Exhibit 10.10
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXCLUSIVE LICENSE AND KNOW-HOW AGREEMENT
NO. L99037
by and between the undersigned:
LE CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, national public
scientific and technological institution, whose head office is at 0 Xxx
Xxxxxx Xxxx, 00000 XXXXX Cedex 16, herein represented by its Executive
Director, Xxxxxxxxx XXXXXXXXXX (hereinafter called the "CNRS")
and
L'UNIVERSITE XXXXX XXXXXXX STRASBOURG 1, public scientific and
professional institution, whose head office is at 0 Xxx Xxxxxx Xxxxxx,
00000 Xxxxxxxxxx Cedex, herein represented by its president, Xxxx-Xxxx
MERINDOL (hereinafter designated the "UNIVERSITY")
CNRS and the UNIVERSITY being hereinafter designated together as the
"INSTITUTIONS"
the INSTITUTIONS herein acting in their own name and on behalf of the
Laboratoire de Chimie Bioorganique, URA No. 1386 CNRS/UNIVERSITE XXXXX
XXXXXXX-STRASBOURG 1, and the Integrated and Cellular Neurophysiology
Laboratory, URA No. 1446 CNRS/UNIVERSITE XXXXX XXXXXXX-STRASBOURG 1
(hereinafter designated the "LABORATORIES").
party of the first part
AND
BIOSPHERE MEDICAL INC., corporation registered in the UNITED STATES in
the State of Massachusetts, whose head office is at 000 Xxxxx Xxxxx,
Xxxxxxxxxxx, XX 00000, Xxxxxx Xxxxxx, herein represented by its
President and Chief Executive Officer Xxxx-Xxxxx XXXXX, (hereinafter
designated "BIOSPHERE MEDICAL INC.").
party of the second part.
The INSTITUTIONS and BIOSPHERE MEDICAL INC are hereinafter designated
together as the "PARTIES".
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
WHEREAS:
The INSTITUTIONS and I.B.F. BIOTECHNICS signed a license agreement No.
L90128 on November 26, 1990 for the use of Patents and Know-how in
order to manufacture and sell the Products in the Domain, as these
terms are defined in License Agreement L90128.
I.B.F. BIOTECHNICS has changed its corporate name and is now called
BIOSEPRASA, business corporation with capital of FRF 21,300,000,
registered in the Registry of Business Names and Corporations of
Nanterre under No. B 331 502 641, whose intra-community VAT No. is FR
12 331 502 641 and whose head office is at 00 Xxxxxx Xxxx Xxxxxx, 00000
Xxxxxxxxxx Xx Garenne. Until May 17, 1999, BIOSEPRA-SA was a subsidiary
of BIOSPHERE MEDICAL INC. when it became a subsidiary of Life
Technologies, a corporation registered in the USA.
BIOSEPRA-SA, BIOSPHERE MEDICAL INC and the INSTITUTIONS have agreed to
amend the terms of license L90128.
BIOSEPRA-SA, BIOSPHERE MEDICAL INC and the INSTITUTIONS have agreed
that license L90128 will be cancelled by mutual consent and replaced by
two licenses:
- License No. L99036, granted to BIOSEPRA-SA, for the working of the
PATENTS OF THE AGREEMENT and the KNOW-HOW OF THE AGREEMENT,
limited solely to the use of TRANSFECTAM, in all domains excluding
medical.
- License No. L99037, granted to BIOSPHERE MEDICAL INC for the
working of the PATENTS OF THE AGREEMENT and the KNOW-HOW OF THE
AGREEMENT only in the medical domain (excluding in particular the
domain of research reagents).
Finally, it was agreed that CNRS, starting with the coming into force
of this agreement, would resume at its expense the management and
industrial property fees relative to the PATENTS OF THE AGREEMENT.
