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EXHIBIT 10.11
ENGLISH TRANSLATION (the French text shall prevail)
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PATENT LICENSE AGREEMENT
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BETWEEN
THE REGION WALLONNE
Represented by Xx. Xxxx-Xxxxxx XXXXX Secretary of Research, Technological
development, Sport and International relations, Xxx xx xx Xxx, 00 - 0000-
XXXXXXXX,
Hereafter the "REGION",
THE UNIVERSITE CATHOLOIQUE DE LOUVAIN
Represented by Mr. Marcel CROCHET, Xxxxxx and by the Lecturer Xxxxx XXXXXX,
Xxxxx xx x'Xxxxxxxxxx, 0 - 0000 - XXXXXXX-XX-XXXXX,
Hereafter the "UNIVERSITY",
AND
The societe anonyme XXXXXXX PHARMACEUTICAL BELGIUM to be incorporated
Represented by Xx. Xxxxxx X. XXXXXXX, President and Chief executive Officer of
the American company XXXXXXX PHARMACEUTICAL, 000, Xxxxxxxxxx Xxxxxx, xxxxx 000,
XXXX XXXX, XX 00000-0000, future member of the board of directors of the societe
anonyme XXXXXXX PHARMACEUTICAL BELGIUM to be incorporated and which shall have
its registered office, Carnoy Building C 461, place Xxxxx xx Xxx, 0 - 0000 -
XXXXXXX-XX-XXXXX.
Hereafter the "COMPANY",
WHEREAS:
1. The REGION has filed a belgian patent application n(Degree) 09400752 on
August 19, 1994.
2. The UNIVERSITY has filed a Belgian patent application n(Degree)
09400751 on August 19, 1994.
3. The REGION and UNIVERSITY have filed a P.C.T. patent application
n(Degree) PCT/BE95/00076, on August 21, 1995, for the above mentioned
patents and for the following countries: Kenya, Malawi, Soudan,
Swaziland et Ouganda, Autriche, Belgique, Suisse + Liechtenstein,
Allemagne, Danemark, Espagne, France, Grande-Bretagne, Grece,
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Irlande, Italie, Luxembourg, Monaco, Pays-Bas, Portugal, Suede,
Burkina-Faso, Benin, Republique Centrafricaine, Congo, Cote d'Ivoire,
Cameroun, Gabon, Guinee, Mali, Mauritanie, Niger, Senegal, Tchad, Togo,
Armenie, Australie, Barbade, Bulgarie, Bresil, Belarus, Canada, Chine,
Republique Tcheque, Estonie, Finlande, Georgie, Hongrie, Islande,
Japon, Kenya Kirghizistan, Republique Populaire Democratique de Coree,
Republique de Coree, Kazakhstan, Sri-Lanka, Liberia, Lituanie,
Lettonie, Republique de Moldova, Madagascar, Mongolie, Mexique,
Norvege, Nouvelle-Zelande, Pologne, Roumanie, Federation de Russie,
Singapour, slovenie, Slovaquie, Tadjikistan, Turkmenistan, Trinite et
Tobago, Ukraine, Etats-Unis d'Amerique, Ouzbekistan, Viet-nam et
Republique de Macedoine.
4. The COMPANY wishes to establish itself on the territory of the REGION
WALLONNE to undertake the research and the manufacturing of SUPERLEUDOX
and other products.
CONSEQUENTLY IT IS HEREBY AGREED AS FOLLOWS:
ARTICLE 1: DEFINITIONS
In this agreement, the following words shall bear the following meanings:
1.1. PATENTS: The patents applications n(Degree) 09400751
and n(Degree) 09400752, filed respectively
by the UNIVERSITY and the REGION.
1.2. THE EXTENSION: The PCT extension application for Belgian
patents n(Degree) 09400751 and 09400752,
filed on August 21, 1995, with n(Degree)
PCT/BE95/00076 for the countries mentioned
in the 3rd point of the preamble of the
present agreement.
1.3. SUPERLEUDOX: A "prodrogue" of the DOXORUBICINE which
requires, for a therapeutic and/or
diagnostic application, the implementation
of the PATENTS and the EXTENSION.
1.4. OTHER PRODUCTS: All antitumour "prodrogues", which
properties are initiated by cancerous cells
and which requires, for therapeutic and/or
diagnostic application, the implementation
of the PATENTS and the EXTENSION.
