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AMENDED AND RESTATED
LICENSE AGREEMENT
THIS AMENDED AND RESTATED LICENSE AGREEMENT made effective as of the
day of March, 1998.
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, ▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇ (hereinafter referred to as
"PARTEQ")
-and-
DUSA Pharmaceuticals, Inc., a corporation
incorporated under the laws of the State of New
Jersey and having its registered office at ▇▇▇ ▇▇▇▇▇
▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, P.O. Box 5369, Somerville, New
Jersey, United States of America, 08876 (hereinafter
referred to as "DUSA")
WHEREAS, the Invention (as hereinafter defined) was made in the course
of research at Queen's University at Kingston ("Queen's") and Royal Military
College ("RMC"); and
WHEREAS, all right, title and interest in and to the Invention have
been assigned to Queen's, and PARTEQ, as the technology transfer arm of Queen's,
has the exclusive worldwide rights to the Invention and has all right and
authority to enter into this Agreement; and
WHEREAS, Queen's, RMC, PARTEQ, and DUSA are desirous of amending and
restating the License Agreement dated as of August 27, 1991, among them (the
"Original License") to better reflect the current development opportunities for
the Invention pursuant to the terms and conditions set forth below; and
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WHEREAS, PARTEQ is desirous of releasing Draxis Health, Inc. (formerly
Deprenyl Research Limited, Inc.) as Guarantor of the obligations of DUSA under
the Original License;
NOW, THEREFORE, for and in consideration of the covenants, conditions
and undertakings hereinafter set forth, it is agreed by and between the parties
(as hereinafter defined) that the Original License is amended and restated as
follows:
1. DEFINITIONS
1.1 "Affiliate", as used herein, shall mean any person, corporation,
firm, partnership or other entity in which DUSA owns or controls more than fifty
percent (50%) of the equity (e.g., a subsidiary); or which owns or controls DUSA
to the extent of more than fifty percent (50%) of its equity (e.g., a parent);
or which is owned or controlled to the extent of more than fifty percent (50%)
by the same corporation, firm, partnership or other entity also owning or
controlling more than fifty percent (50%) of the equity in DUSA (e.g., a sister
corporation); or a person, corporation, firm, partnership or other entity in
which the sister corporation owns or controls more than fifty percent (50%) of
the equity hereof (e.g., a subsidiary of the sister corporation).
1.2 "Cost of Goods", as used herein shall mean all costs to manufacture
Products, including, but not limited to, the cost of raw material supplies,
devices and components, labor and services and manufacturing overhead related to
the Product determined by United States generally accepted accounting
principles, consistently applied by DUSA's independent certified public
accountants.
1.3 "...covered by...", as used herein, shall mean any Products or
Method that when made, used, practiced or sold would, in the context of Queen's
Patent Rights, fall within the scope of any claim of Queen's Patent Rights or,
in the context of Improvements, fall within the scope of any
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Improvement.
1.4 "Drug Products", as used herein, means pharmaceutical formulations
containing, as active ingredient, one or more precursors to protoporphyrin IX,
including 5-amino levulinic acid, whose use is covered by Queen's Patent Rights
or Improvements, which are manufactured, packaged and ready for resale or
distribution to the end-user.
1.5 "Execution Date", as used herein, means the date first above
written.
1.6 "Improvements", as used herein, shall mean any and all inventions,
developments or discoveries, including trade secrets, not disclosed as of the
Execution Date in the Queen's Patent Rights, whether or not patented or
patentable, relating to the Invention and the development and commercialization
of same, discovered, developed or acquired by or for PARTEQ, Queen's or RMC
prior to or during the term of this Agreement and in respect of which PARTEQ has
the right to grant a license hereunder.
1.7 "Invention" as used herein, means a method for detecting and/or
treating primary or secondary malignant and non-malignant tissue abnormalities
and lesions of the skin; conjunctiva; respiratory, digestive and vaginal mucosa;
endometrium and urothelium in which a precursor to protoporphyrin IX, including
5-amino levulinic acid (ALA), is administered in an amount sufficient to induce
synthesis of protoporphyrin IX in the abnormality or lesion, followed by
exposure of the thus treated tissue to a photoactivating light, as described and
claimed in the applications for patent set forth in Exhibit A hereto.
1.8 "Method", as used herein, means any method, procedure, process or
other subject matter whose manufacture, use, or sale is covered by Queen's
Patent Rights or Improvements.
1.9 "Net Selling Price", as used herein, means gross invoice price less
the sum of the
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following deductions where applicable: cash discounts, trade or quantity
discounts, government mandated discounts such as Medicaid or Veterans
Administration rebates, sales, use tariff, import/export duties or other excise
taxes imposed upon particular sales; transportation charges and allowances or
credits to customers because of rejections or returns.
