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 Xxxxxxxxx 0, XXX-00000 Xxxxx, Xxxxxxx.
(hereinafter "Hormos")
and
Orion Corporation
ORION PHARMA
a corporation duly organized and existing under the laws
of the Republic of Finland, located at Xxxxxxxxxx 0, X.X. Xxx 00, XXX-00000,
Xxxxx, Xxxxxxx
(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;
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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
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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
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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
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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
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(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
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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 Orion's other undertakings hereunder, Hormos agrees to pay a
running royalty of **** (**** %) of all Net Sales of Products made by
Hormos, any Affiliated Company of Hormos, and any third party sublicensee
of Hormos or its Affiliated Company, to unaffiliated customers or
purchasers, including but not limited to, HMO's, hospitals, pharmacies,
clinics, physicians and others who sell and supply Product to patients.
The royalty amount payable under this clause shall apply to Products
covered by any pending
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Patent Application as well as any issued Patents, subject to the terms of
clause 5.2. below.
(b) Hormos shall be responsible for calculating and remitting to Orion all
royalties payable on Net Sales made by Hormos, an Affiliated Company or a
Hormos sublicensee, unless a separate written agreement is entered into
between Hormos, Orion and an Affiliated Company or sublicensee with
respect to such royalties being paid by such Affiliated Company or
sublicensee directly to Orion.
5.2 In those countries where (a) no Triphenylethylenes Patent Applications are
filed; or (b) where there has been a final rejection of all claims under
Triphenylethylenes Patent Applications; or (c) where all issued
Triphenylethylenes Patents have expired, or have been declared invalid and
unenforceable by a court of competent jurisdiction; or (d) Orion has
abandoned its Triphenylethylenes Patent Applications and Patents; or (e)
Orion has assigned its Patent Applications and its Patents to any party
other than Hormos, an Affiliated Company of Hormos, or an Affiliated
Company of Orion, then the royalty amount referenced in 5.1. above shall
thereafter be **** to **** percent (****%) of Net Sales made in or to such
countries so affected during the Term of this Agreement. Such **** percent
(****%) royalty is in consideration for the rights granted to Hormos to
use the Orion Documentation and in consideration for Orion's other
undertakings hereunder.
5.3 All royalty payments due under Clauses 5.1, and 5.2. shall be made within
sixty (60) days of the end of each calendar year in respect of payments
accruing on Net Sales made in that calendar year. The royalty payments
shall be in full amount, less any taxes required by a government or
governmental agency to be withheld therefrom; provided, however, that
Orion shall have the right to first contest any such taxes and Hormos
will, if requested, and at Orion's expense, provide reasonable assistance
with respect to dealing with such matters, and in having appropriate
certificates of tax payment or withholdings issued by relevant tax
authorities.
5.4 All payments to Orion shall be made in Euros. In the event that conversion
from any other currency is required in calculating a payment hereunder,
the exchange rate used shall be the rate as published by the Bank of
Finland and in effect on the last business day of the month just prior to
the month in which payment is required to be made hereunder.
5.5 The royalty payments obligations of Hormos hereunder shall remain in
effect for the Term of this Agreement.
5.6
(a) Hormos shall keep and maintain and require its Affiliated Companies and
sublicensees to keep and maintain, complete and accurate records and books
of account in sufficient detail and form so as to enable verification of
royalties paid or payable hereunder. Such records and books of account
shall be maintained for a period of no less than three (3) years following
the royalty payment year to which they pertain. Hormos shall permit, and
procure the permission to such records and books of account to be examined
by Orion or a duly authorized representative of Orion to the extent
necessary to verify the amount of royalties payable. Such examination
shall be at Orion's expense and be done during the normal business hours
and upon ten (10) days' prior written notice to Hormos.
(b) Hormos will also allow and arrange for Orion to audit Hormos, or any
Hormos Affiliated Company's or sublicensees records for correctness of
royalty payments and Net Sales, if requested, and at Orion's expense.
(c) Orion shall make any claim relating to the royalty for a given calendar
year payable within three
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(3) years after the end of such calendar year. Thereafter Orion shall be
deemed to waive its rights. to demand any royalty relating to the
Product(s) but only for such calendar year of accounting waived.
