[ * ] CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS
BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED
BY AND BETWEEN
The CENTRE NATIONAL DE RECHERCHE SCIENTIFIQUE,
a scientific and technological public establishment, having a registered office
at 0 xxx Xxxxxx-Xxxx - 00000 XXXXX Cedex 16 - France, represented by its
General Manager, Mrs. Xxxxxxxxx XXXXXXXXXX, hereafter referred to as “CNRS”,
acting on its own name and on behalf of:
• the “Centre d’Etudes
d’Océanographie et de Biologie Marine”, Unité Propre de Recherche CNRS
n° 9042, CNRS- Station Biologique, XX 00, Xxxxx Xxxxxxx Xxxxxxxx, 00000
XXXXXXX Xxxxx - Xxxxxx,
• the “Unité de
Conception, de Synthèse et Vectorisation d’Antitumoraux et Antiviraux” - UMR
176 - CNRS/Institut Xxxxx - Section de Recherche, Institut Xxxxx- 26 rue
d’Xxx - 00000 XXXXX - Xxxxx 00 - Xxxxxx,
a private, non profit foundation of
public interest having a registered office at 26 rue d’Xxx - 00000 Xxxxx xxxxx
00 - Xxxxxx, represented by Mr. Xxxx-Xxxx BRUEL, President of the Board of
Directors, hereafter referred to as “XXXXX”, acting in its own name
and in the name of and on behalf of “Unité de Conception, de Synthèse et
Vectorisation d’Antitumoraux et Antiviraux” - UMR 176 - CNRS/Institut Xxxxx -
Section de Recherche, Institut Xxxxx- 26 rue d’Xxx - 00000 XXXXX - Xxxxx 00
The CNRS and XXXXX are jointly hereafter
referred to as the “ESTABLISHMENTS”
CYCLACEL a limited liability company in the United Kingdom whose registered
office is - 00 Xx Xxxxx’x Xxxxxx - Xxxxxx - XX0X0XX - Xxxxxx Xxxxxxx whose
intracommunity VAT N° is 672 2290 40 represented by Xx. X.X. XXXXXXXX, Chief
Executive hereafter referred to as “CYCLACEL”
The “Centre d’Etudes d’Océanographie et de
Biologie Marine”, Unité Propre de Recherche CNRS n° 9042 and in particular, the
group directed by Xx. Xxxxxxx MEIJER has been working for many years on the
cell cycle field and in particular on cdc kinase used as a target for blocking
Certain research performed in this
laboratory and concerning cdc kinase inhibitors has resulted in the filing of
the French patent application N° 9514237 entitled “Nouveaux dérivés de purine possédant
notamment des propriétés anti-prolifératives et leurs applications biologiques”,
filed on December 1st, 1995 in the name of the CNRS, which
was extended by an international patent application, PCT n°96/01905 entitled “Novel purine
derivatives having, in particular, antiproliferative properties, and biological
uses thereof” filed on November 29th, 1996, naming
as inventors, Xxxxx XXXXXXX, Xxxxxx XXXXXXXXXXX, Laurent MEIJER and Xxxxxxxx
XXXXXX, and naming the United States, Europe (European Patent Application),
Canada and Japan.
The development of some research for this
invention was performed in part by Xxxxx XXXXXXX, and Xxxxxx XXXXXXXXXXX at the
“Unité de Conception, de Synthèse et Vectorisation d’Antitumoraux et
Antiviraux”, Unité Mixte de Recherche CNRS-Institut Xxxxx N°176.
The development of some research for this
invention was performed in part by Xxxxxxxx XXXXXX at the INSTITUTE OF
EXPERIMENTAL BOTANY, Academy of Science of the Xxxxx Xxxxxxxx, Xxxxxxxxx 000,
000 00 Xxxxx 6 - Lysolaje - the Czech Republic (hereafter referred to as
“IEB”). IEB has expressed its desire to be a co-owner of the CONTRACT PATENTS.
On February 13, 1999 the CNRS and IEB
signed a joint patent agreement n°L98095 for the CONTRACT PATENTS in order to
formalize the rules applicable to the joint ownership of the CONTRACT PATENTS
and the rights and obligations resulting therefrom. CNRS has been chosen to be
the party which shall identify and contact potential partners for the
exploitation of the CONTRACT PATENTS, and negotiate, conclude, or modify
exclusive and non-exclusive licenses or assignments under the CONTRACT PATENTS.
The CNRS hereby agrees not to abandon said
role as Exploitation Manager during the term of the present Agreement. A copy
of the joint patent agreement n°L98095 is in Annex IV of the present Agreement.
CYCLACEL, was created in 1996 for the
purpose of commercially exploiting certain technologies, in particular those
relating to certain novel peptides, small molecules and genes related to cell
cycle control. These technologies could benefit from the technologies which have
been developed by the ESTABLISHMENTS mentioned herein and CYCLACEL has
expressed an interest in obtaining a patent license from the ESTABLISHMENTS for
the research work mentioned herein in certain therapeutic fields.
In order to facilitate the exchange of
information between CYCLACEL and the ESTABLISHMENTS, a confidentiality
agreement was entered into on August 12, 1997 by and between CYCLACEL and
FIST who was acting in the name and on behalf of the CNRS.
CYCLACEL has expressed an interest in
obtaining an exclusive license under the CONTRACT PATENTS to make, have made,
sell, use, and otherwise commercially exploit the CONTRACT PRODUCTS in the
CONTRACT FIELD and the CONTRACT TERRITORY.
In accordance with the agreement between
the CNRS and XXXXX dated June 17, 1994, the CNRS is responsible for
implementing the ESTABLISHMENTS obligations in the present Agreement.
NOW, THEREFORE THE PARTIES AGREE AS
Preliminary Article - DEFINITIONS
AFFILIATES shall mean any legal entity
which, at the EFFECTIVE DATE:
• directly or indirectly controls CYCLACEL; or
• is under the same direct or indirect control as CYCLACEL; or
• is directly or indirectly controlled by CYCLACEL.
