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 ▇▇▇▇▇▇▇▇▇ ▇, ▇▇▇-▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇.
(hereinafter "Hormos")
and
ORION CORPORATION
ORION PHARMA
a corporation duly organized and existing
under the laws of the Republic of Finland,
located at ▇▇▇▇▇▇▇▇▇▇ ▇, ▇.▇. ▇▇▇ ▇▇, ▇▇▇-▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇▇▇
(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 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ 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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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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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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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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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 sublicensee.
6.2.4 A one time payment of **** EURO **** within thirty days of the NDA
approval issued by the FDA, or any approval issued by any other regulatory
authority in any country or territory of the world, allowing commercial
marketing or sale of any Product.
6.2.5 Hormos shall be responsible for above mentioned (i-iii) payments
regardless of whether the respective 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 sublicensee..
6.3 Royalties. Hormos shall pay to Orion a running royalty of **** per cent
(****) of all Net Sales for Product(s) in any country of the world sold by
Hormos, any Affiliated Company of Hormos, 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(s) to patients.
6.4 For the avoidance of doubt, for each Product the Net Sales shall be
calculated only once for the first sale of such Product by either Hormos
or its Affiliated Company or sublicensee to a customer.
Hormos shall keep 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. Hormos shall allow and arrange Orion to audit its
own or its Affiliated Company's and/or sublicensees' records and books of
account for correctness of royalty payments and Net Sales, if requested
and at the auditing party's expense.
6.5 All payments, once made, shall be non-refundable.
7. COLLABORATION AND ORION'S RIGHT OF FIRST REFUSAL
7.1 In further consideration for the rights granted to Hormos hereunder Hormos
hereby
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grants, and as necessary shall cause its Affiliated Companies and
sublicensees to grant, to Orion a right of first refusal (ROFR) to become
the exclusive importer, market seller and 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).
7.2 Orion's ROFR shall be exercised as follows:
7.2.1 Promptly after the final report for phase II clinical results sufficient
for obtaining the Proof of Concept are available, Hormos will inform Orion
on a confidential basis of said results and status and plans of the
development of any Product. 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.
7.2.2 If Orion has indicated its positive interest in the Product, then, not
later than sixty (60) 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").
7.2.3 Within thirty (30) days from the receipt of the Heads of Agreement
pursuant to clause 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 concerning the Product
("License Agreement"). If Orion indicates in writing that it is
interested in engaging in good faith negotiation on a License Agreement
based on the Heads of Agreement, then Orion and Hormos shall negotiate
exclusively with each other on 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 right subject to Orion's ROFR to a third party.
7.2.4 Notwithstanding what is stated above, for a period of twelve months (12)
after the expiration of Negotiation Period, Hormos shall not offer or
grant any more favorable terms to any third party marketing and/or
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 with regard to the Product
concerned.
8. WARRANTIES
Each Party hereby represents and warrants to the other Party as follows
that it is a
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corporation duly organized and validly existing under the laws of Finland
and that it has the power and authority to execute and deliver this
Agreement, and to perform its obligations hereunder;
Even though the intention of Hormos is to develop at least one of the
compounds included in the Invention to a Product, it is acknowledged by
Orion that Hormos is not under obligation to do so. Hormos gives no
warranties and makes no representation whatsoever, express or implied
regarding achievement of results in the development of a Product, or
regarding the patentability, fitness, suitability or usefulness of any
result for any purpose, and any such representation or warranty by or on
behalf of Hormos that is not expressly stated herein, is disclaimed.
Orion gives no other warranties and makes no representation whatsoever,
express or implied.
9. INDEMNIFICATION
Hormos shall indemnify, defend and hold Orion and its Affiliated
Companies, and its and their directors, officers, employees and agents
harmless from and against any and all third party claims related to the
infringement of intellectual property rights or product liability for
pharmaceutical products marketed by Hormos. Nevertheless, the
indemnification set forth herein shall not be interpreted as an indemnity
by Hormos in respect of claims and suits for injury and damages caused by
the negligence, or wrongdoing of Orion or its employees, agents or
Affiliated Companies.
