RESTATED AND AMENDED
DEVELOPMENT AND LICENSE AGREEMENT
between
PHARMACIA & UPJOHN S.p.A.
and
MIRAVANT MEDICAL TECHNOLOGIES
June 8, 1998
RESTATED AND AMENDED
DEVELOPMENT AND LICENSE AGREEMENT
THIS RESTATED AND AMENDED DEVELOPMENT AND LICENSE AGREEMENT is made and
entered into as of the 8th day of June, 1998 by and between PHARMACIA & UPJOHN
S.p.A., an Italian corporation organized and existing under the laws of Italy,
with its head offices at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇.▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ (hereinafter
referred to as "P&U"), and MIRAVANT MEDICAL TECHNOLOGIES, a corporation
organized and existing under the laws of the State of Delaware, with its head
offices at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇.▇.▇.
(hereinafter referred to as "MRVT").
WITNESSETH THAT:
WHEREAS, P&U is a pharmaceutical company doing research, development and
marketing of pharmaceutical products;
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 parties, photoreactive drugs
and related light devices for the diagnosis and treatment of a wide variety of
diseases;
WHEREAS, P&U and MRVT are parties to a Development and License Agreement
dated July 1, 1995, as amended (the "License Agreement").
WHEREAS, the experience of the parties over the term of the License
Agreement has given rise to the need to modify the License Agreement in order to
expedite development and meet P&U's desire to be involved only in the Fields of
Oncology and Urology.
WHEREAS, the parties have agreed that, in lieu of the cumbersome structure
contemplated in the License Agreement, MRVT will have full and complete control
of the Development Program for SnET2 for indications in the Fields of Oncology
and Urology and will pay for all expenses, subject to payment by P&U to MRVT of
a significant portion of the expected costs of the Development Program in
Oncology and Urology through June 30, 2000.
WHEREAS, P&U's affiliate, Pharmacia & Upjohn AB, will continue to have the
rights in the Ophthalmology Field pursuant to a mutually agreeable agreement
entered into on the date hereof.
NOW, THEREFORE, in consideration of the above premises and the covenants
contained herein, the parties hereto agree as follows:
ARTICLE I - DEFINITIONS
1.01 Affiliate. "Affiliate" shall mean, with respect to any specified
party, any person or entity 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).
1.02 Agreement. "Agreement" shall mean this Restated and Amended
Development and License Agreement. The term "Ancillary Agreements," as used
herein, shall mean the following related agreements: SnET2 Device Supply
Agreement, dated July 1, 1995, as amended, and the Product Supply Agreement,
dated July 1, 1995, as amended.
1.03 Clinical Tests. "Clinical Tests" shall mean any tests performed on
humans in preparation and support of regulatory submissions.
1.04 Development Program. "Development Program" shall *****.
1.05 Effective Date. The term "Effective Date" shall mean January 1, 1998.
1.06 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 or
biological medical products and/or medical devices in the United States or where
appropriate, the equivalent governmental authority in any foreign country.
1.07 Fields. The term "Fields" shall mean the fields of Oncology and
Urology.
1.08 Gross Sales. "Gross Sales" shall mean the final gross invoiced price
from the sale of Product by P&U and its Affiliates or Sublicensees; provided,
however, that Gross Sales shall exclude sales of Products which are intended for
resale between P&U entities, its Affiliates and Sublicensees.
1.09 GCP. "GCP" shall mean current "good clinical practices" for carrying
out clinical studies in humans as set forth in regulations promulgated by the
FDA as such may be amended from time to time or, where appropriate, the
equivalent regulations promulgated by the equivalent governmental authority in
any foreign country.
1.10 GLP. "GLP" shall mean current "good laboratory practices" for
conducting nonclinical laboratory studies as set forth in regulations (21 CFR
Part 58) promulgated by the FDA as such may be amended from time to time or,
where appropriate, the equivalent regulations promulgated by the equivalent
governmental authority in any foreign country.
1.11 GMP. "GMP" shall mean current "good manufacturing practices" for
preparation of drug products as set forth in regulations (21 CFR Parts 210 and
211) promulgated by the FDA as such may be amended from time to time or, where
appropriate, the equivalent regulations promulgated by the equivalent
governmental authority in any foreign country.
1.12 Light Devices. "Light Devices" shall mean the instruments that
produce, deliver or measure light for use with the Product.
1.13 Major Countries. "Major Countries" shall mean the ***** and *****.
1.14 Net Sales. "Net Sales" shall mean Gross Sales less the following:
trade, cash and quantity discounts; returns, normal trade allowances, normal
charge-backs, federal, state, or other governmental rebates and adjustments;
taxes on the sale or transportation absorbed by P&U; and sales to P&U's
Affiliates or third parties of Product not for resale in the Territory
1.15 New SnET2. "New SnET2" shall mean the Photodynamic Therapy drug
designated by MRVT as tin ethyl etiopurpurin in any formulation or strength,
other than SnET2, as defined in Section 1.21.
