AMENDED AND RESTATED OPHTHALMOLOGY
DEVELOPMENT & LICENSE AGREEMENT
between
PHARMACIA & UPJOHN AB
and
MIRAVANT MEDICAL TECHNOLOGIES
o , 1999
AMENDED and RESTATED
OPHTHALMOLOGY DEVELOPMENT AND LICENSE AGREEMENT
THIS AMENDED and RESTATED OPHTHALMOLOGY DEVELOPMENT AND LICENSE AGREEMENT
(the "Agreement") is made and entered into as of o, 1999, by and between
PHARMACIA & UPJOHN AB, a company organized and existing under the laws of
Sweden, (hereinafter referred to as "P&U AB"), and MIRAVANT MEDICAL
TECHNOLOGIES, INC., a company organized and existing under the laws of the State
of Delaware, with its head offices at 0000 Xxxxxxxxx Xxxxxx, Xxxxx Xxxxxxx,
Xxxxxxxxxx 00000, X.X.X. (hereinafter referred to as "Miravant").
WITNESSETH THAT:
WHEREAS, on 8 June 1998, P&U AB and Miravant entered an Amended and
Restated Development and License Agreement for the field of ophthalmology (the
"1998 AB License Agreement"); and
WHEREAS, P&U AB and Miravant desire to amend the 1998 AB License Agreement
to provide for the transfer to P&U AB of certain clinical, regulatory and
manufacturing responsibilities with respect to the Development Program (as
defined herein) and to modify inter alia the rights and obligations of the
parties accordingly;
NOW, THEREFORE, in consideration of the above premises and the covenants
contained herein, the parties hereby amend and restate the 1998 AB License
Agreement in its entirety as follows, effective as of the date hereof:
ARTICLE 1 - DEFINITIONS
The following capitalized terms used herein shall have the meanings set forth
below:
1.1 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).
1.2 Agreement. "Agreement" shall mean this Amended and Restated Development
and License Agreement.
1.3 Aggregate Borrowings. "Aggregate Borrowings" shall mean the aggregate
principal amount of Quarterly Loans made pursuant to the Credit Agreement, dated
as of January o, 1999, between P&U AB and Miravant, without giving effect to any
repayments or prepayments thereof.
1.4 Clinical Tests. "Clinical Tests" shall mean any tests, performed on
humans in preparation and support of regulatory submissions.
1.5 Development Program. "Development Program" shall mean the program to be
conducted by Miravant and P&U AB to develop Product (as hereinafter defined) and
obtain regulatory approvals for the sale of Product in the Territory (as
hereinafter defined) in accordance with the provisions of Article 4 hereof.
1.6 Effective Date. The term "Effective Date" shall mean the date on which
this Agreement has been duly executed by both parties.
1.7 FDA. "FDA" shall mean the United States Food and Drug Administration or
the equivalent governmental authority in any other country, 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.
1.8 Field. "Field" shall mean the field of Ophthalmology, including for the
avoidance of doubt all current and future indications in the Field.
1.9 Gross Sales. "Gross Sales" shall mean the final gross invoiced price
from the sale of Product by P&U AB and its Affiliates or Sublicensees; provided,
that Gross Sales shall exclude sales of Product intended for resale between P&U
AB and its Affiliates and Sublicensees. Gross Sales from the sale of the Product
in Eastern Europe, the Middle East, Africa and Central America by Sublicensees
which are not Affiliates of P&U AB shall be measured by the F.O.B. invoiced
price from P&U AB or one of its Affiliates to such distributors.
1.10 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 other country.
1.11 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 other country.
1.12 GMP. "GMP" shall mean current "good manufacturing practices" for the
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 other country.
1.13 IND. "IND" shall mean all governmental approvals required to commence
clinical testing in humans, including an "investigational new drug application"
submitted to the FDA under 21 CFR ss.312 for the purpose of conducting clinical
investigations of Product or the equivalent in any other country.
