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EXHIBIT 10.14
Hormos - Orion
SERM Licensing agreement
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PATENT LICENSE AGREEMENT
This Agreement
(hereinafter the "Agreement")
dated __________________________, 2004
(hereinafter "Date of Agreement")
by and between
HORMOS MEDICAL CORPORATION
a corporation duly organized and existing
under the laws of the Republic of Finland,
with its
principal offices at PharmaCity, Itainen Pitkakatu 4, FIN-20520
Turku, Finland.
(hereinafter "Hormos")
and
ORION CORPORATION
ORION PHARMA
a corporation duly organized and existing
under the laws of the Republic of Finland,
located at Orionintie 1, P.O. Box 65, FIN-02101, Espoo, Finland
(herein after "Orion")
WITNESSETH
WHEREAS,
****, **** and **** have made a novel invention related to
*******
derivatives (herein after Invention as further defined herein
below) and
notified their then employer Orion July 30, 1997 of the
Invention.
Orion informed inventors that it will not exercise its right to
the
Invention as an employer and the rights to same have reverted back
to
the
inventors ****, **** and *******. Subsequently Orion has acquired
the
share of
Arto Karjalainen to the Invention.
WHEREAS,
Hormos has acquired shares of **** and **** to the Invention
believing
that it has acquired all rights to the Invention. Hormos has
filed
November 15 2000 a US patent application, whose claims include
together
with developed biological data the compounds presented in the
Invention
and certain additional compounds for pharmaceutical use
invented
at Hormos
by inventors also other than ****, **** and ****.
WHEREAS,
Hormos and Orion recognize the role of **** as an original
inventor
to the Invention and Hormos wishes to amend the filed patent
application by adding **** name also to the Patents (as herein
defined).
Accordingly, through this Agreement Hormos and Orion wish to agree
on the
terms and
conditions for a license to the share of **** to the Invention
from Orion
to Hormos.
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Hormos - Orion
SERM Licensing agreement
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Now,
therefore, the Parties agree as follows in consideration of the
promises
and the mutual covenants and agreements contained herein:
1.
DEFINITIONS
As used in
this Agreement, the following terms shall carry the meanings
set forth
below:
1.1
"Affiliated
Company" shall mean:
(a) any
organization or business entity of which fifty percent (50%) or
more of
the voting stock is controlled or owned directly or indirectly
by
Hormos or
Orion, as the case may be;
(b) any
organization or business entity which directly or indirectly
owns
or controls
fifty percent (50%) or more of the voting stock of Hormos or
Orion, as
the case may be;
(c) any
organization or business entity, the majority ownership of
which
is
directly or indirectly common to, or commonly owned or controlled
by
the
majority ownership of Hormos or Orion, as the case may be;
1.2
"Invention" shall mean the invention described in the appendix
(Appendix
1) to the invention notification "****" dated July 29 1997
provided
by the inventors to Orion, including without limitation the
therein
identified compounds.
1.3 "Net Sales"
shall mean the gross amount invoiced by Hormos, its Affiliated
Companies
or sublicensees on account of sales of Products to customers,
less the
following deductions to the extent actually allowed or
specifically allocated to the Products using generally accepted
accounting
standards:
(i)
value added
taxes, sales and excise taxes and duties paid or allowed
by the selling party and any other governmental charges imposed
upon
the importation or sale of such Product;(ii) customary and
reasonable trade, quantity and cash discounts actually allowed
with
respect to the sale of Products;
(iii)
customary and reasonable allowances or credits to customers on
account of rejection, withdrawal, recall or return of Products
(iv)
customary and
reasonable freight and insurance costs, if they are
included in the selling price for the Products invoiced to
customers
or otherwise paid by customers, provided always that such
deduction
shall not be greater than the balance between the selling price
actually invoiced to the customer and the standard selling
price
which would have been charged to such customer for such
Products
exclusive of freight and insurance costs
1.4 "Party" and
"Parties" shall mean in singular either Orion or Hormos and in
plural
both Orion and Hormos.
1.5 "Patents"
shall mean granted US patent No **** (Appendix 2) and its
divisional
allowed US patent application No *********** (claims as
Appendix
3), both titled "*****************" and any corresponding
issued
patent or
filed patent application based on the inventions
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Hormos - Orion
SERM Licensing agreement
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described
in US patent **** or the US patent application **** that are
filed or
granted in any country of the world including any corresponding
patent
applications filed in any country or territory, or based on any
divisionals, continuations, continuations-in-part, reissues,
re-examinations, and extensions of any of the foregoing (including
any
"patent
term restoration" period or supplementary protection
certificate
granted
under applicable laws in a given country);
1.6 "Product(s)"
shall mean any pharmaceutical product containing i) any of
the
compounds identified in the Invention as its active ingredient
alone
or in
combination of other active ingredients; ii) any molecule that
has
similar
pharmacological properties with such compounds and falls within
the claims
of the Patents;
1.7 "Term" shall
mean the period of time commencing on the Date of the
Agreement
and ending on a country-by-country basis when the last of any
of
the issued
Patents expires or is finally adjudged invalid and
unenforceable by a competent court or tribunal.