1.5. TURNOVER: Any gross receipt received by the COMPANY or
by a sub-licensee less the reimbursements
for returned goods, commercial discount, VAT
and other taxes on sale and less
commissions, insurance costs, freight
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and clearance charges, or any other costs
directly linked to the sales taken into
account.
1.6. TRADE SECRETS: All trade secrets, commercial know how and
similar information owned or controlled by
the UNIVERSITY or the REGION pertaining to
the PATENTS or to the EXTENSION or the
production or sale of SUPERLEUDOX or the
other PRODUCTS.
1.7. PRE COMMERCIALIZATION: Stage preceeding the commercialization of
SUPERLEUDOX and/or of the other products
after release from laboratory and enabling
to define the parameters to be taken into
consideration for the manufacturing and
commercialization of these products on a
wide scale.
ARTICLE 2: OWNERSHIP OF THE PATENTS
The REGION and the UNIVERSITY are the owners of the PATENTS and the EXTENSION
defined in articles 1.1 and 1.2..
No license has yet been granted on these PATENTS which are clear of any
security, pledge or charge whatsoever.
ARTICLE 3: LICENSE
The REGION and the UNIVERSITY grant the company an exclusive world license to
produce, have produced, use and sell SUPERLEUDOX and other products.
This exclusivity can be opposed to the REGION and the UNIVERSITY.
The license applies to all the applications of the invention described in the
PATENTS and the EXTENSION which on the object of this contract and to the
applications implicitly connected with the PATENTS and the EXTENSION, on a
therapeutic as well as on a diagnostic level.
The REGION and the UNIVERSITY grant the COMPANY the exclusive use of the rights
deriving form the PATENTS and the EXTENSION, i.e., among others, trade secrets
mentioned in article 1.6, manufacturing secrets and results of the experiences
made during the elaboration of the PATENTS and the know-how related to them.
ARTICLE 4: CONTRIBUTION, ASSIGNMENT AND SUBLICENSE
4.1. The COMPANY shall refrain from bringing the license to a company or to
substitute a third party in its rights and obligations or to undertake
any assignment which would have the
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effect of transferring the whole of its rights and obligations to a
third party, without previous consent of the REGION and the UNIVERSITY.
4.2. The COMPANY is authorised to grant sub-licenses limited to the
commercialization or pre-commercialization of SUPERLEUDOX and OTHER
PRODUCTS.
4.3. In the same way, the COMPANY shall be authorized to grant sub-licenses
to subsidiaries or its parent company as long as this granting of
sub-licenses does not infringe any provision of the present contract
and that the company, benefiting from the sub-license, undertakes, in
writing, to respect the entirety of the commitments contained in the
present contract.
ARTICLE 5: OBLIGATIONS OF THE COMPANY TOWARDS THE REGION
The COMPANY undertakes, towards the region, to respect the following
obligations:
5.1. Operate or have operated, exclusively on the territory of the Region
Wallonne (provinces du Brabant wallon, du Hainaut, de Liege, de
Luxembourg et de Namur), the pre-clinical research and the clinical
research related to SUPERLEUDOX and OTHER PRODUCTS, except if the
company proves it impossible for technical and/or scientific reasons.
Operate or have operated, exclusively on the territory of the REGION
WALLONNE, the manufacturing of SUPERLEUDOX and other products.
Within the limits here above described, the COMPANY undertakes to
operate, on this territory, activities of a high technological level
and to employ to this effect local workforce.
The breach of these obligations entails the immediate payment, by the
company to the region, of an amount equal to the difference between
[ * ] BEF and the total of the amounts already paid in
accordance with articles 5.2 or 5.3.
The obligations described here above and at article 4, will come to an
end as soon as the company pays the REGION an overall amount of
[ * ], as provided in articles 5.2 and 5.3.
5.2. If the clinical tests on SUPERLEUDOX are positive, that is if a
medicine for human use can be finalized, the COMPANY undertakes:
5.2.1 to pay to the REGION the amount of [ * ] BEF, after a
delay of five years calculated from the date the present
agreement becomes effective.