ACCORDINGLY, THE PARTIES HERETO HAVE AGREED TO THE FOLLOWING:
Preliminary Clause - DEFINITIONS
PATENTS OF THE AGREEMENT means:
- the French patent application filed on [**] under no. [**],
entitled "[**]" in the name of [**], citing as inventors[**] and
[**],
- the French patent application filed on [**] under no. [**],
entitled "[**]" in the name of [**], citing as inventors [**]
and [**],
- and the extensions abroad of the French patent applications
cited above, the French and foreign patents corresponding to
these applications, and the later complementary certificates of
protection.
A list of the PATENTS OF THE AGREEMENT appears in Schedule 1 to
this Agreement.
2
DATE OF COMING INTO FORCE means the last signature date of this
Agreement.
DATE OF FIRST MARKETING means the date on which a PRODUCT OF THE
AGREEMENT is first marketed.
DISTRIBUTORS means all corporations or legal entities acting on
their own behalf and for their personal account as purchasers of
PRODUCTS OF THE AGREEMENT packaged or not for their resale.
DOMAIN OF THE CONTRACT means the applications of the PRODUCTS OF
THE AGREEMENT only in the medical domain (specifically excluding
the domain of research reagents).
PARTIES means the INSTITUTIONS and BIOSPHERE MEDICAL INC.
PRODUCTS OF THE AGREEMENT means all products implementing some or
all of the PATENTS OF THE AGREEMENT and/or KNOW-HOW OF THE
AGREEMENT or which could not be developed, used, fabricated or
marketed without using some or all of the KNOW-HOW OF THE
AGREEMENT and/or infringing some or all of the PATENTS OF THE
AGREEMENT.
KNOW-HOW OF THE AGREEMENT means a set of technical information,
whether written, graphic or oral, whatever medium used, acquired
by the LABORATORIES during their research until the DATE OF COMING
INTO FORCE, and concerning the application of the invention that
is the subject of the PATENTS OF THE CONTRACT.
SUB-LICENSEE means any third party that has obtained from
BIOSPHERE MEDICAL INC a license to develop, use, manufacture or
market the PRODUCTS OF THE AGREEMENT in the DOMAIN OF THE
AGREEMENT.
TERRITORY OF THE AGREEMENT means the whole world.
TRANSFECTAM means a lipopolyamine used as a transfection agent
marketed by BIOSEPRA-SA under the registered trade name
Transfectam.
NET SALES means the gross amounts invoiced by BIOSPHERE MEDICAL
INC to its customers, including the DISTRIBUTORS, for the sales of
the PRODUCTS OF THE AGREEMENT, after deduction of the usual
commercial discounts, balances resulting from returns of the
PRODUCTS OF THE AGREEMENT, sales, purchase, import and value added
taxes and transport costs.
The plural may be understood to refer to the singular and
vice-versa.
3
Section 1 - SUBJECT, NATURE AND SCOPE OF THE AGREEMENT
1.1 By this agreement, the INSTITUTIONS grant BIOSPHERE MEDICAL INC,
which accepts, an exclusive license for the PATENTS OF THE
AGREEMENT and the KNOW-HOW OF THE AGREEMENT in the TERRITORY OF
THE AGREEMENT for the development, use, manufacture and marketing
of the PRODUCTS OF THE AGREEMENT within the DOMAIN OF THE
AGREEMENT.
BIOSPHERE MEDICAL INC agrees not to work the PATENTS OF THE
AGREEMENT and the KNOW-HOW OF THE AGREEMENT outside the TERRITORY
OF THE AGREEMENT or the DOMAIN OF THE AGREEMENT.
1.2 The license granted under 1.1 of this agreement is accompanied by
granting by the INSTITUTIONS to BIOSPHERE MEDICAL INC the right to
sub-license the PATENTS OF THE AGREEMENT and the KNOW-HOW OF THE
AGREEMENT to SUB-LICENSEES for the development, use, manufacture
and marketing of the PRODUCTS OF THE AGREEMENT in the TERRITORY OF
THE AGREEMENT and DOMAIN OF THE AGREEMENT.