1.14 Light Devices. "Light Devices" shall mean the instruments that
produce, deliver or measure light for use with Product.
1.15 *****
***** Confidential Treatment Requested
1.16 Major Indication. "Major Indication" shall mean the indications in the
Field as set forth in Schedule 1.16.
1.17 Minor Indication. "Minor Indication" shall mean the indications in the
Field as set forth in Schedule 1.17.
1.18 Net Sales. "Net Sales" shall mean Gross Sales less the following:
trade, cash and quantity discounts; returns, normal trade allowances,
charge-backs, federal, state, or other governmental rebates and adjustments;
taxes on the sale or transportation of the Products absorbed by P&U AB.
1.19 *****
***** Confidential Treatment Requested
1.20 NDA. "NDA" shall mean all approvals (including, where applicable,
pricing and reimbursement) to sell a pharmaceutical product in any country,
including a "New Drug Application" or other premarket approval application for
Product, and any supplement or abbreviated application relating thereto,
submitted to the FDA or the equivalent in any other country.
1.21 Other Indications. "Other Indications" shall mean the indications in
the Field set forth in Schedule 1.21.
1.22 Out-of-Pocket Expenses. "Out-of Pocket Expenses" shall mean actual
expenses, including expenses for outside consultants and CRO's, in relation to
Product paid after the Effective Date by Miravant or its Affiliates to third
parties who are not Affiliates of Miravant.
1.23 Patent Rights. "Patent Rights" shall mean all 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 are now or hereafter
owned or acquired by Miravant or any of its Affiliates, or licensed to Miravant
or any of its Affiliates, and all extensions and supplementary protection
certificates relating thereto. Patent Rights licensed to Miravant will only be
granted to P&U AB to the extent permitted by Miravant's license agreement and
P&U AB will do nothing to disturb such agreement.
1.24 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.
1.25 Preclinical Tests. "Preclinical Tests" shall mean any nonhuman tests
performed in preparation and support of regulatory submissions.
1.26 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, for use in the Field.
1.27 Project Team. "Project Team" shall have the meaning set forth in
Section 4.4.
1.28 SnET2. "SnET2" shall mean the Photodynamic Therapy drug designated by
Miravant as tin ethyl etiopurpurin in any formulation or strength for use in the
Field.
1.29 Steering Committee. "Steering Committee" shall have the meaning set
forth in Section 4.2.
1.30 Sublicensee. "Sublicensee" shall mean a third party to whom P&U AB or
any of its Affiliates has granted, in whole or in part, the right to market or
comarket 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.
1.31 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
Miravant as of the Effective Date or generated or obtained by Miravant during
the term of this Agreement relating to the registration, manufacture, use or
sale of Product, in each case to the extent Miravant has the right to provide
the same to P&U AB hereunder; provided, that "Technology" shall not include any
such information or data regarding the design or manufacture of any Light
Device.
1.32 Territory. "Territory" shall mean the entire world.
1.33 Unit. "Unit" shall mean *****
***** Confidential Treatment Requested
1.34 Schedules. The Schedules which are attached to this Agreement and
which are herein incorporated, are as follows:
Schedule Description
1.16 Major Indications
1.17 Minor Indications
1.21 Other Indications
3.3 Key Countries
ARTICLE 2 - INTENTIONALLY OMITTED
ARTICLE 3 - LICENSE GRANT AND ROYALTIES
3.1 License. Subject to the terms of this Agreement, Miravant hereby grants
to P&U AB and P&U AB's Affiliates an exclusive worldwide, royalty-bearing,
license under the Patent Rights and the Technology, not to mean devices, to
manufacture or have manufactured, use, distribute and sell Product for diagnosis
or treatment in the Field in the Territory. P&U AB may sublicense, totally or in
part, the license rights granted under this Section 3.1; provided, that (i) P&U
AB must notify Miravant in writing of any such sublicense at least thirty (30)
days in advance; (ii) P&U AB remains responsible to Miravant 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 AB's sales; and (iii) the Sublicensee agrees to be bound by the
terms of this Agreement to the same extent as P&U AB to the extent applicable to
the Sublicensee.