5.2.2 to pay to the REGION annual royalties amounting to [ * ] of
the worldwide turnover pertaining to SUPERLEUDOX and other
PRODUCTS. These royalties are limited to a global amount of
[ * ] BEF.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
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5.3. If the clinical tests of SUPERLEUDOX cannot be realized or are
negative, which means that a medicine for human use cannot be
finalized, the COMPANY undertakes:
5.3.1. to pay to the REGION the amount of [ * ] BEF, after
a delay of five years calculated from the date the present
contract becomes effective.
5.3.2. to pay to the REGION annual royalties amounting to [*] of
the worldwide turnover pertaining to OTHER PRODUCTS. These
royalties are limited to a global amount of [ * ]
BEF.
5.4. The COMPANY shall make the payment mentioned in articles 5.2.2. and
5.3.2. after having received from the "Xxxxxxxx Regional de la Region
wallonne" an "invitation to pay".
The latter is sent each year, two months after the end of the financial
year of the COMPANY.
The COMPANY has to pay within a delay of fifteen days after the sending
by registered mail of the invitation to pay.
Any delay in payment renders automatically the COMPANY debtor of an
interest calculated on the legal rate increased by [ * ] per year, the
maturity of payment constituting notice.
ARTICLE 6: OBLIGATIONS OF THE COMPANY TOWARDS THE UNIVERSITY
The COMPANY undertakes, towards the UNIVERSITY, to respect the following
obligations:
6.1. to finance the future pharmacological research and future pre-clinical
tests pertaining to SUPERLEUDOX an OTHER PRODUCTS which should be
realized by Lecturer X. XXXXXX.
This obligation is submitted to the condition that a public aid on
these activities be granted to the UNIVERSITY. Nevertheless, the
present agreement does not form, in any way, a right to a public aid of
the REGION towards the UNIVERSITY or towards the COMPANY.
6.2. To pay to the UNIVERSITY annual royalties calculated on the turnover
pertaining to SUPERLEUDOX and OTHER PRODUCTS:
- [ * ] on the turnover realized in Europe;
- [ * ] on the turnover realized in United States, Canada and
Japan;
- a percentage to be defined in an agreement to be concluded
between the COMPANY and the UNIVERSITY for the turnover
realized elsewhere and which cannot exceed [ * ].
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
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These royalties have to be paid on the following bank account: [*].
The UNIVERSITY and the COMPANY shall precise their contractual relations in a
separate document.
Nevertheless, the clauses of the present agreement shall prevail on any other
stipulation if there is no written agreement on an eventual derogation.
ARTICLE 7: MAINTENANCE OF THE PATENT
The COMPANY undertakes towards the REGION and the UNIVERSITY to respect the
following obligations:
7.1. pay the annuities on the patents pertaining to SUPERLEUDOX and other
PRODUCTS;
7.2. pay the expenses related to the EXTENSION;
7.3. do the necessary formalities for the maintenance of the patents and
completion of the EXTENSION;
ARTICLE 8: PROTECTION OF THE PATENT
8.1 Each party will immediately inform the other parties of any
infringement or breach by third parties to the PATENTS or the EXTENSION
of which it would be informed.
The REGION, the UNIVERSITY and the COMPANY will decide together of the
judicial or extra judicial measures to be taken.
In case of inaction of the REGION or the UNIVERSITY, the COMPANY may
bring an action against the counterfeiter or any other proceeding
judged necessary.
8.2 The UNIVERSITY and the REGION undertake to assist the COMPANY, among
others, by informing the COMPANY of any element or information useful
to reinforce its means of defense. They shall join, by way of voluntary
intervention, the action brought by the COMPANY or shall take part in
the negotiation if the COMPANY asks them to do so.
8.3 Any costs or fees payed during a procedure against the COMPANY or a
negotiation, aiming to protect the PATENTS or the EXTENSION against any
breach whatsoever, shall be borne by the COMPANY.
The same shall apply to the costs linked to an eventual procedure of
voluntary intervention requested by the COMPANY.
Any damages obtained shall only benefit to the COMPANY.
Any damages to be paid shall entirely be paid by the COMPANY.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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ARTICLE 9: GUARANTEE AGAINST THIRD PARTIES
9.1 The REGION and the UNIVERSITY guarantee the COMPANY that no
counterfeiting action against the EXTENSION and the PATENTS is
currently pending.