1.3 Exclusivity means that the INSTITUTIONS agree not to grant another
license on the PATENTS OF THE AGREEMENT and the KNOW-HOW OF THE
AGREEMENT for the working of the PRODUCTS OF THE AGREEMENT in the
DOMAIN OF THE AGREEMENT and in the TERRITORY OF THE AGREEMENT. The
INSTITUTIONS however retain the right to use the PATENTS OF THE
AGREEMENT and the KNOW-HOW OF THE AGREEMENT for research purposes
and to work them directly.
Section 2 - TERM
2.1 This Agreement will come into force on the DATE OF COMING INTO
FORCE and remain in force except if cancelled early as provided in
section 14 below:
2.1.1 In any country where there is no or no longer a PATENT OF
THE AGREEMENT (applied for or issued) in force, for 10
years after the DATE OF FIRST MARKETING in this country
(or for the countries that are members of the European
Union, for 10 years after the DATE OF FIRST MARKETING in
one of the member countries of the European Union).
After the 10-year period, the license will be
non-exclusive and free in the countries where there is no
or is no longer a PATENT OF THE AGREEMENT in force.
2.1.2 In countries where there is a PATENT OF THE AGREEMENT in
force, for the term of the validity of the said PATENT OF
THE AGREEMENT (possibly extended by a Complementary
Certificate of Protection or equivalent authorization),
when this term exceeds the period provided in 2.1.1.
4
2.2 License L90128 is cancelled by mutual consent starting on the date
of coming into force of license No. L99036 granted to BIOSEPRA-SA.
Section 3- SUB-LICENSE
3.1 BIOSPHERE MEDICAL INC may, in application of the stipulations of
section 1.2 above, grant sub-licenses to SUB-LICENSEES in the
DOMAIN OF THE AGREEMENT and in the TERRITORY OF THE AGREEMENT on
condition of having obtained prior written consent from the
INSTITUTIONS as to the person of the SUB-LICENSEES and the terms
of the sub-license agreement. Moreover, BIOSPHERE MEDICAL INC
agrees to convey to the INSTITUTIONS a copy of these sub-license
agreements within one (1) month of their signing.
3.2 BIOSPHERE MEDICAL INC will remain responsible to the INSTITUTIONS
for the execution by its SUB-LICENSEES of all obligations placed
on BIOSPHERE MEDICAL INC in this agreement.
Section 4 - TRANSFER OF THE LICENSE AGREEMENT
4.1 This agreement is entered into INTUITU PERSONAE. Accordingly, it
is personal, non-assignable and non-transferable subject to any
sub-licenses granted by BIOSPHERE MEDICAL INC in compliance with
the stipulations of 1.2 and 3 of this agreement and stipulations
of 4.2 below.
4.2 In the case of the take-over, merger, absorption, assignment or
transfer of BIOSPHERE MEDICAL INC or of its activities to another
legal entity or any other transformation of BIOSPHERE MEDICAL INC
seeking to modify the INTUITU PERSONAE characteristics taken into
account for this Agreement, this Agreement many not be transferred
or assigned except with the consent of the INSTITUTIONS. This
consent can only be refused if the INSTITUTIONS justify it in
writing within thirty (30) days of notification by BIOSPHERE
MEDICAL INC that the transfer of this agreement would place it in
a conflict of interest. Without a duly explained refusal within
thirty (30) days of receipt of notice from BIOSPHERE MEDICAL INC
informing the INSTITUTIONS of a request to transfer, the consent
will be deemed granted and the transfer may take place
automatically.
In the case of the consent by the INSTITUTIONS, it is now agreed
that the said legal entity will be, in any event, subject to the
same obligations as those placed on BIOSPHERE MEDICAL INC in this
agreement, unless the new parties together agree otherwise.
5
A supplement to this agreement between the INSTITUTIONS and the
said legal entity must be prepared simultaneous to the merger or
transfer executed with BIOSPHERE MEDICAL INC in which the option
chosen by the new parties, in compliance with the previous
paragraph, is set out.
Section 5 - DELIVERY OF KNOW-HOW
BIOSPHERE MEDICAL INC acknowledges that it has received the
KNOW-HOW OF THE AGREEMENT before the DATE OF COMING INTO FORCE.