1.10 "Non-drug Products", as used herein, means any product or
component other than pharmaceuticals whose manufacture, use or sale is covered
by Queen's Patent Rights or Improvements, and other than Drug Products (i.e.,
devices).
1.11 "Party" or "parties", as used herein, means PARTEQ and/or DUSA, as
the context requires, but shall not include Queen's or RMC.
1.12 "Products", as used herein, means Drug Products and Non-drug
Products.
1.13 "Queen's Patent Rights", as used herein, means the issued patents
and pending patent applications recited in Exhibit A, any continuing or
divisional applications thereof and any patents issuing on said applications or
continuing or divisional applications including reissues thereof.
1.14 "Tangible Research Materials", as used herein, shall mean all
notes, progress reports, computer files, laboratory notebooks, and test results
capable of being reduced to any permanent form, excluding the name of any
patient who has not waived confidentiality.
2. GRANT
2.1 Subject to the terms and conditions herein set out, PARTEQ hereby
grants to DUSA an exclusive, worldwide license under Queen's Patent Rights and
Improvements to make, have made, use and sell Products and Method.
2.2 PARTEQ hereby grants to DUSA the right to sublicense to any third
party or Affiliate any portion or all of the license rights granted by PARTEQ to
DUSA hereunder. In the event DUSA
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terminates this Agreement, all sublicenses to Affiliates will automatically
terminate and all sublicenses other than those to Affiliates will revert
directly to PARTEQ. DUSA agrees to be responsible for the performance under any
sublicense by its sublicensees and to promptly report to PARTEQ the granting of
any sublicenses.
2.3 PARTEQ expressly reserves:
2.3.1 the non-exclusive right to permit Queen's the
personal, non-transferable and non-exclusive right to
use the Invention for educational and research
purposes; the rights reserved under this subsection
2.3.1 expressly exclude any rights for commercial use
of the Invention or to commercialize, including by
license or sale, the results of any such education
and research; and
2.3.2 the non-exclusive right to grant to Her Majesty, the
Queen, in right of Canada, as represented by the
Minister of National Defense (hereinafter referred to
as "DND") an irrevocable, royalty-free, non-exclusive
license to use the Invention and Improvements solely
for defense purposes within DND, its educational
institutions and other establishments in Canada and
overseas, without the right to sublicense for any
commercial use; for the purpose of this subsection
2.3.2, "defense purposes" does not include sales to
any third party, but does include DND procurement.
3. IMPROVEMENTS
3.1 PARTEQ shall promptly disclose to DUSA any patent applications,
Improvements and Tangible Research Materials related thereto which PARTEQ,
Queen's or RMC has discovered, developed or acquired or has had discovered,
developed or acquired on its behalf prior to the
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Execution Date which has not been previously disclosed to DUSA. PARTEQ shall
promptly disclose to DUSA any Improvements and Tangible Research Materials
related thereto which PARTEQ, Queen's or RMC may discover, develop or acquire or
may have discovered, developed or acquired on its behalf from time to time
during the term of this Agreement. Improvements shall be included in the license
hereunder for no additional consideration.
3.2 Without limitation to any other provision of this Agreement, PARTEQ
agrees to use its best efforts to obtain and maintain the right to grant a
license under any invention, development or discovery, including any trade
secret, relating to the Invention and the development and commercialization of
same discovered, developed or acquired by or for Queen's or RMC.
4. COMPENSATION AND ROYALTIES
4.1 During the continuance, and in further consideration, of the rights
and licenses granted hereunder, DUSA agrees to pay to PARTEQ a fee of fifty
thousand Canadian dollars (CA$50,000.00), (or one hundred thousand Canadian
dollars (CA $100,000) if by the payment due date hereof DUSA has entered into a
sublicense agreement as defined in Section 4.5.2 below) within thirty (30) days
of the receipt by DUSA or sublicensee hereunder of approval from the United
States Food and Drug Administration to market Products in the United States of
America.
4.2 PARTEQ acknowledges that it has received from DUSA CA$150,000.00
and that pursuant to Section 4.4 of the Original License, such fees shall be
deducted from any royalties payable pursuant to Sections 4.3 and 4.12 hereof;
provided, however, that the credit shall not exceed CA$75,000 in any year, and
further provided that the credit shall be taken only to the extent that
royalties payable under Section 4.3 exceed the minimum royalties specified in
Section 4.12 (e.g., to obtain a credit of CA$75,000 in year 1, royalties under
Section 4.3 would have to equal or exceed CA$125,000).