1.16 NDA. "NDA" shall mean a "New Drug Application" or other premarket
approval application for Product and any supplement or abbreviated application
relating thereto, submitted to the FDA or its equivalent in any foreign country.
***** Confidential Treatment Requested
1.17 Patent Rights. "Patent Rights" shall mean all United States and
foreign patent applications, as well as continuation, divisional or
continuation-in-part applications, and all patents issuing therefrom including
reissue or reexamination patents containing at least one claim covering Product,
its use or sale, and only to the extent such Patent Rights are directed to
Product, which Patent Rights are now or hereafter owned or acquired by MRVT or
any of its Affiliates, or licensed to MRVT or any of its Affiliates. Patent
Rights licensed to MRVT will only be granted to P&U to the extent permitted by
MRVT's license agreement and P&U will do nothing to disturb such agreement. 1.18
Photodynamic Therapy. "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.
1.19 Preclinical Tests. "Preclinical Tests" shall mean any nonhuman tests
performed in preparation and support of regulatory submissions.
1.20 Product. "Product" shall mean pharmaceutical products for Photodynamic
Therapy containing tin ethyl etiopurpurin as the active drug substance and any
isomers and derivatives thereof, in any formulation, whether SnET2 as defined in
Section 1.21 or New SnET2 as defined in Section 1.15.
1.21 SnET2. "SnET2" shall mean the Photodynamic Therapy drug designated by
MRVT as tin ethyl etiopurpurin in the injectable lipid emulsion formulation
being tested in clinical trials as of the Effective Date, regardless of the vial
or other container size.
1.22 Sublicensee. "Sublicensee" shall mean a third party to whom P&U has
granted, in whole or in part, the right to market or co-market the Product in
one or more countries in the Territory and who performs selling activities such
as invoicing customers in one or more countries in the Territory.
1.23 Technology. "Technology" shall mean all information and data
including, but not limited to, technical, pharmacological, toxicological and
clinical information, know-how, inventions and improvements possessed by MRVT as
of the Effective Date or generated or obtained by MRVT during the term of this
Agreement relating to the registration, manufacture, use, or sale of Product, in
each case to the extent MRVT has the right to provide the same to P&U hereunder,
provided however, that "Technology" shall not include any such information or
data regarding the design or manufacture of any Light Device.
1.24 Territory. "Territory" shall mean the entire world.
1.25 Unit. "Unit" shall mean *****.
ARTICLE II - NOT USED
ARTICLE III - LICENSE, GRANT AND ROYALTIES
3.01 License. Subject to the terms of this Agreement. MRVT hereby grants to
P&U and P&U's Affiliates an exclusive worldwide, royalty-bearing, license under
the Patent Rights and Technology, to use, distribute and sell Product for
diagnosis or treatment in the Fields in the Territory. P&U may sublicense,
totally or in part, the license rights granted under this Section 3.01,
provided, however, (i) P&U must notify MRVT, in writing, of any such sublicense
at least thirty (30) days in advance; (ii) P&U remains responsible to MRVT for
all contractual obligations of the Sublicensee including, but not limited to,
payment of royalties, keeping of records and reporting of sales, as if the
Sublicensee's sales were P&U's sales and (iii) the Sublicensee agrees to be
bound by the terms of this Agreement to the same extent as P&U to the extent
applicable to the Sublicensee.
3.02 Term of License. The license rights granted under Section 3.01 shall
remain in effect in each country in the Territory for the duration of the Patent
Rights or for a period of ten (10) years from the first commercial sale of
Product in such country, whichever shall be longer. After this period, P&U shall
have an irrevocable, fully paid-up, nonexclusive license under the Technology in
such country.
3.03 *****
(a) *****
(b) *****
(c) *****
***** Confidential Treatment Requested
3.04 Development Prograam - Expense. P&U shall reimburse MRVT its actual
direct and indirect costs and expenses incurred to perform the *****, up to an
aggregate of Twenty Million Dollars (US) ($20,000,000). Such payments shall be
made in advance in quarterly calendar installments of Two Million Five Hundred
Thousand Dollars (US) ($2,500,000), commencing on July 1, 1998. *****.
3.05 Royalties. P&U shall, for the term of the license specified by Section
3.02, pay MRVT royalties on Net Sales of Product to third parties at the rate of
***** on total Net Sales of Product of *****, per calendar year and a royalty of
***** on the part of total Net Sales of Product ***** per calendar year, subject
to the provisions of Section 6.03. In a number of countries in *****, P&U
operates through distributors, which are local companies appointed to manage the
importation, distribution, promotion and sale of P&U's products. Royalties due
to MRVT by P&U under this Agreement on sales of Product in countries where P&U
operates through distributors shall be calculated on the F.O.B. prices at which
the Product is invoiced to distributors by P&U.