9.2 If the use of the PATENTS or the EXTENSION should lead the COMPANY or
the sub-licencees to be sued as counterfeiters, the costs and fees
exposed for their defense and the payment of eventual damages shall be
borne by the COMPANY and the sub-licencees.
The same shall apply to costs and fees linked to a counterclaim or a
compromise, the sums eventually obtained in these last two cases shall
only benefit to the COMPANY and the sub-licencees.
9.3 The COMPANY shall immediately inform the REGION and the UNIVERSITY of
any lawsuit or notice filed against it and shall then give them the
possibility to intervene in the dispute and/or in the lawsuit in which
it would be implied for whatever reason.
9.4 The COMPANY shall be free - if no amicable settlement is found between
the parties - to put an end to the contract if no judicial decision is
rendered as long as two patent attorneys - one being chosen by the
COMPANY and the other by the REGION and the UNIVERSITY - give a joint
advice according to which the use of the PATENTS or the EXTENSION
constitutes an infringement of the patent rights of a third party.
ARTICLE 10: IMPROVEMENTS
10.1. The REGION and the UNIVERSITY undertake to communicate to the COMPANY
and to put at its disposal any modification or improvement brought to
the PATENTS or the EXTENSION during the length of the present
agreement, without it resulting, for the COMPANY in an increase of the
royalties and to grant, if need be, a license free of charge to the
COMPANY.
10.2. The modifications and improvements brought by the COMPANY do not
require any authorization. The company shall, however, inform the
UNIVERSITY and the REGION.
If inventions of applications or improvements realised by the COMPANY
are patentable and are, according to the applicable law, likely to be
patented because they are sufficiently different from the PATENTS, the
COMPANY shall patent them in accordance with the international
conventions applicable in the field of patents.
The COMPANY is under no obligation whatsoever to assign, neither in
whole nor in part, to the UNIVERSITY or the REGION neither its rights
pertaining to patents mentioned in the previous paragraph, nor its
right to such patents.
The COMPANY shall nevertheless grant the UNIVERSITY a non-exclusive
licence on these patents, free of charge, in order to enable the latter
to carry on its scientific research.
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The UNIVERSITY shall however refrain from publishing or evaluating the
patents in a way that could harm the patents filed by the COMPANY.
10.3. The parties will exchange the experience acquired through the research
and the exploitation linked to the license and shall grant each other
licenses for the inventions resulting from the improvements or from the
application of the patents and the EXTENSION.
ARTICLE 11: VERIFICATION OF THE ACCOUNTS
The COMPANY undertakes to keep special account books on which it mentions the
number and the prices of the sales linked to SUPERLEUDOX and OTHER PRODUCTS, as
well as any other indication of interest for the calculation of the royalties.
The REGION and the UNIVERSITY are authorized to have these account books
verified by a chartered accountant of their choice, approved by the COMPANY.
The detailed account of the royalties shall be drawn up yearly.
ARTICLE 12; REGISTRATION OF THE LICENSE
The REGION and the UNIVERSITY shall register the license and pay the costs
resulting form this registration.
ARTICLE 13: OBLIGATIONS OF THE REGION AND THE UNIVERSITY
13.1. The REGION and the UNIVERSITY garantee:
- that the result of the PATENTS and the EXTENSION can be
obtained with the means and process described;
- the COMPANY against conception defects of the invention that
would make the PATENTS and the EXTENSION impossible to use;
On the contrary, the REGION and the UNIVERSITY guarantee neither the
result of the pre-clinical and clinical research nor the technical and
commercial value of the PATENTS and the EXTENSION.
The results and risks of the industrial and commercial exploitation of
the results of the research are exclusively borne by the COMPANY.
13.2. The REGION and the UNIVERSITY shall provide the COMPANY with any
document and information necessary to use the PATENTS and the
EXTENSION.
They shall also provide the COMPANY with the technical assistance
requested, the necessary and useful advise and shall transfer to it the
know how linked to the PATENTS and the EXTENSION.
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ARTICLE 14: LENGTH OF THE AGREEMENT
The present agreement shall only come into force when the suspensive condition
mentioned in article 15 is completed.
The agreement shall terminate after the expiration of the protection of the
PATENTS, the EXTENSION and the patents filed in application of article 10 of the
present contract.