A legal entity is considered as controlling another:
• when it directly or indirectly owns over 50% (fifty percent) of the
capital of this legal entity or more than 50% (fifty percent) of the voting
rights of its shareholders or associates; or
• when it has the direct or indirect de facto, directly or indirectly,
the power to decide within this legal entity how the affairs shall be
BLOCKING IP shall mean any and all
patent rights other than the CONTRACT PATENTS licensed hereunder which may
dominate or block development, manufacture, use, or sale of CONTRACT PRODUCT in
the CONTRACT FIELD and the CONTRACT TERRITORY.
CONFIDENTIALITY AGREEMENT means the
confidentiality agreement entered into on August, 12, 1997 by and between
CYCLACEL and FIST who was acting in the name and on behalf of the CNRS.
CONTRACT FIELD shall mean the
applications of the CONTRACT PATENTS in the six (6) following fields of
application: auto-immune diseases, cardiovascular diseases, dermatological
diseases, infectious diseases, inflammatory diseases and proliferative diseases
(in particular cancers).
For the avoidance of doubt, it is hereby agreed that the CONTRACT FIELD
shall not include the domain of non-acute chronic diseases of the central
nervous system, neurological diseases or diseases of the peripheral nervous
CONTRACT PATENTS shall mean French
patent application N°9514237, entitled “Nouveaux dérivés de purine possédant notamment des
propriétés anti-prolifératives et
leurs applications biologiques”,
filed on December 1st, 1995 in the name of the CNRS, the
international patent application, PCT n°96/01905 entitled “Novel purine derivatives having, in
particular, antiproliferative properties, and biological uses thereof”
filed on November 29th, 1996, naming as inventors, Xxxxx
XXXXXXX, Xxxxxx XXXXXXXXXXX, Laurent MEIJER and Xxxxxxxx XXXXXX, as well as any
continuations, divisions, or extensions thereof, including patent term
extensions, including but not limited to Supplementary Protection Certificates
or Xxxxxx-Xxxxx extensions, any foreign counterparts thereof and any patents
which issue therefrom in any country, as set out in Annex I.
It is hereby understood that any improvement of the CONTRACT PATENT
that is protected by a patent shall not be considered as a CONTRACT PATENT. For
the avoidance of doubt CYCLACEL has the clear right to patent in its own name
any derivative compounds falling within the broad compound family of the
CONTRACT PRODUCTS, shall mean any
products which are covered by the CONTRACT PATENTS or which could not be
identified, developed, manufactured, used or sold without infringing upon at
least one of the claims of the CONTRACT PATENTS.
CONTRACT TERRITORY shall mean the
EFFECTIVE COMPETITION shall mean a
situation in which one or more third parties, in a country of the CONTRACT
TERRITORY, is marketing a product, which competes with a CONTRACT PRODUCT in
the CONTRACT FIELD and the third party’s product’s sales for a calendar quarter
are [*] of the total sales of such CONTRACT PRODUCT in such country expressed
in equivalent units. The third party sales determination in any calendar
quarter is conclusively deemed to be [*] of the total sales of all CONTRACT
PRODUCTS in such country, if a market research organization such as IMS has
made such determination based on its conduct of a market share study, in such
country, during such quarter. Once a determination is made that EFFECTIVE
COMPETITION exists for a CONTRACT PRODUCT in any country, such determination
shall be made again each calendar quarter for so long as such CONTRACT PRODUCT
is marketed in that country.
EFFECTIVE DATE, shall mean the last
date of signature of the present Agreement by the PARTIES.
FIRST COMMERCIAL SALE shall mean the
first commercial sale of the CONTRACT PRODUCTS to a third party made by either
CYCLACEL or its AFFILIATES after marketing authorization is received from the
US Food and Drug Administration (FDA) or from any equivalent administrative
body in any country of the CONTRACT TERRITORY.
NET SALES, shall mean the gross amount
invoiced by CYCLACEL and its AFFILIATES to their customers including
distributors, for sales of CONTRACT PRODUCTS, less any normal trade discounts
and credit notes issued in respect of
returned CONTRACT PRODUCTS, purchase, sales, import,
or value added taxes and charges in respect to carriage.
Should CYCLACEL sell CONTRACT PRODUCTS to an AFFILIATE (or vice-versa)
which thereafter sell them to an unrelated third party, the sales between the
AFFILIATE (or CYCLACEL) and the unrelated third party (and not the sales
between CYCLACEL and its AFFILIATE) shall be considered NET SALES.
It is hereby understood that the sales by SUBLICENSEES shall not be
considered as NET SALES.
PARTIES, shall mean the ESTABLISHMENTS
SUBLICENSEES, shall mean any third
parties who may obtain a sublicense from CYCLACEL to develop and/or
commercially exploit the CONTRACT PRODUCTS in the CONTRACT FIELD.
VALID CLAIM shall mean any claim of an
issued and unexpired patent or a claim of a pending patent application within
the CONTRACT PATENTS which has not been held unpatentable, invalid or
unenforceable by a court or other government agency of competent jurisdiction
and has not been admitted to be invalid or unenforceable through reissue,
re-examination, disclaimer or otherwise; provided, however, that if the holding
of such court or agency is later reversed by a court or agency with overriding
authority, the claim shall be reinstated as a VALID CLAIM after the date of
All plurals may be read in the singular and vice
Article 1 - OBJECT NATURE AND SCOPE OF THE AGREEMENT
1.1 The ESTABLISHMENTS hereby grant CYCLACEL which accepts, subject to
the terms and conditions of the present Agreement, an exclusive license under
the CONTRACT PATENTS to make, have made, sell, use, and otherwise commercially
exploit the CONTRACT PRODUCTS in the CONTRACT FIELD and the CONTRACT TERRITORY.
