EXHIBIT 10(A)
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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PATENT LICENSE AGREEMENT
This Patent License Agreement (this "AGREEMENT") is effective as of the
Effective Date (as defined below) by and among DUSA Pharmaceuticals, Inc., a
corporation organized and existing under the laws of the State of New Jersey,
having a principal office and place of business at 25 Upton Drive, Wilmington,
Massachusetts, USA 01887 ("DUSA") and PhotoCure ASA, a corporation organized and
existing under the laws of Norway, having a principal office and place of
business at Hoffsveien 48, NO-0377 Oslo, Norway ("PHOTOCURE").
RECITALS:
WHEREAS, DUSA owns or controls the Licensed Patents (as defined below) in
connection with and pursuant to the Amended and Restated License Agreement
between PARTEQ Research and Development Innovations, a non-profit corporation
without share capital incorporated under the laws of the Province of Ontario and
having a principal office and place of business at Queen's University at
Kingston, Kingston, Ontario, Canada K7L 3N6 ("PARTEQ"), and DUSA dated March 11,
1998 ("PARTEQ/DUSA AGREEMENT");
WHEREAS, PhotoCure desires to obtain from DUSA certain license and
sublicense rights under the Licensed Patents, and DUSA desires to grant such
rights, each under the terms and conditions set forth in this Agreement;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:
1. DEFINITIONS.
The capitalized terms set forth below and used in this Agreement have the
following meanings:
"AFFILIATE" means any corporation, firm, partnership or other entity,
whether de jure or de facto, which directly or indirectly through one or more
intermediaries controls, is controlled by or is under common control with an
entity. An entity shall be deemed to control another entity if it: (i) owns,
directly or indirectly, fifty percent (50%) or more of the outstanding voting
securities or capital stock (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular jurisdiction) of
such other entity; (ii) has the right to appoint or nominate (A) fifty percent
(50%) or more of the directors of such other entity, or (B) the president or
chief executive officer of such other entity; or (iii) has other comparable
ownership interest with respect to any entity other than a corporation.
"ALA ESTERS" means any and all esters of 5-aminolevulinic acid, and any and
all salts of such esters.
"AK/BCC INDICATIONS" means [C.I.] actinic keratosis ("AK INDICATION") or
basal cell carcinoma.
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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"ANCILLARY AGREEMENTS" has the meaning provided in Section 5.6(a).
"BANKRUPTCY LAWS" means Title 11 of the United States Code, as it may be
amended from time to time, any successor statute or any applicable state or
foreign laws relating to bankruptcy, dissolution, liquidation, winding up or
reorganization.
"CALENDAR QUARTER" means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31 of any
given year.
"DERMATOLOGICAL INDICATIONS" means the [C.I.] or the diagnosis, treatment
or prevention of [C.I.], including diseases or conditions of [C.I.] disorders.
"DISTRIBUTOR" means a Person other than PhotoCure or an Affiliate of
PhotoCure that in a country promotes the sale of, markets, sells and distributes
Licensed Products manufactured by or for PhotoCure. For the avoidance of doubt,
Distributor does not include [C.I.] activities without being primarily
responsible for the [C.I.] of the Licensed Product.
"DUSA ENTITIES" means DUSA, PARTEQ and Queen's University at Kingston, a
body corporate under Royal Charter 1841 (as amended by the Parliament of Canada)
having a principal office and place of business at Kingston, Ontario, Canada K7L
3N6.
"EFFECTIVE DATE" means the later of:
(a) the date of execution and delivery of this Agreement by both
Parties; or
(b) the date on which all conditions precedent set forth in Section
5.6(a) are satisfied.
"FIRST COMMERCIAL SALE" means the first sale of a Licensed Product in a
country by PhotoCure, its Sublicensees or its Distributors to a Third Party
after all required marketing approvals therefor have been granted, or otherwise
permitted, by the appropriate governing health authority. First Commercial Sale
shall [C.I.] of any Licensed Product [C.I.].
"GOVERNMENTAL ENTITY" means any governmental authority or any court of
competent jurisdiction or administrative agency, commission or instrumentality
thereof, and any multi-jurisdictional entity having similar authority to such
governmental authority, including the United States Patent and Trademark Office
and the United States Food and Drug Administration.
"HEXVIX PRODUCT" means the pharmaceutical formulation containing [C.I.]
substantially in the form approved by the Swedish Medical Products Agency
(Lakemedelsverket) (as the reference member state under the European Union
mutual recognition procedure) under marketing authorization number 19227 as of
the Effective Date for sale in European Union under the trademark "HEXVIX,"
including any supplements to such approvals changing the manufacturer of (a)
such formulation or (b) any component thereof.
"INDEMNITEE" has the meaning provided in Section 8.4.
"INDEMNITOR" has the meaning provided in Section 8.4.
"INFORMATION" means any and all information and data, whether communicated
in writing or orally or by any other method, which is provided by one Party to
the other Party in connection with this Agreement.
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Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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"KENNEDY LICENSED PATENTS" means and is limited to the Patents listed on
SCHEDULE A attached to this Agreement, [C.I.].
"LICENSED PATENTS" means the Kennedy Licensed Patents and Other Licensed
Patents.
"LICENSED PRODUCTS" means any and all pharmaceutical formulations
containing an ALA Ester, including the Hexvix Product and the Metvix Product,
which formulations are sold by or on behalf of PhotoCure, its Affiliates or any
of their Sublicensees or Distributors.
"METVIX PRODUCT" means the pharmaceutical formulation containing [C.I.]
substantially in the form approved by the Swedish Medical Products Agency
(Lakemedelsverket) (as the reference member state under the European Union
mutual recognition procedure) under marketing authorization number 16338 as of
the Effective Date for sale in European Union under the trademark "METVIX" and
also approved by the FDA under NDA number 021415 as of the Effective Date for
sale in the United States under the trademark "METVIXIA," including any
supplements to such approvals changing the manufacturer of (a) such formulation
or (b) any component thereof.
"NET SALES" means, with respect to any Licensed Product, the [C.I.] for
such Licensed Product (including such amounts invoiced [C.I.]), less deductions
for: [C.I.] in each case, as accounted for in accordance with United States
Generally Accepted Accounting Principles, as applicable, or their equivalents in
other countries, as applicable, but in any case, consistently applied.
Notwithstanding the foregoing, [C.I.] of such Licensed Product and [C.I.] of
such Licensed Product in the relevant country in the Territory for the
applicable Calendar Quarter. As used herein, [C.I.] means such number of [C.I.]
of the applicable Licensed Product, except that following the First Commercial
Sale of a particular Licensed Product in the United States (or the first sale of
a particular Licensed Product in the United States by PhotoCure, its
Subsidiaries or its Distributors to a Third Party under an FDA approved label
expanding its clinical indications), such [C.I.] or (ii) (X) [C.I.] per full
Calendar Quarter for the first and second full Calendar Quarters following such
sale and [C.I.] for any portion of a Calendar Quarter preceding the first full
Calendar Quarter following such sale, and (Y) [C.I.] per Calendar Quarter for
each of the third and fourth full Calendar Quarters following such sale.
"NON-DERMATOLOGICAL INDICATIONS" means the diagnosis, treatment or
prevention of diseases or conditions affecting humans other than the
Dermatological Indications.
"OTHER LICENSED PATENTS" means and is limited to all Patents, other than
the Kennedy Licensed Patents, that are, as of [C.I.] owned by or licensed (with
right to grant a sublicense) to DUSA and which cover the Hexvix Product or the
Metvix Product [C.I.] including all Patents issuing from or claiming priority
from United States patent application [C.I.].
"PARTY" means PhotoCure and DUSA, individually, and "PARTIES" means
PhotoCure and DUSA, collectively.
"PATENTS" means issued patents and patent applications, including any
continuing or divisional applications thereof and any patents issuing on said
applications or continuing or divisional applications, including reissues
thereof.
"PERSON" means any natural person, corporation, firm, business trust, joint
venture, association, organization, company, partnership or other business
entity, or any government or any agency or political subdivision thereof.
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Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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[C.I.] means only those activities undertaken by PhotoCure or its
Sublicensees or Distributors which are [C.I.] which PhotoCure or its
Sublicensees believes in good faith is required for [C.I.] and which activities
in any case shall be limited to [C.I.] For the avoidance of doubt, [C.I.] do not
include any [C.I.] in the United States.
"REGULATORY APPROVAL" means any and all approvals of NDA's, notices of
compliance and marketing authorization applications, or other licenses,
registrations or authorizations of any governmental entity (including, to the
extent necessary to sell a Licensed Product in Europe, pricing and reimbursement
approvals) that are necessary for the commercial sale of a Licensed Product in a
regulatory jurisdiction.