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4.3 During the continuance, and in further consideration of the rights
and licenses granted hereunder, DUSA shall pay to PARTEQ royalties as follows:
4.3.1 In countries where Queen's Patent Rights are issued,
(a) six percent (6%) of sixty-six percent (66%)
of the Net Selling Price of DUSA or its
Affiliates of Products when first sold to
non-Affiliates, other than Products sold to
sublicensees and other than Non-drug
Products sold at or below cost; and
(b) six percent (6%) of the Net Selling Price
less Cost of Goods Sold charged by DUSA for
Products sold to sublicensees, other than
Non-drug Products sold at or below cost.
4.3.2 In countries where Queen's Patent Rights have not
issued,
(a) four percent (4%) of sixty-six percent (66%)
of the Net Selling Price of DUSA or its
Affiliates of Products first sold to
non-Affiliates, other than Products sold to
sublicensees and other than Non-drug
Products sold at or below cost; and
(b) four percent (4%) of the Net Selling Price
less Cost of Goods Sold charged by DUSA for
Products sold to sublicensees other than
Non-drug Products sold at or below cost.
4.3.3 Six percent (6%) of royalty payments received by DUSA
from sublicensees based upon such sublicensees (or
their Affiliates) sales of Drug Products.
4.4 Royalties under Section 4.3 hereof shall accrue, subject to Section
4.14 hereof, until no United States patent or United States patent application
included in Queen's Patent Rights
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subsists, whether by virtue of expiry, invalidation or rejection, at which time
the rights and licenses granted by virtue of this Agreement shall become
perpetual and royalty-free.
4.5 In the event DUSA grants a sublicense to an unrelated third-party
of the rights and licenses granted to DUSA hereunder, DUSA shall pay to PARTEQ:
4.5.1 five percent (5%) of lump sum sublicense fees paid
for the grant of any such sublicense (i.e., license
fees) or right to market Products; provided, however,
no royalties shall be paid to PARTEQ hereunder with
respect to any consideration received by DUSA which
may be designated in the sublicense for future
research and development efforts.
4.5.2 The amounts stated in 4.5.1 above shall become due to
PARTEQ as and when lump sum fees are received by
DUSA; provided, however, if the sublicense is granted
to an unrelated third-party for the field of use
encompassing substantially all dermatological
indications for Products and for the territory
including both the United States and Europe on or
before ▇▇▇▇▇ ▇▇, ▇▇▇▇, ▇▇▇▇ shall pay to PARTEQ
CA$200,000 on that date, and if such sublicense
agreement is executed on or before the first
anniversary of this Amended and Restated License
Agreement, DUSA shall pay to PARTEQ CA$500,000, in
the aggregate (e.g. an additional CA$300,000 if
CA$200,000 has been paid previously) on such first
anniversary date. Further provided, that if any such
sublicense agreement(s) under this Section 4.5.2 is
(are) executed during the term of this Amended and
Restated License Agreement, then DUSA shall pay to
PARTEQ a minimum royalty equal to the difference
between all amounts
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paid under Section 4.5.1 and this Section 4.5.2, and
CA$1,100,000 (if any). Such minimum royalty shall be
due and payable, if at all, when DUSA has received
all lump sum fees to which it is entitled under any
such sublicense agreement(s) remaining in full force
and effect which fees did not equal or exceed
CA$22,000,000 in the aggregate from any and all such
sublicense agreements.
4.6 If DUSA has not entered into a sublicense agreement as described in
Section 4.5.2 above on or before ▇▇▇▇▇ ▇▇, ▇▇▇▇, ▇▇▇▇ shall pay to PARTEQ a
minimum royalty of Canadian One Hundred Thousand Dollars (CA$100,000).
4.7 If DUSA has not entered into a sublicense agreement as described in
Section 4.5.2 by the first anniversary date of this Amended and Restated License
Agreement, and if DUSA's balance sheet for the month ended prior to the first
anniversary date of this Amended and Restated License Agreement states that
"Cash and U.S. Government Securities" plus "Marketable Securities", if any,
exceed U.S. $15,000,000, then DUSA shall pay to PARTEQ an additional minimum
royalty payment of Canadian Two Hundred Thousand Dollars (CA$200,000) on such
first anniversary date.
4.8 All minimum royalties payable under Sections 4.6 and 4.7 shall be
credited in full against royalties payable under Section 4.5.2 above, which in
turn shall be credited in full against royalties payable under Section 4.5.1
above. In addition, if DUSA pays to PARTEQ CA$100,000 under Section 4.1 above,
then CA$50,000 of such CA$100,000 will be credited against royalties due under
Section 4.5.1 above, if and to the extent such royalties exceed CA$1,100,000
(i.e., the CA$50,000 will be credited in full if PARTEQ receives royalties of at
least CA$1,150,000 under Section 4.5.1) during the term of this Amended and
Restated License Agreement.