CNRS will not commercially exploit the CONTRACT
PATENTS in the CONTRACT FIELD for the duration of the present Agreement. The
ESTABLISHMENTS shall be free to use the CONTRACT PATENTS for internal research
1.2 The right to license granted to CYCLACEL by the ESTABLISHMENTS
includes the right to grant sublicenses.
1.3 For the avoidance of doubt, the license which is hereby granted to
CYCLACEL is for the CONTRACT PATENTS. This license does not give CYCLACEL any
rights to compounds developed in the LABORATORIES which are not protected by at
least one of the claims of the CONTRACT PATENTS.
However, if CYCLACEL makes developments on CDK
inhibitors corresponding to the composition of matter disclosed in claims 1 to
9 of the international patent application, PCT n°96/01905 entitled “Novel purine
derivatives having, in particular,
antiproliferative properties, and biological uses thereof”as filed on November 29th, 1996, and if these
compounds are not protected by said patent as issued, the ESTABLISHMENTS agree
to make reasonable efforts to grant licenses to CYCLACEL under all patents
covering these CDK inhibitors in the CONTRACT FIELD, filed in the name of the
CNRS and/or XXXXX, and developed by the LABORATORIES.
Thus, it is hereby agreed that said licenses shall be
granted to CYCLACEL only if the ESTABLISHMENTS have the freedom to grant them
in the CONTRACT FIELD, and will be subject to existing third party rights.
If the ESTABLISHMENTS have the freedom to grant said
licenses, the terms that would apply shall be no more onerous to CYCLACEL than
those in the present Agreement and will exclude any fee for [*] as the PARTIES
consider these elements to have already been fully compensated for in the
present Agreement by the payments as set out in Article 5.1 herein.
If the ESTABLISHMENTS do not have the freedom to grant
said licenses, because a third party has rights on said patents, CYCLACEL will
have to negotiate and obtain a license from said third party. However, the
ESTABLISHMENTS agree to make reasonable efforts, if requested by CYCLACEL, to
assist CYCLACEL in obtaining such rights from said third party.
In this case, in the event that CYCLACEL
has to pay royalties to said third party to commercially exploit CONTRACT
PRODUCTS, the provisions set out in Article 5.2.2 herein shall apply.
Article 2 - TERM
The present Agreement shall take effect at the
EFFECTIVE DATE and unless earlier terminated in accordance with the terms
herein shall remain in effect on a country by country basis for the life of the
last of the CONTRACT PATENTS in said country or for 10 (ten) years from the
FIRST COMMERCIAL SALE in said country, whichever occurs later.
Article 3 - SUBLICENSES
3.1 Pursuant to Article 1.2, CYCLACEL may grant sublicenses to SUBLICENSEES
subject to prior notification to the ESTABLISHMENTS by registered letter with
acknowledgement of receipt of the name of any proposed SUBLICENSEE and the
terms of such proposed sublicenses.
3.2 CYCLACEL agrees to include within the terms of any sublicenses a
clause that permits CYCLACEL to show to the ESTABLISHMENTS a copy of the
SUBLICENSEE’s accounts to CYCLACEL to prove they are consistent with the
obligations of CYCLACEL hereunder.
3.3 CYCLACEL shall include within the terms of any sublicense a similar
obligation of confidentiality as that set out in Article 8 herein, as set
out in Article 8.2.
3.4 CYCLACEL agrees to include within the terms of any sublicense
royalties which are at least as favorable to CYCLACEL as those in the present
Agreement are for the ESTABLISHMENTS. CYCLACEL shall be solely responsible for
the correct execution of the obligations of SUBLICENSEES in said sublicenses
pursuant to Article 3.5 herein.
3.5 Should termination of the present Agreement occur, any payments due
by SUBLICENSEES to CYCLACEL with effect from the date of termination shall be
payable directly to the ESTABLISHMENTS and CYCLACEL shall make reasonable
efforts to ensure that clauses are included in any sublicense to this effect.
3.6 The ESTABLISHMENTS will be obliged upon request of a SUBLICENSEE of
CYCLACEL to provide such SUBLICENSEE with an undertaking that in the event that
the present Agreement is terminated the ESTABLISHMENTS shall enter into a direct
license with the SUBLICENSEE on no less favorable terms. In that case a new
agreement will be signed between the ESTABLISHMENT and this SUBLICENSEE.
Article 4 - TRANSFER
4.1 The present Agreement is granted intuitu personae. It is therefore
personal, non-transferable and non-assignable. It is hereby agreed that the
present Article does not prevent CYCLACEL from granting sublicenses.
4.2 In case of the majority take-over, merger, transfer of CYCLACEL or
transfer of its activity to another company other than an AFFILIATE, or any
other transformation of CYCLACEL which modifies the intuitu personae nature of
the present Agreement, the present Agreement shall only be assigned or
transferred with the consent of the ESTABLISHMENTS, which consent shall not be unreasonably
withheld or delayed.
It is hereby understood that any company to which
CYCLACEL’s rights and obligations are assigned, shall be subject to the same
obligations as those of CYCLACEL herein, unless the contracting parties should
reach another mutual agreement.
For the avoidance of doubt, any changes to the terms
and conditions of the present Agreement which are agreed to and occur as a
result of said transfer, for example, the name and address of the assignee,
shall be set out in writing, signed by the ESTABLISHMENTS and CYCLACEL and
included as an amendment to the present Agreement at the same time as said
majority take-over merger or transfer of CYCLACEL occurs.
Article 5 - FINANCIAL CONDITIONS
5.1 The present license is granted in exchange for payment by CYCLACEL
to the ESTABLISHMENTS of:
• [*] due upon the EFFECTIVE DATE;
• [*] due at each anniversary date of the EFFECTIVE DATE in exchange
for maintaining exclusivity until either US CONTRACT PATENT is officially
published as granted or a European CONTRACT PATENT is officially published as
granted, whichever is sooner;
• [*] due once, when the US CONTRACT PATENT(S) containing the claims
as defined in Annex II is/are officially published as granted;
• [*] when a European CONTRACT PATENT is officially published as
granted and the claims defined in Annex II issued;
• [*] for each commercialized CONTRACT PRODUCT due on the FIRST
COMMERCIAL SALE for each and every new chemical entity, regardless of
formulation changes, stereo-isomer change, salt form, in each of the 6 (six)
fields of application in the CONTRACT FIELD.
