<PAGE>
EXHIBIT 10.15
PATENT LICENSE AGREEMENT
This Agreement
(hereinafter the "Agreement")
is made this 10th day of October, 2005
(hereinafter "Date of Agreement")
by and between
Hormos Medical Corporation
a corporation
duly organized and existing under the laws of the Republic of
Finland, located 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
(hereinafter "Orion")
WHEREAS, *******, *******, *******, *******, ******* and *******
made an
invention with application to the prevention and treatment of
osteoporosis, for
which patent application number ** **** entitled "******" was filed
in the
United Kingdom Patent and Trademark Office on ******* (hereinafter
"U.K Patent
Application") and patent applications corresponding to the U.K.
Patent
Application, which are listed on Appendix A hereto, have been
filed, and to date
seven patents has resulted therefrom, as identified in said
Appendix;
WHEREAS, by means of written assignments and the laws of Finland,
Orion has
acquired all the rights, title and interests of Dr. *******, Dr.
*******,
******* and *******, whereas Hormos acknowledges that it has
acquired all the
rights, title and interests of ******* and ******* in the U.K.
Patent
Application and any corresponding patent applications and any
patents resulting
therefrom or corresponding thereto;
WHEREAS, Orion and Tess Diagnostics and Pharmaceuticals, Inc. from
USA
(hereinafter "Tess") entered into a Patent License and Technical
Assistance
Agreement, dated 28th day of April 1998 (hereinafter the "Tess
Agreement"), with
respect to the prevention and treatment of osteoporosis;
WHEREAS, Tess and Hormos subsequently entered into the License,
Sub-license and
Research and Co-development Agreement, dated May 24th 1998, in
order to form a
consortium to co-develop a commercially viable pharmaceutical
product for the
prevention and treatment of osteoporosis by exercising the claims
of U.K. Patent
Application (as defined in such Agreement) and any corresponding
patent
applications and patents resulting therefrom;
1
<PAGE>
WHEREAS, Hormos wishes to further pursue the development of the
Product (as
defined herein below);
WHEREAS, Tess has transferred and assigned the Tess Agreement to
Hormos with any
and all rights and obligations arising therefrom and Orion has
given its consent
to the transfer of the Tess Agreement, on the terms and conditions
of the
Assignment Agreement of even date herewith December 5, 2002, by and
between
Tess, Hormos and Orion, and as of such date Orion and Hormos, in
place of Tess,
are parties to the Tess Agreement. By the execution of this
Agreement Orion and
Hormos desire with this Agreement to supersede and replace the Tess
Agreement as
of the Date of Agreement, with the express agreement of Orion and
Hormos that
such replacement of the Tess Agreement by this Agreement shall in
no way affect
Hormos obligations and undertakings under the Assignment
Agreement;
WHEREAS, Hormos has been developing ospemifene for certain
additional
indications identified herein, and Orion has granted new licenses
in order to
enable Hormos to develop and commercialize ospemifene with regard
to such new
therapeutic indications as are defined hereinafter, and accordingly
the Parties
have 5 December, 2002 entered into a patent license agreement
concerning the
above referred to matters, which they now wish to replace with this
agreement;
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 "Licensee"
shall mean Hormos;
1.3 "Licensor"
shall mean Orion;
1.4 "Net Sales"
shall mean gross sales of the Product(s) invoiced by Hormos
or an
Affiliated Company on such sales, less custom charges, duties
and
taxes
(including but not limited to "VAT" and other turnover taxes)
less
delivery,
shipping and transportation costs, less credits or allowance on
account of
rejections or returns of Product(s) previously sold and less
trade
discounts. Product(s) shall be deemed to have been sold when
invoiced.