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4.9 As further consideration for this Amended and Restated License
Agreement and subject to its execution hereof, DUSA confirms that it has granted
to PARTEQ options to purchase up to 85,000 shares of Common Stock of DUSA. Such
options shall have an exercise price of $10.875 per share. Options shall vest
over a period of four (4) years and shall have a term of ten (10) years from the
date of grant. Other terms and conditions, consistent with options previously
granted by DUSA shall apply.
4.10 DUSA shall be entitled to deduct from any fees and royalties
payable under this Article 4 any amounts required to be withheld from such fees
and royalties and remitted to any governmental or other taxing authority. Upon
request, DUSA shall provide to PARTEQ evidence of such withholding and remittal.
4.11 Royalties under Sections 4.3.1 (a) and 4.3.2(a) hereof shall be
paid to PARTEQ within forty-five (45) days following the end of the calendar
quarter in which the Products were sold. Royalties under Sections 4.3.1(b),
4.3.2(b), 4.3.3, and 4.5.1 hereof shall be paid to PARTEQ within forty-five (45)
days following the end of the calendar quarter in which the royalties or
sublicensing fees were received by DUSA or its Affiliates.
4.12 DUSA shall pay to PARTEQ minimum annual royalties calculated under
Section 4.3 as follows, such minimums to commence when DUSA or an Affiliate or
sublicensee receives approval from the United States Food and Drug
Administration to market Products in the United States of America:
4.12.1 in the first calendar year during which such approval
is received, fifty thousand Canadian dollars
(CA$50,000.00) where such approval is received on
January 1 or in the case of a partial calendar year,
that sum obtained by
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multiplying the number of days contained in the
partial calendar year by fifty thousand Canadian
dollars (CA$50,000.00) and dividing by three hundred
and sixty-five (365); and
4.12.2 in succeeding calendar years, one hundred thousand
Canadian dollars (CA$100,000.00) or in the case of a
partial succeeding calendar year, that sum obtained
by multiplying the number of days contained in the
partial calendar year by one hundred thousand
Canadian dollars (CA$100,000.00) and dividing by
three hundred and sixty-five (365).
In the event that royalties payable pursuant to Section 4.3 hereof for any given
calendar year or partial calendar year total less than the minimum royalties
specified in this Section 4.12 for such year, DUSA shall pay the difference
within forty-five (45) days following the end of such year or partial year.
4.13 Fees and royalties due PARTEQ hereunder shall be paid in Canadian
funds collectible at par in ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇. For sales made and
royalties or sublicensing fees received by DUSA or an Affiliate in a currency
other than Canadian dollars, royalties on such sales and royalties on such
royalties or sublicensing fees shall be calculated in the currency of sale or
payment and converted into Canadian funds at the rate published by the Bank of
Canada on the last business day of the calendar quarter in which the sale is
made or the royalties or sublicensing fees are received. Any royalties or
sublicensing fees in kind received by DUSA or an Affiliate from sublicensees
shall be valued at fair market value.
4.14 Subject to Section 4.4 hereof, in the event that any patent or
patent application or any claim of either included within Queen's Patent Rights
shall be held invalid or rejected in a decision
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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, all obligations to pay royalties pursuant to Section 4.3.1 hereof based
on such patent or patent application or claim or any claim patentably indistinct
therefrom shall cease as of the date specified in such decision. Furthermore, if
any such patent action occurs, or if a product which competes directly with a
DUSA Product is introduced into the marketplace, and such new product captures
at least five percent (5%) of the marketplace in the territory, then the parties
agree to renegotiate the royalties under Sections 4.3.2 and 4.3.3 hereof.
4.15 All payments to PARTEQ relating to goods and services subject to
tax under the Excise Tax Act (Canada) shall be increased by the amount of tax
payable. PARTEQ shall be responsible for remitting that tax to the Canadian
Government, and shall provide DUSA with receipts in a form suitable for DUSA to
claim an input tax credit under the Excise Tax Act (Canada).
5. DUE DILIGENCE
5.1 Subject always to the exercise of prudent and justifiable business
and medical judgment, DUSA, upon execution of this Agreement, shall diligently
proceed with the development of Products in order to achieve a first commercial
sale of such Products.
5.2 DUSA agrees to keep PARTEQ informed as to its progress in the
development and testing of all Products and preparing, filing, and obtaining of
the approvals necessary for marketing. Beginning January 1, 1998 and
semi-annually thereafter, DUSA shall submit to PARTEQ a progress report covering
DUSA's activities related to the development of Products and the securing of the
requisite approvals. These reports shall be made until the market introduction
of the first Product.
5.3 During the term of this Agreement, representatives of DUSA and
PARTEQ will meet at times and places mutually agreed upon not less than annually
to discuss progress and results and
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each party shall bear the expense of its own representatives attending such
meetings. Should DUSA request the attendance of any representative of Queen's or
RMC at any such meeting, DUSA shall reimburse such representative for reasonable
travel and lodging expenses.