3.2 Term of License. With respect to Product, the license rights granted
under Section 3.1 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 on a country-by-country basis, whichever shall
be longer. After this period, P&U AB shall have an irrevocable, fully paid-up,
nonexclusive license under the Technology in such country.
3.3 Milestone Payments. For Major and Minor Indications, P&U AB shall pay
Miravant only the following sums upon achievement of the stated milestones:
(i) if, after conducting ***** for any Major and Minor Indication, the
Steering Committee decides to proceed with ***** for such indication *****, P&U
AB shall pay Miravant: ***** for each Major Indication; and ***** for each Minor
Indication; provided, that in the event ***** are not required for any
indication and the Steering Committee decides to proceed with *****, P&U AB
shall not owe Miravant a ***** milestone payment for each such indication;
***** Confidential Treatment Requested
(ii) for each Major and Minor Indication, at the ***** in one or more of
the Key Countries listed in Schedule 3.3, P&U AB shall pay Miravant ***** for
each Major Indication so approved, and ***** for each Minor Indication so
approved.
***** Confidential Treatment Requested
(iii) P&U AB shall not owe Miravant any milestone payments for ***** or for
Other Indications (as defined in Section 1.21).
***** Confidential Treatment Requested
3.4 Royalties.
(i) P&U AB shall, for the term of the license specified by Section 3.2, pay
Miravant royalties on Net Sales of such Products 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 such Products ***** per calendar year.
***** Confidential Treatment Requested
(ii) *****
***** Confidential Treatment Requested
3.5 Sublicense Fees. P&U AB shall pay Miravant ***** of any up-front or
lump-sum fees received by P&U AB in consideration of the grant of a sublicense
to Product, other than to an Affiliate.
***** Confidential Treatment Requested
3.6 Payment of Milestone Payments and Out-of- Pocket Expenses. All amounts
of money due pursuant to Section 3.4 and for the payment of Out-of-Pocket
Expenses described in Article 4 shall be paid to Miravant or its designated
Affiliate within thirty (30) days from receipt by P&U AB of the relevant
Miravant invoice.
3.7 Payment of Royalties. The royalties due pursuant to Section 3.4 shall
be reported quarterly within thirty (30) days after March 31, June 30, September
30 and December 31. Such royalties shall be paid to Miravant or its designated
Affiliate quarterly within sixty (60) days after March 31, June 30, September 30
and December 31. Each payment to Miravant or its designated Affiliate shall be
accompanied by a report containing sufficient information to enable Miravant 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,
rebates and other deductions contemplated by Section 1.14 to calculate Net Sales
from Gross Sales.
3.8 Payment of Royalties, Fees, and Expenses. The milestone payments
specified by Section 3.3 herein shall be paid to Miravant in US dollars. For the
purpose of converting and paying royalties, Out-of-Pocket Expenses and
sublicense fees specified by Section 3.5 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 Miravant, converted
into US dollars at the most favorable buying exchange rates prevailing on the
day P&U AB converts the local currency into US dollars for payment to Miravant.