"ROYALTY PERIOD" means, with respect to a country and a Licensed Product,
the period of time beginning on the Effective Date and continuing for so long as
royalties are payable on Net Sales of such Licensed Product in such country as
provided in Section 4.2.
"SUBLICENSEE" has the meaning provided in Section 2.5(a).
"TERM" has the meaning provided in Section 10.1.
"TERRITORY" means all countries of the world in which there are one or more
Valid Claims.
"THIRD PARTY" means any party other than DUSA, PhotoCure or their
respective Affiliates. For purposes of Net Sales and First Commercial Sale, a
[C.I.] shall not include [C.I.].
"UNITED STATES" means the United States of America and its territories and
possessions.
"VALID CLAIM" means a claim of a Licensed Patent that has not expired and
has not been: (a) abandoned or withdrawn; (b) revoked or held invalid,
unenforceable or rejected in a decision of a tribunal of competent jurisdiction
(including a patent examiner) and from which no appeal can be taken, or if such
appeal can be taken, no appeal has been taken within the applicable deadline; or
(c) lost in any interference proceeding.
INTERPRETATIVE RULES. For the purpose of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise requires:
(a) defined terms include the plural as well as the singular and the use of any
gender shall be deemed to include the other gender; (b) references to Articles,
Sections and other subdivisions and to Schedules and Exhibits without reference
to a document, are to designated Articles, Sections and other subdivisions of
and to Schedules and Exhibits to this Agreement; (c) the use of the term
"including" means "including but not limited to"; and (d) the words "herein",
"hereof", "hereunder" and other words of similar import refer to this Agreement
in whole and not to any particular provision.
2. GRANT OF LICENSES.
2.1 Non-U.S. Territory License. Subject to the terms and conditions set
forth in this Agreement, during the Term, DUSA hereby grants to PhotoCure a
non-exclusive, royalty-bearing license or sublicense, as the case may be, in the
Territory (other than the United States) under (a) the Kennedy Licensed Patents
to make, have made, use, offer to sell, sell and import Licensed Products for
all uses, and (b) the Other Licensed Patents to make, have made, use, offer to
sell, sell and import the Hexvix Product
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Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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and the Metvix Product for all uses, in each case including the right to grant
sublicenses to Sublicensees pursuant to Section 2.5.
2.2 United States Licenses.
(a) Subject to the terms and conditions set forth in this Agreement,
during the Term, DUSA hereby grants to PhotoCure a non-exclusive,
royalty-bearing license or sublicense, as the case may be, throughout the United
States under (i) the Kennedy Licensed Patents to make, have made, use, offer to
sell, sell and import Licensed Products for Non-Dermatological Indications, and
(ii) the Other Licensed Patents to make, have made, use, offer to sell, sell and
import the Hexvix Product and the Metvix Product for Non-Dermatological
Indications, in each case including the right to grant sublicenses to
Sublicensees pursuant to Section 2.5.
(b) Subject to the terms and conditions set forth in this Agreement,
DUSA hereby grants to PhotoCure a non-exclusive, royalty-bearing license or
sublicense, as the case may be, throughout the United States under (i) the
Kennedy Licensed Patents to make, have made, use, offer to sell, sell and import
Licensed Products during the period [C.I.] and (ii) the Other Licensed Patents
to make, have made, use, offer to sell, sell and import the Metvix Product
during the period [C.I.] in each case including the right to grant sublicenses
to Sublicensees pursuant to Section 2.5. For the avoidance of doubt, the license
granted in this Section 2.2(b) does not include any right to conduct [C.I.].
(c) Subject to the terms and conditions set forth in this Agreement,
DUSA hereby grants to PhotoCure a non-exclusive, royalty-bearing license or
sublicense, as the case may be, throughout the United States under (i) the
Kennedy Licensed Patents to make, have made, use, offer to sell, sell and import
Licensed Products [C.I.] and (ii) the Other Licensed Patents to make, have made,
use, offer to sell, sell and import the Metvix Product [C.I.] in each case
including the right to grant sublicenses to Sublicensees pursuant to Section
2.5.
(d) Subject to the terms and conditions set forth in this Agreement,
DUSA hereby grants to PhotoCure a non-exclusive, royalty-bearing license or
sublicense, as the case may be, throughout the United States under (i) the
Kennedy Licensed Patents to make, have made, use, offer to sell, sell and import
Licensed Products [C.I.] for Dermatological Indications, and (ii) the Other
Licensed Patents to make, have made, use, offer to sell, sell and import the
Metvix Product [C.I.] in each case including the right to grant sublicenses to
Sublicensees pursuant to Section 2.5.
(e) For the avoidance of doubt, nothing in this Section 2.2 or
otherwise in this Agreement shall [C.I.] or [C.I.] in the United States for any
uses, or manufacturing or importing Licensed Products for such purposes or in
anticipation of selling Licensed Products as permitted under this Section 2.2.
(f) For the avoidance of doubt, [C.I.] shall not be attributed to
PhotoCure and its Sublicensees and Distributors, and shall not be deemed to
breach any of the restrictions in Section 2.2 or otherwise give rise to a claim
[C.I.].
2.3 Licenses On Unscheduled Patents. If there are any Patents licensed to
or owned by DUSA on the Effective Date that claim any composition of matter
containing, or any method of use or manufacture of, any ALA Ester or the Hexvix
Product or the Metvix Product that are not listed on Schedule
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Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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A, PhotoCure shall have and DUSA hereby grants to PhotoCure licenses under such
Patents in accordance with and on the same terms as the licenses granted in this
Agreement under the Kennedy Licensed Patents, [C.I.].
2.4 Limitations on Licenses. The licenses and sublicenses granted in
Sections 2.1, 2.2 and 2.3 do not include the grant of any rights in or to
[C.I.]. Except as expressly set forth in Sections 2.1, 2.2 and 2.3, PhotoCure
shall not acquire any license, sublicense or other intellectual property
interest under this Agreement, by implication or otherwise, under any Patents
owned or controlled by DUSA or its Affiliates. For the avoidance of doubt, DUSA
shall not acquire any license or other intellectual property interest under this
Agreement, by implication or otherwise, under any Patents owned or controlled by
PhotoCure.
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Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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2.5 Conditions for Sublicenses and Distribution.
(a) Each Person to whom PhotoCure or a Sublicensee has granted a
sublicense under and in accordance with this Agreement shall be deemed to be a
sublicensee hereunder (a "SUBLICENSEE"). The right of PhotoCure or any
Sublicensee to grant sublicenses to other Sublicensees pursuant to Sections 2.1,
2.2 and 2.3 is conditioned upon the requirements set forth in this Section 2.5.
PhotoCure shall [C.I.] and the [C.I.] under this Agreement, by reason of sales
of any Licensed Products by Sublicensees or Distributors and their compliance
with all applicable licensing terms of this Agreement to the extent that they
are applicable to a Sublicensee. All sublicenses granted hereunder will be in
writing and their terms shall reflect the requirements set forth in this
Agreement. Any Affiliate of PhotoCure which makes, uses, sells or offers for
sale any Licensed Product shall be granted a sublicense hereunder by PhotoCure
in accordance with the terms of this Section 2.5. Without limiting the
generality of any of the foregoing, PhotoCure shall contractually require each
Sublicensee and each Distributor to: (1) agree to comply with Sections 2.5
(Conditions for Sublicenses and Distribution), 6.3 (Records Retention), 8
(Indemnification), 9 (Confidentiality), and 10.5 (Effect of Termination by DUSA)
of this Agreement; and (2) agree that DUSA is a third party beneficiary with a
right of enforcement of such Sublicensee's or Distributor's compliance with such
terms; provided, that PhotoCure has failed to enforce such terms [C.I.] after
notice from DUSA.
(b) PhotoCure may grant sublicenses hereunder without first obtaining
the prior written consent of DUSA, subject to its compliance with the terms of
this Section 2.5. PhotoCure shall notify DUSA [C.I.] of all such sublicenses.
DUSA hereby acknowledges that PhotoCure has granted a sublicense to Galderma
S.A. and its Affiliates.
(c) PhotoCure hereby [C.I.] and [C.I.] this Agreement to the extent
the performance or lack of performance is a breach of this Agreement. For the
avoidance of doubt, any act or omission by any Sublicensee or Distributor that
breaches any obligation of PhotoCure under this Agreement or any obligation
sublicensed to such Sublicensee or Distributor under this Agreement shall be
deemed a breach by PhotoCure and DUSA shall be entitled to all available
remedies under this Agreement, including, termination of the rights sublicensed
to such parties pursuant to the terms of Section 10.2 of this Agreement.
(d) PhotoCure shall provide DUSA [C.I.] granting a sublicense
hereunder to any Sublicensee [C.I.] following its execution by such Sublicensee
and the other parties thereto [C.I.].