5.4 At the request of either party, any controversy or claim arising
out of or relating to the diligence provisions of this Agreement shall be
subject to arbitration conducted in accordance with the then current Arbitration
Act of Ontario. Judgment upon the award rendered by the arbitrator(s) shall be
binding on the parties and may be entered by either party in the court or forum,
provincial or federal, having jurisdiction.
6. MAINTENANCE OF PROPERTY, TRADE SECRET AND KNOW-HOW RIGHTS
6.1 Each of PARTEQ and, except as is necessary for the
commercialization of Products, DUSA (the "receiving party") agrees to maintain
as confidential all information (including Tangible Research Materials) of the
other party (the "disclosing party") received by the receiving party from the
disclosing party. Except to DUSA, PARTEQ shall not disclose or permit to be
disclosed by Queen's or RMC any information relating to the Invention or
Improvements, except that which is disclosed in patents or published patent
applications and except that which is made the subject of the prior written
consent of DUSA, not to be unreasonably withheld after DUSA having been accorded
a ninety (90) day review period.
6.2 A receiving party shall not be prevented from disclosing to third
parties any information of a disclosing party:
6.2.1 which the receiving party can demonstrate by written
records was previously known to it;
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6.2.2 which is now, or becomes in the future, publicly
available other than through acts or omissions of the
receiving party; or
6.2.3 which is lawfully obtained by the receiving party
from sources independent of the disclosing party.
6.3 PARTEQ agrees that it shall use its best efforts to procure and
maintain the prior agreement of each individual at Queen's and RMC who shall be
conducting or otherwise involved in research and development relating to
Improvements in the form attached as Exhibit B, mutatis mutandis.
Notwithstanding the immediately foregoing, PARTEQ shall procure and maintain the
prior agreement of each individual at Queen's and RMC who shall be conducting or
otherwise involved in research and development relating to Improvements funded
by DUSA-sourced funds in the form attached as Exhibit B, mutatis mutandis, and
shall cause Queen's and PARTEQ to preclude the conduct of or involvement in any
such research and development by or of any individual who declines to enter into
such agreement.
7. QUARTERLY REPORTS
7.1 After the first commercial sale of Products, DUSA shall provide
PARTEQ with written reports made no later than forty-five (45) days following
the end of each calendar quarter showing all sales of Products by DUSA and its
Affiliates and royalties or sublicensing fees received from sublicensees,
hereunder other than Affiliates during such preceding calendar quarter. If no
sales of Products have been made or royalties received during such calendar
quarter, a statement to this effect shall be required.
7.2 DUSA agrees to report to PARTEQ the date of first commercial sale
of Products in each country within thirty (30) days of its occurrence.
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8. BOOKS AND RECORDS
8.1 DUSA shall keep books and records accurately showing all Products
sold under the terms of this Agreement by DUSA and its Affiliates and all
royalties received from sublicensees hereunder other than Affiliates. Such books
and records shall be open to inspection by representatives or agents of PARTEQ
at reasonable times for the purpose of verifying the accuracy of the quarterly
reports and the royalties due.
8.2 The fees and expenses of the representatives performing such an
examination shall be borne by PARTEQ, unless such examination reveals an error
of more than fifteen thousand Canadian dollars (CA$15,000.00) in the computation
of royalties due. In such case, the cost of such examination shall be borne by
DUSA.
8.3 The books and records required by paragraph 8.1 herein shall be
preserved for at least five (5) years from the date of the royalty payment to
which they pertain.
9. TERM AND TERMINATION
9.1 Subject to any termination pursuant to the terms hereof, this
Agreement shall remain in full force and effect until expiration of the last to
expire of the United States patents listed in Exhibit A.
9.2 DUSA has the right to terminate this Agreement with or without
cause at any time upon ninety (90) days' notice to PARTEQ.
9.3 If either party (the "defaulting party") should commit any breach
of this Agreement, the other party (the "non-defaulting party") shall be
entitled to terminate this Agreement upon ninety (90) days' notice to the
defaulting party particularizing the breach; provided however that, if the
defaulting party cures such breach within the ninety (90) day notice period,
this Agreement shall
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continue in full force and effect as if the notice from the non-defaulting party
had never been given.
9.4 No termination of this Agreement shall relieve either party of any
obligation or liability of such party accrued hereunder prior to such
termination nor affect the rights of either party arising under this Agreement
prior to such termination.