If Hormos sublicenses the manufacture and/or sale of Product(s)
to any
third party, then the royalty payable to Orion hereunder, shall
be
based on
the Net Sales of such Hormos sublicensee less any deduction, if
applicable, defined hereinabove;
1.5 "Orion's
Documentation" means Orion's dossier relating solely to
Ospemifene
for Osteoporosis Indication, including its Finnish IND
information and applicable chemistry, pharmacological and
2
<PAGE>
safety
data relating thereto;
1.6 "Orion's
Patent Rights" means Orion's share of the rights, title and
interest
in the Patents and Patent Applications, as defined herein;
1.7 "Ospemifene"
shall mean ****** *****;
1.8.
"Triphenylethylenes Patents" shall mean any patent applications and
any
valid and
enforceable patents that are filed or granted in any country of
the world
as described in European Patent Specification ****** and based
on the
United Kingdom priority patent application filed on September
7,
1994
(******, hereinafter "Triphenylethylenes Priority Patent
Application") entitled "******" or based on any corresponding
patent
applications filed in any country or territory, or based on any
divisionals, continuations, continuations-in-part, reissues,
re-examinations, or extensions of any of the foregoing (including
"patent
term
restorations" periods granted under applicable laws in a given
country);
1.9 "Cholesterol
Patents" shall mean any patent applications and any valid and
enforceable patents that are filed or granted in any country of the
world
as
described in European Patent Specification ***** (as further
identified
in
Appendix B) and based on the United Kingdom priority patent
application
filed on
March 4, 1996 (*****, hereinafter "Cholesterol Priority Patent
Application", as further identified in Appendix 2) entitled "*****"
or
based on
any corresponding patent applications filed in any country or
territory,
or based on any divisions, continuations,
continuations-in-part, reissues, re-examinations, or extensions of
any of
the
foregoing (including "patent term restorations" periods granted
under
applicable
laws in a given country);
1.10. "Patents" shall mean both Triphenylethylenes Patents and
Cholesterol
Patents;
1.11 "Patent
Applications" means any filed but not granted patent
application
for
Triphenylethylenes Patents or Cholesterol Patents based on
Triphenylethylenes Priority Patent Application or Cholesterol
Priority
Patent
Application and all divisionals, continuations, or
continuations-in-part thereof;
1.12 "Product(s)"
herein shall mean any pharmaceutical product containing
Ospemifene
as its sole active ingredient;
1.13 "Term" means the
duration for which this Agreement shall remain in effect
which
shall be 15 years from the Date of Agreement, or until the last
of
any of the
issued Patents expires (expiration to include any applicable
patent
term restoration or extension that may be allowed) or is
finally
adjudged
invalid and unenforceable by a competent court or tribunal,
whichever
is longer;
1.14 "Atrophy" shall
mean urogenital atrophy in women, including vaginal
atrophy;
1.15 "Atrophy
Indication" shall mean prevention and treatment of Atrophy;
1.16 "Osteoporosis
Indication" shall mean prevention and treatment of
osteoporosis in women;
1.17 "Cholesterol
Indication" shall mean the reduction of serum total
cholesterol in women treated with Ospemifene;
1.18 "Confidential
Information" shall mean all information, documentation,
samples
and data relating to
3
<PAGE>
Ospemifene
and/or the Orion Documentation and all other Orion products,
the
business affairs, trade secrets and other activities of Orion
and/or
its
Affiliates, whether disclosed or made available prior to, or after
the
Date of
Agreement or by or on behalf of Orion and/or Tess, (whether
orally
or in
writing or any other medium. Any and all information,
documentation,
samples
and data relateing to Ospemifene and/or Orion Documentation
shall
be deemed
included within the scope of Confidential Information
regardless
of whether
it is identified as confidential or not, whereas any
information related to all other Orion products, the business
affairs,
trade
secrets and other activities of Orion shall be deemed included
within the
scope of Confidential Information if it is expressly stated to
be
confidential.
2.