Section 6 - WORKING
6.1 BIOSPHERE MEDICAL INC agrees to work this license and to apply
diligence to develop, manufacture and sell the PRODUCTS OF THE
AGREEMENT in the DOMAIN OF THE AGREEMENT and in the TERRITORY OF
THE AGREEMENT and to find markets, especially by use of serious
commercial marketing and reasonable advertising efforts.
BIOSPHERE MEDICAL INC agrees to satisfy the orders it receives by
delivering the PRODUCTS OF THE AGREEMENT within the shortest
possible time and to ensure product support.
6.2 BIOSPHERE MEDICAL INC, without prejudice to what is provided in
the following paragraph, is prohibited from using for commercial
promotion purposes the names "Centre National de la Recherche
Scientifique" or "CNRS" or UNIVERSITE XXXXX XXXXXXX - STRASBOURG
1", any trademark or distinctive sign belonging to the
INSTITUTIONS and any adaptation of them as well as the name of the
inventors and of any agent of the INSTITUTIONS without having
received in advance of any such use the written consent of the
INSTITUTIONS and, where appropriate, of the individual person
concerned.
Only to provide information on the origin of the license, the
words "CNRS-UNIVERSITY XXXXX XXXXXXX-STRASBOURG 1 License" may
appear on any advertising document, technical or explanatory
materials related to the PRODUCTS OF THE AGREEMENT. It is the
responsibility of BIOSPHERE MEDICAL INC to ensure that this
notice, because of its form or the context in which it is placed,
cannot be construed as a warranty offered by the INSTITUTIONS
concerning the PRODUCTS OF THE AGREEMENT.
BIOSPHERE MEDICAL INC must impose the same obligations on any
SUB-LICENSEES and DISTRIBUTORS.
6.3 BIOSPHERE MEDICAL INC hereby acknowledges that it has the
competence required to use the KNOW-HOW OF THE AGREEMENT and the
PATENTS OF THE AGREEMENT and to develop, use, manufacture or
market the PRODUCTS OF THE AGREEMENT.
6
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
6.4 BIOSPHERE MEDICAL INC will market the PRODUCTS OF THE AGREEMENT
under its own trade names or those for which it has regularly
obtained a license. The INSTITUTIONS may not claim any right to
these trade names or to the clientele of BIOSPHERE MEDICAL INC.
Any administrative authorization obtained by BIOSPHERE MEDICAL INC
for the manufacture and/or marketing of the PRODUCTS OF THE
AGREEMENT will be done on behalf of BIOSPHERE MEDICAL INC or any
person it designates; the INSTITUTIONS may not, subject to what is
provided in 6.5 below, claim any right to any of them.
6.5 Notwithstanding the stipulations of 6.4 above, BIOSPHERE MEDICAL
INC agrees to convey to the INSTITUTIONS a copy of all
administration authorizations (including Marketing Authorizations)
it obtains in order to manufacture and/or market the PRODUCTS OF
THE AGREEMENT.
Section 7 - FINANCIAL TERMS AND CONDITIONS
7.1 In consideration for this agreement, BIOSPHERE MEDICAL INC shall
pay CNRS on behalf of the INSTITUTIONS the following amounts:
7.1.1 Royalties
DIRECT WORKING
In case of direct working, BIOSPHERE MEDICAL INC shall pay
CNRS on behalf of the INSTITUTIONS an annual royalty equal
to [**] of NET SALES. This royalty is payable on all
PRODUCTS OF THE AGREEMENT sold, whatever the country of
the TERRITORY OF THE AGREEMENT where the PRODUCTS OF THE
AGREEMENT are sold.
INDIRECT WORKING
In case of indirect working, BIOSPHERE MEDICAL INC shall
pay CNRS on behalf of the INSTITUTIONS [**] of the sums of
all kinds (lump sums, royalties, guarantee minimums, etc.)
received by BIOSPHERE MEDICAL INC from its SUB-LICENSEES,
whether these payments are due upon the signing of the
sub-license agreements or at later stages of their
implementation. The above notwithstanding, the lump sums
paid to BIOSPHERE MEDICAL INC by SUB-LICENSEES as part of
research and development agreements containing sub-license
of PATENTS OF THE AGREEMENT will not be included in the
royalty base provided herein.