CYCLACEL shall inform the ESTABLISHMENTS in writing of
the dates of each FIRST COMMERCIAL SALE, allowing for a delay of 2 (two) months
following the occurrence of each of these FIRST COMMERCIAL SALES.
Should the conditions defined in Annex II not be met,
the PARTIES may sign an addendum to the present Agreement which will set out
new lump sum payments which would reflect the reduced protection offered by the
CONTRACT PATENTS or CYCLACEL may terminate the agreement subject to the
termination procedure set out in Article 12 herein.
5.2 Moreover, the ESTABLISHMENTS should receive royalties,
of [*] of NET SALES in countries in which the CONTRACT PRODUCTS are
protected by at least one VALID CLAIM;
[*] of NET SALES of CONTRACT PRODUCTS in all other cases.
If at any time prior to or during the period when royalties fall due
hereunder in relation to any particular country, it is necessary or advisable
to take a license to any BLOCKING IP and therefore the cumulative royalties
expressed as a percentage of NET SALES payable to licensors of such BLOCKING
IP and the ESTABLISHMENTS exceed 5%, then the ESTABLISHMENTS agree that the
royalties payable to the ESTABLISHMENTS in such country may be reduced to a
percentage calculated as follows, subject to providing written proof of said
royalties paid by CYCLACEL to third parties in such country:
of the NET SALES of the CONTRACT PRODUCTS, if the cumulative royalty rate due
by CYCLACEL for any BLOCKING IP and for the present Agreement, is greater
than [*] and less than [*];
[*] of the
NET SALES of the CONTRACT PRODUCTS if the cumulative royalty rate due by
CYCLACEL for any BLOCKING IP and for the present Agreement is greater than
[*] and less than [*];
of the NET SALES of the CONTRACT PRODUCTS if the cumulative royalty rate due
by CYCLACEL for any BLOCKING IP and for the present Agreement is greater than
or equal [*].
royalty rates shall be reduced by [*] in countries in which the CONTRACT
PRODUCTS are not protected by at least one VALID CLAIM of the CONTRACT
Royalties as set out in Articles 5.2.1 and 5.2.2,
shall be payable on a country by country basis for as long as there are a VALID
CLAIM of CONTRACT PATENTS in that country or 10 years from the FIRST COMMERCIAL
SALE of CONTRACT PRODUCT in that country, which ever is longer.
An addendum to the present Agreement which sets out
the rate of royalties for said CONTRACT PRODUCTS on a country by country basis
shall be signed by the PARTIES. In no event shall any modifications in the
royalty rate be retroactive. Any modifications shall take effect on
April 1 of the year following the modification.
the claims of the CONTRACT PATENTS set out in Annex II of the present
Agreement not be granted neither by the European Patent Office (“EPO”) nor by
the US Patent and Trademark Office (“USPTO”), then the PARTIES shall, at the
written request of CYCLACEL, sign an addendum to the present Agreement which
sets out a new royalty rate due by CYCLACEL or terminate the present
Agreement subject to the termination procedure set out in Article 12
the avoidance of doubt, should the claims of the CONTRACT PATENTS set out in
Annex II of the present Agreement not be granted by the EPO but granted by
the USPTO, or granted by the EPO but not granted by the USPTO, then the
provisions of Articles 5.2.1 and 5.2.2 shall apply.
5.3 CYCLACEL shall pay to the ESTABLISHMENTS [*] of all payments (lump
sum payments, royalties...) made by SUBLICENSEES to CYCLACEL or to its
AFFILIATES, upon execution of any sublicense contracts, whether said payments
are due upon signature of said agreements or later.
Notwithstanding the previous paragraph, should
CYCLACEL take a CONTRACT PRODUCT into phase II clinical trials, the
ESTABLISHMENTS agree that the payment herein of [*] of all payments made by SUBLICENSEES
to CYCLACEL or to its AFFILIATES, upon execution of any sublicense contracts
concerning said CONTRACT PRODUCT shall be reduced to a percentage of 11%
Any payments made to CYCLACEL or its AFFILIATES by
SUBLICENSEES under normal market conditions, which are shown to be for
CYCLACEL’s research and development under collaborative research, shall not be
included in payments set out in present Article 5.3.
5.4 The payments properly due to the ESTABLISHMENTS under the present
Agreement shall in no event be refundable to CYCLACEL.
Furthermore, in the event of expiration or
termination of the present Agreement, CYCLACEL shall pay all and any sums due
to the ESTABLISHMENTS up to the expiration date or the date of termination.
5.5 Any payments due by CYCLACEL under the present Agreement shall be
paid in French Francs.
Pursuant to the European Union Treaty, the
French Franc shall be replaced by a single currency, the Euro.
In accordance with the general principles
of monetary law, any references to the Franc herein, shall be considered to be
references to the Euro by right.
The substitution of said terms shall not affect the
conditions or prevent the execution of the present Agreement and does not
confer the right to unilateral modification or termination of the present
Agreement by any of the PARTIES. Said substitution shall take effect on the
date of and pursuant to the terms set out by European Union regulations
5.6 For the avoidance of doubt, if upon application of the
ESTABLISHMENTS, any withholding tax can be reduced, CYCLACEL will file an
application on behalf of the ESTABLISHMENTS for such reduction.
The ESTABLISHMENTS has provided CYCLACEL
with a form of proxy authorizing CYCLACEL to make such an application in its
behalf in Annex III.
5.7 Should the royalty rate change during fiscal year pursuant to the
terms of the present Agreement, it is hereby agreed that the existing rate
shall be applied until March 31 of the year in question.