6. MILESTONE PAYMENTS
6.1 In further consideration for the rights granted with regard to
Osteoporosis Indication to Hormos and the undertakings by Orion hereunder,
Hormos agrees to pay Orion:
(a) A one time payment of **** U.S. dollars **** within thirty days after the
NDA for any Product is filed for ******** and accepted for filing by the
USA FDA, or in any other corresponding 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 sublicensee's benefit or behalf; and
(b) A one time payment of **** U.S. dollars **** within thirty days of the
official approval issued by the FDA, or any corresponding regulatory
authority in any country or territory of the world, allowing commercial
marketing or sale of any Product for an *****.
6.2. In further consideration for the rights granted with regard to Atrophy
Indication to Hormos and the undertakings by Orion hereunder, Hormos
agrees to pay Orion:
(a) A one time payment of **** EURO **** within thirty
(30) days of the ****.
(b) A one time payment of **** EURO **** within two (2)
years of the ****.
(c) A one time payment of **** EUROS **** within thirty days after the NDA for
any Product is filed for ******** and accepted for filing by the USA FDA,
or in any other corresponding 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 sublicensee's benefit or behalf.
6.3. In case Hormos and/or its Affiliated Companies or its or their
sublicensees decide to develop Ospemifene for Cholesterol Indication,
Hormos agrees to pay Orion further consideration for the rights granted
with regard to Cholesterol Indications to Hormos and the undertakings by
Orion hereunder
(a) A one time payment of **** EURO ****
within thirty days after ***********************************************
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(b) A one time payment of **** EURO (****.-) within thirty days of the
official approval issued by the FDA, or any corresponding regulatory
authority in any country or territory of the world, allowing commercial
marketing or sale of any Product for an **********************************
************************************************.
6.4 For the avoidance of doubt, under this Agreement, Hormos will be entitled
to describe cholesterol lowering properties of Ospemifene in label text
and pharmacological description other than as an Indication Claim, and to
grant sublicenses with regard to this right subject to the terms and
conditions of this Agreement, without any obligation to pay consideration
to Orion in accordance of section 6.3, it being agreed that the foregoing
shall not affect Hormos' obligation pay royalty pursuant to clause 5.
Furthermore, Hormos shall be under no obligation whatsoever to develop
Ospemifene for Cholesterol Indication.
6.5 All payments, once made, shall be non-refundable.
7. COLLABORATION AND ORION'S RIGHT OF FIRST REFUSAL
7.1 Hormos and Orion may further collaborate on clinical development of
Product(s), and/or evaluation and selection of suitable potential
marketing and sales and/or manufacturing sublicensees for Hormos and
Product(s) on such terms and conditions as may be separately agreed in
writing from time to time, with the express understanding and agreement
between the Parties that such collaboration, shall be subject to and
conditioned by a mutually acceptable separate written agreement, if any,
signed by duly authorized representatives of both Parties.
7.2 In consideration of Orion's presence and marketing capabilities in
Scandinavia and the Baltic area, Hormos hereby grants, and shall cause its
Affiliated Companies and sublicensees to grant, to Orion a right of first
refusal (ROFR) to become the exclusive importer and marketing and sales
distributor in Scandinavia (being defined as Finland, Sweden, Norway,
Denmark and Iceland) and the Baltic area (being defined as Estonia,
Lithuania, Latvia, and Russia) for each and every Product(s) that may
eventually run through phase III clinical trials,
7.3 Orion's ROFR shall be exercised as follows:
7.3.1 Promptly after the phase III clinical results sufficient for the filing of
an NDA for a Product are available and before said NDA in Europe for such
Product is filed, Hormos will inform Orion on a confidential basis of its
clinical program underway and provide Orion sufficient results and data to
allow Orion to evaluate the clinical program and the scientific
feasibility and commercial viability of Product concerned.
Within ninety (90) days from the receipt of sufficient results and data,
Orion will indicate to Hormos in writing whether it is interested in such
Product(s) or not.