3.06 Sublicense Fees. P&U shall pay MRVT ***** of any up-front or lump-sum
fees received by P&U in consideration of the grant of a sublicense to Product.
3.07 Payment of Royalties. The royalties due pursuant to Section 3.05 shall
be reported quarterly within thirty (30) days after March 31, June 30, September
30, and December 31. Such royalties shall be paid to MRVT or its designed
Affiliate semi-annually within sixty (60) days after June 30 and December 31 of
each calendar year. Each payment to MRVT or its designated Affiliate shall be
accompanied by a report containing sufficient information to enable MRVT or its
designated Affiliate to verify the accuracy of the calculation of Net Sales on
which such payment was based during the payment period, including a statement of
Gross Sales and Net Sales and a reconciliation of the credits, allowances and
rebates contemplated by Section 1.14 to calculate Net Sales from Gross Sales.
3.08 Payment of Royalties and Fees. For the purpose of converting and
paying royalties and sublicense fees specified by Section 3.06 herein, monies
shall be first computed in the currency of the country where the sales took
place or the expense was incurred, and then, unless another currency is
designated by MRVT, converted into US dollars at the most favorable buying
exchange rates prevailing on the day P&U converts the local currency into US
dollars for payment to MRVT.
3.09 P&U Ceases to Market or Sell Product. Subject to the provisions of
Section 5.06, unless otherwise mutually agreed to by the parties and provided
that a particular Product is sold or is to be sold in a Major Country by one
party only, be it P&U or its Affiliate or a Sublicensee, should P&U or its
Affiliates or Sublicensee cease to market or sell a Product in that Major
Country or fail to launch a particular Product in that Major Country within
***** from the occurrence of the latest to occur of the following events (if
applicable in such Major Country): (i) issuance of Product's NDA approval in
that Country, (ii) governmental price approval, (iii) reimbursement of the
social security payment (if any), and (iv) NDA approval of all relevant Light
Devices, P&U shall have no further rights to the Product in that country nor
shall P&U have any further obligations for the Product in that country, except
such obligation that accrued prior to divestment from P&U of rights to the
Product. Subject to MRVT's responsibility for regulatory matters, in the event
rights to Product are divested from P&U pursuant to this Section 3.09 and upon
MRVT's request, P&U shall immediately transfer the NDA approval in that country
to MRVT or to an appointee of MRVT, provide to MRVT all data in P&U's possession
or control relating to that Product and take all such other actions as are
necessary or useful to permit MRVT to obtain regulatory approvals to market
Product in such country. If P&U fails to comply with the foregoing within thirty
(30) business days after Miravant's notice, P&U hereby irrevocably appoints MRVT
as its attorney-in-fact to secure the transfer of the NDA approval to MRVT. MRVT
shall market the Product under its own tradenames or brands and shall not use
P&U's tradenames or brands. Failure by P&U to launch a Product or interruption
of marketing or sale of a Product pursuant to this Section 3.09 shall not be
considered a breach of this Agreement within the meaning of Article X. For the
avoidance of doubt it is understood between the parties hereto that the
provisions of this Section 3.09 shall not apply in the event that P&U or its
Affiliates or Sublicensees cease to sell a Product or fails to launch a Product
in a Major Country as described above, for reasons related to the safety and
efficacy of a Product.
***** Confidential Treatment Requested
3.10 Books and Records. P&U shall keep, and shall cause its Affiliates and
Sublicensees to keep, full, true and accurate books of accounts and other
records, for a period of ***** containing sufficient detail as may be necessary
for MRVT to properly ascertain and verify the royalties payable to it hereunder
in accordance with generally accepted accounting principles. Upon MRVT's
request, P&U shall permit an independent certified accountant selected by MRVT
(except one to whom P&U has some reasonable objection) to have access once each
year during ordinary business hours to such P&U records as may be necessary to
determine the correctness of any report and payment made under this Agreement.
If the audit shows that P&U has underpaid any royalties by ten percent (10%) or
more, for any period covered by the audit, P&U shall, in addition to immediately
remitting to MRVT the amount of underpayment, pay for the cost of such audit. In
the event the audit shows that P&U has overpaid any royalties due pursuant to
Section 3.05, P&U shall be allowed to deduct the amount of such overpayment from
the next semiannual royalty payment due to MRVT.
ARTICLE IV - DEVELOPMENT PROGRAM
4.01 Development. *****
4.02 Preparation of Regulatory Filings. MRVT shall be responsible for
preparing and filing in its own name any regulatory filings necessary for
conducting Clinical Tests.
4.03 MRVT Responsibility. MRVT shall be responsible for conducting all
necessary Preclinical Tests and Clinical Tests for SnET2 to be used in any
indications within the Fields, and shall pay all costs and expenses to perform
such work, *****.
4.04 New SnET2 for Any Indication. MRVT shall be responsible for conducting
all necessary Development Program work for any New SnET2 for any indication in
the Fields. The Development Program Expenses associated with such Preclinical
Tests and Clinical Tests shall be paid by P&U so long as such work is performed
in accordance with the development plan accepted by P&U and such expenses are
incurred in accordance with the budget accepted by P&U.
