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conditions set forth in the Former Supply Agreement as superceded by this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:
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 Agreement, or
does not comply with legal requirements, DUSA shall inform MEDAC C.I.
after receipt of the API of apparent defects in quality or quantity in
writing. Failure or delay shall mean acceptance of the delivered
products and waiver any potential rights DUSA may have with respect to
the delivered API.
6.2. DUSA shall inform MEDAC within C.I. of receipt of its testing results
in case DUSA discovers any defects.
6.3. C.I. and C.I., MEDAC shall C.I. and C.I. API.
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6.4. If there is a disagreement between the Parties as to the compliance of
the API with specifications, warranties and legal requirements C.I.,
which C.I. on the Parties. The C.I. shall be selected by C.I.. In case
C.I. do not agree upon C.I., such shall be C.I.. If the C.I. finds the
API to conform to the specifications, warranties and legal
requirements C.I. and C.I.. Otherwise C.I. shall be C.I..
7. LIABILITY
7.1. Unless otherwise expressly stated, the Parties shall be liable to
C.I., caused by or arising out of or relating to C.I. with the
contractual obligations of this Agreement, unless C.I. further
liability.
7.2. Unless otherwise expressively stated in this Agreement the Parties
shall C.I. arising under or as a result of this Agreement (or
termination thereof), including but not limited to C.I., or on
account of C.I. connection with the business or C.I.or otherwise.
8. INDEMNIFICATION
8.1. Where a loss, claim or damage to persons or to property is caused by
the C.I. of DUSA, PHOTONAMIC or MEDAC, respectively, its employees or
AFFILIATES, relating to the obligations under this Agreement, then the
Party shall indemnify and hold the other Parties harmless from the
loss, claim or damage, C.I..
8.2. In the event that any person (an "Indemnitee") entitled to
indemnification under the above Section is seeking such
indemnification, such Indemnitee shall inform the indemnifying Party
of the claim as soon as reasonably practicable after such Indemnitee
receives notice of such claim, C.I. of the defense of the claim C.I.,
provided that such settlement C.I., or otherwise C.I., the Indemnitee
or the other Party) and shall cooperate as requested (C.I., if the
indemnifying Party selects counsel) in the defense of the claim.
9. TERM AND TERMINATION
9.1. Subject to Section 12.10, this Agreement becomes effective on the
EFFECTIVE DATE and C.I., unless earlier terminated pursuant to this
provision. This Agreement will automatically and continuously be
renewed for a period of a C.I., unless terminated C.I. period to the
then running agreement term.
9.2. DUSA or MEDAC shall be entitled at any time, by notice to the other,
to terminate this Agreement C.I.only if
- Either of them C.I. or C.I. of the API in the TERRITORY;
- Either of them C.I. of any of the provisions of this Agreement
and C.I. after written notice of such breach has been received;
or
- Either of them should be C.I. otherwise be faced with
circumstances C.I., for causes within its control and C.I., under
this Agreement.
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10. CONFIDENTIALITY
10.1. The Parties agree to keep secret and not to communicate all
CONFIDENTIAL INFORMATION disclosed or produced under this Agreement or
under the Former Supply Agreement or License Agreement. The Parties
shall disclose such CONFIDENTIAL INFORMATION only to those employees,
agents etc, who have a need to know and only if such employees, agents
etc. are bound by confidential obligations comparable to this
provision. The Parties shall be responsible for any breach of
confidentiality by its employees, agents etc.
10.2. This secrecy obligation does not apply to any information of which
the receiving Party can prove by written documents
- was known to the public at the time of the receiving Party's
receipt;
- was lawfully received by the Party from a third party who has no
obligation of confidentiality to the disclosing Party;
- was independently developed by the Party or available to it prior
to this agreement;
- was released from the restrictions of this provision by the
express prior written consent of the disclosing Party; or
- has been disclosed in compliance with any legal requirement,
provided that the disclosing Party has notified the other Party
prior to the disclosure of the information and provided that the
Party shall disclose only the minimum amount of information
required for the purpose of the said legal requirement.
10.3. This provision shall continue in full force and effect,
notwithstanding the expiration or termination of this Agreement for
any reason for a period of C.I..
11. FORCE MAJEURE
11.1. Neither Party hereto shall not be liable for any damage if the
performance of all or parts of this Agreement is hindered or prevented
by causes beyond the performing party's control and without its
intention or negligence, including, but not limited to, acts of God or
acts, laws, orders or regulations of any government or department or
agency thereof acting in either its sovereign or contractual capacity,
fires, floods, strikes, machinery breakage, work stoppages or other
job actions, freight embargoes, boycotts, riots and wars.
11.2. Either DUSA or MEDAC may, in the event that any Force Majeure cannot
be removed or overcome C.I. from the date the Party affected first
became affected, C.I. notice to the other Party C.I..