If Orion has indicated its positive interest in the Product, then, not
later than thirty (30) days after (I) Hormos has received from Orion in
writing an indication of Orion's positive interest, or (II) the first NDA
for such Product is filed by, or on behalf of Hormos, its Affiliated
Company or a sublicensee of Hormos or its Affiliated Company in Europe
under either the EMEA centralized procedure, or in any country of the EU
under the Mutual Recognition procedure, whichever is later, Hormos shall
make a written proposal under which Orion shall be offered the exclusive
rights to market, sell and distribute the Product throughout Scandinavia
and the Baltic area on commercially reasonable terms and conditions
customary in the business ("Heads of Agreement").
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7.3.2 However, if already after the evaluation of the first phase III clinical
final results or at any stage after that before obtaining the sufficient
data for filing the NDA, Hormos in its discretion considers to have
sufficient data to prove the clinical profile of the Product, Hormos shall
inform Orion on a confidential basis of its clinical program underway and
provide Orion with sufficient results and data to allow Orion to evaluate
the clinical data and scientific feasibility and commercial viability of
Product concerned. Within ninety (90) days from the receipt of sufficient
data and result, Orion shall inform Hormos in writing whether or not Orion
considers having enough data to evaluate the clinical program and the
scientific feasibility and commercial viability of Product concerned. If
Orion has indicated that the data and results then available are
insufficient for evaluating the clinical program and the scientific
feasibility and commercial viability of Product concerned , then Hormos
shall provide the results and data as agreed in section 7.3.1 above, it
being agreed that Orion's rights under this clause 7.3.2 shall be without
prejudice to its rights under clause 7.3.1 and a possible indication by
Orion pursuant to this clause 7.3.2 that Orion considers the data and
results presented to be insufficient to evaluate the clinical program and
the scientific feasibility and commercial viability of Product concerned,
shall not affect Orion's rights under clause 7.3.1.
If Orion has indicated its positive interest in the Product, then, not
later than thirty (30) days after receipt of such indicated interest,
Hormos shall make a written proposal under which Orion shall be offered
the exclusive rights to market, sell and distribute the Product throughout
Scandinavia and the Baltic area on commercially reasonable terms and
conditions customary in the business ("Heads of Agreement").
7.3.3 Within thirty (30) days from the receipt of the Heads of Agreement,
pursuant to clause 7.3.1 or 7.3.2, Orion shall indicate to Hormos in
writing whether or not it is interested in engaging in good faith
negotiations for a commercially reasonable license agreement on the
Product ("License Agreement"). If Orion indicates in writing that it is
interested in engaging in good faith negotiation on an License Agreement
based on the Heads of Agreement, then Orion and Hormos shall negotiate
exclusively with each other the terms and conditions of a binding,
commercially reasonable License Agreement under which Hormos would grant
Orion the exclusive right to import, market distribute and sell the
Product in Scandinavia and the Baltic Area. Such negotiations shall
continue for up to one hundred and twenty (120) days after Hormos receives
such notification from Orion (hereinafter referred to as "Negotiation
Period"). If the Parties, despite conducting good faith negotiations, if
any, are unable to or do not finalize and execute a binding License
Agreement within the Negotiation Period, then Hormos shall have the right
to offer such the right subject to Orion's ROFR to a third party.
For the avoidance of doubt, Orion's ROFR shall apply on a Product by
Product basis, it being understood that Orion's ROFR, and Hormos' Heads of
Agreement, shall for each Product include the indications(s) being
developed and/or registered as well as all possible future indications and
line-extensions for such Product.
7.3.4 Hormos agrees to take into account, in good faith, Orion's earlier
participation, contribution and investments in initially generating Orion
Documentation when framing its Heads of Agreement, including the supply
price of Product, to Orion and throughout the negotiations contemplated
herein and in the License Agreement, if any.