4.05 Submission of NDA. MRVT shall be responsible for assembling the
information to prepare each NDA for a Product and to submit it to the concerned
health authorities in the Territory. All such NDAs shall be filed in the name
of, and shall remain the sole and exclusive property of, MRVT; provided, that
P&U shall have the right to control all pricing and reimbursement approvals.
MRVT shall be responsible for all reporting and other actions required to comply
with any regulatory requirements applicable to the holder of an NDA. If P&U
markets Product for an indication, MRVT will file any necessary regulatory
notices to support P&U's marketing, including in any country, where legally
required, transferring an NDA into the name of P&U. ***** After due
consideration of P&U's views and good pharmaceutical practices, MRVT shall make
the final decisions on any NDA, other than pricing and reimbursement matters.
ARTICLE V - DUTIES OF THE PARTIES
5.01 Promotion and Customer Service. As MRVT's exclusive licensee for
Product in the Territory, P&U agrees to use all reasonable efforts to introduce,
promote, market and sell Product in the Territory for the Fields. P&U shall
maintain adequate facilities, Product inventory and personnel to ensure prompt
handling and servicing of customers' inquiries and orders and prompt shipment
and servicing of Product.
5.02 Care of Product. P&U shall comply with all applicable regulatory
requirements regarding acceptable methods for care, handling, storage and
shipment of Product. Each party hereby agrees that it shall promptly provide the
other, on request, all information known to it that is necessary for compliance
with the applicable law and regulations concerning the care, handling, storage,
labeling, packaging and shipment of Product.
5.03 Exclusive. During the term of this Agreement, unless otherwise agreed
to by MRVT, P&U shall not either directly, or indirectly, develop or sell other
Photodynamic Therapy drugs in the Fields. P&U agrees that it shall secure the
same agreement from its Affiliates and Sublicensees. P&U's United States
Affiliate's rights under Section XI of the Development and Commercial Supply
Agreement, between such Affiliate and Miravant, dated as of August 31, 1994 (the
"▇▇▇▇▇▇▇ Agreement"), are expressly excluded from the provisions of this Section
5.03.
***** Confidential Treatment Requested
5.04 Authorization. P&U and MRVT each warrant that it has the legal
capacity to enter into this Agreement and that it has secured all necessary
approvals.
5.05 Obligations to MRVT's Licensor. P&U agrees to undertake all
sublicensee obligations set forth in any license agreement MRVT entered into
relating to Patent Rights or Product as of the Effective Date. MRVT represents
and warrants that it has fully disclosed to P&U all such licenses in effect as
of the Effective Date.
5.06 Sale of Product by MRVT. Subject to the terms of this Agreement, MRVT
agrees, while the license granted to P&U under Article III hereof with respect
to any Product is in effect in any country in the Territory, not to license
and/or appoint any other licensee, distributor or marketing representative in or
for such country for such Product, not to sell such Product in or for use in
such country, and not to accept orders for such Product from the purchasers
located within such country or from purchasers MRVT has reason to believe will
sell such Product within or for use in such country, except as provided in this
Section 5.06. *****.
5.07 Right to License Patent Rights, Product and Technology. MRVT hereby
represents and warrants that it owns or has rights to use the Technology and
Patent Rights described herein, and that it has the right to grant sublicenses
under any license to SnET2 or covering Product held by MRVT.
5.08 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 country laws or rules. Each party further represents and warrants that it
shall comply with all applicable rules and regulations governing the
manufacture, distribution, promotion, marketing and sale of Product in the
Territory and that it shall specifically comply with GLPs, GCPs, GMPs or other
equivalent regulatory requirements of that country.
5.09 Duty to Develop Product. MRVT shall use all reasonable efforts to
develop Product in the Fields in accordance with the MRVT Development Plan.
5.10 Patent Filing, Prosecution and Maintenance. MRVT shall be responsible
for all decisions relating to and all costs associated with preparing, filing,
prosecuting and maintaining the Patent Rights. MRVT shall timely notify P&U
about each patent application filed that relates to Product, its progress and
subsequent disposition. MRVT shall not voluntarily abandon or forfeit any Patent
Rights, without the prior approval of P&U, such approval not to be unreasonably
withheld or delayed.
5.11 MRVT's Representations. MRVT hereby represents and warrants that:
(a) It is not party to any agreement, arrangement or understanding
with any third party that in any material way conflicts with its ability to
fulfill any of its obligations under this Agreement.
(b) It will not knowingly commit any material act or fail to take any
act which would cause a material omission or permit any acts or omissions
to occur that would be in conflict with its obligations under this
Agreement or diminish in any material respect the potential scope of the
grant of rights to P&U under this Agreement.