3. [C.I.] All rights and licenses granted pursuant to this Agreement are, and
shall otherwise be deemed to be, for purposes of [C.I.]. PhotoCure, as a
licensee of such rights under this Agreement, shall [C.I.] under any of the
[C.I.]. To the fullest extent permitted by law, in the event of the [C.I.] shall
be entitled to all applicable rights [C.I.].
4. ROYALTIES.
4.1 Pre-Paid Royalty Payment. Upon June 1, 2006, PhotoCure shall pay to
DUSA a one-time, non-refundable payment of one million U.S. dollars (US
$1,000,000) which, during the Term, shall be creditable toward future royalties
under Section 4.2. PhotoCure shall be entitled to take such credit
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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during each Calendar Quarter during the Term until such credit is exhausted,
provided that PhotoCure shall not be entitled to reduce royalty payments for any
particular Calendar Quarter [C.I.]. During the Term, any unused credit shall be
carried over and credited against royalties payable by PhotoCure in succeeding
Calendar Quarters until the entire credit is exhausted. Upon the expiration or
termination of this Agreement for any reason, any then remaining unused credit
shall be forfeited and no longer creditable or due to PhotoCure in any manner
whatsoever.
4.2 Royalties on Net Sales.
(a) Non-Dermatological Indications. Subject to Section 4.3, PhotoCure
shall pay DUSA a royalty equal to [C.I.] of all Net Sales of each Licensed
Product, including the Hexvix Product, in [C.I.] in the Territory in which
PhotoCure has received Regulatory Approval of such Licensed Product for any use
for [C.I.] in such country from the Effective Date and continuing for so long as
such Licensed Product is approved for any Non-Dermatological Indication claimed
by a Valid Claim in such country.
(b) Sales for Dermatological Indications Generally. Subject to Section
4.3, except with respect to Net Sales in the United States of Licensed Products,
including the Metvix Product, for Dermatological Indications with respect to
which a royalty is due to be paid to DUSA under Sections 4.2(c) or (d),
PhotoCure shall pay DUSA a royalty on Net Sales of each Licensed Product,
including the Metvix Product, [C.I.] in the Territory in which PhotoCure has
received Regulatory Approval of such Licensed Product for any use for [C.I.] in
such country beginning on the Effective Date and continuing for so long as such
Licensed Product is approved for any Dermatological Indication claimed by a
Valid Claim in such country according to the following schedule:
ANNUAL NET SALES IN THE TERRITORY FOR DERMATOLOGICAL INDICATIONS ROYALTY RATE
- ---------------------------------------------------------------- ------------------------
Increment that [C.I.] [C.I.] of such Net Sales
Increment that [C.I.] but less than [C.I.] [C.I.] of such Net Sales
Increment that [C.I.] but less than [C.I.] [C.I.] of such Net Sales
Increment that [C.I.] but less than [C.I.] [C.I.] of such Net Sales
Increment that [C.I.] [C.I.] of such Net Sales
Subject to Section 4.3, "Annual Net Sales in the Territory for Dermatological
Indications" as set forth in the table above means any and all Net Sales of all
Licensed Products in all countries in the Territory on which royalties are
payable under this Section 4.2(b).
(c) Sales for Dermatological Indications in the United States [C.I.]
and [C.I.]. Subject to Section 4.3, with respect to Net Sales in the United
States made after [C.I.] of Licensed Products, including the Metvix Product, for
which PhotoCure has received Regulatory Approval in the United States
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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for use for any Dermatological Indication claimed by a Valid Claim in the United
States, PhotoCure shall pay DUSA a royalty on such Net Sales in an amount equal
to one of the following percentages [C.I.]:
(1) at times that the United States Food and Drug Administration
("FDA") has approved a Licensed Product for sale for the AK Indication (and the
AK Indication is claimed by a Valid Claim of a United States patent) and has not
approved any Licensed Product for sale for any other Dermatological Indication:
[C.I.] of all such Net Sales;
(2) at times that the FDA has approved a Licensed Product for
sale for a Dermatological Indication other than the AK Indication (and such
other Dermatological Indication is claimed by a Valid Claim of a United States
patent), and either (a) the FDA has not approved a Licensed Product for sale to
diagnose, treat or prevent acne vulgaris; or (b) the FDA has approved a Licensed
Product for sale to diagnose, treat or prevent acne vulgaris but such use is not
claimed in a Valid Claim of a United States patent: [C.I.] of all such Net Sales
(the parties have agreed to this figure as an accommodation to reflect that,
while some portion of Net Sales in this case are likely to be for non-AK
Indication uses not possibly covered by any Licensed Patent, ascertaining the
percentage of possibly covered versus non-covered sales would likely be
impossible or unreasonably expensive);
(3) at times that the FDA has expanded the approved uses for the
Metvix Product sold under the trademarks "METVIX" or "METVIXIA" to include the
diagnosis, treatment or prevention of acne vulgaris and such use is claimed in a
Valid Claim of a United States patent: [C.I.] of all such Net Sales (the parties
have agreed to this figure as an accommodation to reflect that, while some
portion of Net Sales in this case may be for uses other than diagnosing,
treating or preventing actinic keratosis or acne vulgaris that could not
possibly be covered by any Licensed Patent, ascertaining the percentage of
possibly covered versus non-covered sales would likely be impossible or
unreasonably expensive); and
(4) at times that the FDA has approved a Licensed Product for
sale to diagnose, treat or prevent acne vulgaris and such use is claimed in a
Valid Claim of a United States patent and such Licensed Product either is a
different formulation than any of the Hexvix Product or the Metvix Product, or
is sold under a trademark other than "METVIX" or "METVIXIA": [C.I.] of such Net
Sales of such Licensed Products and [C.I.] of such Net Sales of all other
Licensed Products (the parties have agreed to this figure as an accommodation to
reflect that, while some portion of Net Sales in this case may be for uses other
than diagnosing, treating or preventing actinic keratosis or acne vulgaris that
could not possibly be covered by any Licensed Patent, ascertaining the
percentage of possibly covered versus non-covered sales would likely be
impossible or unreasonably expensive).
(d) Sales for Dermatological Indications [C.I.]. Subject to Section
4.3, PhotoCure shall pay DUSA a royalty on Net Sales in the United States made
[C.I.] and [C.I.] of Licensed Products, including the Metvix Product, for which
PhotoCure has received Regulatory Approval in the United States for use for any
Dermatological Indications claimed by a Valid Claim in the United States in an
amount equal to one of the following percentages [C.I.]:
(1) at times that the FDA has not approved a Licensed Product for
sale to treat acne vulgaris: [C.I.] of such Net Sales [C.I.];
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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(2) at times that the FDA has approved a Licensed Product for
sale to diagnose, treat or prevent acne vulgaris (and such use is claimed in a
Valid Claim of a United States patent) and such Licensed Product is neither a
different formulation than the Hexvix Product or the Metvix Product nor sold
under a trademark other than "METVIX" or "METVIXIA": [C.I.] of all such Net
Sales of such Licensed Products and [C.I.] of all such Net Sales of other
Licensed Products (the parties have agreed to this figure as an accommodation to
reflect that, while some portion of Net Sales in this case are likely to be for
non-acne vulgaris uses not possibly covered by any Licensed Patent, ascertaining
the percentage of possibly covered versus non-covered sales would likely be
impossible or unreasonably expensive); and
(3) at times that the FDA has approved a Licensed Product for
sale to diagnose, treat or prevent acne vulgaris (and such use is claimed in a
Valid Claim of a United States patent) and such Licensed Product is either a
different formulation than the Hexvix Product or the Metvix Product or sold
under a trademark other than "METVIX" or "METVIXIA": [C.I.] of such Net Sales of
such Licensed Product and [C.I.] of all such Net Sales of all other Licensed
Products.
4.3 Current Products and Existing Licensed Products. The Parties agree
that, for purposes of this Article 4, (a) [C.I.] and (b) with respect to
photodiagnosis and with respect to the AK/BCC Indications and acne vulgaris, the
[C.I.]. [C.I.] shall be payable under Section 4.2 with respect to any Kennedy
Licensed Patent (i) for any Net Sales of the Hexvix Product or the Metvix
Product [C.I.] or (ii) for any Net Sales of the Hexvix Product or the Metvix
Product [C.I.]. The foregoing and Schedule 4.3 do not address [C.I.] if any, on
[C.I.] of other Licensed Products, new esters of ALA, or other Licensed Products
nor do they address [C.I.] if any, in respect of [C.I.] that may [C.I.].
Schedule 4.3 is provided for the convenience of the parties in determining the
royalties payable under this Agreement and neither Party shall be deemed to make
any admission in Schedule 4.3 or otherwise about the validity, enforceability or
infringement of any of the Kennedy Licensed Patents.