3.9 P&U AB Ceases to Market or Sell Product. 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 entity only, be it P&U AB or its Affiliate or
a Sublicensee, should P&U AB or its Affiliates or Sublicensees 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 (if any), and (iv) NDA approval of all
relevant Light Devices, P&U AB shall have no further rights to the Product in
that country nor shall P&U AB have any further obligations for the Product in
that country, except such obligations which accrued prior to divestment from P&U
AB of rights to the Product. In the event rights to a Product are divested from
P&U AB in any country pursuant to this Section 3.9 and upon Miravant's request,
P&U AB shall immediately transfer the NDA approval and IND in that country to
Miravant or to an appointee of Miravant, provide to Miravant all data in P&U
AB's possession or control relating to that Product and take all such other
actions as are necessary or useful to permit Miravant to obtain regulatory
approvals to market Product in such country. If P&U AB fails to comply with the
foregoing within thirty (30) business days after such Miravant request, P&U AB
hereby irrevocably appoints Miravant as its attorney-in-fact to secure the
transfer of the NDA approval and IND to Miravant. Miravant shall market the
Product under its own tradenames or brands and shall not use P&U AB's tradenames
or brands. Failure by P&U AB to launch a Product or interruption of marketing or
sale of a Product pursuant to this Section 3.9 shall not be considered a breach
of this Agreement within the meaning of Article 10. For the avoidance of doubt,
it is understood between the parties hereto that the provision of this Section
3.9 shall not apply in the event that P&U AB or its Affiliates or Sublicensees
cease to sell a Product or fail to launch a Product in a Major Country for
reasons related to the safety and efficacy of a Product.
***** Confidential Treatment Requested
3.10 Books and Records. P&U AB shall keep, and shall cause its Affiliates
and Sublicensees to keep, complete and accurate books of accounts and other
records, for a period of ***** from the relevant sale, containing sufficient
detail as may be necessary for Miravant to properly ascertain and verify the
royalties payable to it hereunder in accordance with generally accepted
accounting principles. Upon Miravant's request, P&U AB shall permit an
independent certified accountant selected by Miravant (except one to whom P&U AB
has some reasonable objection) to have access once each year during ordinary
business hours to such P&U AB 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 AB has underpaid any royalties by ten percent (10%) or more, for
any period covered by the audit, P&U AB shall, in addition to immediately
remitting to Miravant the amount of underpayment, pay for the cost of such
audit. In the event the audit shows that P&U AB has overpaid any royalties due
pursuant to Section 3.4, P&U AB shall be allowed to deduct the amount of such
overpayment from the next semiannual royalty payment due to Miravant.
***** Confidential Treatment Requested
ARTICLE 4 - STRATEGIC PLAN, DEVELOPMENT AND FUNDING
4.1 Strategic Plan. The parties shall develop a written plan in respect to
the Field of Ophthalmology, by March 31, 1999. This plan shall be called the
"Strategic Plan".
4.2 Steering Committee. The direction and activities to be conducted under
the Strategic Plan are under the oversight of a Steering Committee consisting of
***** members. The *****. Each of the parties shall have***** representatives on
the Steering Committee. Responsibilities of the Steering Committee shall be
limited to recommendation of additions and deletions to the indications to the
Strategic Plan, amendment and approval of the Development Program including
schedules and budgets. If the Steering Committee recommends to add any
indication not identified in Schedules 1.16, 1.17 or 1.21, it shall also
determine whether it is a Major, Minor or Other Indication, based on criteria
including but not limited to, ***** and *****. Any addition or deletion of an
indication shall be made by the parties as an amendment of this Agreement. Each
party may replace any of its respective members without the consent of the other
party.
***** Confidential Treatment Requested
4.3 Voting. Each member of the Steering Committee shall have one (1) vote
and all decisions of the Steering Committee shall require a majority vote. *****
***** Confidential Treatment Requested
4.4 Project Team. The details of the planning and conduct of the activities
under the Strategic Plan shall be supervised by a Project Team (the "Project
Team"). The membership of the Project Team shall be chosen by P&U AB in
consultation with Miravant and shall contain up to four representatives of
Miravant.