7.3.5 Notwithstanding that the Parties may fail to enter into a License
Agreement for a Product within the Negotiation Period, Orion shall, for a
period of twenty four (24) months after (I) the expiration of the
Negotiation Period, or (II) the first NDA for such Product is filed by, or
on behalf of Hormos, its Affiliated Company or a sublicensee of Hormos or
its Affiliated Company in Europe, whichever is later, have a continuing
right of first refusal to obtain the exclusive license to
11
commercialize such Product in the Scandinavia and Baltic area as follows:
Hormos shall not offer or grant any more favorable financial terms to any
third party for the Product marketing and distribution rights in the
Scandinavia and Baltic area for a Product than were last offered to Orion,
unless Orion is first offered the opportunity to consider and accept the
same. Orion shall have thirty (30) days to accept or reject such offer by
written notice to Hormos and failure to accept or reject within such
period shall be deemed to be a waiver by Orion of its rights under this
clause 7.3.5 with regard to the Product concerned only.
8. PRIOR AGREEMENTS BETWEEN TESS AND ORION AND MUTUAL RELEASES
8.1 By the stipulation in Tess Agreement, The Chemistry Agreement between Tess
and Orion was terminated and was thereafter of no force or effect.
8.2 Based on the Tess Agreement, Orion was released from any obligation to
Tess under clause 3.1. of the Research Agreement between Tess and Orion
dated January 1st 1996 including the invoice of January 30, 1997 for USD
180.000 and any other amounts which might otherwise be owed under the
Research Agreement, for which credit is hereby issued and is also released
from all obligations under the Chemistry Agreement, between Tess and Orion
dated March 1st 1996.
By the stipulation in Tess Agreement Tess and Orion released and forever
discharged each other from any and all claims, demands, causes of action,
obligations, damages, liabilities of any nature whatsoever, whether or not
now known, suspected or claimed, which either ever had, now has or may
claim to have against the other, arising out of the Research Agreement or
the Chemistry Agreement.
Hormos recognizes on its behalf the mutual releases of Tess and Orion
mentioned afore.
9. SHARES TO THE TRIPHENYLETHYLENES INVENTION
9.1 As stated above, by means of written assignments and the laws of
Finland, Orion has acquired all the rights, title and interests of Dr.
******, Dr. ******, Dr. ****** and Dr. ******, whereas Hormos has acquired
all the rights, title and interests of Dr. ****** and Dr. ****** in the
invention described in Triphenylethylenes Patent and any corresponding
patent applications and any patents resulting therefrom.
Hormos hereby warrants that it shall give its consent to the assignment of
the rights of Dr. ****** to Orion with regard to Triphenylethylenes
invention, if Dr. ****** and Orion will reach a written consensus of the
terms and conditions of such an assignment, provided that Orion shall
simultaneously grant Hormos equivalent rights as are the transferred from
Dr. ****** without any additional costs. Any agreement between Dr. ******
and Orion shall be subject to separate written agreement between Orion and
*****, if any, and Orion shall have no obligation, express or implied,
to enter into any agreement with ******. ****** shall not be deemed an
intended beneficiary hereunder.
10. RIGHT TO EARLIER TERMINATION
10.1 Either of the Parties shall have the right without prejudice to any other
rights or remedies or other
12
relief available to it, to terminate this Agreement forthwith for cause by
written notice to the Party in any of the following events:
(a) If the other Party becomes insolvent, is adjudged bankrupt applies for
judicial or extra-judicial settlement with its, creditors, makes an
assignment for the benefit of its creditors, voluntarily files for
bankruptcy or has a receiver or trustee (or the like) in bankruptcy
appointed by reason of its insolvency, or in the event an involuntary
bankruptcy action is filed against the other Party and not dismissed
within ninety (90) days, or if the other Party becomes the subject of
liquidation or dissolution proceedings or otherwise discontinues business.
(b) If the other Party breaches any of the material terms or conditions of
this Agreement and the defaulting Party shall fail to fully cure, or have
taken appropriate action to cure such breach within thirty (30) days of
receipt of written notice from the Party asserting the breach, except in
the event of non-payment by Hormos of any royalties or other amounts
payable to Orion hereunder, in which case the cure period shall be fifteen
(15) days from Orion's written notice of payment delinquency.
(c) If the Product is not commercialized (launched) in the U.S.A., Germany,
the United Kingdom and France before 31.12.2015, Orion has a right to
terminate this Agreement with immediate effect.
