, of any such claim and Xillix shall, at
its expense, with attorneys reasonably acceptable to MRVT, handle, defend, and
control such claim or lawsuit.
14.03 Notice of Defense of Actions.
Each party shall give the other prompt notice of any potential liability,
and promptly after receipt by a party claiming indemnification under this
Article XIV, of notice of the commencement of any action, such indemnified party
shall notify the indemnifying party of the commencement of the action and
generally summarize such action. The indemnifying party shall have the right to
participate in and to assume the defense of such action with counsel of its
choosing. An indemnifying party shall not have the right to direct the defense
in such an action of an indemnified party if counsel to such indemnified party
has reasonably concluded that there may be defenses available to it that are
different from or additional to those available to the indemnifying party;
provided, however, that in such event, the indemnified party shall bear the fees
and expenses of separate counsel reasonably satisfactory to the indemnifying
party. The failure to notify an indemnifying party promptly of the commencement
of any such action, if prejudicial to the ability to defend such action, shall
relieve such indemnifying party of any liability to the indemnified party under
this Article XIV. No settlement of any claim or action, or decision not to
appeal a judgment, may be made without the consent of the indemnifying party
(which consent shall not be unreasonably withheld or delayed).
ARTICLE XV - MISCELLANEOUS
15.01 Force Majeure.
No party to this Agreement shall be liable to another party for any loss,
injury, delay, damage or other casualty suffered or incurred by such other party
due to strikes, lockouts, accidents, fire, delays in manufacture, transportation
or delivery of material, embargoes, inability to ship, explosions, floods, war,
governmental action or any other cause similar thereto which is beyond the
reasonable control of such other party and any failure or delay by a party in
the performance of any of its obligations under this Agreement, other than for
the payment of money, shall not be considered as a breach of this Agreement due
to, but only so long as there exists, one or more of the foregoing causes.
15.02 Relationship.
This Agreement shall not be construed to create between the parties hereto
or their respective successors or permitted assignees the relationship of
principal and agent, joint ventures, co-partners or any other similar
relationship, the existence of which is hereby expressly denied by each party.
The parties shall not be liable to any third party in any way for engagement,
obligation, contract, representation or transaction or for any negligent act or
omission to act of the other except as expressly provided.
15.03 Governing Law.
The provisions of this Agreement shall be governed in all respects by the
laws of the State of California, without regard to the conflict of law
provisions thereof, or the United Nations Convention on Contracts For the
International Sale of Goods.
15.04 Notice.
All notices, proposals, submissions, offers, approvals, agreements,
elections, consents, acceptances, waivers, reports, plans, requests,
instructions and other communications required or permitted to be made or given
hereunder (all of the foregoing hereinafter collectively referred to as
"Communications") shall be in writing, and shall be deemed to have been duly
made or given when: a) delivered personally with receipt acknowledged; b) sent
by registered or certified mail or equivalent, return receipt requested, or c)
sent by facsimile or telex (which shall promptly be confirmed by a writing sent
by registered or certified mail or equivalent, return receipt requested), or d)
sent by recognized overnight courier for delivery within twenty-four (24) hours,
in each case addressed or sent to the parties at the following addresses and
facsimile numbers or to such other or additional address or facsimile as any
party shall hereafter specify by communication to the other parties:
To MRVT: Miravant Medical Technologies
0000 Xxxxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
Attention: President
Facsimile: 000-000-0000
With a copy to: Nida & Xxxxxxx, P.C.
000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
Attention: Xxxxxx X. Xxxx
Facsimile: 000-000-0000
To Xillix: Xillix Technologies Corp.
#000 - 00000 Xxxxxxxx Xxxxxxx
Xxxxxxxx, X.X. Xxxxxx X0X 0X0
Attention: President and Chief
Executive Officer
Facsimile: 000-000-0000
With a copy to: Fraser & Xxxxxx
15th Floor, The Grosvenor Building
1040 W. Georgia Street
Vancouver, B.C., V6E 4H8
Attention: Xxxx Xxxxxx
Facsimile: 000-000-0000
Notice of change of address shall be deemed given when actually received, all
other Communications shall be deemed to have been given, received and dated on
the earlier of: (i) when actually received, or on the date when delivered
personally; (ii) one (1) day after being sent by facsimile, cable, telex (each
promptly confirmed by a writing as aforesaid) or overnight courier; or four (4)
business days after mailing.