Article 6 - ACCOUNTING-ROYALTIES
6.1 CYCLACEL shall prepare accounts, which shall include all the
elements necessary to precisely calculate the NET SALES within the framework of
the present Agreement.
6.2 If necessary these accounts shall be made available once a year with
30 days notice to the ESTABLISHMENTS or an accredited designee of the
ESTABLISHMENTS during the term of the present Agreement and for one year
6.3 These accounts shall be prepared annually within 90 (ninety) days of
the closing date of March 31 of each year which represents the end of
CYCLACEL’s fiscal year.
6.4 All payments shall be preceded by a sales report by country and by
SUBLICENSEE. On or before June 30 of every year this report shall be sent
to the Service Financier de la Délégation du Siège du CNRS, 0 xxx Xxxxxx-Xxxx -
00000 XXXXX Cedex 16. Said
report shall include the license number and the sales
figures used to calculate the royalties due to the ESTABLISHMENTS, as well as
the quantities sold, the unit price of any quantity of the CONTRACT PRODUCTS
and details of any revenue of any nature as set out in Article 5 of the
present Agreement, received for the commercial exploitation of the CONTRACT
PRODUCTS both by CYCLACEL, its AFFILIATES and its SUBLICENSEES.
6.5 Any sums due by CYCLACEL pursuant to Article 5 shall be paid
within the 35 (thirty five) days following issuance of an invoice from the
ESTABLISHMENTS to the person and the bank address indicated in Article 6.9
6.6 Should no sales occur, CYCLACEL shall nonetheless send the
ESTABLISHMENTS a sales-report in the month of June each year attesting to
such lack of sales during the period under consideration and stating the reasons
therefor and the difficulties encountered.
6.7 Any sums which remain unpaid within the periods set out hereunder
shall be subject to interest at the rate of [*] without prejudice to the
ESTABLISHMENTS’s right to terminate the contract in accordance with
Article 12 of the present Agreement. [*] accordance with law n° 89 [*].
6.8 To amounts due to the ESTABLISHMENTS shall be added the legal taxes
in effect at the date of payment, in particular VAT if applicable.
6.9 CYCLACEL shall make payments due to the CNRS, in the name of the
6.10 The ESTABLISHMENTS shall have the right once a year with 30 days
notice to audit or have audited the royalty accounts kept by CYCLACEL. Should
there be an audit, an expert accountant shall be appointed by mutual agreement
of both PARTIES at the expense of the ESTABLISHMENTS, except that if the amount
of any royalties shown by such audit to be due to the ESTABLISHMENTS exceed the
amount actually paid by CYCLACEL by [*]
6.11 If CYCLACEL justifies the existence of EFFECTIVE COMPETITION in any
of the countries of the CONTRACT TERRITORY, the PARTIES shall meet and
negotiate in good faith new financial conditions, for said countries, to be
mutually agreed by the PARTIES.
Article 7 - EXPLOITATION
7.1 CYCLACEL agrees to exploit the present license and to make
reasonable efforts to develop, make, have made, sell, use, and otherwise
commercially exploit the CONTRACT PRODUCTS.
7.2 CYCLACEL agrees to provide annual reports justifying the development
and exploitation of the CONTRACT PRODUCTS.
7.3 CYCLACEL, its AFFILIATES or SUBLICENSEES agree not to use the names
“Centre National de la Recherche Scientifique” or “CNRS” or “XXXXX” or
“INSTITUT XXXXX” or any trademark, distinctive sign or adaptations thereof
which belongs to the ESTABLISHMENTS or the names of the ESTABLISHMENTS
inventors or of any ESTABLISHMENTS agent, for commercial purposes, without
receiving prior written approval from the ESTABLISHMENTS and the natural person
concerned, as the case may be.
7.4 CYCLACEL, its AFFILIATES or SUBLICENSEES shall commercialize the
CONTRACT PRODUCTS under their own trademarks or under trademarks for which they
have obtained a license. The ESTABLISHMENTS shall have no rights to such
trademarks. All administrative authorizations obtained by CYCLACEL for the
purpose of manufacturing and/or commercializing the CONTRACT PRODUCTS shall be
obtained for CYCLACEL or for any party which it shall have designated and
subject to Article 7.5 hereunder, the ESTABLISHMENTS shall claim no rights
7.5 Without prejudice to the terms of Article 7.4 hereunder,
CYCLACEL accepts the obligation to inform by writing the ESTABLISHMENTS of all
administrative authorizations, notably any official marketing approval that it
obtains for the purpose of manufacturing and/or commercializing the CONTRACT
PRODUCTS no later than [*] after obtaining such final authorizations.
7.6 CYCLACEL hereby confirms that it has the expertise necessary to make
use of the CONTRACT PATENTS, and to develop, make, have made, sell, use, and
otherwise commercially exploit the CONTRACT PRODUCTS.
Article 8 - CONFIDENTIALITY
8.1 Each PARTY agrees to respect and keep strictly confidential all
scientific and technical information belonging to the other PARTY and any other
information of any nature belonging to the other PARTY about which they may
have knowledge due the negotiations and execution of the present Agreement. The
PARTIES shall not use such information for any other purpose than the
performance of the present Agreement and shall only disclose this information
its employees on a strict need-to-know basis.
CYCLACEL shall be free to use all information for
submissions and communications with regulatory and governmental authorities as
required for the development of the CONTRACT PRODUCTS.