4.5 Reporting of Results. Within ten (10) days after March 31 and September
30 of each year, each party shall provide the other party with a detailed
progress report on its implementation of the Strategic Plan, including
experimental results and Phase I, Phase II and Phase III Clinical Test data. The
parties shall also consult periodically and at such times as determined by the
Steering Committee
4.6 *****
***** Confidential Treatment Requested
4.7 SnET2 for Ophthalmology. Unless otherwise determined by the Project
Team, P&U AB shall be responsible for conducting all necessary Preclinical and
Clinical Tests for SnET2 to be used in any indications in the Field. The
Out-of-Pocket Expenses associated with Preclinical and Clinical Tests being
conducted by Miravant on the Effective Date, or conducted by Miravant
thereafter, shall be reimbursed by P&U AB; provided, that these studies were
conducted in accordance with the protocols and budget approved by the Project
Team and Steering Committee. P&U AB shall be responsible for conducting all
post-NDA approval studies which may be necessary. The Steering Committee has the
right to determine, in its reasonable judgment, whether to proceed to Clinical
Tests for any indication in the Field. All Clinical Tests shall be conducted in
accordance with the protocols approved by the Project Team. Miravant shall
supply to P&U AB SnET2 and Light Devices to enable P&U AB to carry out such
Tests conducted by it. The actual costs of SnET2 and Light Devices for all Test
phases shall be shared equally by the parties hereto.
4.8 Submission of NDA. P&U AB shall be responsible for assembling the NDA
for a Product and to submit it to the concerned health authorities of the
Territory. All such NDAs shall be filed in the name of, and shall remain the
sole and exclusive property of, P&U AB, subject to Section 3.9 hereof. Before an
NDA is submitted to the concerned health authorities, it shall be reviewed and
approved by the Steering Committee. Following the submission of the NDA to the
concerned health authorities, P&U AB will prosecute such NDA diligently in
accordance with the time schedule set forth in the Strategic Plan.
4.9 Audit of Out-of-Pocket Expenses. Miravant shall keep, or cause its
Affiliates to keep, complete and accurate records of Out-of-Pocket Expenses in
sufficient detail for P&U AB to verify the accuracy of any invoices submitted to
P&U AB by Miravant for payment of Out-of-Pocket Expenses pursuant to Section
4.7. P&U AB shall have the right to audit such records on an annual basis, using
an independent certified accountant, at a date and time acceptable to Miravant
during normal business hours. If as a result of the audit, it is determined that
P&U AB has been overcharged by Miravant during a calendar year by more than ten
percent (10%) of the actual expenses, Miravant shall pay for the cost of the
audit, and P&U AB shall, at its discretion, either deduct the amount of the
overcharge from the next semiannual royalty payment or take a credit against
payment of future invoices for Out-of-Pocket Expenses.
ARTICLE 5 - DUTIES OF THE PARTIES
5.1 Promotion and Customer Service. As Miravant's exclusive licensee for
Product in the Territory, P&U AB agrees to use all reasonable efforts to
introduce, promote, market and sell Product in the Territory. P&U AB 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.
5.2 Care of Product. P&U AB shall comply with all applicable regulatory
requirements regarding acceptable methods for the care, handling, storage and
shipment of Product. Each party hereby agrees that it shall promptly provide to
the other, on request, all information known to it which is necessary for
compliance with the applicable laws and regulations concerning the care,
handling, storage, labeling, packaging and shipment of Product.
5.3 Exclusive. During the term of this Agreement, unless otherwise agreed
to by Miravant, P&U AB shall not, directly, or indirectly, develop or sell other
Photodynamic Therapy drugs for use in the Field. P&U AB agrees that it shall
secure the same agreement from its Affiliates and Sublicensees.
5.4 Authorization. P&U AB and Miravant each warrant that it has the legal
capacity to enter into this Agreement and that it has secured all necessary
approvals.
5.5 Obligations to Miravant's Licensor. To the extent relating to Patent
Rights or Products in the Field, P&U AB agrees to undertake all sublicensee
obligations set forth in any license agreement between Miravant and third
parties which was fully disclosed to P&U AB on or prior to July 10, 1996.