ARTICLE 15: SUSPENSIVE CONDITION
The present agreement is submitted to the following suspensive condition:
- incorporation of a Belgian societe anonyme, subsidiary of the
American company XXXXXXX PHARMACEUTICAL. This incorporation depends on
investments to be made by third parties to XXXXXXX PHARMACEUTICAL.
If this condition is not fulfilled within three months of the signature of the
present agreement, the latter shall be considered as void and non existent,
without any costs for the parties.
ARTICLE 16: TERMINATION
16.1. The present agreement is automatically terminated and without prior
notice in case of bankruptcy, liquidation or bankrupt's certificate.
16.2. The present agreement can also be terminated by the REGION or the
UNIVERSITY in case of non commercialization of the licence by the
COMPANY or insufficient commercialization, after a first
commercialization.
By non commercialization of the license is meant: stoppage of all
pre-clinical or clinical research related to SUPERLEUDOX and other
products except if this research has been brought to an end and that
the commercialization of the products is about to be set up.
By insufficient commercialization is meant: a commercialisation which,
during the first five years following the beginning of the
commercialization of SUPERLEUDOX or other products, would give rise to
payments of amounts inferior to [ * ] BEF, for the royalties
provided for in points 5.2 and 5.3 to be paid to the REGION and to the
payment of amounts inferior to [ * ] BEF for royalties provided
for in point 6.2, to be paid to the UNIVERSITY. This termination does
not give, in any case, a right to reimbursement of the amounts already
paid by the COMPANY.
16.3. The COMPANY can terminate the present agreement by sending a registered
mail if the PATENT or the EXTENSION are not granted, are declared void
or depend on a previous invention already patented.
The royalties already paid nevertheless remain the property of the
REGION and the UNIVERSITY.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
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16.4. After an end has been put to the present agreement, the REGION and the
UNIVERSITY are free to grant to anyone a license relating to the
PATENTS and the EXTENSION.
ARTICLE 17: NOTICES
Any mail exchanged within the framework of the present agreement is to be sent:
- For the REGION:
DIRECTION GENERALE DES TECHNOLOGIES, DE LA RECHERCHE ET DE L'ENERGIE
Avenue Prince de LIEGE, 7,
5100 JAMBES.
- For the UNIVERSITY:
UNIVERSITE CATHOLIQUE XX XXXXXXX
Xxxxx xx x'Xxxxxxxxxx, 0,
0000 XXXXXXX-XX-XXXXX.
- For the COMPANY:
XXXXXXX PHARMACEUTICAL, 000 Xxxxxxxxxx Xxxxxx, xxxxx 000, XXXX XXXX-XX
00000-0000 and as soon as the company is incorporated, to its registered office.
ARTICLE 18: CONFIDENTIALITY
The parties undertake to maintain confidential any information or document
exchanged during the present agreement and this for the whole duration of the
agreement.
ARTICLE 19: ENTIRE AGREEMENT
The present agreement constitutes the entire agreement between the parties.
It supersedes and cancels all previous undertakings, written or verbal
agreements having the same object.
It cannot be modified except by a written agreement signed by the parties.
ARTICLE 20: INVALIDITY
Any article of the present agreement that threatens public order or infringes a
mandatory statute or regulation shall be considered as non written. Its nullity
shall however not affect the validity of the agreement as a whole.
On the contrary, the parties shall endeavour to replace the void article by a
clause with equivalent economical effect.
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ARTICLE 21: DISPUTES
This agreement shall be governed by the laws of Belgium.
Any claim arising from or in connection with this agreement shall be submitted
to the exclusive jurisdiction of the Courts of Brussels.
Signed on ... (date), in ... (place), in six copies.
POUR LA REGION
Menslem Xxxx-Xxxxxx XXXXX,
Ministre de la Recherche, du Developpement technologique,
du Sport et des Relations internationales
POUR L'UNIVERSITE
Monsieur Marcel CROCHET Monsieur Xxxxx XXXXXX
Recteur Professeur
POUR L'ENTREPRISE
Xx. Xxxxxx X. XXXXXXX
future member of the board of directors of the company
* Signatures are found on the French version of this Agreement,
dated March 15, 1996.
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I, Xxxxxxx X. Xxxxxx, hereby certify that the above Exhibit is a fair and
accurate French to English translation.
/s/ XXXXXXX X. XXXXXX
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Xxxxxxx X. Xxxxxx
Vice President and Chief Financial Officer
December 23, 1996
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