12. MISCELLANEOUS
12.1. Notices shall be made in writing to the addresses stated at the
beginning of this Agreement, or to such other address for such Party
as it shall have specified by like notice to the other Party, provided
that notices of a change of address shall be effective only upon
receipt thereof. If delivered personally or by facsimile transmission,
the date of delivery shall be deemed to be the date on which such
notice or request was given. If sent by overnight express courier
service, the date of delivery shall be deemed to be the next business
day after such notice or
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request was deposited with such service. If sent by certified mail,
the date of delivery shall be deemed to be the fifth (5th) business
day after such notice or request was deposited with the U.S. or German
Postal Service, as the case may be.
12.2. The Parties hereto C.I. any of their rights or duties hereunder
C.I. of the other Party C.I., and any such C.I., except that C.I.
shall not be required in the event such C.I. is subject to C.I., so
long as the C.I. subject to all the terms and conditions of this
Agreement. Furthermore, MEDAC shall have the right to C.I. so long as
C.I. with all applicable laws and regulations. Notwithstanding such
C.I., C.I. for all of its obligations under this Agreement.
12.3. The waiver by either Party of a breach of any of the provisions of
this Agreement by the other Party shall not be construed as a waiver
of any succeeding breach of the same or other provisions.
12.4. Besides the rights and obligations stated in this Agreement no Party
shall have any further rights and obligations under or due to this
Agreement.
12.5. The Parties hereto acknowledge that this Agreement and all Schedules
or exhibits hereto set forth the entire Agreement.
12.6. Modifications of this Agreement have to be made in writing. This
applies to this modification provision as well.
12.7. This Agreement is construed in accordance with and shall exclusively
be governed by the C.I.. The C.I. for the C.I. and C.I. shall not
apply.
12.8. Before either Party brings any proceedings against the other that
Party shall notify the other of the cause of dispute and the Parties
shall try to resolve the dispute amicably by negotiation. If the
Parties fail to negotiate a settlement of such dispute C.I. of the
commencement of negotiations, such dispute shall be submitted to the
exclusive jurisdiction of the courts of C.I..
12.9. Should provisions of the present Agreement not be legally effective,
completely or partially, or later lose their legal effectiveness, the
validity of the remaining provisions of the contract shall not thereby
be affected. Instead of the ineffective provision an appropriate
provision shall be inserted, which - as far as legally permitted -
comes the closest to that which the contracting Parties wanted or is
nearest in meaning to their intended economic purpose.
12.10. All of the Parties' rights and obligations under, and/or the
provisions contained in, Section 1 (Definitions, as appropriate),
Section 2.1 (second sentence), Section 2.2 (second and third
sentences) including the provisions of the Former Supply Agreement and
License Agreement stated therein, Section 10 (Confidentiality),
Section 12.1 (Notices), shall survive any termination, relinquishment
or expiration of this Agreement for any reason whatsoever.
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IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be
executed by its duly authorised representative as of the day and year first
above written.
For and behalf of For and behalf of
DUSA Pharmaceuticals Inc. medac GmbH
/s/ D. Geoffrey Shulman /a/ Wilfried Mohr
- ------------------------------------- ----------------------------------------
D. Geoffrey Shulman, MD, FRCPC Wilfried Mohr
(Chairman & Chief Strategic Officer) (Managing Director)
Date: 8/07/07 Date: 16.07.07
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For and behalf of
photonamic GmbH & Co. KG
/s/ Ulrich Kosciessa
----------------------------------------
Dr. Ulrich Kosciessa
(Managing Director)
Date: 16.07.07
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EXHIBIT 1: DEFINITION OF THE API
NAME AND STRUCTURE
NAME OF ACTIVE SUBSTANCE: (INN) 5-Aminolevulinic acid hydrochloride
CHEMICAL NAME: 5-Amino-4-oxo-pentanoic acid
hydrochloride
SYNONYMS: 5-Aminolevulinic acid hydrochloride,
&-Aminolevulinic acid hydrochloride
ABBREVIATIONS: 5-ALA, (-)-ALA, 5-ALS
EMPIRICAL FORMULA: C(5)H(9)NO(3)HCl
MOLECULAR WEIGHT: 167.59 g/mol
(5-Aminolevulinic acid hydrochloride)
STRUCTURAL FORMULA: (GRAPHIC)
For and behalf of For and behalf of
DUSA Pharmaceuticals Inc. medac GmbH
/s/ D. Geoffrey Shulman /s/ Wilfried Mohr
- ------------------------------------- ----------------------------------------
D. Geoffrey Shulman, MD, FRCPC Wilfried Mohr
(Chairman) (Managing Director)
Date: 08/7/07 Date: 16.07.07
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For and behalf of
photonamic GmbH & Co. KG
/s/ Ulrich Kosciessa
----------------------------------------
Dr. Ulrich Kosciessa
(Managing Director)
Date: 16.07.07
----------------------------------