(c) It has no knowledge that the license rights granted to P&U with
respect to the Product shall be subject to any material retained right of
any state, federal or foreign government or governmental entity, except for
the rights of the United States government under the ▇▇▇▇-▇▇▇▇ Act and
except as disclosed to P&U.
(d) It has no knowledge that making, using or selling any Products
(along or in combination with any Light Devices) may infringe the patent
rights of any third party nor does it have any knowledge that any third
party is infringing the Patent Rights.
(e) Other than as disclosed to P&U prior to July 1, 1995, it has no
agreement, understanding or undertakings with any third parties regarding
ownership or disposition of tin ethyl etiopurpurin, isomers and derivatives
thereof, or any Product.
***** Confidential Treatment Requested
5.12 Access to Information Relating to Light Devices. MRVT shall provide
P&U with access to information or data relating to Light Devices that P&U may
need to perform its obligations and exercise its rights hereunder, including
compliance with any regulatory requirements and the marketing and sale of the
Products.
5.13 Access to Light Devices. The parties mutually acknowledge that an
essential feature of the development of Product for marketing hereunder is
access by P&U to Light Devices. MRVT agrees that it shall undertake all
necessary action to enable P&U to access Light Devices and to insure that P&U
has continued access to Light Devices during the term of the license rights
specified by Section 3.02 and in accordance with the Ancillary Agreements.
ARTICLE VI - SUPPLY OF PRODUCT
6.01 Commercial Supply of Product. P&U shall purchase from MRVT, and MRVT
shall supply P&U, all of P&U's requirements of Product in finished form to be
sold by P&U in the Territory. P&U acknowledges that MRVT's obligations to supply
P&U with Product are dependent upon P&U's United States Affiliate fulfilling its
obligations to MRVT under the ▇▇▇▇▇▇▇ Agreement.
6.02 Commercial Transfer Price. The "Transfer Price" for Product supplied
to P&U by MRVT shall be equal to the sum of the following:
(a) *****
(b) *****
6.03 *****
*****
6.04 Ownership of Trademarks. ***** The parties shall jointly select all
trademarks to be used in connection with the Products in the Fields, and
Miravant shall not grant rights to use such marks outside the Fields without
P&U's prior consent, which consent shall not be unreasonably withheld if such
use is not likely to adversely affect the sales and marketing of the Products in
the Fields. All trademarks related to SnET2 will be the property of MRVT, and
MRVT will indemnify and hold harmless P&U from and against any and all
infringement claims related to the trademarks.
ARTICLE VII - *****
7.01*****
7.02*****
7.03 Limitation of Section 7.1. Section 7.1 shall not apply to any
non-Photodynamic Therapy drug or any product other than a New Product developed
by Miravant and Miravant's grant of rights or licenses with respect to such
non-Photodynamic Therapy drug or other product shall not be limited by Section
7.01. Transfer of all or substantially all of the business or assets of Miravant
to a third party, whether by merger, acquisition or otherwise, shall not be
deemed a grant to a third party of a right or license with respect to a New
Product nor give rise to any right or obligation under Section 7.01 herein.
Section 7.01 shall not apply to a New Product unless at the time the right of
first negotiation is offered the New Product is being developed, or Miravant
expects to develop, for an indication within the Fields.
***** Confidential Treatment Requested
ARTICLE VIII - REGULATORY RESPONSIBILITIES
8.01 Complaints. MRVT and P&U shall share with each other all data on
complaints in respect of Product subject to this Agreement including, but not
limited to, complaints or information regarding performance or allegations or
reports of any effects on a patient from use of such Product, as soon as such
data is available. To the extent that it has knowledge thereof, each party shall
promptly notify the other in writing of any defect in, or condition of, Product
subject to this Agreement that may cause any such Product to violate the
applicable laws and regulations of any country in the Territory where such
Product is being sold by P&U. As the holder of the NDA, MRVT shall be
responsible for complying with all regulatory requirements relating to the
reporting and processing of complaints and adverse events.
8.02 Recall. In the event of a total or partial recall of Product sold by
MRVT to P&U under this Agreement, whether voluntary or mandated by law, the
parties agree to cooperate fully to effect the recall. In the event such recall
results from the gross negligence or willful misconduct of MRVT, MRVT shall bear
all the expenses associated with such recall. In the event such recall results
from the gross negligence or willful misconduct of P&U, P&U shall bear all the
expenses associated with such recall. If any recall results without gross
negligence or willful misconduct of either party, then MRVT and P&U shall
equally bear the expenses of such recall. P&U agrees to maintain adequate sales
and service records to enable it to carry out any Product recall and to conduct
such recall.
8.03 Adverse Reactions. Each party shall be responsible for maintaining
such records and making such reports as may be required in connection with any
regulatory approval held by the party. Each party shall immediately inform the
other of all adverse drug experience reports and other information relating to
the safety or effectiveness of Product which come to its attention.