GRANTS
2.1 During the
Term, Orion hereby grants to Hormos, only with respect to (I)
the
Osteoporosis Indication, (II) the Atrophy Indication and (III)
the
Cholesterol Indication, any and all rights that it has under
the
Triphenylethylenes Patents and any and all rights granted to it as
a
result of
a Triphenylethylenes Priority Patent Application to develop,
manufacture, promote market and sell Product(s) by itself or to
have done
on behalf
of Hormos, including the right to grant sublicences, subject to
the terms and
conditions of this Agreement.
2.2 Subject to
clause 2.2.1, during the Term, Orion hereby grants to Hormos
with
respect to the Cholesterol Indication only any and all rights that
it
has under
and the Cholesterol Patents and any and all rights granted to
it
as a
result of a the Cholesterol Priority Patent Application to
develop,
manufacture, promote market and sell Product(s) by itself or to
have done
on behalf
of Hormos, including the right to grant sublicences.
2.2.1 The rights and licenses pursuant to clause 2.2 are contingent
upon
******
giving, where required under laws of a particular jurisdiction,
his
written consent, as a co-owner of the Cholesterol patents and
rights
based on
the Cholesterol Priority Patent Application, to the license to
Hormos.
Hormos
acknowledges that as the Date of Agreement, ****** has not
given such
consent. Orion makes no representation and gives no warranty
when, or
if at all, ****** will give such consent. To the extent
Hormos
desires to exercise the contingent license set forth in clause
2.2,
then it
shall be Hormos' sole responsibility and obligation to cause
****** to
give such written consent(s) to Orion, and Orion shall have
no
obligation in this regard. Hormos agrees that lack of such consent
by
****** may
not be deemed a breach of this Agreement by Orion.
2.3 Having
granted any and all of its rights defined in section 2.1 and,
subject to
section 2.2.1, in section 2.2 to Hormos, Orion shall not grant
the same
rights to a third party and shall not itself exercise any such
rights,
unless pursuant to the terms of this or a separate agreement
between
Orion and Hormos.
2.4 Except for
the rights granted in clause 2.1 and 2.2 above, nothing
contained
herein shall give or be deemed to give or grant Hormos any
license or
rights to any existing or future Orion patents or other
intellectual property rights.
2.5 Hormos shall
have the right to sublicense its rights received under this
Agreement
to any third party or parties. Hormos shall notify Orion within
fifteen
(15) days after execution of an agreement between Hormos and
its
sublicensee. No sublicense shall relieve Hormos of any of its
obligations
4
<PAGE>
or
commitments under this Agreement and Hormos shall cause its
Affiliated
Companies
and sublicensees to comply with all of Hormos obligations and
commitments under this Agreement.
Hormos
shall remain jointly and severally liable to Orion with its
Affiliated
Companie(s) and sublicensees for performance of Hormos'
obligations under this Agreement. Hormos shall be responsible
for
complying
and ensuring that such of its Affiliated Companies and
sublicensees, as applicable, comply with all relevant laws,
regulations
and
requirements relating to the importation, packaging,
distribution,
marketing,
promotion, sale and use of Product
3. ORION
DOCUMENTATION
3.1 To the best
of Orion's management's belief as of the Date of Agreement,
Orion has
prior to the Date of Agreement provided Hormos with all
material
Orion
Documentation which is available to and disclosable by Orion.
Consequently, Orion will have no obligation to provide any
additional
data,
documentation or information to Hormos, its Affiliated Company
or
sublicensee(s). However, Orion gives no warranty that additional
Orion
Documentation in existence prior to the Date of Agreement may not
in fact
prove to
exist and/or become available to and disclosable by Orion.
Should
any such
additional Orion Documentation become available to and
disclosable by Orion, then Orion shall without undue delay provide
Hormos
with a
copy of same.