8.2 The PARTIES shall assure that their personnel and others in their
service are bound by the same obligations of confidentiality described
hereunder. Moreover, CYCLACEL shall include confidentiality obligations no less
onerous than the present Article 8 in any sublicenses it may grant to
However, should the SUBLICENSEES have prior
activities or obligation concerning the use of cdc kinase inhibitors in the
CONTRACT FIELD, CYCLACEL shall make reasonable efforts to include
confidentiality obligations no less onerous than the present Article 8 in
8.3 The confidentiality obligations between the PARTIES in the present
Article 8 shall not include the use or disclosure of confidential
information that the receiving PARTY can show:
a) Was disclosed by the mutual agreement of the PARTIES, or was
disclosed by the owning PARTY; or
b) Was in the public domain at the moment of disclosure or entered the
public domain through no act or fault of the receiving PARTY; or
c) Was made available as a matter of lawful right by a third party
without breach of any of the confidentiality obligations herein; or
d) Was in the possession of the receiving PARTY at the time of
disclosure by the owning PARTY; or
e) Was disclosed by lawful right, to remain in compliance with a legal
or regulatory imperative, an arbitration settlement or a final legal decision;
f) Was disclosed after obtaining the prior authorization of the owning
g) Was independently developed by or on behalf on the receiving PARTY
without use of any confidential information received from the owning PARTY.
8.4 The present Article shall remain in effect until the expiration
of the last of the CONTRACT PATENTS, the expiration or termination of the
present Agreement notwithstanding.
Article 9 - INTELLECTUAL PROPERTY
9.1 Any and all decisions concerning the maintenance of the intellectual
property necessary to the validity of the CONTRACT PATENTS shall belong
exclusively to the ESTABLISHMENTS. The ESTABLISHMENTS shall consult CYCLACEL in
relation to any decisions concerning the CONTRACT PATENTS, and agree to provide
CYCLACEL with copies of all relevant correspondence with patent authorities.
The ESTABLISHMENTS shall make reasonable efforts to take into consideration the
commercial strategy of CYCLACEL when taking actions in relation to prosecution
of the CONTRACT PATENTS in particular in the actions related to replies to
office actions especially including but not limited to those regarding support
of claim scope,
final text and agreement under Rule 51(4) reply in
addition to actions related to the filing of CIP and divisional applications in
relation to the CONTRACT PATENTS.
9.2 It is hereby agreed by the PARTIES that the French patent
application n° 9514237 filed on December 1st, 1995, in the name
of the CNRS was extended by an international patent application, PCT n°96/01905
purine derivatives having, in particular, antiproliferative properties, and
biological uses thereof” filed on November 29th,
1996, and naming the United States, Europe (European Patent Application),
Canada and Japan.
It is hereby agreed by the PARTIES that the European
patent application shall name all following countries: France, Germany, United
Kingdom, Belgium, Italy, Spain, Austria, Switzerland, Liechtenstein, Denmark,
Finland, Greece, Ireland, Luxembourg, Monaco, the Netherlands, Portugal and
9.3 Should the ESTABLISHMENTS wish to abandon any one of the CONTRACT
PATENTS it shall notify CYCLACEL 2 (two) months prior to the next deadline for
payment of maintenance fees of said CONTRACT PATENTS. CYCLACEL may take over
the prosecution and maintenance of said CONTRACT PATENTS subject to notifying
the ESTABLISHMENTS no later than 1 (one) month prior to such payment deadline.
In this case the terms of the present Agreement shall remain in effect and
CYCLACEL shall be responsible for the maintenance fees for said CONTRACT
PATENT(S) and may deduct any annual amounts paid for this purpose from any of
the royalties due to the ESTABLISHMENTS for the same year, subject to providing
receipts for said amounts and including them in the corresponding sales report
addressed to the CNRS. All patent prosecution procedures for the CONTRACT
PATENTS shall be undertaken in the name of the ESTABLISHMENTS.
Should the CONTRACT PATENTS be licensed to a licensee
other than CYCLACEL, and should the ESTABLISHMENTS wish to abandon all or part
of said CONTRACT PATENTS, the present Article shall be amended in an
addendum to the present Agreement such that all licensees under the CONTRACT
PATENTS may share the intellectual property costs and prosecution
9.4 From the date of the FIRST COMMERCIAL SALE, should the annual
royalties pursuant to Article 6 herein fail to reimburse the annual
intellectual property fees due by the CNRS for the CONTRACT PATENTS in one, several
or all of the countries in the
CONTRACT TERRITORY for 2 consecutive years the ESTABLISHMENTS shall be free to
abandon said CONTRACT PATENTS in said country (or countries) of the CONTRACT
Pursuant to Article 9.3 herein, CYCLACEL may take over prosecution
of said patents.
Article 10 - INFRINGEMENT
10.1 Each PARTY shall inform the other within the shortest possible delay
of any third party infringement of which it may become aware and/or of any
infringement claims or actions, which may be taken against it.
10.2 Should there be third party infringement of the CONTRACT PATENTS in
the CONTRACT FIELD, the ESTABLISHMENTS may, at their sole expense, undertake
legal action against the infringing party. Any damages which may be allotted in
relation to said infringement shall belong solely to the ESTABLISHMENTS.
The foregoing shall not prevent CYCLACEL
from intervening in any such action at its sole expense in compensation for
prejudice which it has incurred. Any indemnification or damages which may be
allotted by the courts will belong solely to CYCLACEL.
Should the ESTABLISHMENTS not wish to undertake any
action, CYCLACEL may, after having notified the ESTABLISHMENTS in writing, and
in the absence of response from the ESTABLISHMENTS in the month following such
notification, and subject to any applicable laws in the country in which the
infringement has occurred, take action against said infringement in its own
name and at its own expense. The costs of such actions shall be borne by
CYCLACEL and any damages awarded by court decision shall belong entirely to
The PARTIES agree to provide any documents and
elements that may be necessary for the above-mentioned action to the other
10.3 Should CYCLACEL, its AFFILIATES, SUBLICENSEES or distributors become
the object of infringement claims as a result of the use, manufacturing or
commercialization of the CONTRACT PRODUCTS, due to the use of the CONTRACT
PATENTS, the ESTABLISHMENTS shall not be held liable or held in guarantee by
CYCLACEL. During such infringement proceedings, should CYCLACEL, its AFFILIATES
or SUBLICENSEES be prohibited from selling the CONTRACT PRODUCTS, CYCLACEL may
suspend payments due herein, until termination of such proceedings. Should
CYCLACEL, its AFFILIATES or SUBLICENSEES continue selling CONTRACT PRODUCTS
during said proceedings, CYCLACEL may deduct any annual external legal costs
from its calculation of NET SALES for royalty payments due for the same year
pursuant to Article 6 herein and for the corresponding year, subject to
providing written proof of said costs.