5.6 Sale of Product by Miravant. Subject to the terms of this Agreement,
while the license granted to P&U AB under Article III hereof with respect to any
Product is in effect in any country in the Territory, Miravant shall not license
or appoint any other licensee, distributor or marketing representative in or for
such country for such Product in the Field, sell such Product in or for use in
such country, nor accept orders for such Product from purchasers located within
such country or from any purchasers Miravant has reason to believe will sell
such Product within or for use in such country except as provided for in Section
3.9.
5.7 Right to License Patent Rights, Product and Technology. Miravant 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 Miravant.
5.8 Access to Information Relating to Light Devices. Both parties agree to
provide the other with access to information or data relating to Light Devices
which either party may need for regulatory approval to market Product in the
Field and which Miravant may need for regulatory purposes for products other
than Product in the Field.
5.9 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 AB to Light Devices. Miravant agrees that it shall undertake all
necessary action (i) to enable P&U AB to enter a supply relationship among P&U
AB, Miravant and Iridex Corporation for the supply of the Light Devices to P&U
AB and its Affiliates or Sublicensees and (ii) to insure that P&U AB has
continued access to Light Devices during the term of the license rights
specified by Section 3.2.
5.10 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 GLP's, GCP's, GMP's or
other equivalent regulatory requirements of any country. Unless otherwise
disclosed, Miravant represents and warrants that all studies which were done
prior to the Effective Date and which are included in the IND or NDA for KS
and/or BCC have been conducted in accordance with GLP's, GCP's, and GMP's where
applicable.
5.11 Duty to Develop Product. Each party agrees that it shall use
reasonable efforts to develop Product in the Field in accordance with the
Strategic Plan.
5.12 Patent Filing, Prosecution and Maintenance; Trademarks. (i) Miravant
shall be responsible for all decisions relating to and all costs associated with
preparing, filing, prosecuting and maintaining Patent Rights. Miravant shall
timely notify P&U AB about each patent application filed which relates to
Product, its progress and subsequent disposition and consult with P&U AB prior
to taking any significant action with respect to Patent Rights. Miravant shall
not voluntarily abandon or forfeit any Patent Rights, without the prior approval
of P&U AB, such approval shall not be unreasonably withheld or delayed. (ii) P&U
AB shall own all trademarks, logos and/or trade dress which it registers for use
or otherwise uses in connection with the Product.
5.13 Miravant's Representations. Miravant hereby represents and warrants
that:
(i) It is not party to any agreement, arrangement or understanding with any
third party which in any material way conflicts with its ability to fulfill any
of its obligations under this Agreement.
(ii) 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
which 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 AB
under this Agreement.
(iii) It has no knowledge that the license rights granted to P&U AB with
respect to the Product shall not be subject to any material retained rights of
any state, federal or foreign government or governmental entity, except for the
rights of the United States government under the Xxxx-Xxxx Act and except as
disclosed to P&U AB prior to July 10, 1996.
(iv) It has no knowledge that making, using or selling any Products (alone
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.
(v) It has no agreement, understanding or undertaking, with any third
parties regarding the ownership or disposition of tin ethyl etiopurpurin,
isomers and derivatives thereof or any Product.
5.14 Complaints. Miravant and P&U AB 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 which 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 AB.
5.15 Recall. In the event of a total or partial recall of Product sold by
Miravant to P&U AB 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 Miravant,
Miravant shall bear all the expenses associated with such recall. In the event
such recall results from the gross negligence or willful misconduct of X&X XX,
X&X XX shall bear all the expenses associated with such recall. If any recall
results without gross negligence or willful misconduct of either party, then
Miravant and P&U AB shall equally bear the expenses of such recall. P&U AB
agrees to maintain adequate sales and service records to enable it to carry out
any Product recall and to conduct such recall.