10. PATENT PROSECUTION AND MAINTENANCE
10.1 PARTEQ shall diligently prosecute and maintain Queen's Patent
Rights and shall diligently make, prosecute and maintain such patent
applications and patents in such jurisdictions for such Improvements as are
agreed upon by DUSA and PARTEQ using counsel of PARTEQ's choice and after due
consultation with DUSA. PARTEQ shall provide DUSA with copies of all relevant
documentation so that DUSA may be informed and apprised of and meaningfully
consulted as to the continuing prosecution. In the event that DUSA does not
agree that any given patent application or patent should be made, prosecuted or
maintained (hereinafter referred to as a "PARTEQ patent"), PARTEQ shall have the
right unilaterally to make, prosecute and maintain such PARTEQ patent, and same
shall be deemed licensed hereunder for no additional consideration.
10.2 PARTEQ shall use its best efforts to amend any patent application
to include claims reasonably requested by DUSA and required to protect the
Products contemplated to be sold under this Agreement.
10.3 PARTEQ agrees to advance all costs and legal fees incurred for the
prosecution, maintenance and taxes for all patent applications referred to in
Section 10.1 and patents issuing therefrom. Subject to the said counsel of
PARTEQ's choice giving reasonably accurate advance quotes of out-of-pocket
expenses for prosecution, maintenance and taxes for all patent applications
referred to in Section 10.1 and patents issuing therefrom, all reasonable
out-of-pocket expenses
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incurred after the Execution Date for such prosecution, maintenance and taxes
shall be promptly reimbursed to PARTEQ by DUSA, except for those expenses
relating to PARTEQ patents, which shall be borne by PARTEQ.
11. USE OF NAMES, TRADE NAMES, AND TRADEMARKS
11.1 Except as required by law, no party shall have any right to use in
advertising, publicity, or other promotional activities any name, trade name,
trademark, or other designation of the other party (including any contraction,
abbreviation or simulation of any of the foregoing), without the prior written
consent of such other party.
12. WARRANTY BY PARTEQ
12.1 PARTEQ hereby warrants:
12.1.1 that it has the right to grant the rights and
licenses granted hereunder;
12.1.2 that each of ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇ ▇. ▇▇▇▇
have, on or prior to the Execution Date, executed
agreements to assign all Improvements to PARTEQ in
the form attached as Exhibits B and C hereto and that
such agreements will be maintained for as long as
each of ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇ ▇. ▇▇▇▇ are
conducting or otherwise involved in research and
development relating to Improvements and remain on
the faculty of Queen's.
12.1.3 that it is not aware of any present challenge to the
validity of the Queen's Patent Rights in any
governmental proceeding or in any pending or
threatened lawsuit. Further, PARTEQ has no knowledge
or reason to know of any inquiry, claim or threat of
infringement or
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unfair trade practices of any third party patents,
which threaten the validity of any rights granted to
DUSA under this Agreement.
13. INDEMNITY
13.1 DUSA covenants and agrees to indemnify and save PARTEQ, Queen's
and RMC harmless from and against all actions, claims, damages, lawsuits,
losses, costs or expenses which any of same may sustain, incur, or be liable for
by reason of DUSA's omission, negligence, or wrongful act in the use of the
Invention or any Improvement or in the development, exploitation, or marketing
of the Products or Method.
13.2 Subject to Section 13.3, PARTEQ covenants and agrees to indemnify
and save DUSA harmless from and against all actions, claims, damages, lawsuits,
losses, costs or expenses (other than any action, claim, damage, lawsuit, loss,
cost or expense referred to in Section 13.1 hereof) which DUSA may sustain,
incur or be liable for by reason of DUSA's use of the Invention or any
Improvement or DUSA's development, exploitation or marketing of the Products or
Process and by reason of any breach of representation or warranty made hereunder
by PARTEQ.
13.3 In the event that DUSA, acting reasonably, decides to acquire
third party rights which otherwise constitute a potential infringement threat,
or is required to defend against any assertion by any third party of
infringement, DUSA shall be entitled to deduct fifty percent (50%) of all costs
and expenses of such acquisition or defense from royalties payable pursuant to
Sections 4.3, 4.5 and 4.12 hereof as follows:
13.3.1 in respect of any such costs and expenses arising
prior to the commencement of royalty payments under
Section 4.3 in respect of sales following health
regulatory approval in the United States, such
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fifty percent (50%) of costs and expenses shall be
deducted from all royalties payable pursuant to
Sections 4.3, 4.5 and 4.12 hereof; and
13.3.2 in respect of any such costs and expenses arising
after the commencement of royalty payments under
Section 4.3 in respect of sales following health
regulatory approval in the United States, such fifty
percent (50%) of costs and expenses shall be deducted
from fifty percent (50%) of royalties payable
pursuant to Sections 4.3, 4.5 and 4.12 hereof.
13.4 Notwithstanding Section 13.3 hereof, in the event that DUSA makes
an acquisition pursuant to Section 13.3 hereof having a total cost in excess of
one hundred thousand Canadian dollars (CA$100,000.00), DUSA shall be entitled to
deduct from royalties payable only the sum of fifty thousand Canadian dollars
(CA$50,000.00) in respect of acquisition.