(d) If Hormos, its Affiliated Company or sublicensee decides to discontinue
permanently the development and/or registration of the Product for all
indications, Hormos shall inform Orion in writing thereof within thirty
(30) days from such decision, and Orion shall have the right to terminate
this Agreement upon thirty (30) days prior written notice thereof to
Hormos.
10.2 Termination or expiration of this Agreement, for whatever reason, shall be
without prejudice to any rights, claims or obligations of either Party
which may have accrued prior to, or become due at the date of such
termination.
11. FORCE MAJEURE
11.1 Neither Party shall be held in breach of this Agreement for any
performance required of it to the other hereunder to the extent and for
the duration of time the same is prevented in whole or in part by reason
of force majeure.
11.2 The Party so affected shall give prompt written notice to the other Party
of the nature and date of commencement of the force majeure and expected
duration.
11.3 The Party so affected shall also use its reasonable efforts to avoid or
remove the force majeure to the extent it is so able to do.
12. SEVERABILITY OF CLAUSES
In case one or more of the provisions contained in this Agreement shall,
for any reason, be held invalid, illegal or unenforceable in any respect,
such invalidity, illegality or unenforceability shall not affect any other
provisions of this Agreement, but this Agreement shall be construed by
limiting such invalid, illegal or unenforceable provision, or, if such is
not possible, by deleting such provision from this Agreement.
13. ASSIGNMENT
13
This Agreement is deemed personal to Hormos and Orion. Therefore, neither
Party shall, without the prior written consent of the other, assign this
Agreement or any of its rights hereunder, nor delegate any of its duties
or obligations hereunder without the prior written consent of the other,
except that Orion and Hormos shall have the right to assign this
Agreement, Patents or Patent Applications to any of their Affiliated
Companies upon an undertaking by the assignee, in writing, to be bound by
the terms of this Agreement. A party agrees not to unreasonably withhold
its consent if such an assignment is contemplated in connection with the
sale or merger by a Party of all or substantially all of its assets to a
third party provided the non-assigning Party receives and accepts such
written assurances of continued performance and commitments from the
assignee under this Agreement as it may reasonably require prior to such
an assignment becoming effective. Any assignment or delegation in
derogation of this provision shall be deemed null and void.
14. DISPUTE RESOLUTION
14.1 This Agreement is acknowledged to have been made in and shall be
construed, governed, interpreted and applied in accordance with the laws
of Finland, without giving effect to its conflict of laws provisions.
14.2 In the event of any controversy, claim, or dispute arising out of or
relating to any provisions of this Agreement, the Parties shall try to
settle those conflicts amicably between themselves within ninety (90) days
of either Party's request for amicable settlement negotiations. Should the
Parties fail to so settle then the matter in dispute shall be finally and
exclusively settled by binding arbitration procedure.
The Parties hereto hereby agree that all disputes arising out of or in
connection with this Agreement (except those involving actions commenced
by or involving third parties and affecting or involving only one of the
other Parties to this Agreement), shall be finally and exclusively settled
by arbitration under the Rules of the Arbitration of the Central Chamber
of Commerce in Finland in accordance with said Rules and with such
proceedings to be held in Helsinki, Finland in Finnish language.
Judgement upon the award rendered by arbitration may be issued and
enforced by any court having competent jurisdiction.
15. TERM OF AGREEMENT
15.1 This Agreement shall commence as of the Date of Agreement first
hereinabove entered and remain in effect for the Term, unless sooner
terminated as provided herein.
15.2 This Agreement may also be earlier terminated or modified according to
other provisions as set out herein.
16. INDEPENDENT CONTRACTOR STATUS OF PARTIES
Orion's and Hormos' status under the business arrangement established by
this Agreement is solely that of independent contractors, not as partners,
joint ventures or the like.
Unless otherwise specifically agreed herein or to the extent specifically
agreed by the Parties in a separate writing, neither Party has any
authority whatsoever to act as an agent or representative of the other,
nor has either any authority or power to contract, or create or assume any
obligation or
14
liability in the other's name, on behalf of the other or otherwise bind
the other in any way for any purpose nor shall either Party hereto
represent to any third parties it possesses any such authority to bind the
other Party.