5.16 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 6 - *****
***** Confidential Treatment Requested
ARTICLE 7 - PUBLICATION AND CONFIDENTIALITY
7.1 Publication. At least thirty (30) days prior to the time either party
submits any data or articles related to Product or Technology for publication or
presentation, the proposed publication or presentation must be sent to the
Project Team for review and clearance. If the Project Team so decides, such
publication or presentation can be delayed as long as necessary to preserve US
or foreign patent or other property rights.
7.2 Disclosure. Miravant shall disclose to P&U AB from time to time all
information relating to the Patent Rights, Technology and Product for the Field
which was not previously disclosed; provided, that Miravant shall only be
required to disclose such information to P&U AB as is necessary for P&U AB to
fulfill its obligations under this Agreement. All information disclosed by one
party to the other under this Section 7.2 shall be deemed "Confidential
Information" and treated as provided in Section 7.3 hereof. P&U AB shall
disclose to Miravant, or Miravant shall have access to, information developed by
P&U AB related to Product including, but not limited to, the NDA's and other
regulatory data including clinical data and investigators' reports, applications
and licenses.
7.3 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 7.2 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 connections 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.
7.4 Limitations on Confidentiality. The obligation of confidentiality
contained in Section 7.3 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 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 8 - TERM AND TERMINATION
8.1 Term. Subject to the provisions of this Article 8, the term of this
Agreement shall continue so long as P&U AB shall be obligated to pay royalties
on the sale of any Product in the Territory.
8.2 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 60 day period shall have cured the breach.
The 60 day period shall be extended for a period not exceeding an additional
ninety (90) days for breaches which cannot be reasonably cured within the 60 day
period if the party has commenced to cure the breach within that period.
8.3 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.
8.4 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 Miravant to receive any amounts then owing from P&U AB for
royalties due hereunder, all of which amounts shall be immediately due and
payable on such date.
ARTICLE 9 - PATENT INFRINGEMENT
9.1 Infringement by Third Parties. If, during the term of this Agreement,
either Miravant or P&U AB shall acquire knowledge or have reasonable cause to
believe that any of the Patent Rights claiming a Product, or its use or
manufacture, shall be infringed or used without authorization by any other
person in the Territory, such party shall promptly notify the other of such
knowledge. Miravant and P&U AB 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.
9.2 Initiation of Action by Miravant or P&U AB. Miravant 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. Miravant 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 Miravant. If Miravant does not commence such an action
within one hundred eighty (180) days after a request to do so by P&U AB, then
P&U AB 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 AB 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 AB. Each party agrees to reasonably cooperate with
the other party in any legal proceeding and to pay all of its own costs taken
pursuant to this Section 9.2.
9.3 Claims Against P&U AB or Miravant. If any claim is made or action
brought against P&U AB or Miravant based on the claim that P&U AB or Miravant is
infringing any third party patent rights by virtue of the manufacture, use or
sale of Product hereunder, P&U AB or Miravant 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.
P&U AB shall solely be responsible for any trademark infringement claims and for
all damages claimed against P&U AB and its Affiliates by any third party.
9.4 Damages Paid to Third Party. If, in any such action described in
Section 9.3, a court of competent jurisdiction determines that P&U AB or
Miravant is obligated to pay damages to any third person (excluding trademark
claims) because P&U AB or Miravant's manufacture, use or sale of a Product was
held to be an infringement of a third party right, *****.
***** Confidential Treatment Requested
9.5 Reduction of Royalties. In the event the legal proceedings described in
Section 9.3 result in a settlement or other final action which requires P&U AB
to pay a royalty to a third party in order to continue to use or sell Product,
the royalty paid by P&U AB to Miravant for such Product shall be reduced by an
amount equal to ***** of the rate of the royalty that P&U AB is required to pay
to such third party, not to exceed ***** of the royalties which would otherwise
be payable to Miravant.
***** Confidential Treatment Requested
ARTICLE 10 - INDEMNIFICATION
10.1 Indemnification. Except for matters relating to indemnification for
infringement of intellectual property rights, as to which Article 9 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 action, causes
of action, claims, demands, suits, controversies, damages, verdicts, judgments,
executions and all cost 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").