Should said companies be condemned for said
infringement, the ESTABLISHMENTS shall not be called in warranty by CYCLACEL or
be liable to indemnify reimburse or reduce any of the sums due by CYCLACEL at
the moment of the final legal decision except as a result of a breach of a
warranty provided by the ESTABLISHMENTS pursuant to Article 11. Should any
or all of the CONTRACT PATENTS become null or void the conditions of
Article 11 shall be applicable without exception.
The present Article shall not in any way be
considered to constitute a waiver by the ESTABLISHMENTS to take any action or
Article 11 - WARRANTIES
11.1 The ESTABLISHMENTS warrant that they own the CONTRACT PATENTS, in
part or in whole, and that they have the right to grant CYCLACEL the license
herein, such right having been explicitly agreed in writing by and between the
ESTABLISHMENTS and IEB. The ESTABLISHMENTS warrant that their agreement with
IEB provides for a certain financial compensation to be paid by the
ESTABLISHMENTS to IEB and
that CYCLACEL will not be liable for any payments to
IEB for the license herein. The ESTABLISHMENTS agree that they will take all
necessary steps to record joint ownership of the CONTRACT PATENTS with the IEB
at each patent office in which the CONTRACT PATENTS were filed. The
ESTABLISHMENTS warrant that they are not aware of any patents that may be
infringed by the CONTRACT PATENTS.
Prior to signature of this agreement, the
ESTABLISHMENTS have supplied to CYCLACEL all documents in their possession
relating to the prosecution history of the CONTRACT PATENTS under the
CONFIDENTIALITY AGREEMENT to enable CYCLACEL to study each history.
11.2 The hazards, risks and perils associated with the exercise of rights
granted under the present Agreement and any legal defects contained in the
CONTRACT PATENTS are the sole responsibility of CYCLACEL who hereby accepts
them. In consequence, should any of the CONTRACT PATENTS be invalidated,
annulled or be declared dependent upon a prior dominant patent, or should the
CONTRACT PRODUCTS be declared in infringement in a final legal decision, the
ESTABLISHMENTS shall not be liable to reimburse any sums acquired from
CYCLACEL, or to pay damages to CYCLACEL in retribution for prejudice caused for
such invalidation, cancellation or infringement.
The PARTIES shall meet to evaluate the effect of said
decision and to renegotiate in good faith if necessary, in an addendum to the
present Agreement, the financial terms of Article 5 of the present
Agreement or terminate the agreement at CYCLACEL’s absolute discretion in
accordance with the procedure set out in Article 12.2. All the remaining
terms of the present Agreement shall continue in full effect. In no event shall
any modifications in the royalty rate be retroactive. Any modifications shall
take effect on April 1 of the year following the modification.
In accordance with the present Article, the
ESTABLISHMENTS do not provide any express or implied guarantee of the CONTRACT
PATENTS in particular of their utility or application for any particular
11.3 CYCLACEL shall not call on the ESTABLISHMENTS in guarantee for any
damages or prejudice of any nature caused by the CONTRACT PRODUCTS. CYCLACEL is
solely responsible to its clients and/or any third parties for the quality and
performance of the CONTRACT PRODUCTS.
Article 12 - TERMINATION
12.1 Should CYCLACEL cease business operations or be the object of a
liquidation procedure, the ESTABLISHMENTS may terminate the present Agreement
if it so wishes subject to notifying CYCLACEL. After 1 (one) month without a
response to this notification, and subject to the applicable legal regulations
in England and Wales, the present Agreement shall be immediately terminated by
right. Any termination under Article 12.1 will be subject to the
Insolvency Xxx 0000 of the laws of England and Wales.
12.2 The present Agreement may be terminated by right by either of the
PARTIES in the event that the other PARTY fails to perform one or more of the
obligations contained in the various clauses of the present Agreement notably
Article 5. This termination shall only become effective 3 (three) months
after the complaining PARTY sends a notice exposing the motives of the
complaint and then only if the PARTY at fault has not, within this period,
fulfilled its obligations or shown proof of a case of force majeure that
prevented it from fulfilling its obligations. The exercise of such right to
termination does not exempt the PARTY in default from fulfilling the
obligations accrued prior to the date of termination and this, without
prejudice to any compensation due for damages incurred as a result early
termination of the agreement.
12.3 In particular if after 5 (five) years from the EFFECTIVE DATE,
CYCLACEL has not submitted a regulatory application to a European government
authority to begin human clinical trials of CONTRACT PRODUCTS, and cannot
provide any reasonable justification for such failure the ESTABLISHMENTS may
terminate the present Agreement in accordance with the procedure set out in
Article 12.2 above.
12.4 Should the present Agreement expire or be terminated, CYCLACEL
agrees not to use or allow any direct or indirect use of the CONTRACT PATENTS
until the expiration of the last of the CONTRACT PATENTS. However, CYCLACEL
shall have the right to dispose of existing inventory for 180 (one hundred and
eighty) days following any such expiration or termination and subject to the
provisions of Article 5 of the present Agreement. Furthermore, CYCLACEL
agrees to return or destroy all proprietary or confidential information,
material, and documents that it has received from the ESTABLISHMENTS and not to
conserve any copies for any purposes whatsoever.
Furthermore, in the event of early termination of the present
Agreement, CYCLACEL hereby agrees to provide the ESTABLISHMENTS with any
results obtained in relation to the invention protected by the CONTRACT PATENTS
and shall allow the ESTABLISHMENTS to directly exploit said results. Indirect
exploitation of said results shall be subject to conclusion of a separate
agreement to this effect between the PARTIES.