4.4 Royalty Period. Upon the expiration of the Royalty Period for a
Licensed Product in a country, the licenses and sublicenses granted to PhotoCure
pursuant to Sections 2.1, 2.2 and 2.3 in respect of such Licensed Product and
such country, and any and all sublicenses granted to Sublicensees thereunder,
shall become non-exclusive, royalty-free licenses and sublicenses for the
remainder of the patent term of the Licensed Patents, if any, in such countries,
but shall otherwise continue in accordance with their terms.
5. REPRESENTATIONS AND WARRANTIES; COVENANTS; CONDITIONS.
5.1 DUSA's Representations and Warranties. As of the Effective Date, DUSA
represents and warrants to PhotoCure that:
(a) DUSA has the full right, power and authority to enter into this
Agreement, and to grant the licenses and sublicenses granted under Sections 2.1,
2.2 and 2.3 hereof;
(b) DUSA has not previously granted and will not grant any rights in
conflict with the rights and licenses granted herein;
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(c) DUSA has received no notice of breach from PARTEQ under the
PARTEQ/DUSA Agreement and DUSA is not in default under the PARTEQ/DUSA
Agreement;
(d) The Patents listed on Schedule A are, as of the Effective Date,
all of the Patents licensed to or owned by DUSA that claim any composition of
matter containing, or any method of use or manufacture of, the Hexvix Product or
the Metvix Product.
(e) The execution, delivery and performance of this Agreement do not:
(i) conflict with DUSA's charter and by-laws; (ii) conflict with or result in
any violation of or default under any instrument, judgment, order, writ, decree,
contract or provision; (iii) give rise to any event that results in the creation
of any lien, charge or encumbrance upon any assets of DUSA or the suspension,
revocation, impairment, forfeiture or non-renewal of any material permit,
license, authorization or approval that applies to DUSA, its business or
operations or any of its assets or properties; (iv) conflict with or result in
any violation of or default under any rights granted by DUSA to any Third Party;
or (v) breach any obligation that DUSA has to any Third Party;
(f) There are no actions before any court or governmental agency or
other tribunal, except for those pending as of the Effective Date before
governmental patent agencies or listed on SCHEDULE 5.1(F), relating to the
Licensed Patents; and DUSA has not received any notice or claim asserting, and
has no knowledge of, any infringement, opposition, conflict or interference in
respect of the practice, or the proposed practice of the Licensed Patents; and
(g) The PARTEQ/DUSA Agreement is in full force and effect as of the
Effective Date and that, as of the Effective Date, neither of the parties to the
PARTEQ/DUSA Agreement is in default in the performance of its obligations
thereunder.
5.2 PhotoCure's Representations and Warranties. As of the Effective Date,
PhotoCure represents and warrants to DUSA that:
(a) PhotoCure has the full right, power and authority to enter into
this Agreement; and
(b) The execution, delivery and performance of this Agreement do not:
(i) conflict with PhotoCure's or its Affiliates' charter and by-laws; (ii)
conflict with or result in any violation of or default under any instrument,
judgment, order, writ, decree, contract or provision; (iii) give rise to any
event that results in the creation of any lien, charge or encumbrance upon any
assets of PhotoCure or its Affiliates or the suspension, revocation, impairment,
forfeiture or non-renewal of any material permit, license, authorization or
approval that applies to PhotoCure or its Affiliates, their business or
operations or any of their assets or properties; (iv) conflict with or result in
any violation of or default under any rights granted by PhotoCure or any of its
Affiliates to any Third Party; or (v) breach any obligation that PhotoCure or
any of its Affiliates has to any Third Party.
5.3 Disclaimers of DUSA. Nothing in this Agreement shall constitute a
representation or warranty by DUSA that:
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(a) any patent applications included in the Licensed Patents shall
proceed to grant;
(b) any of the Licensed Patents are valid or enforceable;
(c) the sale, offer for sale or use of Licensed Products do not and
will not infringe on any intellectual property rights of Third Parties; or
(d) the exercise of the rights granted under this Agreement does not
or will not infringe on any intellectual property rights of Third Parties.
5.4 General Disclaimers. [C.I.]
5.5 Covenants. The following shall apply to all Licensed Products for
Dermatological Indications and, in the case of subsection (c), all products
covered by any of the Licensed Patents that are sold by or for DUSA, including
its Levulan(R) 5-aminolevulinic acid product:
(a) PhotoCure agrees, and agrees to also require each Sublicensee and
Distributor, [C.I.] that are not permitted under Section 2.2(e), including such
[C.I.] in which the [C.I.] including supporting related [C.I.] or (ii) prior to
[C.I.] any activity in respect of a Licensed Product that is not permitted by
the license grant in Section 2.2(b) [C.I.].
(b) PhotoCure agrees, and agrees to also require of each Sublicensee
and Distributor, [C.I.] of Licensed Products for [C.I.] by physicians,
hospitals, clinics, pharmacists or other healthcare or cosmetic service
providers in the United States, at any time during the Term which is (X) [C.I.]
with respect to the [C.I.] and (Y) [C.I.] with respect to Dermatological
Indications other than the [C.I.].
(c) PhotoCure and DUSA agree, and agree to also require of each
Sublicensee and Distributor, that all [C.I.] in the United States by PhotoCure,
DUSA and their respective Sublicensees, Distributors and/or any of their
respective agents, sales representatives, employees, officers or directors,
including [C.I.] any Licensed Products and any products made or sold by or on
behalf of DUSA at any time shall at all times be undertaken in accordance in all
material respects with and not in violation of applicable laws, regulations,
rules and issued industry guidances of the United States Food and Drug
Administration, or the successor thereto; provided however that in the case of
issued industry guidances, it is acknowledged and agreed that non-compliance
with issued industry guidances shall not be considered a breach of this
Agreement or of any sublicense agreement if such non-compliance is otherwise in
compliance with applicable laws, regulations and rules.
5.6 Conditions Precedent.
(a) This Agreement shall not become effective until each of the
following agreements has been executed and delivered by the Parties and all
other parties thereto:
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(i) the letter agreement attached hereto as SCHEDULE 5.6(A)(I)
terminating the Mediation Agreement entered into by
PhotoCure, DUSA and Queen's University at Kingston as of the
17th of August, 2004; and
(ii) unless waived by PhotoCure, the Non-Disturbance Agreement
attached hereto as SCHEDULE 5.6(A)(II) (collectively, (i)
and (ii), the "ANCILLARY AGREEMENTS").
(b) Notwithstanding the need to satisfy the conditions identified
under Section 5.6(a) in order for this Agreement to become effective, each of
the Parties agrees to use its diligent, commercially reasonable efforts to close
the transactions contemplated by this Agreement and the Ancillary Agreements in
order for each of the conditions set forth in Section 5.6(a) to become satisfied
as soon as reasonably possible.
5.7 PARTEQ/DUSA Agreement Covenant. DUSA shall not [C.I.] or enter into
[C.I.] that, in either case, [C.I.] under this Agreement, [C.I.].
6. PAYMENTS AND REPORTS.
6.1 Royalty Payments.
(a) All royalty payments due hereunder shall be paid quarterly within
[C.I.] of the end of each Calendar Quarter. Each such payment shall be
accompanied by a statement of the amount of gross sales, the calculation of Net
Sales during such quarter and the amount of royalties due on such Net Sales,
product-by-product, by selling party (i.e., whether PhotoCure or any Sublicensee
or Distributor), [C.I.] and on a consolidated basis; provided however, except as
expressly requested by DUSA, for purposes of making such reports to DUSA,
PhotoCure shall consolidate its Net Sales together with the Net Sales of its
Affiliates.
(b) PhotoCure shall report to DUSA the date of First Commercial Sale
in each country within [C.I.] of its occurrence and with respect to [C.I.]
during any quarter.
(c) The obligation to pay royalties to DUSA under Section 4.2 is
imposed only once with respect to each sale of Licensed Product regardless of
the number of patents pertaining thereto. In calculating the above royalty due
with respect to Net Sales of such Licensed Products during any period of less
than a calendar year, the foregoing thresholds for a calendar year Net Sales
shall be pro-rated in accordance with the duration of such period. PhotoCure
shall only be entitled to a credit against royalties once with respect to any
particular sale of a Licensed Product in any country pursuant to any provision
in this Agreement. There shall be [C.I.] under Section 4.2 on sales of Licensed
Products [C.I.] but in such instances the obligation to pay royalties shall
arise upon the sale by PhotoCure, Sublicensees or Distributors to other Third
Parties. Following the end of each calendar year, the Parties shall reconcile
(true-up) any adjustments in the last payment of each year.