ARTICLE IX - PUBLICATION AND CONFIDENTIALITY
9.01 Publication. Each party hereto shall give ten (10) days prior written
notice to the other party of all SEC filings and public announcements relating
to the contractual relationship between the parties, which will be subject to
reasonable approval of the other party, and if there is a dispute, it will be
resolved by the opinion of the disclosing party's counsel in their discretion,
except that the other party shall resolve all disclosure issues relating to such
party's confidential information.
9.02 Disclosure. MRVT shall disclose to P&U all information relating to the
Patent Rights, Technology and Product for the Fields that has not previously
been disclosed; provided, however, that MRVT shall only be required to disclose
such information to P&U as is necessary or useful for P&U to fulfill its
obligations under this Agreement. All information disclosed by one party to the
other under this Section 9.02 shall be deemed "Confidential Information" and
treated as provided in Section 9.03 hereof. P&U shall disclose to MRVT, or MRVT
shall have access to, information developed by P&U related to Product including,
but not limited to, all regulatory data including clinical data and
investigators' reports, applications and licenses.
9.03 Confidential Information. Unless otherwise mutually agreed to by the
parties, the parties agree to maintain in confidence all Confidential
Information disclosed to the other pursuant to Section 9.02 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 to the extent necessary in connection
with either party's activities as contemplated in this Agreement. Each party
shall use its reasonable efforts to ensure that its officers, directors,
employees, Affiliates and Sublicensees do not disclose or make any unauthorized
use of such Confidential Information.
9.04 Limitations on Confidentiality. The obligation of confidentiality
contained in Section 9.03 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 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) the disclosed information was received by a party or its Affiliates or
Sublicensees on an unrestricted basis from a third party source that is not the
other party or an Affiliate of the other party and not under a duty of
confidentiality, and that was rightfully known to said source.
ARTICLE X - TERM AND TERMINATION
10.01 Term.
(a) Subject to the provisions of Section 3.02 and this Article X, the
term of this Agreement shall continue for so long as P&U is required to pay
royalties. Unless terminated earlier, commencing July 1, 2000, and
continuing every two years thereafter, the parties shall agree in writing
upon their respective share of the funding for development of the Product
in the Fields for the following 24 months in accordance with the MRVT
Development Plan.
(b) *****
10.02 Termination for Breach. In the event either party shall materially
breach any of the terms, conditions and agreements contained herein to be kept,
observed and performed by it, then the other party may terminate this Agreement,
at its option and without prejudice to any of its other legal and equitable
rights and remedies, by giving the party which committed the breach sixty (60)
days' notice of its intent to terminate, particularly specifying the breach,
unless the notified party within such sixty (60) day period shall have cured the
breach. The sixty (60) day period may be extended for a period not exceeding an
additional ninety (90) days for breaches which cannot be reasonably cured within
the sixty (60) day period if the party has commenced to cure the breach within
that period.
10.03 Termination by Bankruptcy. In the event either party 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 of substantially all of its assets for
the benefit of creditors, or shall apply for or consent to the appointment of a
receiver or trustee of a substantial part of its property (such party, upon the
occurrence of any such event, a "Bankrupt Party"), then to the extent permitted
by law the other party hereto may thereafter immediately terminate this
Agreement by giving notice of termination to the Bankrupt Party, unless the
proceeding is dismissed within ninety (90) days of its filing.
10.04 *****
10.05 Effect of Termination. It is understood and agreed that the
termination of this Agreement shall not affect the rights or obligations of the
parties which (i) by the terms hereof, continue after the termination of this
Agreement, or (ii) have accrued prior to such termination including, but not
limited to, the rights of MRVT to receive any amounts then owing from P&U for
royalties due hereunder, all of which amounts shall be immediately due and
payable on such termination date. Upon termination of this Agreement, other than
under Section 10.01(a), the Ancillary Agreements will also terminate in respect
to the Fields. Articles VIII, IX and XII shall survive the expiration or
termination of this Agreement.
***** Confidential Treatment Requested
ARTICLE XI - PATENT INFRINGEMENT
11.01 Infringement by Third Parties. If, during the term of this Agreement,
either MRVT or P&U shall acquire knowledge or have reasonable cause to believe
that any of the Patent Rights, as such Patent Rights cover Product, shall be
infringed or used without authorization by any other person in the Territory,
either party shall promptly notify the other of such knowledge. MRVT and P&U
shall promptly meet to discuss the commercial impact of such third party
infringement and the most efficient and expeditious manner to proceed against
said third party.
11.02 Initiation of Action by MRVT or P&U. MRVT may take all steps in its
name 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. MRVT 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 proceedings) or otherwise on
any action initiated by MRVT. If MRVT does not commence such an action within
one hundred eighty (180) days, after a request to do so by P&U, then P&U may
initiate an 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. P&U 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 P&U. Each party agrees to reasonably cooperate with the other party
in any legal proceeding and to pay all its own costs taken pursuant to this
Section 11.02.