Hormos
shall, for the sole purpose of, and in accordance with the
terms
and
conditions of this Agreement and subject to clause 3.2, have the
right
at its own
sole risk and responsibility to utilize Orion's Documentation
disclosed
to it as it sees fit for product development, marketing
approval
and
Product registration purposes, provided that Hormos shall not
be
authorized
to use Orion's name in connection with any such permitted use
thereof,
unless prior written consent of Orion is first obtained, and
further,
unless laws or regulatory requirements make it mandatory that
Orion's
name be disclosed, in which case Hormos shall first inform
Orion
of this
requirement and use Orion's name only to the extent required to
comply
with same.
3.2 Hormos shall
not disclose Confidential Information to any third parties or
otherwise use
such Confidential Information, except to the extent such use
or
disclosure is expressly permitted by the terms of this Agreement,
or
required
or reasonably necessary for proper performance of this
Agreement,
or the
proper exercise of its rights under this Agreement. By way of
example,
Hormos or its Affiliated Companies may disclose Orion's
Confidential Information to potential sublicensees under
confidentiality
obligations no less stringent that those contained herein to the
extent
necessary
to evaluate Ospemifene and its scientific and commercial
viability
or to health or regulatory authorities to the extent necessary
to comply
with any laws applicable to it as distributor of Product
therein
or in
order to obtain marketing authorization for a Product.
Hormos and
its Affiliated may divulge Confidential Information to only
those of
its, and its Affiliates' employees and such permitted
independent
contractors, agents or other third parties who have a bona fide
"need to
know" to
permit Hormos to properly perform its obligations or exercise
their
rights under this Agreement, provided such persons are first
bound
by
confidentiality undertakings that are materially no less
stringent
than, and
consistent with Hormos' confidentiality obligations hereunder.
Hormos'
confidentiality undertakings pursuant to this Clause 3.2 shall
not
apply to
any Confidential Information:
(a)
which at the
time of disclosure is or later has come into the public
domain by publication or otherwise through no fault of Hormos;
or
5
<PAGE>
(b)
is disclosed to
Hormos by a third party (other than Tess or any of
its directors, employees or shareholders) who was under no
obligation of confidentiality, directly or indirectly, to Orion,
or
to any customer, distributor, agent, licensee or affiliate of
Orion;
or
(c)
is required to
be disclosed under law or by order of a court of
competent jurisdiction, provided, however, that Orion is granted
due
advance notice of such a requirement in order to be able to
contest
the same and then only to the minimum extent of disclosure so
required.
(d)
which has been
independently conceived or developed by Hormos
without exploiting Confidential Information.
Hormos
shall have the burden of proof as to any claimed exception from
confidentiality and non-use.
The
confidentiality obligations under this Clause 3.2 shall remain
in
effect
during the Term and for twenty (20) years thereafter.
4.
PROSECUTION OF PATENT APPLICATIONS AND MAINTENANCE OF PATENTS
4.1 Subject to
******'s and ******'S rights and obligations
with
respect to the prosecution of Patent Applications and maintenance
of
Patents,
it is specifically agreed between Orion and Hormos that Orion
shall be
responsible for the prosecution of the Patent Applications
listed
on
Appendices A and B hereto, and shall be responsible for the
maintenance
of any and
all Triphenylethylenes and Cholesterol Patents in countries set
out in
Appendices A and B and to apply for appropriate supplementary
protection
certificates where available.
4.2. Upon Hormos'
request, such request to be made no more than twice in each
calendar
year, Orion shall provide Hormos with a brief status report of
the
prosecution of pending Patent Applications. Orion shall also
notify
Hormos
upon the granting of each Patent within two (2) months from the
grant of
same.
4.3 In the event
that Orion decides not to prosecute a Patent Application
through
issuance of a Patent or not to maintain a Patent, such decision
to
be at the
sole discretion of Orion, Hormos shall have the right of first
refusal to
be assigned such Patent Application or Patents, under a
separate
assignment agreement to be negotiated by Orion and Hormos,
which
agreement
shall provide that Hormos shall reimburse Orion for Orion's
total
costs of prosecuting the Patent Application, as well as patent
maintenance fees, if applicable, up to the date of the assignment,
and in
consideration for the assignment, Hormos shall pay Orion, on a
country by
country
basis, ***% running royalty of Net Sales of Products by Hormos,
its
Affiliated Company and/or its third party sublicensees. Said
royalty
shall be
payable instead of the royalty set forth in Clause 5.1 (a)
herein
below.