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information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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6.2 Mode of Payment. All statements submitted by PhotoCure shall be stated
in U.S. Dollars. All payments to be made by PhotoCure to DUSA under this
Agreement shall be made in United States dollars and shall be paid by bank wire
transfer in immediately available funds to such bank account as may be
designated in writing by DUSA or PhotoCure, respectively, from time to time. In
the case of sales outside the United States, the rate of exchange to be used in
computing the quarterly amount of currency equivalent in United States dollars
due DUSA shall be made at [C.I.] as of the last day of such Calendar Quarter
(or, in the case of all sales [C.I.] the [C.I.] as of the last day of such
Calendar Quarter).
6.3 Records Retention. For purposes of this Agreement, PhotoCure shall keep
complete and accurate records pertaining to all sales of Licensed Products in
the Territory (including all such sales made by any Sublicensee or Distributor)
and covering all transactions from which Net Sales under this Agreement are
derived for a [C.I.] after the year in which such sales occurred, and in
sufficient detail to permit DUSA to confirm the accuracy of royalty payments due
hereunder. In addition each Sublicensee and Distributor shall keep complete and
accurate records pertaining to all of its respective sales of Licensed Products
in the Territory and covering all transactions from which Net Sales under this
Agreement are derived for a period of [C.I.] after the year in which such sales
occurred, and in sufficient detail to permit DUSA to confirm the accuracy of
royalty payments due hereunder.
6.4 Audit Request. At the request and expense (except as provided below) of
DUSA, PhotoCure and its Affiliates shall each permit an independent, certified
public accountant [C.I.] at reasonable intervals and times and upon reasonable
notice [C.I.] unless DUSA is required to do so to comply with applicable laws or
generally accepted auditing standards), to examine those records and all other
material documents relating to or relevant to Net Sales under this Agreement in
the possession or control of PhotoCure or its Affiliates for a period of [C.I.].
In each case, the accounting firm shall disclose to DUSA only whether the
royalty reports are correct or incorrect and the amount of any discrepancy. No
other information shall be provided to DUSA. In the event that such inspection
shall indicate that in any calendar year the royalties which should have been
paid by PhotoCure are [C.I.] than those which were actually paid by PhotoCure,
then PhotoCure [C.I.] of such inspection. DUSA shall treat all financial
information subject to review under this Section 6.4 in accordance with the
confidentiality and non-use provisions of this Agreement, and shall cause its
accounting firm to enter into a reasonably acceptable confidentiality agreement
with PhotoCure and its Affiliates, , as the case may be, obligating it to retain
all such information in confidence pursuant to such confidentiality agreement.
6.5 Taxes. If laws, rules or regulations require withholding of income
taxes or other taxes imposed upon payments set forth in Section 6, [C.I.] as may
be required and shall [C.I.] set forth in Section 6. PhotoCure shall [C.I.]
within a reasonable period of time. The party responsible for making payments to
DUSA hereunder, whether PhotoCure or a Sublicensee, shall be solely responsible
for any and all currency transfer taxes, other transfer taxes and wire transfer
fees arising from making of such payment to DUSA, and there will be no deduction
in the payments due DUSA for such taxes or fees.
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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6.6 Default in Royalty Payments. If there remains an uncured and undisputed
default after PhotoCure has been given notice thereof and an opportunity to cure
pursuant to Section 10.2 with respect to any failure of PhotoCure to comply with
its obligations pursuant to Sections 4 and 6, then in addition to all other
remedies available to DUSA at law or in equity, and without relieving PhotoCure
from liability for payment due with respect to Net Sales by Sublicensees or
Distributors (except to the extent such payments are made by such Sublicensees
or Distributors pursuant to Section 10.5(b)), immediately upon DUSA giving
notice to PhotoCure, [C.I.] shall take effect.
7. PATENT ENFORCEMENT AND INFRINGEMENT.
7.1 PhotoCure shall not have any right to institute enforcement or
infringement actions relating to the Licensed Patents.
8. INDEMNIFICATION.
8.1 Mutual. Each Party shall defend, indemnify and hold the other Party and
its Affiliates and Sublicensees and Distributors, and their respective
directors, officers, employees and agents, harmless from and against [C.I.] (any
of the foregoing, a "CLAIM") arising out of or resulting from any breach of a
representation, warranty, covenant or agreement of the indemnifying Party under
this Agreement.
8.2 By PhotoCure. PhotoCure shall indemnify and hold DUSA, PARTEQ, Queen's
University at Kingston, Kingston, Ontario, and Royal Military College of Canada,
Kingston, Ontario, and their respective directors, trustees, officers,
employees, shareholders and agents, harmless from and against any and all Claims
asserted by Third Parties [C.I.].
8.3 Costs of Enforcement. As the Parties intend [C.I.] any provision of
this Section 8 shall [C.I.] by the indemnifying Party.
8.4 Conditions to Indemnification. A person or entity that intends to claim
indemnification under this Section 8 (the "INDEMNITEE") shall [C.I.] notify the
indemnifying Party (the "INDEMNITOR") of any Claim in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall
assume the defense thereof with counsel mutually satisfactory to the Indemnitee
whether or not such Third Party claim is rightfully brought; provided, however,
that [C.I.] shall have the right [C.I.] (a) if Indemnitor does not assume the
defense, or (b) if representation of such Indemnitee by the counsel retained by
the Indemnitor would be inappropriate due to actual or potential differing
interests between such Indemnitee and any other person represented by such
counsel in such proceedings. The indemnity agreement in this Section 8 shall not
apply to [C.I.] of any Claim if [C.I.]. The failure to deliver notice to the
Indemnitor within a reasonable time after the commencement of any such action,
only if prejudicial to
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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its ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Section 8, but the omission so to deliver
notice to the Indemnitor will not relieve it of any liability that it may have
to any Indemnitee otherwise than under this Section 8. The Indemnitee under this
Section 8, its employees and agents, shall cooperate fully with the Indemnitor
and its legal representatives in the investigation of any Claim covered by this
Section 8.
9. CONFIDENTIALITY.
9.1 Non-Disclosure. All Information disclosed by one Party to the other
Party shall be maintained in confidence by the receiving Party and shall not be
disclosed to any Third Party or used for any purpose except as set forth herein
without the prior written consent of the disclosing Party, except to the extent
that such Information:
(a) is known by the receiving Party at the time of its receipt, and
not through a prior disclosure by the disclosing Party, as documented by the
receiving Party's business records;
(b) is in the public domain by use and/or publication before its
receipt from the disclosing Party, or thereafter enters the public domain
through no fault of the receiving Party;
(c) is subsequently disclosed to the receiving Party by a Third Party
who the receiving Party believes may lawfully do so and is not under an
obligation of confidentiality to the disclosing Party; or
(d) is developed by the receiving Party independently of Information
received from the disclosing Party, as documented by the receiving Party's
records.
Any combination of features or disclosures shall not be deemed to fall within
the foregoing exclusions merely because individual features are published or
available to the general public or in the rightful possession of the receiving
Party unless the combination itself and principle of operation are published or
available to the general public or in the rightful possession of the receiving
Party.
9.2 Permitted Disclosures.
(a) If a Party is required by judicial or administrative process to
disclose Information of the other Party that is subject to the non-disclosure
provisions of this Section 9, such Party shall promptly inform the other Party
of the disclosure that is being sought in order to provide the other Party an
opportunity to challenge or limit the disclosure obligations. Information that
is disclosed by judicial or administrative process shall remain otherwise
subject to the confidentiality and non-use provisions of this Section 9.
(b) If it is deemed necessary by counsel to the receiving Party that
Information be disclosed to such Party's outside attorneys, independent
accountants or financial advisors for the sole purpose of enabling such
attorneys, independent accountants or financial advisors to provide advice to
the
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information. The confidential portions have been omitted and filed separately
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receiving Party, then such Information may be disclosed on the condition that
such attorneys, independent accountants and financial advisors agree to be bound
by confidentiality and non-use obligations that are substantially the same as
those contained in this Agreement.
9.3 Permitted Disclosure Procedure.
(a) In the event a Party is required to make a disclosure of the other
Party's Information pursuant to Section 9.2(a), it shall provide the other Party
advance notice of such disclosure sufficient to permit the other Party to seek
confidential treatment of such Information. The Party disclosing the other
Party's Information pursuant to law or court order shall take all steps
reasonably necessary, including without limitation obtaining an order of
confidentiality, to ensure the continued confidential treatment of such
Information. The Parties expressly acknowledge that each Party, as and to the
extent it might be required to do so in the future, may file a copy of this
Agreement with the Securities and Exchange Commission or corresponding foreign
Governmental Entity (the "SEC") in accordance with public reporting requirements
imposed by applicable law, regulation, or securities exchange rules. In such
event, such filing Party shall request confidential treatment of sensitive terms
hereof to the extent such confidential treatment is reasonably available to such
filing Party under the prevailing circumstances. The filing Party shall
coordinate in advance with the other Party with regard to the terms of this
Agreement that the filing Party shall seek to be redacted in any such SEC
filings, and the filing Party shall use reasonable efforts to seek confidential
treatment for such mutually agreed terms; provided that notwithstanding the
foregoing, each Party shall retain ultimate control and responsibility for their
respective disclosures to the SEC and the public generally, as such are required
by applicable law, regulation, or securities exchange rules.