11.03 Claims Against P&U or MRVT. If any claim is made or action brought
against P&U or MRVT based on the claim that P&U or MRVT is infringing any third
party patent rights by virtue of the manufacture, use or sale of Product
hereunder, P&U or MRVT shall promptly so notify the other. The parties shall
then consult with each other as to the most efficient and reasonable course of
action to take relative to such third party claim. Each party hereto shall pay
its own expenses in defending any such third party claim. MRVT shall solely be
responsible for any trademark infringement claims and for all damages claimed
against P&U and its Affiliates by any third party.
11.04 Damages Paid to Third Party. If, in any such action described in
Section 11.03, a court of competent jurisdiction determines that P&U or MRVT is
obligated to pay damages to any third person (excluding trademark claims)
because P&U or MRVT's manufacture, use or sale of a Product was held to be an
infringement of a third party right, the parties shall equally share such costs.
11.05 Reduction of Royalties. In the event the legal proceedings described
in Section 11.03 result in a settlement or other final action which requires P&U
to pay a royalty to a third party in order to continue to use or sell Product,
the royalty paid by P&U to MRVT for such Product shall be reduced by an amount
equal to one-half (1/2) of the rate of the royalty that P&U is required to pay
to such third party, not to exceed fifty percent (50%) of the royalties that
would be payable to MRVT.
ARTICLE XII - INDEMNIFICATION
12.01 Indemnification. Except for matters relating to indemnification for
infringement of intellectual property rights, as to which Article X shall be the
sole and exclusive provisions, each party to this Agreement shall indemnify and
hold the other party hereto harmless from and against any and all actions,
causes of action, claims, demands, suits, controversies, damages, verdicts,
judgments, executions and all costs and expenses in connection therewith
including, but not limited to, reasonable attorneys' fees, whether or not well
founded in fact or in law, brought or claimed by any third persons, which and to
the extent thereof shall arise from any breach of this Agreement by or from the
negligent acts or omissions of the indemnifying party under this Agreement (a
"Liability"). Except to the extent P&U is required to indemnify MRVT under the
foregoing sentence and to the extent P&U's Affiliate is required to indemnify
MRVT under the ▇▇▇▇▇▇▇ Agreement, MRVT shall defend, indemnify and hold harmless
P&U and its Affiliates and each of their directors, officers, employees and
agents against any and all claims, costs, liabilities, damages and expenses
(including reasonable attorneys' fees) arising out of or incurred in connection
with the practice of the licenses granted hereunder or the clinical testing,
manufacture, handling, ingestion, distribution, sale, administration, or other
use (including any failure to warn or comply with any regulatory or applicable
legal requirements) of any Product or Light Device.
12.02 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 Section 12.02 of notice of the commencement
of any action, such indemnified party will 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 of 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 indemnifying
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 Section 12.02, but the omission to
so notify the indemnifying party will not relieve such party of any liability
that such party may have to any indemnified party otherwise than under this
Section. No settlement of any claim or action may be made without the consent of
the indemnifying party (which shall not be unreasonably withheld or delayed).
ARTICLE XIII - RESOLUTION OF DISPUTES
13.01 Arbitration. Any and all disputes arising out of or in connection
with the performance of this Agreement shall be finally settled by arbitration
in accordance with the rules of the American Arbitration Association, except
that each party will be entitled to select one (1) arbitrator and the two (2)
arbitrators so selected shall select a third arbitrator and if they cannot
agree, then the third arbitrator, who shall not be a citizen of the United
States or Italy, will be selected by the American Arbitration Association. The
arbitration shall be held in New York, New York. 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. 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.
ARTICLE XIV - MISCELLANEOUS
14.01 Force Majeure. Neither P&U nor MRVT shall be in default under this
Agreement nor liable for any failure to perform or for delay in performance
resulting from any cause beyond its reasonable control or due to compliance with
any regulations, orders or act of any federal, provincial, state or municipal
government, or any department or agency thereof, civil or military authority,
acts of God, fires, floods or weather, strikes or lockouts, factory shutdowns,
embargoes, wars, hostilities or riots.
14.02 Taxes. Each of the parties hereto shall be responsible for its own
taxes imposed as a result of the performance by such party under this Agreement
including, but not restricted to, any sales tax, any tax on or measured by any
royalty or other payment required to be made by it hereunder, any registration
tax, any tax imposed with respect to the granting of or transfer of licenses or
other rights hereunder or the payment or receipt of royalties hereunder. For the
avoidance of any doubt, it is agreed that any withholding tax levied on a
payment required to be made pursuant to this Agreement, shall be the
responsibility of the party receiving such payment. The parties shall cooperate
fully with each other in obtaining and filing all requisite certificates and
documents with the appropriate authorities and shall use their best efforts to
take such further action as may reasonably be necessary to avoid the deduction
of any withholding or similar taxes from any remittance of funds by P&U to MRVT
hereunder, provided, however, that P&U may withhold tax it is required to
collect or pay on behalf of MRVT.