14. INFRINGEMENT
14.1 DUSA shall consult with PARTEQ in respect of, but shall have
ultimate and sole control over, all litigation or threatened or anticipated
litigation (including any settlement thereof) arising out of DUSA's performance
under this Agreement including that relating to infringement of third party
rights and infringement by third parties. PARTEQ agrees to cooperate with DUSA
in the prosecution of any such litigation or threatened or anticipated
litigation including any preparations therefor and settlement negotiations in
respect thereof.
14.2 In the event that PARTEQ learns of the infringement of Queen's
Patent Rights or of any patent rights relating to Improvements or of any
confidential information referred to in Section 6 hereof (hereinafter referred
to as "intellectual property infringement by a third party"), PARTEQ shall
immediately notify DUSA and shall provide DUSA with any evidence of intellectual
property
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infringement by a third party which PARTEQ may have.
14.3 PARTEQ shall not commence any action or enter into any settlement
negotiation in respect of intellectual property infringement by a third party.
At the request of DUSA, PARTEQ agrees to be joined as a party plaintiff in any
litigation relating to intellectual property infringement by a third party and
PARTEQ shall be represented by counsel of DUSA's choosing.
14.4 The expenses of any litigation or settlement negotiations in
respect of intellectual property infringement by a third party shall be borne by
DUSA and all recovery pursuant thereto shall be for the account of DUSA.
15. WAIVER
15.1 It is agreed that no waiver by either party hereto of any breach
or default of any of the covenants or agreements herein set forth shall be
deemed a waiver as to any subsequent and/or similar breach or default.
16. ASSIGNABILITY
16.1 This Agreement is binding upon and shall inure to the benefit of
both parties and their successors and assigns. DUSA may assign this Agreement to
any Affiliate or, with the written consent of PARTEQ, to any third party, which
consent shall not be unreasonably withheld.
17. FORCE MAJEURE
17.1 In the event of acts of God, action of the elements, war,
invasions, civil commotion, insurrection, labor disturbance, fire, flood,
restrictions in availability of materials or government restriction, which
render performance under this Agreement impossible, failure on that account
during each period shall be excused; and any minimum royalty called for shall
not be required during each period or periods of inability to perform.
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18. LATE PAYMENTS
18.1 In the event royalty payments or fees are not paid by DUSA when
due, DUSA shall pay to PARTEQ interest charges at the rate of two percent (2%)
over the Bank of Canada rate as set on the day the fees are due per annum on the
unpaid royalties or fees due for the reporting period.
19. NOTICES
19.1 Any payment, notice or other communication required or permitted
to be given to either party hereto, other than routine quarterly reports and
payments, shall be given in writing and shall be effective on the date of
delivery if delivered in person or by registered mail, return receipt requested,
to the respective addresses given below, or to such other address as shall be
designated by notice hereunder:
In the case of DUSA: DUSA Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇
with a copy to:
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Esq.
LANE and ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇
P.O. Box 8539
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇
In the case of PARTEQ: Office of Patents & Licensing
PARTEQ Innovations
Queen's University
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇
20. FOREIGN LICENSE REGISTRATION
20.1 DUSA agrees to register this Agreement when required by local
national law, to pay all costs and legal fees connected therewith, and to
otherwise insure that the local national laws, regulations and/or ordinances
affecting this Agreement are fully satisfied.
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21. GOVERNING LAWS
21.1 This Agreement shall be interpreted and construed in accordance
with the laws of the Province of Ontario and the laws of Canada applicable
therein.
22. MISCELLANEOUS
22.1 The headings of sections herein are inserted for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
22.2 This Agreement will not be binding upon the parties until it has
been signed hereinbelow by or on behalf of each party, in which event, it shall
be effective as of and from the Execution Date.
22.3 No amendment or modification hereof shall be valid or binding upon
the parties unless made in writing and signed as aforesaid.
22.4 This Agreement embodies the entire understanding of the parties
and shall supersede all previous communications, representations or
understandings, either oral or written, between the parties relating to the
subject matter hereof including the Original License.
22.5 In case any one or more of the provisions contained in this
Agreement shall for any reason be held to be invalid, illegal or unenforceable
in any respect, such invalidity, illegality or unenforceability shall not affect
any other provision hereof, but this Agreement shall be construed as if such
invalid or illegal or unenforceable provisions had never been contained herein.
23. PUBLICITY
23.1 Except as required by law, neither party shall make public the
details or existence of this Agreement without the prior consent of the other
party.