(b) PhotoCure may provide an unredacted or redacted copy of this
Agreement to Sublicensees and Distributors; provided, such Persons agree that
the existence and terms of this Agreement shall be protected under
confidentiality, non-disclosure, non-use provisions no less restrictive than
those set forth in this Agreement. DUSA may provide an unredacted or redacted
copy of this Agreement to PARTEQ; provided, that PARTEQ agrees that the
existence and terms of this Agreement shall be protected under confidentiality,
non-disclosure, and non-use provisions no less restrictive than those set forth
in this Agreement.
9.4 PhotoCure acknowledges and agrees that DUSA is obligated to provide to
PARTEQ certain Information of PhotoCure relating to the payment of royalties
hereunder and the reporting of Net Sales in connection therewith, and that DUSA
may do so provided such Information be provided to PARTEQ pursuant to the
confidentiality and non-use obligations of the PARTEQ/DUSA Agreement.
9.5 No Disclosure.
(a) Subject to Sections 9.2 and 9.3, no disclosure of the existence or
the terms of this Agreement may be made by either Party, and neither Party shall
use the name, trade name or logo of the other Party or its Affiliates or
Sublicensee or their respective employees, in any publicity, promotion, news
release or disclosure relating to this Agreement or its subject matter, without
the prior express written permission of the other Party, except as may be
required by law.
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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(b) Upon the Effective Date, the Parties shall issue press release(s)
in the form(s) attached hereto as Schedule 9.5(b).
10. TERM; TERMINATION.
10.1 Term and Expiration. The term of this Agreement (the "TERM") shall
commence upon the Effective Date and, unless terminated earlier pursuant to
Sections 10.2 or 10.3, shall continue until the expiration of all Royalty
Periods.
10.2 Termination for Cause. Either Party may, without prejudice to any
other remedies available to it at law or in equity, terminate this Agreement in
the event the other Party shall have materially breached or defaulted in the
performance of any of its material obligations hereunder and such breach or
default shall have continued for [C.I.] after written notice of such breach or
default was provided to the Party in breach or default specifying the nature of
such breach or default and stating the intent to terminate under this Section
10.2. Any such termination shall become effective at the end of such [C.I.]
period unless the Party in breach has cured any such breach or default prior to
the expiration of such [C.I.] period. The right of either Party to terminate
this Agreement as provided in this Section 10.2 shall not be affected in any way
by its waiver or failure to take action with respect to any previous breach or
default. Notwithstanding the foregoing, no attempt to terminate under this
Section 10.2 shall be effective pending completion of any dispute resolution
proceeding arising out of such attempted termination, breach or default.
10.3 Termination in Connection with Bankruptcy. DUSA may terminate this
Agreement effective immediately in the event that PhotoCure: (i) has been become
insolvent or has dissolved or liquidated or files, has filed or had filed
against it a petition, case or other proceeding under any Bankruptcy Laws and
such petition, case or proceeding, if filed against it, has not been dismissed
within [C.I.] days of the filing; (ii) makes a general assignment for the
benefit of creditors; or (iii) has a receiver, custodian, trustee or other
Person exercising similar functions appointed for all or substantially all of
its assets.
10.4 Effect of Expiration of this Agreement. Upon the expiration of the
Term in accordance with Section 10.1, the licenses and sublicenses granted to
PhotoCure pursuant to Sections 2.1, 2.2 and 2.3, and any and all sublicenses
granted to Sublicensees thereunder, shall become perpetual, royalty-free
licenses and sublicenses, but shall otherwise continue in accordance with their
terms.
10.5 Effect of Termination of this Agreement.
(a) Breach by PhotoCure; Rights of DUSA to Terminate. If this
Agreement is terminated by DUSA pursuant to Sections 10.2 or 10.3, in addition
to all other remedies available to DUSA at law or in equity, the licenses and
sublicenses granted to PhotoCure pursuant to Sections 2.1, 2.2 and 2.3 shall
terminate as of such termination date. To the extent a breach or default giving
rise to a termination under Section 10.2 relates to [C.I.] any termination under
Section 10.2 shall be limited to [C.I.] including termination of all licenses
and sublicenses to make, have made, use, offer to sell, sell or import any
Licensed Product for any [C.I.] and to the extent a breach or default giving
rise to a termination under Section 10.2 relates to [C.I.] any termination under
Section 10.2 shall be limited [C.I.] including termination of all
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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licenses and sublicenses to make, have made, use, offer to sell, sell or import
any Licensed Product for any [C.I.].
(b) Sublicensees. In the event that PhotoCure's licenses under this
Agreement are terminated or DUSA exercises its rights under Section 6.6, with
respect to each sublicense which has been granted under this Agreement to one or
more Sublicensees, then DUSA agrees to grant to each such Sublicensee (other
than an Affiliate of PhotoCure) a direct license under the terms and conditions
of this Agreement and such license shall be of the same scope sublicensed to
such Sublicensee, provided, that such Sublicensee (1) agrees to be bound to DUSA
under the terms and conditions of this Agreement applicable to such sublicense;
(2) the Sublicensee is not in breach of its sublicense agreement with PhotoCure
or in breach of any obligations sublicensed to such Sublicensee under this
Agreement; (3) the Sublicensee pays to DUSA any amount due and owing under this
Agreement with respect to such sublicense at the time of termination that has
not been paid by PhotoCure; and (4) the Sublicensee shall directly pay to DUSA
all royalties due to DUSA on the sales invoiced by such Sublicensee in
accordance with this Agreement after taking into consideration the aggregation
of Net Sales made by all parties and with appropriate true-up after annual sales
are reported. In such event, DUSA shall not become obligated under any
commitments or undertakings made to such Sublicensee and in no event (X) shall
DUSA have any obligations to such Sublicensee other than applicable obligations
which are expressly set forth in this Agreement, and (Y) any obligations that
DUSA does have to such Sublicensee shall be limited to and no greater in scope
than the applicable obligation DUSA has agreed to undertake in this Agreement.
Sublicensees are intended third-party beneficiaries of, and shall have the right
to enforce, this Section 10.5(b).
(c) Breach by DUSA. If PhotoCure exercises its remedies under Section
10.2, it may elect to continue all licenses and other rights granted to it under
this Agreement, in which case the following provisions, in addition to those set
forth in Section 10.6 below, shall continue: 2, 4, and 6.
10.6 Effect of Expiration or Termination. Expiration or termination of this
Agreement shall not relieve the Parties of any obligation accruing prior to such
expiration or termination. Any expiration or termination of this Agreement shall
be without prejudice to the rights of either Party against the other accrued or
accruing under this Agreement prior to expiration or termination, including the
obligation to pay royalties for Licensed Product(s) sold prior to such
expiration or termination. The provisions of Section 9 shall survive the
expiration or termination of this Agreement and shall continue in effect for
[C.I.] thereafter. In addition, the provisions of Sections 1, 6, 8, 10 and 11,
and any other provision of this Agreement that by its terms survives, shall
survive any expiration or termination of this Agreement.
11. MISCELLANEOUS.
11.1 Force Majeure. Neither Party shall be held liable to the other Party
nor be deemed to have defaulted under or breached this Agreement for failure or
delay in performing any obligation under this Agreement (other than a failure to
make any payments due under this Agreement) to the extent that such failure or
delay is caused by or results from embargoes, war, acts of war (whether war be
declared or not), acts of terrorism, insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, fire, floods, or other acts of
God or acts or omissions of governmental agencies. The affected Party shall
notify
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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the other Party of such force majeure circumstances [C.I.] and shall [C.I.]
undertake all reasonable efforts necessary to mitigate such force majeure
circumstances.
11.2 Assignment/Change of Control. Except as provided in Section 2.5 and
this Section 11.2, this Agreement may not be assigned or otherwise transferred,
nor may any right or obligation hereunder be assigned or transferred, by
PhotoCure without the written consent of DUSA; provided, however, that PhotoCure
may, without such consent, assign this Agreement and all or substantially all of
its rights and obligations hereunder to: (a) an Affiliate of PhotoCure; or (b)
any Third Party in connection with the transfer or sale to such Third Party of
all or substantially all of PhotoCure's business with respect to the Licensed
Products; or (c) any Third Party in the event of PhotoCure's merger,
consolidation or reorganization. DUSA may freely assign and otherwise transfer
this Agreement, or any right or obligation of DUSA hereunder, without obtaining
the written consent of PhotoCure, so long as PhotoCure's and its Sublicensees'
rights are not adversely affected. Any attempted assignment not in accordance
with this Section 11.2 shall be void. Any permitted assignee shall assume in
writing all assigned obligations of its assignor under this Agreement. The Party
making any assignment permitted under this Section 11.2 shall provide prompt
written notice to the other Party of such assignment.