10.2 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 10.2 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, 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 10.2, but the omission so to 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 11 - RESOLUTION OF DISPUTES
11.1 Resolution of Disputes by Parties' Presidents. The parties recognize
that a bona fide dispute as to certain matters may from time to time arise
during the term of this Agreement which relate to either party's rights or
obligations hereunder. In the event of the occurrence of such a dispute, either
party may, by written notice to the other, have such dispute referred to their
respective officer designated below or their successors, for attempted
resolution by good faith negotiations within sixty (60) days after such notice
is received. Said designated officers are as follows:
For Miravant - President
For P&U AB- Managing Director or his designate
In the event the designated officers are not able to resolve such
dispute within such sixty (60) day period, any party may invoke the provisions
in Section 11.2 below, other than for matters within the scope of the Steering
Committee.
11.2 Arbitration. Except as expressly provided in Section 11.1, 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 of Sweden, 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 arbitration shall be shared
equally by the parties.
ARTICLE 12 - MISCELLANEOUS
12.1 Force Majeure. Neither P&U AB nor Miravant 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, order 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.
12.2 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 AB to
Miravant hereunder; provided, that P&U AB may withhold any tax it is required to
collect or pay on behalf of Miravant.
12.3 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 AB: Pharmacia & Upjohn AB
Xxxxxxxxxxxxxxx 000
X-000 00 XXXXXXXXX
XXXXXX
Attention: Associate General Counsel
Fax: x00 0 000 00 00
With a copy to: Pharmacia & Upjohn, Inc.
00 Xxxxxxxxx Xxxxx
Xxxxxxxxxxx, XX 00000
Fax # 000-000-0000
Attention: General Counsel
Miravant: Miravant, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
U.S.A.
Attn: President
Fax # 000-000-0000
With a copy to: Nida & Xxxxxxx, P.C.
000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
X.X.X.
Attn: Xxxxxx X. Xxxx
Fax # 000-000-0000
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.
12.4 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 of partner of the other party.
12.5 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.
12.6 Other Instruments. The parties hereto covenant and agree that they
will execute such other and further instruments and documents as 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.
12.7 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.
12.8 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. 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.
12.9 Agreements Read as a Whole. It is the intent of the parties that the
terms of this Agreement and the terms of any other agreements between the
parties related to the Product and/or the Strategic Plan be read as a whole and
as being consistent with one another. In the event of an inconsistency between
the terms of this Agreement and any of such other agreements, which
significantly impacts the parties' ability to carry out the Strategic Plan, such
inconsistency shall be resolved by the Steering Committee.
12.10 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.
12.11 Amendment. This Agreement may only be amended in writing by an
agreement designated as an amendment and executed by the parties hereto.
12.12 Survival. Articles 7 and 10 shall survive the expiration or
termination of this Agreement.
ARTICLE 13 - BINDING EFFECT: ASSIGNMENT
13.1 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 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 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.
13.2 Right to Seek Assurance. In the event all or substantially all of the
assets of either P&U AB or Miravant are acquired by a third party, the
non-acquired party shall have the right pursuant to Section 13.1 to receive a
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 action necessary to
enable the non-acquired party to obtain such written assurance.
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 AB
By ________________________________ By _________________________
Xxxx X. Xxxxxxx, Chairman of the Board Title: _______________________
and Chief Executive Officer
By ____________________________
SCHEDULE 1.16
Major Indications
*****
***** Confidential Treatment Requested
SCHEDULE 1.17
*****
*****
*****
*****
***** Confidential Treatment Requested
SCHEDULE 1.21
Other Indications
*****
***** Confidential Treatment Requested
SCHEDULE 3.3
Key Countries
*****
*****
*****
*****
*****
*****
***** Confidential Treatment Requested