10. TERM AND PREMATURE TERMINATION
10.1 This Agreement shall remain in effect for the Term, unless sooner
terminated as provided for herein.
10.2 Either of the Parties shall have the right without prejudice to any other
rights or remedies or other relief available to it, to terminate this
Agreement forthwith for cause by thirty (30) days written notice to the
other Party if the other Party breaches any of the material terms or
conditions of this Agreement and the defaulting Party fails 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.
11. ASSIGNMENT
This Agreement is deemed personal to Orion and Hormos. 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
Party, provided further that such consent shall not be required 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
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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.
12. NON-WAIVER
Either Party's failure to exercise or enforce any right conferred upon it
hereunder shall not be deemed to be a waiver of any such right unless
specifically so stipulated or operate to bar the exercise of performance
thereof at any time or times thereafter, nor shall its waiver of any right
hereunder at any given time, including rights to any payment, be deemed a
waiver thereof for any other time.
13. SEVERABILITY
In case any provision of this Agreement shall be invalid, illegal or
unenforceable due to the legislation of Finland or the European Union,
such invalidity, illegality or unenforceability shall not affect any other
provision hereof. The Parties shall negotiate in good faith in order to
agree the terms of a mutually satisfactory provision to be substituted for
the provision which is invalid, illegal of unenforceable and which as
nearly as possible validly gives effect to the Parties' intentions as
expressed herein.
14. HEADINGS
All section headings in this Agreement are for convenience only and shall
not in any way affect the meaning or interpretation of the Agreement.
15. ENTIRE AGREEMENT AND AMENDMENTS
This Agreement, together with all Appendices hereto, represents the full
and complete understanding and agreement of the Parties pertaining to the
subject matter hereof and prevails over all statements, clauses or
conditions which may be contained in any other form or document. No
modifications and amendments to this agreement shall be valid unless made
in writing and signed by duly authorized representatives of Orion and
Hormos.
16. NOTICES
Notices provided hereunder and concerning validity or term of this
Agreement are to be given by either Party to the other shall be in writing
and shall be given in person or be prepaid registered mail to the
respective addresses or to such other addresses as the Parties may
hereafter communicate to each other in writing.
Notices to Orion shall be sent to: Orion Corporation
▇.▇. ▇▇▇ ▇▇
▇▇▇-▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇
Telefax: 358 9 4293600
Telex. 124721 orion fi
(phone ▇▇▇ ▇▇▇▇▇)
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Notices to Hormos shall be sent to: Hormos Medical Corporation
PharmaCity, Itainen ▇▇▇▇▇▇▇▇▇ ▇
▇▇▇-▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇
Telefax: 358 2 410 8001
17. DISPUTE RESOLUTION
17.1 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.
17.2 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 Board 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.
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18. SIGNATURES
In witness hereof, the Parties hereto have executed this Agreement as, of
the day and year first written above.
ORION CORPORATION ORION PHARMA
Signatures /s/ A W /s/ Hannu Wennonen
------------------ ------------------
Name ▇.▇. ▇▇▇▇▇ Wennonen
Title Director, BD and Disc.
Place and date Espoo 25.3 2004 Espoo 22.3 2004
HORMOS MEDICAL CORPORATION
Signatures /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇
----------------------
Name ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇
Title Chief Executive Officer
Place and date Turku 17.3 2004
List of Appendices:
Appendix 1: Attachment to the notification for invention describing the
molecules of the invention, dated July 29 1997.
Appendix 2: Patent text of granted US patent no ****
Appendix 3: Claims of the approved divisional patent application no ****
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Appendix 1
*The content of this exhibit has been redacted pursuant to a confidential
treatment request.
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Appendix 2
* The content of this exhibit has been redacted pursuant to a confidential
treatment request
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Appendix 3
* The content of this exhibit has been redacted pursuant to a confidential
treatment request
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