17. REPRESENTATIONS AND WARRANTIES
17.1 Each Party hereby represents and warrants to the other Party as follows:
(a) It is a corporation duly organized and validly existing under the laws of
the state or other jurisdiction of incorporation or formation;
(b) It has the power and authority to execute and deliver this Agreement, and
to perform its obligations hereunder;
(c) No authorization, consent or approval of any governmental authority or
third party is required for the execution by it of this Agreement, and the
execution of this Agreement will not violate any law, rule or regulation
applicable to such Party.
17.2 Orion gives no warranties and makes no representation whatsoever, express
or implied regarding the Orion Patent Rights or the validity thereof, or
regarding the fitness, suitability or usefulness of any Orion
Documentation or Confidential Information for any purpose whatsoever, or
regarding any other matter, and any representation or warranty, express or
implied, by or on behalf of Orion which is not set forth in writing
herein, is expressly disclaimed. For the avoidance of doubt, Orion shall
neither, itself or its Affiliated Companies, have any obligations to
defend any Patents or Patents Applications, nor compensate for or
indemnify, defend or hold harmless Hormos, Hormos' Affiliated Companies or
Hormos' sublicensees or the sublicensees of Hormos' Affiliated Companies
against any Claim , third party infringement claim or other claim.
It is agreed by Hormos that it will solely assume all risk,
responsibility, and liabilities with respect to the Product(s) (in whole
and in part), Orion Patent Rights and Orion Documentation and use of
Confidential Information, which are the subject matter of this Agreement
and its activities under this Agreement (but not to the extent caused by
Orion or its subsidiaries, affiliates or their respective directors,
officers, employees, agents and shareholders). Hormos agrees to defend,
indemnify and hold Orion, its subsidiaries and affiliates, and its and
their directors, officers, employees, agents and shareholders (the "Orion
Indemnitees") harmless from and against any and all third party claims,
demands, costs, expenses, liabilities, damages law suits and other legal
actions of any kind whatsoever (including without limitation for personal
injury and/or death) arising out of Hormos', its Affiliates' and/or
licensees' research, development and commercialization, manufacture or use
by end-users of Products (including patent infringements and validity
related actions to the extent same concern Hormos' herein agreed rights to
Patents), , both during and after the Term of this Agreement, except to
the extent caused by Orion's or any of its subsidiaries', affiliates' or
their respective directors', officers', employees', agents' and
shareholders' negligence or willful misconduct under, or breach of, this
Agreement (a "Claim"). Hormos agrees to contractually require its
Affiliated Companies and licensees to also so indemnify, defend and hold
harmless each of the Orion Indemnitees.
Orion agrees to defend, indemnify and hold Hormos, its subsidiaries and
affiliates, and its and their directors, officers, employees, agents and
shareholders (the "Hormos Indemnitees") harmless from and against any and
all claims by third parties for costs, expenses and liabilities arising
out of
15
Orion's negligence or willful misconduct under, or breach of, this
Agreement, except to the extent caused by Hormos, its subsidiaries,
affiliates or licensees or their respective directors, officers,
employees, agents and shareholders (a "Claim").
In the event that either party is seeking indemnification under this
Section (the "Indemnified Party"), it shall inform the other party (the
"Indemnifying Party") of a Claim as soon as reasonably practicable after
it receives notice of the Claim, shall permit the Indemnifying Party to
assume direction and control of the defense of the Claim (including the
right to settle the Claim solely for monetary consideration), and shall
reasonably cooperate as requested in the defence and settlement of the
Claim at the Indemnifying Party's expense. The Indemnified Party shall not
voluntarily make any payment or incur any expense in connection with any
claim or suit without the consent of the Indemnifying Party, provided that
if the Indemnifying Party does not assume direction and control of the
defence of the Claim, the Indemnified Party may assume direction and
control of the defence of the Claim and, if successful, shall be
reimbursed by the Indemnifying Party for reasonable costs, actually
incurred, in connection with such defence.
