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EXHIBIT 10
C.I. = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED.
SUPPLY AND LICENSE AGREEMENT
This Supply and License Agreement (hereinafter referred to as
this "AGREEMENT")
is entered into by and among
DUSA Pharmaceuticals, Inc.,
a company duly organized and existing under the laws of New
Jersey,
having its principal office at 25 Upton Drive, Wilmington,
Massachusetts 01887,
United States
- hereinafter referred to as "DUSA" -
medac Gesellschaft fur klinische Spezialpraparate mbH,
a company duly organised and existing under the laws of
Germany,
having its registered office at Fehlandtstrasse 3, 20354
Hamburg, Germany
- hereinafter referred to as "MEDAC" -
photonamic GmbH & Co. KG,
a company duly organised and existing under the laws of
Germany,
having its registered office at Fehlandtstrasse 3, 20354
Hamburg, Germany
- hereinafter referred to as "PHOTONAMIC" -
hereinafter individually and collectively referred to
respectively as a "Party"
and the "Parties"
WHEREAS DUSA and MEDAC entered into a Supply Agreement dated
December 30, 2002,
(the "Former Supply Agreement'"), which the Parties to wish to
terminate and
supercede with this Agreement; and
WHEREAS contemporaneously with the execution of the Supply
Agreement, DUSA and
PHOTONAMIC entered into a License and Development Agreement
dated December 30,
2002 (the "License Agreement"), which the Parties wish to
terminate, except as
provided in this Agreement; and
WHEREAS MEDAC directly or indirectly through a third party
manufactures API, as
defined below; and
WHEREAS, DUSA is entitled to purchase the API from MEDAC under
the terms and
conditions set forth in the Former Supply Agreement as
superceded by this
AGREEMENT and MEDAC is willing to supply the API to DUSA on such
terms and
conditions.
NOW, THEREFORE, in consideration of the mutual covenants and the
premises
contained herein which the parties acknowledge as sufficient
consideration for
this Agreement, the Parties hereto agree as follows:
1. DEFINITIONS
For the purpose of this AGREEMENT the following words and
phrases shall have the
following meaning:
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1.1. "AFFILIATES" shall mean, with respect to any Party, any
person,
corporation, company, partnership, joint venture, firm or other
entity
which is controlled by, controls or is under direct or indirect
common
control with such Party. For the purposes of this definition
"control" shall mean (a) in the case of corporate entities,
direct or indirect ownership of at least C.I. of the stock or
shares
entitled to vote for the election of directors, or managing
directors,
and (b) in the case of non-corporate entities, direct or
indirect
ownership of at least C.I. of the equity interest with the power
to
direct management and policies of such non-corporate
entities.
1.2. "API" shall mean the active pharmaceutical ingredient
5-aminolevulinic
acid HCI, as more particularly described on Exhibit 1 hereto in
oral
or intravenous formulations.
1.3. "CONFIDENTIAL INFORMATION" shall mean all documents,
methods,
technical know-how and all other information that is
non-public,
confidential and proprietary in nature disclosed by one Party to
the
others or any of its directors, officers, employees, agents,
consultants or representatives relating to the business of
the
disclosing Party or its AFFILIATES.
1.4. "EFFECTIVE DATE" shall mean date of the last Party to sign
this
Agreement.
1.5. "FIELD" shall mean the fluorescence-guided resection of
glioblastoma.
1.6. "TERRITORY' shall mean the following countries: United
States, C.I..
2. TERMINATION
2.1. DUSA and MEDAC hereby agree to terminate the Former Supply
Agreement
with immediate effect. Notwithstanding the language stated in
the
previous sentence, pursuant to Section 11.6 of the Former
Supply
Agreement, Section 1 (Definitions, as appropriate), Section
7.1
(Adverse Event Reporting), Section S (Confidentiality), Section
13.3
(Books and Records), Section 13.5.2 (English language), and
Exhibit
1.26 (Specifications) shall survive such termination. Neither
Party
shall have any ongoing rights and obligations under the Former
Supply
Agreement except pursuant those sections stated in this Section
2.1.
2.2. DUSA and PHOTONAMIC hereby terminate the License Agreement
with
immediate effect. Notwithstanding the language stated in the
previous
sentence, pursuant to Section 13.6.2 of the License Agreement,
DUSA
shall have the non-exclusive right to use the Licensed
Technology
obtained under the License Agreementin the TERRITORY. For that
purpose
Section 1 (Definitions, as appropriate)Section 2.2.1
(representation
of ownership), Section 6.2 second sentence (right to reference
FDA
dossier), Sections 10.4-10.7 (regarding confidentiality),
Sections
13.5.4 and 13.5.5 (rights to use the Licensed Technology, as
defined
in the License Agreement, outside the Field within the
Territory),
Section 15.3 (Books and Records), Exhibit 1.26 (Licensed
Technology)
of the License Agreement shall survive termination.
By terminating the License Agreement, except as provided in this
Agreement,
PHOTONAMIC shall have C.I., subject to the confidentiality
provisions in
this Agreement.
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3. OBJECT OF AGREEMENT
3.1. DUSA hereby appoints MEDAC as a supplier of the API in the
TERRITORY.
3.2. DUSA may use the API, from time to time, for manufacturing
and
marketing a finished pharmaceutical product in its own name and
at its
own risks.
4. FORECAST/ ORDERS /TERMS OF DELIVERY
4.1. DUSA shall advise MEDAC of its estimated needs of API for
the
succeeding twelve (12) calendar months and will provide C.I. of
its
forecast during the term. Unless expressly stated in this
Agreement
C.I..
4.2. DUSA shall place its orders at least C.I. in advance of its
requested
delivery date but the first order shall be placed no later than
C.I.
in advance of its requested delivery date. Each order shall bear
the
exact quantity ordered and the delivery date.
4.3. DUSA and MEDAC shall C.I. in good faith, based upon C.I.
(as defined
in the Former Supply Agreement) by DUSA.
4.4. Deliveries shall be made C.I. (according to C.I.) if not
otherwise
agreed upon between MEDAC and DUSA.
5. PRICES AND PAYMENT
5.1. The cost to DUSA for the API supplied by MEDAC under this
Agreement
shall be negotiated in good faith taking into account that the
cost
per unit of C.I. was C.I.. The Cost of the API shall C.I.
following
the C.I. to DUSA and thereafter may be adjusted C.I., provided
that,
MEDAC gives DUSA C.I. prior written notice of any increase.
5.2. Invoices are due C.I. after date of invoice.
5.3. All payments shall be made C.I..
6. DEFECTS IN QUALITY/QUANTITY
6.1. DUSA shall be obliged to inspect, examine and analyze the
API promptly
upon receipt. In the event that the API does not conform to
Specifications of this Agreement, or the Former Supply Agree
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