Article 13 - ENTIRE AGREEMENT
13.1 The present Agreement expresses the entire understanding of the
PARTIES. No general or specific condition appearing in any document sent or
given by the PARTIES can be integrated in the present Agreement.
Should there be a contradiction between the
terms of the present Agreement and the terms of the CONFIDENTIALITY AGREEMENT,
the terms of the present Agreement shall prevail.
13.2 The present Agreement replaces any previous agreements and may only
be modified or renewed by an amendment signed by duly authorized
representatives of the PARTIES.
13.3 It is hereby agreed that the relationship established by the PARTIES
in the present Agreement does not confer any other rights than those set out
hereof. It is expressly agreed that the present Agreement does not confer any
rights to CYCLACEL outside the CONTRACT FIELD, nor rights to any patents other
than the CONTRACT PATENTS.
Article 14 - HEADINGS
In the event of difficulties of
interpretation between any of the headings preceding the clauses and any one of
the clauses, the headings shall be ignored.
Article 15 - INVALIDITY OF A CLAUSE
Should one or more provisions of the
present Agreement be held to be invalid by law or regulation - and in
particular the laws or regulations of the European Union or based on a
definitive decision of a competent court, all the other provisions shall remain
in full effect and the PARTIES shall make the necessary modifications without
delay while respecting, as closely as possible, the spirit of the present
Agreement at the moment of signature.
Article 16 - WAIVER
The failure of one of the PARTIES to assert
a breach of the present Agreement by the other PARTY shall not be interpreted
as a waiver of said obligation.
Article 17 - DISPUTES - GOVERNING LAW
17.1 The laws of France shall govern the present Agreement.
17.2 In the event that a difficulty arises in the validity,
interpretation or execution of the present Agreement, the PARTIES shall try to
settle their differences out of Court.
The PARTIES will each nominate one representative who is not an
executive of the respective PARTY who will jointly attempt to settle any
differences of opinion.
If necessary the present Article shall not prevent the PARTIES
seeking injunctive, emergency or interim relief from the Court.
17.3 In case of persistent disagreement for more than 3 months after one
PARTY has been notified of a difficulty by the other, the competent French
Courts shall have sole jurisdiction.
17.4 The present Article shall remain in effect regardless of the
expiration or termination of the present Agreement.
Article 18 - REGISTRATION AT THE REGISTRE NATIONAL DBS BREVETS -FISCAL
18.1 The present Agreement may be registered at the Registre National des
Brevets, which is controlled by the Institut National de Propriété
Industrielle, and each National Patent Office for the purpose of registering
the CONTRACT PATENTS; the fees of said registrations to be paid by CYCLACEL.
18.2 Any fiscal registrations of the present Agreement shall be performed
by CYCLACEL at its sole expense.
Article 19 - LANGUAGE
The present Agreement has been established
in two versions, one in French and one in English. In case of difficulties of
interpretation, both versions shall be authoritative.
Article 20 - NOTIFICATIONS
All notifications for the present Agreement shall be
sent by registered letter with acknowledgement of receipt to the PARTY for
which the notice is intended at the following address:
For the ESTABLISHMENTS:
Xxxxx Cedex 16
In four copies including one for the
Institut National de la Propriété Industrielle and one for the contracting
Mrs. Xxxxxxxxx XXXXXXXXXX
General Manager of CNRS
Xx. X.X XXXXXXXX
Chief Executive of CYCLACEL
Mr. Xxxx-Xxxx BRUEL
President of the Board of Directors of XXXXX
French patent application N°9514237,
dérivés de purine possédant notamment des propriétés anti-prolifératives et
leurs applications biologiques”, filed on December 1st
, 1995 in the name of the CNRS.
The claims of
the CONTRACT PATENTS as granted shall contain:
1) At least one of the following applications for the pharmaceutical
compounds set out in 2):
a) use as an antimitotic or antiproliferative drug, in particular for
b) use for the treatment of psoriasis,
c) use for the treatment of parasitosis.
2) At least one pharmaceutical compound, characterized by its including
at least one of the purine derivatives mentioned in 2.1 and 2.2:
a) Purine derivatives as defined in claims 1 to 9 in the International
PCT patent application published under number WO97/20842,
b) At least 14 of any of the 23 purine derivatives mentioned in claim
n° 10 of the International PCT patent application published under number
WO97/20842 and whose chemical formulas are listed below:
2-hydroxymethyl-pyrrolidine-l -yl]- 9 -isopropyle- (9H) purine none
2- (R, S) -[6
For the avoidance of doubt, the conditions
set out in points 1 and 2 of the present Annex are cumulative.
In relation to point 1, the three
conditions a), b) and c) are alternatives, and if one of these three alternatives
are fulfilled, point 1 shall be considered fulfilled.
In relation to point 2, the conditions 2.1
and 2.2 are cumulative.
0.xx) and 2.1b) are alternatives. If one of these two alternatives are
fulfilled, 2.1 shall be considered fulfilled.
Attention: Chief Executive
00 Xx Xxxxx’x Xxxxxx
December 13th, 1999
Appointment of CYCLACEL as authorised representative
We, the Centre National de la Recherche
Scientifique, a public establishment of scientific and technological nature,
having its headquarters at 0 xxx Xxxxxx-Xxxx - 00000 XXXXX Cedex 16 - France,
hereby appoint CYCLACEL a company incorporated in England, whose registered
office is at 00 Xxxxx Xxxxx’x Xxxxxx- Xxxxxx XX0X0XX - Xxxxxx Xxxxxxx to act on
our behalf as our duly and legally appointed representative and to do all
things necessary to obtain relief for us in accordance with the convention
between the United Kingdom and France with respect to taxes on income and
capital for the avoidance of double taxation from UK withholding taxes levied
on royalties payable to us by CYCLACEL for the payment of royalties for licence
Copy of the joint patent agreement n°L98095