4.4 Each of
Orion and Hormos shall promptly inform the other in writing of
any
infringement of Patents by a third party which may come to its
attention
and shall
provide the other with any information in its possession
relating
to such infringement. Hormos shall have the first right to
prosecute
infringers to the extent the infringement concerns Hormos'
herein
agreed rights to Patents at its own cost and expense. Orion
shall
reasonably
cooperate with Hormos, at Hormos's expense, in connection
therewith.
If within
ninety (90) days after having been notified of any alleged
infringement, Hormos has been unsuccessful in persuading the
alleged
infringer
to desist and has not brought, and is not diligently
maintaining
an
infringement action or if Hormos notifies Orion at any time
prior
thereto of
its intention not to bring suit against any alleged infringer,
then Orion
may, but shall not be obligated
6
<PAGE>
to,
prosecute, at its own expense, any infringement of the Patents,
provided
that Hormos may, at Hormos's expense, participate in any such
litigation
to the extent reasonably required to protect its rights.
Any
recovery of damages by Hormos for any such suit shall be applied
first
in satisfaction
of any unreimbursed expenses and legal fees of Hormos
relating
to the suit or settlement thereof, and the balance thereafter
remaining
from such recovery shall be treated as Net Sales to Hormos and
Hormos
shall pay a royalty to Orion as though such amount constituted
Net
Sales in
the year of recovery for purposes of this Agreement. No
settlement, or consent judgment, or other voluntary final
disposition of
the suit
may be entered into without the consent of Orion, which consent
shall not
be unreasonably withheld or delayed.
In the
event that Orion undertakes the enforcement and/or defence of
the
Patents by
litigation or settlement action, any recovery of damages by
Orion
shall be retained in full by Orion. Provided Hormos is not in
breach
of this
Agreement and is current in reimbursing Orion for all costs and
expenses,
including reasonable attorney fees and legal costs, in
connection
with such litigation or action, no settlement, or consent
judgment,
or other voluntary final disposition of the suit, which may
limit
Hormos's rights hereunder may be entered into without the consent
of
Hormos,
which consent shall not be unreasonably withheld or delayed.
In the
event any action in a court of competent jurisdiction alleging
invalidity, unenforceability, or non-infringement of any of the
Patents is
brought
against Hormos or Orion, Hormos shall, within thirty (30) days
after
commencement of such action, intervene and take over, at its
sole
responsibility and expense, the sole defence of the action to the
extent
such
action concerns Hormos' herein agreed rights to Patents. If
within
thirty
(30) days after having been notified of any such action, Hormos
has
not
diligently initiated and pursued the defence against same or if
Hormos
notifies
Orion at any time prior thereto of its intention not to so
defend
or pursue
the defence, then Orion may, but shall not be obligated to so
defend, at
its own expense, against any such action, provided that Hormos
may, at
Hormos's expense, participate in any such litigation to the
extent
reasonably
required to protect its rights.
In any
infringement suit that either Party may institute to enforce
the
Patents or
in any declaratory judgment or other action alleging
invalidity, unenforceability or non-infringement of any Patents
brought
against
either Party, the other Party hereto agrees, at the request and
expense of
the Party initiating or defending the suit or action, to
cooperate
in all reasonable respects, including without limitation by
exercising
commercially reasonable efforts to have its employees testify
when
requested and to make available relevant records, papers,
information
samples,
specimens, and the like.
5.
ROYALTIES
5.1
(a) In
consideration for the rights and licenses granted to Hormos
hereunder,
and for
Ori
