Agreement for the Manufacturing
of a Liposomal Formulation
between
Sign Path Pharmaceuticals,
Inc.
45 Broadway 2nd Floor New York,
NY 10006, USA
- hereinafter
called „Principal“ -
and
Polymun Scientific
Immunbiologische Forschung GmbH
Nussdorfer Lände 11, A-1190
Vienna, Austria
- hereinafter
called „Contractor“ -
PREAMBLE
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Contractor is
owner and authorized to dispose of the patents and patent
applications listed in Annex 1 of this Agreement (hereinafter
referred to as „Polymun liposome
technology“).
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Furthermore,
Contractor has technical and operational experience, knowledge, as
well as other information and know-how in the field of development
and utilization of the liposome technology (hereinafter referred to
as „Polymun-know-how“).
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Principal
disposes of a liposomal formulation of the active pharmaceutical
ingredient curcumin.
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Contractor has
no existing contractual relationship regarding curcumin to other
parties than Principal at the date of signing this Agreement and
will not enter into such contractual relationship during the term
of this Agreement.
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The parties
intend to apply the Polymun liposome technology and the
Polymun-Know-how for the efficient production of a liposomal
formulation of curcumin and to co-operate for that
purpose.
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“Agreement” means the body of this
Agreement for the Manufacturing of a Liposomal Formulation, signed by both
parties including all annexes and amendments thereto.
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“Ingredient” means the active
pharmaceutical ingredient curcumin (diferuloyl-methane) that
Principal intends to use in the kind of liposomes described in
Annex 2 of this Agreement.
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„Subject
Matter of Agreement“ shall mean the development of an
efficient production method for a liposomal formulation of the
Ingredient and production of GMP-like material as well as
GMP-compliant material by Contractor under application and
utilization of the Polymun liposome technology and the
Polymun-Know-how. For this purpose, Principal will make available
the Ingredient and all relevant information about physical and
chemical properties and descriptions of according analytical
methods. Principal and Contractor will cooperate to issue
specifications for the product to be manufactured and Contractor
agrees to meet these specifications if possible by commercially
reasonable efforts.
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„Contractual Intellectual Property
Rights“ shall mean
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all patents and
patent applications listed in Annex 1, as well as patents that will
be issued following these patent applications;
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all further
intellectual property rights including additional patents, process
patents, etc., which Contractor will file or acquire during the
term of this Agreement in connection with the liposome
technology.
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„Contractual Know-how“ shall mean
all technical and operational experience, knowledge, results from
development and experiments, especially data and knowledge about
production, production procedures, application technologies,
reports, modifications, improvements as well as other information
and know-how of Contractor regarding the liposome technology
that
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exist directly
and indirectly at signing of this Agreement at the Contractor
and
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are acquired
during the term of this Agreement.
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All Know-How
and Proprietary Rights of Principal existing on September 6, 2007
(thereinafter referred to as “Effective Date”) hereof
or arising during the term of this Agreement from the separate and
independent efforts of Principal (“Background Rights of
Principal”) shall be the sole and exclusive property of
Principal. Contractor shall have no right or license to use any
such Background Rights of Principal except as may be necessary for
performing hereunder.
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All Know-How
and Proprietary Rights of Contractor existing on the Effective Date
hereof or arising during the term of this Agreement from the
separate and independent efforts of Contractor (“Background
Rights of Contractor”) shall be the sole and exclusive
property of Contractor. Principal shall have no right or license to
use any such Background Rights of Contractor except as may be
necessary for performing hereunder. Notwithstanding the foregoing,
Contractor and Principal may negotiate in good faith license terms
for Background Rights of Contractor at any further point in time.
However, Contractor shall disclose in writing any such Background
Rights of Contractor as soon as practicable or prior to use,
whichever occurs first, Ingredient so that Principal may have the
opportunity to accept its use, provide alternatives or terminate
this Agreement at Principal’s sole discretion.
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All Proprietary
Rights arising from Development Activities of Contractor and/or its
agents and subcontractors, solely by Contractor or jointly or
severally with the assistance activities of Principal regarding the
Ingredient (“Ingredient Resulting Proprietary Rights”),
shall be the sole and exclusive property of Principal. Principal
shall have the right to prepare, file, prosecute, obtain and
maintain at its sole expense patent applications and patents
relating to Ingredient Resulting Proprietary Rights in countries of
its choice. Both parties agree that each will identify and
memorialize Ingredient Resulting Proprietary Rights for itself and
the other party. Contractor hereby assigns and conveys to Principal
all right, title, and interest in and to such Ingredient Resulting
Proprietary Rights and agrees to execute any and all legal
instruments reasonably requested by Principal to effect,
acknowledge, or perfect such assignment and conveyance.
Notwithstanding the limitations of existing and disclosed
agreements with third parties, Contractor represents and warrants
that each and every officer, employee, agent and subcontractor
assigned to work for Principal hereunder shall have entered into an
agreement with Contractor for the assignment of relevant Ingredient
Resulting Proprietary Rights to Contractor. In addition,
Contractor, its agents, and subcontractors shall treat such
Ingredient Resulting Proprietary Rights confidentially under the
provisions of § 8 and shall have no right or license to use
such Ingredient Resulting Proprietary Rights for any purpose other
than as expressly set forth herein. Principal will name those
employees and consultants of Contractor as inventors on patent
applications who have substantially contributed to the according
invention. However, Principal has no obligation whatsoever to
compensate such inventors for their contribution.
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All Proprietary
Rights arising from Development Activities of Contractor and/or its
agents and subcontractors, solely by Contractor or jointly or
severally with the assistance activities of Principal regarding the
Polymun liposome technology in general (“PLT Resulting
Proprietary Rights”), shall be the sole and exclusive
property of Contractor. Contractor shall have the right to prepare,
file, prosecute, obtain and maintain at its sole expense patent
applications and patents relating to PLT Resulting Proprietary
Rights in countries of its choice. Both parties agree that each
will identify and memorialize PLT Resulting Proprietary Rights for
itself and the other party. Principal hereby assigns and conveys to
Contractor all right, title, and interest in and to such PLT
Resulting Proprietary Rights and agrees to execute any and all
legal instruments reasonably requested by Contractor to effect,
acknowledge, or perfect such assignment and conveyance.
Notwithstanding the limitations of existing and disclosed
agreements with third parties, Principal represents and warrants
that each and every officer, employee, agent and subcontractor
assigned to work for Principal hereunder shall have entered into an
agreement with Principal for the assignment of relevant PLT
Resulting Proprietary Rights to Principal. In addition, Principal,
its agents, and subcontractors shall treat such PLT Resulting
Proprietary Rights confidentially under the provisions of § 8
and shall have no right or license to use such PLT Resulting
Proprietary Rights for any purpose other than as expressly set
forth herein. Contractor will name those employees and consultants
of Principal as inventors on patent applications who have
substantially contributed to the according invention. However,
Contractor has no obligation whatsoever to compensate such
inventors for their contribution. Notwithstanding the foregoing,
Contractor and Principal may negotiate in good faith license terms
for PLT Resulting Proprietary Rights at any further point in time,
for which Principal shall have a right of first refusal for PLT
Resulting Proprietary Rights that includes Ingredient Resulting
Proprietary Rights. However, Contractor shall disclose in writing
any such PLT Resulting Proprietary Rights as soon as practicable
or
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