11.3 Severability. If any one or more of the provisions contained in this
Agreement is held invalid, illegal or unenforceable in any respect such
provisions shall be limited or eliminated to the minimum extent necessary, and
to the extent such provisions are limited or eliminated the Parties shall use
their best efforts to reform such provisions, in each case so as to give effect
to the intent of the Parties hereunder. In such event, the validity, legality
and enforceability of the remaining provisions contained herein shall not in any
way be affected or impaired thereby and this Agreement will otherwise remain in
full force and effect and enforceable.
11.4 Notices. All notices which are required or permitted hereunder shall
be in writing and either delivered personally, sent by facsimile (and promptly
confirmed by personal delivery or overnight courier), or sent by
internationally-recognized overnight courier (signature required), addressed as
follows:
If to DUSA, to: DUSA Pharmaceuticals, Inc.
25 Upton Drive
Wilmington, Massachusetts 01887
USA
Attn: D. Geoffrey Shulman, M.D. FRCPC
P: 978-657-7500
F: 978-657-9193
With copy to: Nanette Mantell, Esq.
Reed Smith LLP
Princeton Forrestal Village
20
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
136 Main Street - Suite 250
Princeton, New Jersey 08543
USA
P: 609-514-5842
F: 609-951-0824
If to PhotoCure, to: PhotoCure ASA
Hoffsveien 48
N-0377 Oslo
NORWAY
Attn: President & CEO
Fax: +47 22 06 22 18
With a copy to: Wiggin and Dana LLP
400 Atlantic Street
Stamford, CT 06911
USA
Attn: James F. Farrington, Jr.
Fax: +1 203 363 7676
or to such other address(es) as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. All notices
given pursuant to this Section 11.4 shall be deemed to have been given: (a) when
delivered, if personally delivered or sent by facsimile on a business day (or if
delivered or sent on a non-business day, then on the next business day); (b) on
the business day after dispatch, if sent by nationally-recognized overnight
courier; or (c) on the fifth (5th) business day following the date of mailing,
if sent by mail.
11.5 Applicable Law; Venue.
(a) This Agreement shall be governed by and construed in accordance
with the laws of the [C.I.] and the patent laws of the relevant jurisdiction of
a patent included within the Licensed Patents, without reference to any rules of
conflict of laws or renvoi.
(b) [C.I.] If a dispute arising out of or relating to this Agreement,
including any question regarding this Agreement's existence, validity or
termination, or a dispute as to whether PhotoCure has made, used, sold, offered
for sale, or imported a Licensed Product in a manner that infringes a Licensed
Patent and is not covered by the licenses granted in Sections 2.1, 2.2 and 2.3
occurs, any Party may, by written notice to the other, refer such dispute to
[C.I.] designated below or their successors, for attempted resolution by good
faith negotiations [C.I.] after such notice is received by the other Party. Such
negotiations shall not be admissible in any [C.I.] proceeding. [C.I.].
21
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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(c) Arbitration. If [C.I.] do not resolve any such dispute within such
[C.I.] the dispute shall be [C.I.] by arbitration in [C.I.] under the Rules of
the [C.I.] by three (3) arbitrators appointed in accordance with said Rules. The
decision reached by such arbitrators in any such proceeding shall be final and
binding upon the parties thereto. The arbitration proceeding shall be conducted
in the English language. The parties expressly agree that leave to appeal under
[C.I.] or an application for the determination of a [C.I.] under [C.I.] may not
be sought with respect to any question of law arising from an award.
(d) Provisional Remedies. The procedures specified in this Section 11.5
shall be [C.I.] for the resolution of disputes between the Parties arising out
of, relating to, or in connection with this Agreement or the breach, termination
or validity thereof and disputes between the Parties concerning whether
PhotoCure has made, used, sold, offered for sale, or imported a Licensed Product
in a manner that infringes a Licensed Patent and is not covered by the licenses
granted in Sections 2.1, 2.2 and 2.3; provided, that a Party, [C.I.] if in its
sole judgment such action is necessary to avoid [C.I.]. Despite such action, the
Parties will continue to participate in good faith in the procedures specified
in this Section 11.5.
11.6 Entire Agreement; Amendments. This Agreement contains the entire
understanding of the Parties with respect to the subject matter hereof. Any
other express or implied agreements and understandings, either oral or written,
with regard to the license and sublicense to PhotoCure of Licensed Patents are
superseded by the terms of this Agreement. This Agreement may be amended, or any
term hereof modified, only by a written instrument duly executed by authorized
representatives of both Parties hereto.
11.7 Headings. The captions to the several Sections hereof are not a part
of this Agreement, but are merely for convenience to assist in locating and
reading the several Sections hereof.
11.8 Independent Contractors. It is expressly agreed that DUSA and
PhotoCure shall be independent contractors and that the relationship between the
Parties shall not constitute a partnership, joint venture or agency. Neither
DUSA nor PhotoCure shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other Party, without the prior written consent of the other
Party.
11.9 Waiver. The waiver by either Party hereto of any right hereunder, or
of any failure of the other Party to perform, or of any breach by the other
Party, shall not be deemed a waiver of any other right hereunder or of any other
breach by or failure of such other Party, whether of a similar nature or
otherwise.
22
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
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CONFIDENTIAL
11.10 Cumulative Remedies. No remedy referred to in this Agreement is
intended to be exclusive, but each shall be cumulative and in addition to any
other remedy referred to in this Agreement or otherwise available under law.
11.11 Waiver of Rule of Construction. Each Party has had the opportunity to
consult with counsel in connection with the review, drafting and negotiation of
this Agreement. Accordingly, the rule of construction that any ambiguity in this
Agreement shall be construed against the drafting Party shall not apply.
11.12 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
11.13 Recording. Each of the DUSA Entities shall sign such documents and
take such steps as may be reasonably requested by PhotoCure to allow the
recording of a notice of license or other evidence of this Agreement in the
United States Patent and Trademark Office and other applicable patent offices.
All recording fees and other costs incurred shall be paid by PhotoCure.
* * *
23
EXHIBIT 10(a)
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the
Effective Date.
DUSA PHARMACEUTICALS, INC. PHOTOCURE ASA
BY: BY:
--------------------------------- ------------------------------------
D. Geoffrey Shulman, Kjetil Hestdal,
Chairman of the Board and Chief President
Executive Officer
SIGNATURE PAGE for Patent License Agreement
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
SCHEDULE A
LICENSED PATENTS
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
- ------ ------ ------ ------ ------ ------
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
2
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
- ------ ------ ------ ------ ------ ------
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.]
3
EXHIBIT 10(A)
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
SCHEDULE 4.3
ROYALTIES ON CURRENT PRODUCTS UNDER EXISTING LICENSED PATENTS
ROYALTY DUE IF APPROVED INDICATION FOR:
-----------------------------------------
PHOTODIAGNOSIS METVIX PRODUCT
EXPIRATION (I.E., HEXVIX ------------------------
TITLE COUNTRY PATENT NO. DATE PRODUCT) AK BCC ACNE
- ----- ------- ---------- ---------- -------------- ------ ------ ------
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
ROYALTY DUE IF APPROVED INDICATION FOR:
-----------------------------------------
PHOTODIAGNOSIS METVIX PRODUCT
EXPIRATION (I.E., HEXVIX ------------------------
TITLE COUNTRY PATENT NO. DATE PRODUCT) AK BCC ACNE
- ----- ------- ---------- ---------- -------------- ------ ------ ------
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
2
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that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
EXECUTION COPY
CONFIDENTIAL
ROYALTY DUE IF APPROVED INDICATION FOR:
-----------------------------------------
PHOTODIAGNOSIS METVIX PRODUCT
EXPIRATION (I.E., HEXVIX ------------------------
TITLE COUNTRY PATENT NO. DATE PRODUCT) AK BCC ACNE
- ----- ------- ---------- ---------- -------------- ------ ------ ------
[C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.] [C.I.]