15.05 Legal Construction.
In case any one or more of the provisions contained in this Agreement shall
be invalid or unenforceable in any respect, the validity and enforceability of
the remaining provisions contained herein shall not in any way be affected or
impaired thereby and the parties will attempt to agree upon a valid and
enforceable provision which shall be a reasonable substitute for such invalid
and unenforceable provision in light of the tenor of this Agreement, and, upon
so agreeing, shall incorporate such substitute provision in this Agreement.
15.06 Entire Agreement, Modifications, Consents, Waivers.
This Agreement contains the entire agreement of the parties with respect to
the subject matter hereof. This Agreement may not be modified or amended except
by an instrument or instruments in writing signed by the party against whom
enforcement of any such modification or amendment is sought. Each party hereto
may, by an instrument in writing, waive compliance by another party hereto with
any term or provision of this Agreement on the part of such other party to be
performed or complied with. The waiver by either party hereto of a breach of any
term or provision of this Agreement shall not be construed as a waiver of any
other or subsequent breach.
15.07 Section Headings; Construction.
The section headings and titles contained herein are each for reference
only and shall not be deemed to affect the meaning or interpretation of this
Agreement. The words "hereby", "herein", "hereinabove", "hereinafter", "hereof"
and "hereunder", when used anywhere in this Agreement, refer to this Agreement
as a whole and not merely to a subdivision in which such words appear, unless
the context otherwise requires. The singular shall include the plural, the
conjunctive shall include the disjunctive and the masculine gender shall include
the feminine and neuter, and vice versa, unless the context otherwise requires.
15.08 Execution Counterparts.
This Agreement may be executed in any number of counterparts and each such
duplicate counterpart shall constitute an original, any one of which may be
introduced in evidence or used for any other purpose without the production of
its duplicate counterpart. Moreover, notwithstanding that any of the parties did
not execute the same counterpart, each counterpart shall be deemed for all
purposes to be an original, and all such counterparts shall constitute one and
the same instrument, binding on both of the parties hereto.
ARTICLE XVI - BINDING EFFECT; ASSIGNMENT
16.01 Binding Effect and Assignment.
This Agreement shall inure to the benefit of and be binding upon each of
the parties hereto and their respective successors and assigns. Neither this
Agreement, nor any of the rights and obligations under this Agreement, may be
assigned, transferred or otherwise disposed of by either party without prior
written consent of the other party, unless such assignment, transfer or
disposition is to a successor to substantially all the business or assets of the
transferor; provided that, such successor shall in any event agree in writing
with the other party to assume all obligations of the transferor under this
Agreement in a manner satisfactory to the other party. Subject to the foregoing
limitations, the Agreement shall be binding upon and inure to the benefit of the
respective successors and assigns of the parties.
16.02 Right to Seek Assurance.
In the event all or substantially all of the assets of either MRVT or
Xillix are acquired by a third party, the non-acquired party shall have the
right pursuant to Section 16.01 to receive written assurance from such third
party that the third party intends to faithfully perform all of the duties and
obligations of the acquired party set forth in this Agreement. The acquired
party shall take all necessary action to enable the non-acquiring party to
obtain such written assurance.
ARTICLE XVII - RESOLUTION OF DISPUTES
17.01 Resolutions.
Any and all disputes arising out of or in connection with this Agreement
unable to be resolved by the Operating Committee shall be negotiated in good
faith by the Presidents of MRVT and Xillix to achieve a reasonable resolution of
such issue.
17.02 Arbitration.
Any and all disputes arising out of or related to this Agreement, and which
are not resolved in accordance with Section 17.01 hereof, shall be finally
settled by arbitration in accordance with the rules of the American Arbitration
Association by arbitrators familiar with medical technology. The arbitration
will be held in Los Angeles, California, on consecutive business days. The award
rendered shall be final and binding upon the parties. Judgment on any award may
be entered in any court having jurisdiction over the parties or their assets.
Notwithstanding anything to the contrary contained in this paragraph, or to the
extent any claims relate to the validity, construction, scope, enforceability or
infringement of any Patent Rights, such claim shall not be required to be
submitted to arbitration hereunder and shall be resolved by a court of competent
jurisdiction. The costs of the arbitration shall be shared equally by the
parties. Each party will pay their own attorneys' fees and costs.
[Signatures on next page.]
IN WITNESS WHEREOF, the parties have cause this Agreement to be executed as
of the day and year first written above.
MIRAVANT MEDICAL TECHNOLOGIES
By:/S/
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Title:__________________________________
Date:___________________________________
XILLIX TECHNOLOGIES CORP.
By:/S/
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Title:__________________________________
Date:___________________________________