2. ORION'S
RIGHTS TO THE PATENTS
Hormos and
Orion hereby recognize the role of **** as an original inventor
of the
Invention. Consequently, **** is entitled to be acknowledged as
an
inventor
and Orion as an assignee with regard to ****'s share to the
Invention
and the Patents filed by Hormos. Hormos undertakes to amend the
Patents by
adding **** to the list of inventors at Hormos' cost. Orion
shall
reasonably assist, at Hormos's cost, in Hormos so amending the
Patents,
if required by the US Patent and Trademark Office or any other
relevant
Patent authority, for example by signing the documents needed,
if
any, to
make such addition.
3.
GRANTS
Orion
grants Hormos an exclusive license subject to the terms and
conditions
hereof, to Orions's rights in the Invention and Patents. Orion
shall not
for the term of this Agreement exercise the rights itself nor
grant any
of said rights to any third party.
Hormos
shall have the right to sublicense the rights granted to it
under
this
Agreement to any third party or parties. Hormos shall notify
Orion
within
thirty (30) days after execution of any such sublicense between
Hormos and
its sublicensee. No sublicense shall relieve Hormos of any of
its
obligations or commitments under this Agreement.
4.
PROSECUTION OF PATENT APPLICATIONS AND MAINTENANCE OF PATENTS
4.1 Hormos shall
be solely responsible for the prosecution and maintenance of
the
Patents. Hormos shall be at its discretion entitled to, and is
responsible for, all decision making related to the Patents and
related to
patenting
strategy. For the avoidance of doubt, it is hereby acknowledged
and agreed
that save as for what is expressly provided for herein,
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SERM Licensing agreement
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Orion
shall have no obligation whatsoever concerning the Invention
and/or
the
Patents.
4.2 In the event
that Hormos decides not to prosecute the patent applications
through
issuance of Patents or to discontinue the maintenance of the
Patents,
such decision to be at the sole discretion of Hormos, Orion
shall
have the
right of first refusal to be assigned such Patents, under a
separate
assignment agreement to be negotiated by Orion and Hormos.
5.
INFRINGEMENT OF PATENTS
5.1 Hormos shall
have the right but no obligation to commence any procedure or
action, at
its cost, against known or suspected infringement of Patents or
defend the
Patents. After Orion's co-ownership is registered in patent
authorities, Orion shall have the same rights but accordingly,
no
obligation.
5.2 For
avoidance of doubt, nothing in this Agreement shall be construed
as
a)
A warranty
or representation by Hormos or Orion as to the validity
or scope of any Patent; or
b)
A warranty
or representation by Hormos or Orion that anything made,
used, sold or otherwise disposed of under any of the Patents is
or
will be free from infringement of any rights of a third
party/parties; or
c)
A
requirement that Hormos shall file any Patent application,
secure
any Patent or maintain any Patent in force, unless so agreed in
this
Agreement or in writing; or
d)
An
obligation on Orion or Hormos to bring or prosecute actions or
suits against any third party for any actual or threatened
infringement of Patents.
6.
REMUNERATION
6.1 As a
consideration for the license granted to Hormos hereunder,
Hormos
agrees to
pay Orion milestones and running royalties and grants Orion a
right of
first refusal for the Product(s) separately for each compound
in
development or developed to as pharmaceutical product as set forth
below.
6.2 License fees
and Milestone payments. Hormos shall pay to Orion license
fees and
milestones as follows:
6.2.1 A one time payment of fifty thousand EURO (50,000.-) within
thirty (30)
days of
signing of this Agreement.
6.2.2 A one time payment of **** EURO (****) within thirty days
(30) days of
*************************
******************************************
*******
****************** **** is deemed to be obtained after ******.
Hormos
undertakes to make the **** decision within **** after the ****
is
obtained.
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SERM Licensing agreement
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If NO GO
decision is made, Hormos is not entitled to develop the
compound
any
further or have the compound developed on behalf of it or
sublicense
the
compound before the payment mentioned in this section 6.2.1 is
made.
Hormos
undertakes to inform its decision to Orion without delays.
6.2.3 A one time payment of **** EURO (****) within thirty (30)
days after an
NDA for
any Product if filed for an indication with, and accepted for
filing by,
the US FDA, or with any other regulatory authority in any other
country or
territory of the world, which filing is made by or on behalf of
Hormos or
any Affiliated Company of Hormos or any sublicensee of Hormos
or
its
Affiliated Company or any other third party for or on Hormos' or
its
Affiliated
Company's or its sublicensee's benefit or behalf or deriving
its rights
from Hormos or its Affiliated company or