3
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
SCHEDULE 5.1(F)
DUSA Pharmaceuticals, Inc., a New Jersey corporation; and Queen's University at
Kingston, a Canadian academic organization v. New England Compounding Pharmacy,
Inc., a Massachusetts corporation
United States District Court for the District of Massachusetts
Civil Action No. 04-12703-NMG
DUSA Pharmaceuticals, Inc., a New Jersey corporation; and Queen's University at
Kingston, a Canadian academic organization v. Amira El-Alayli Soheim, M.D.,
Individually, and d/b/a Harper Laser Clinic
United States District Court for the Eastern District of Michigan Southern
Division
Case No.: 2: 06-cv-10273
DUSA Pharmaceuticals, Inc., a New Jersey corporation; and Queen's University at
Kingston, a Canadian academic organization v. Dianne Quibell, M.D., a
Massachusetts resident, and Premier Medical Associates, a Massachusetts
professional corporation
United States District Court for the District of Massachusetts
Civil Action No. 06-CA-10122-MEL
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
SCHEDULE 5.6(A)(I)
LETTER AGREEMENT TERMINATING THE MEDIATION AGREEMENT
[LETTERHEAD OF DUSA PHARMACEUTICALS, INC.]
____ ___, 2006
PhotoCure ASA
Hoffsveien 48, NO-0377
Oslo, Norway
Galderma S.A.
Zugerstrasse 8
6330 CHAM
Switzerland
Queen's University at Kingston
Kingston, Ontario
Canada K7L 3N6
Re: Termination of the Mediation Agreement in connection with the Patent
License Agreement
Ladies and Gentlemen:
Reference is made to the Mediation Agreement (the "AGREEMENT") dated as of
August 17, 2004 by and among PhotoCure ASA ("PHOTOCURE"), Galderma S.A.,
DUSA Pharmaceuticals, Inc. ("DUSA") and Queen's University at Kingston
(collectively, the "PARTIES"). References in this letter agreement to
"SECTIONS" shall be to Sections of the Agreement.
The Parties hereby agree that in connection with PhotoCure and DUSA
entering into the Patent License Agreement (the "PATENT LICENSE AGREEMENT")
and to facilitate the transactions contemplated thereby, there is no longer
any reason to continue the term of the Agreement. Now therefore, for good
and valuable consideration, the receipt of which is hereby acknowledged by
each Party, the Parties mutually agree to terminate the Agreement and their
respective rights and obligations thereunder effective as of the Effective
Date (as such term is defined in the Patent License Agreement, which date
shall be hereinafter referred to as the "TERMINATION DATE"), except that
Paragraphs 4, 5, 6, 7, 8 and 9 of the Agreement shall continue. The Parties
further agree that there shall be no liability to any Party arising as a
result of or in connection with such termination.
Except as expressly set forth herein, upon termination of the Agreement no
Party shall have any further rights, obligations or liabilities to the
other under the Agreement.
Please confirm your agreement with the foregoing by countersigning both
copies of this letter where indicated and returning one copy to DUSA
Pharmaceuticals, Inc. at the address indicated above.
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
Very truly yours,
DUSA Pharmaceuticals, Inc.
By:
---------------------------------
Name:
-------------------------------
Title:
------------------------------
Accepted and agreed:
PhotoCure ASA
By:
---------------------------------
Name:
-------------------------------
Title:
------------------------------
Queen's University at Kingston
By:
---------------------------------
Name:
-------------------------------
Title:
------------------------------
Galderma S.A.
By:
---------------------------------
Name:
-------------------------------
Title:
------------------------------
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
SCHEDULE 5.6(A)(II)
NON-DISTURBANCE AGREEMENT
___, 2006
PhotoCure ASA
Hoffsveien 48
N-0377 Oslo
NORWAY
Attention: President and CEO
Gentlemen:
PARTEQ Research and Development Innovations, a non-profit corporation without
share capital incorporated under the laws of the Province of Ontario and having
a principal office and place of business at Queen's University at Kingston,
Kingston, Ontario, Canada K7L 3N6 ("PARTEQ") hereby represents and warrants to
PhotoCure that:
(a) the Amended and Restated License Agreement between PARTEQ and DUSA
Pharmaceuticals, Inc., a corporation organized and existing under the
laws of the State of New Jersey, having a principal office and place
of business at 25 Upton Drive, Wilmington, Massachusetts, USA 01887
("DUSA") dated March 11, 1998 (the "PARTEQ LICENSE") is in full force
and effect on the date hereof;
(b) that, as of the date hereof, neither of the parties to the PARTEQ
License is in default in the performance of its obligations thereunder
nor are there any circumstances that with the passage of time or the
giving of notice, or both, could constitute a default thereunder;
(c) the execution and delivery of the attached Patent and License
Agreement, dated as of ____, 2005, between DUSA and PhotoCure (the
"PhotoCure License") is not in violation of the terms and conditions
of the PARTEQ License; and
(d) Notwithstanding anything to the contrary in the PARTEQ License, in the
event that the PARTEQ License is terminated and neither PhotoCure nor
its Sublicensees or Distributors are then in breach of the PhotoCure
License, Queen's and PARTEQ agree that the ongoing rights of PhotoCure
to the Kennedy Licensed Patents as set forth in the PhotoCure License
shall not be affected and shall remain undisturbed and shall continue
in full force and effect as if they were direct licenses between
PARTEQ and Queen's and PhotoCure on the same terms as provided in the
PhotoCure License, except that royalties payable under the PhotoCure
License shall be paid by PhotoCure as directed in a joint written
notice signed by Parteq and DUSA.
Enclosed are triplicate copies of this letter. If the foregoing is
acceptable to you, please have all three copies signed and return one fully
executed copy of this letter to us.
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
Sincerely,
PARTEQ RESEARCH & DEVELOPMENT INNOVATIONS
By:
-------------------------------------
Name:
-----------------------------------
Title:
----------------------------------
AGREED TO AND ACCEPTED BY:
DUSA PHARMACEUTICALS, INC. PHOTOCURE ASA
By: By:
------------------------------------- --------------------------------
Name: Name:
----------------------------------- ------------------------------
Title: Title:
---------------------------------- -----------------------------
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
SCHEDULE 9.5(B)
PRESS RELEASES
FOR IMMEDIATE RELEASE
DUSA PHARMACEUTICALS AND PHOTOCURE ASA SETTLES PATENT DISPUTE
WILMINGTON, MA (USA) AND OSLO, NORWAY date xx/yy/2006- DUSA Pharmaceuticals,
Inc. (NASDAQ NMS: DUSA) and PhotoCure ASA (OSE: PHO) today announced a licensing
agreement under which Dusa grants PhotoCure a worldwide license under its
patents relating to ALA esters.
PhotoCure will pay royalties on sales of its Metvix(R) and Hexvix(R) ester
products as well as new products as long as DUSA holds patents in the US and
certain other territories, including a prepaid royalty amount payable on 1 June
2006.
"This is good news for both companies and will strengthen our ability to achieve
our commercial goals for Metvix, Hexvix and new products in development in
attractive territories", said Kjetil Hestdal, president and CEO, PhotoCure.
"This allows the two companies to focus on commercial development of their own
products and exploring the potentials of their technology platforms," said D.
Geoffrey Shulman, Chairman and CEO, DUSA.
ABOUT DUSA PHARMACEUTICALS
DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in
the development of Levulan(R) Photodynamic Therapy (PDT) and Photodetection (PD)
for multiple medical indications, with its primary focus in dermatology. PDT and
PD utilize light-activated compounds such as Levulan(R) to induce a therapeutic
or detection effect. The Company maintains offices in Wilmington, MA, Valhalla,
NY, and Toronto, Ontario. Except for historical information, this news release
contains certain forward-looking statements that represent our current
expectations and beliefs concerning future events, and involve certain known and
unknown risk and uncertainties. These factors include, without limitation, the
maintenance of our patent portfolio, changes in our long and short term goals
and other risks and uncertainties identified in DUSA's Form 10-K for the year
ended December 31, 2004.
ABOUT PHOTOCURE
PhotoCure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock
Exchange. The company develops and sells pharmaceuticals and medical devices for
the treatment and diagnosis of different types of cancer. The products are based
on proprietary photodynamic technologies, targeting specific dermatology and
oncology markets.
Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
Through worldwide studies, PhotoCure is developing its technology for new
indications, such as acne, colon cancer and cervical cancer. The aim is to
create a broad pipeline of follow-on products and technologies. PhotoCure is
also developing photochemical internalization (PCI), a technology for
light-directed drug delivery through its subsidiary PCI Biotech AS.
For further information contact:
D. GEOFFREY SHULMAN, MD, Chairman & and CEO
or SHARI LOVELL, Director, Shareholder Services
Tel: 416.363.5059 Fax 416.363.6602
or visit www.dusapharma.com
PhotoCure Contacts:
President and CEO KJETIL HESTDAL
Or CFO CHRISTIAN FEKETE
Tel: +47 22 06 22 10 Fax +47 22 06 22 18
Or visit www.photocure.com