14.03 Notices. 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, in the English language, and shall be
deemed to have been duly made or given when (i) delivered personally with
receipt acknowledged, (ii) mailed in any post office, enclosed in a registered
or certified postage-paid envelope, return receipt requested, (iii) sent by
facsimile, telex or cablegram (which shall promptly be confirmed by a writing
sent by registered or certified mail, return receipt requested) or (iv) sent by
a recognized courier (e.g., DHL, Federal Express, etc.), 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 number as any party shall
hereafter specify by Communication to the other party:
P&U: Pharmacia & Upjohn S.p.A.
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇.▇
▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇
Attn: President
Fax #: ▇▇ ▇ ▇▇▇▇ ▇▇▇▇
With a copy to: Pharmacia & Upjohn S.p.A.
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇.▇
▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇
Attn: General Counsel
Fax #: ▇▇ ▇ ▇▇▇▇ ▇▇▇▇
MRVT: Miravant Medical Technologies
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
U. S. A.
Attn: President
Fax #: ▇▇▇ ▇▇▇ ▇▇▇▇
With a copy to: Nida & ▇▇▇▇▇▇▇, P.C.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
U. S. A.
Attn: ▇▇▇▇▇▇ ▇. ▇▇▇▇
Fax #: ▇▇▇ ▇▇▇ ▇▇▇▇
Notice of a 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 or (ii) one (1) day after being sent by facsimile, cable, telex (each
promptly confirmed by a writing as aforesaid) or courier and seven (7) business
days after mailing.
14.04 Relationship. The relationship between the parties shall be governed
by the terms of this Agreement and shall not extend to other activities,
transactions or contracts. Neither party hereto is in any way the agent,
venturer or partner of the other party.
14.05 Governing Law. The provisions of this Agreement shall be governed in
all respects by the laws of New York without regard to conflicts of laws
principles.
14.06 Other Instruments. The parties hereto covenant and agree that they
will execute such other and further instruments and documents as are or may
become reasonably necessary or convenient to effectuate and carry out the
provisions of this Agreement or may be reasonably requested by the other party.
14.07 Legal Construction. In case anyone 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.
14.08 Entire Agreement, Modification, Consents and Waivers. This Agreement
contains the entire agreement of the parties with respect to the subject matter
hereof and no interpretation, change, termination or waiver of or extension of
time for performance under any provision of this Agreement shall be binding upon
any party, unless in writing and signed by the party intended to be bound
thereby. In addition to this Agreement, the parties have entered into two other
agreements, namely, the Product Supply Agreement, dated July 1, 1995, as
amended, and the SNET2 Device Supply Agreement, dated July 1, 1995. It is the
intent of the parties that the terms of these Agreements be read as a whole and
as being consistent with one another. Receipt by any party of money or other
consideration due under this Agreement, with or without knowledge of breach,
shall not constitute a waiver of such breach or any provision of this Agreement.
Except as otherwise provided in this Agreement, no waiver of or other failure to
exercise any right under or default or extension of time for performance under
any provision of this Agreement shall affect the right of any party to exercise
any subsequent right under any provision of this Agreement or otherwise enforce
said provision or any other provision hereof or to exercise any right or remedy
in the event of any other default, whether or not similar.
14.09 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 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.
14.10 Amendment. This Agreement may only be amended in writing by an
agreement designated as an amendment and executed by the parties hereto. 14.11
Limitation of Damages. IN NO EVENT SHALL EITHER PARTY NOR ANY OF ITS RESPECTIVE
AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR SPECIAL,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY,
TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, including, but not limited to,
loss of profits or revenue, loss of use of any equipment, cost of capital, down
time costs, delays, or claims of customers of any of them or other third parties
for such or other damages.
ARTICLE XV - BINDING EFFECT: ASSIGNMENT
15.01 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 right and
obligations under this Agreement, may be assigned, transferred or otherwise
disposed of by either party without the prior 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 specifically assume all
obligations of the transfer or 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.
15.02 Right to Seek Assurance. In the event all or substantially all of the
assets of either P&U or MRVT are acquired by a third party, the non-acquired
party shall have the absolute right pursuant to Section 15.01 to receive a
binding written assurance and undertaking from such party that the third party
intends to faithfully perform all of the duties and obligations of the acquired
party set for in this Agreement. The acquired party shall take all action
necessary to enable the non-acquired party to obtain such written assurance.
ARTICLE XVI - APPROVAL OF BOARD OF DIRECTORS
Each party warrants and represents to the other party that, to the extent
legally required, this Agreement has been approved by its Board of Directors.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate by their respective officer thereunder duly authorized as
of the date first hereinabove written.
MIRAVANT MEDICAL TECHNOLOGIES PHARMACIA & UPJOHN S.p.A.
By: /S/ By: /S/
------------------------- -------------------------------
▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Title:_____________________________
Chairman of the Board and
Chief Executive Officer