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24. RELEASE OF GUARANTEE
24.1 PARTEQ hereby releases and discharges Draxis Health, Inc. from
Draxis' obligation under the Original License to unconditionally and irrevocably
guarantee the obligations of DUSA pursuant to the Original License. PARTEQ and
DUSA agree to notify Draxis of the release stated herein. Furthermore, they
agree to enter a revised ALA Assignment Agreement with Draxis so that the
assignment of rights previously granted to Draxis under the Original License
will be made consistent with the terms of this Amended and Restated License
Agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement, in
triplicate originals, by their respective officers duly authorized.
PARTEQ RESEARCH AND
DEVELOPMENT INNOVATIONS
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------------------
▇▇▇▇ ▇. ▇▇▇▇▇▇
Executive Director
DUSA PHARMACEUTICALS, INC.
By: /s/ D. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
-------------------------------------
D. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, MD, FRCPC
President and Chief Executive Officer
PARTEQ RESEARCH AND
DEVELOPMENT INNOVATIONS
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Chair of the Board of Directors
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EXHIBIT A
Queen's University Patents and Patent Applications
Methods of Diagnosis and/or Treatment Using Photodynamic Therapy Compositions
for Detection or Treatment.
ISSUED PATENTS
COUNTRY PATENT NO. FILING DATE ISSUE DATE
U.S.A. 5,079,262 07/28/89 01/07/92
U.S.A. 5,211,938 10/28/91 05/18/93
U.S.A. 5,234,940 04/08/92 08/10/93
U.S.A. 5,422,093 06/28/93 06/06/95
Australia 624985 07/25/90 10/19/92
Australia 674310 04/02/93 04/09/97
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ 04/02/93 11/10/97
PENDING APPLICATIONS
COUNTRY SERIAL NO. FILING DATE
Japan 02-510192 07/25/90
Korea 700294/1991 07/25/90
Netherlands 9021172 07/25/90
Canada 2,133,741 04/02/93
Europe 93907704-6 04/02/93
Norway P943774 04/02/93
Canada 2,126,761 06/27/94
U.S.A. 08/465,242 06/05/95
New Zealand 314,801 04/28/97
PCT CA96/00363 06/03/96
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EXHIBIT B
UNDERTAKING
I, ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ of ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, being
a named inventor in Applications for Letters Patent of the United States of
America Serial Numbers __________ and __________ and assigned to Queen's
University at Kingston, for good and valuable consideration the receipt and
sufficiency whereof is hereby acknowledged, do hereby undertake to assign all
and any improvements, continuations, continuations-in-part, divisions and
reissues pertaining thereto for all countries of the world to Queen's University
at Kingston, and to sign all such documents as may be reasonably required by
Queen's University to perfect its title thereto, at any time while I am a member
of faculty at Queen's University, or thereafter, provided that any such
improvement shall have been made while I am a member of the faculty of Queen's
University.
Signed this __________ day of ____________________ , 1998, at Kingston,
Ontario.
___________________________________
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
In the presence of __________________ , whose post office address
is_________________________________ .
___________________________________
Witness
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EXHIBIT C
UNDERTAKING
I, ▇▇▇▇▇▇ ▇. ▇▇▇▇ of ▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇.▇. #▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, being
a named inventor in Application for Letters Patent of the United States of
America Serial Number __________ and assigned to Queen's University at Kingston,
for good and valuable consideration the receipt and sufficiency whereof is
hereby acknowledged, do hereby undertake to assign all and any improvements,
continuations, continuations-in-part, divisions and reissues pertaining thereto
for all countries of the world to Queen's University at Kingston, and to sign
all such documents as may be reasonably required by Queen's University to
perfect its title thereto, at any time while I am a member of faculty at Queen's
University, or thereafter, provided that any such improvement shall have been
made while I am a member of the faculty of Queen's University.
Signed this ___________ day of ____________________ , 1998, at
Kingston, Ontario.
___________________________________
▇▇▇▇▇▇ ▇. ▇▇▇▇
In the presence of _____________________, whose post office address is
_________________________.
___________________________________
Witness
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EXHIBIT D
UNDERTAKING
I,__________________________ , of ________________________________________ ,
being a named inventor in Applications for Letters Patent of the United States
of America Serial Numbers ________________________ and
_____________________________ and assigned to Queen's University at Kingston,
for good and valuable consideration the receipt and sufficiency whereof is
hereby acknowledged, do hereby undertake to assign all and any improvements,
continuations, continuations-in-part, divisions and reissues pertaining thereto
for all countries of the world to Queen's University at Kingston, and to sign
all such documents as may be reasonably required by Queen's University to
perfect its title thereto, at any time while I am a member of faculty at Queen's
University, or thereafter, provided that any such improvement shall have been
made while I am a member of the faculty of Queen's University.
Signed this ____________ day of _________________________ , 1998, at
Kingston, Ontario.
___________________________________
In the presence of ________________________ , whose post office address is
________________________________________ .
___________________________________
Witness
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