In no event shall either party be liable for or have any obligation to
compensate or indemnify the other party, its Affiliated Companies or any
of its or their licensees or any other third party (or any director,
officer, employee, agent or shareholder of the foregoing) for any
punitive, indirect or consequential damages claimed by such party, its
Affiliated Companies or any of its or their sublicensees (or any director,
officer, employee, agent or shareholder of the foregoing), including, but
not limited to, any loss of opportunity, loss of use, loss or revenue or
loss of profit, in connection with or arising out of or relating to this
Agreement or any breach thereof.
18. NON-WAIVER CLAUSE
The failure by any Party at any time to enforce any of the terms or
provisions or conditions of this Agreement or exercise any right hereunder
shall not constitute a waiver of the same or affect that Party's rights
thereafter to enforce or exercise the same.
No waiver of any of the provisions of this Agreement shall be deemed
binding unless executed in writing by the Party to be bound by it.
19. MISCELLANEOUS
19.1 No amendment or modification of this Agreement will be deemed legally
binding unless in writing and signed by duly authorized officers both
Parties hereto.
19.2 This Agreement constitutes the entire Agreement of the Parties relating to
the subject matter hereof, and all prior agreements, representations and
understandings, are merged into and superseded hereby.
19.3 Any notices required or permitted under this Agreement shall be sent by
prepaid registered mail, telex, or by telefax and shall be deemed
delivered if sent to the following address of the respective parties or
such other address as is furnished by such notice to the other party.
Notices to Orion shall be sent to: Orion Corporation
X.X. Xxx 00
XXX-00000 Xxxxx, Xxxxxxx
Telefax: 358 9 4293600
Telex. 124721 orion fi
(phone 0000 0000)
16
Notices to Hormos shall be sent to: Hormos Medical Corporation
PharmaCity, Itainen Xxxxxxxxx 0
XXX-00000 Xxxxx, Xxxxxxx
Telefax: 358 2 410 8001
19.4 This Agreement is executed in duplicate originals, one retained by each
party hereto.
20. HEADINGS
The headings in this Agreement may not be used in the interpretation of
any provisions hereof.
In witness hereof, the Parties hereto have executed this Agreement as, of the
day and year first written above.
SIGNATURES
ORION CORPRATION ORION PHARMA
Signatures /s/ Xxxx Xxxxxxxxxxx /s/ Hannu Wennonen
-------------------- -------------------
Name Timo Xxxxxxxxxxx Xxxxx Wennonen
Title Senior Vice President Director
Place and date Espoo 31/10 2005 Xxxxx 00/00 0000
XXXXXX MEDICAL CORPORATION
Signatures /s/ Xxxxx Xxxxxxxxxxxx
Name Xxxxx Xxxxxxxxxxxx
Title Managing Director
Place and date Turku 14/10 2005
17
Appendix A
TITLE ********
INVENTORS **********
**********
PRIORITY ****
Filing date Xxx.Xxxx
Country dd.mm.yy Appln. No. Patent no. dd.mm.yy
Australia **** **** **** ****
Canada **** ****
EPO **** **** **** ****
Finland **** ****
Israel **** **** **** ****
Japan **** ****
Norway **** ****
New Zealand **** **** **** ****
PCT **** ****
USA **** **** **** ****
USA **** **** **** ****
South Africa **** **** **** ****
The EPO Patent is registered in the following countries:
AT, FR, GR, GB, PT, SE, ES, DE, NI, DK, IE, IT, BE, CH, MC, LU
EP Publication No: *****
18
Appendix B
TITLE ******
INVENTORS ************
PRIORITY ******
STATUS ON THE DATE OF SIGNING THE AGREEMENT
FILING DATE
COUNTRY dd.mm.yy APPL. NO PATENT NO EXP. DATE
Australia **** **** **** ****
Canada **** **** **** ****
EPO **** **** **** ****
Japan **** **** **** ****
New Zealand **** **** **** ****
Patent Cooperation **** **** **** ****
USA **** **** **** ****
The EPO patent is registered in following countries:
Austria, France, Greece, Great Britain, Portugal, Spain, Germany, Netherlands,
Denmark, Ireland, Italy, Belgium, Switzerland, Monaco, Luxembourg, Finland,
Slovenia
EP Publication No: ******
19