7
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
In order to avoid any ambiguity, if BIOSPHERE MEDICAL INC
were to sell PRODUCTS OF THE AGREEMENT to a third party
(including a DISTRIBUTOR), who then resells them, only the
sale of BIOSPHERE MEDICAL INC results in the payment of
royalties to the INSTITUTIONS (at the rate of [**]), the
INSTITUTIONS not collecting any royalty on the resale of
the PRODUCTS OF THE AGREEMENT by this third party.
7.1.2 Guarantee Minimum Annual Royalties
a) Starting in 1999, BIOSPHERE MEDICAL INC guarantees
the INSTITUTIONS a minimum annual royalty of [**].
b) BIOSPHERE MEDICAL INC may be released from these
guaranteed minimums on condition of its notifying
CNRS of its intention at least three months before
the planned date of the annual closing of the
accounts of BIOSPHERE MEDICAL INC (as provided in
Section 8) by registered letter with acknowledgement
of receipt. The INSTITUTIONS may then either convert
the exclusive license into a non-exclusive license or
cancel this agreement by applying the cancellation
clauses.
In case of conversion of the exclusive license into a
non-exclusive license, the guaranteed minimums will
not longer be due by BIOSPHERE MEDICAL INC starting
on January 1 of the fiscal year after the conversion
of the exclusive license into a non-exclusive
license.
7.2 Either PARTY may ask for revision of the financial terms and
conditions of the license if as a result of economic imbalances
that it will be the responsibility of the said PARTY to
demonstrate, the balance of contractual relations has been
modified to the point of making it prejudicial to execute its
obligations. As long as the PARTIES have not signed a
supplementary agreement formalizing their agreement on the amount
of these revised rates or on the definition of the royalty base,
the rates and base provided herein remain payable.
7.3 Any change to the financial conditions of this license must be the
subject of a complementary agreement.
Such revision may in no case be retroactive and will only take
effect starting on January 1 of the year following the change.
Section 8 - ACCOUNTING - MONITORING OF ROYALTIES
8.1 BIOSPHERE MEDICAL INC will keep accounting records from which can
be identified all elements necessary for the accurate evaluation
of the commercial transactions related to this Agreement.
8
BIOSPHERE MEDICAL INC agrees to have this obligation to keep
appropriate accounting records respected by its SUB-LICENSEES.
The accounts will end each year on the date on which BIOSPHERE
MEDICAL INC closes its books for the year, i.e. December 31.
8.2 Any payment of royalties due under this Agreement will be preceded
by the sending by BIOSPHERE MEDICAL INC to CNRS of a statement of
commercial transactions related to this Agreement on which will
appear:
- the number of this License Agreement,
- the NET SALES by country for each PRODUCTS OF THE AGREEMENT,
as well as the sums of any kinds received by BIOSPHERE MEDICAL
INC from its SUB-LICENSEES,
- the applicable rate,
- the calculation of the sums due to the INSTITUTIONS.
Such statement of commercial transactions will be sent each year
to the Service Financier, Delegation du Siege du CNRS, 0 xxx
Xxxxxx-Xxxx, 00000 XXXXX Cedex 16 within 30 (thirty) days of the
closing of the accounts of BIOSPHERE MEDICAL INC.
The sums due from BIOSPHERE MEDICAL INC must be paid within 35
(thirty-five) days of the date of the issuing of an invoice by
CNRS, to the person and the bank address shown below.
Payments will be made to CNRS by cheque payable to the Agent
Comptable Principal du CNRS, Paierie Generale Paris - Bank code:
30091 - Branch Code: 75200 - Account. No. 20003000336- Key 91.
Cheques are sent to the attention of the Agent Comptable Principal
du CNRS, 0 xxx Xxxxxx-Xxxx - 00000 XXXXX Cedex 16.
8.3 The sums due to the INSTITUTIONS will be paid in French francs (or
in euros when this currency replaces French francs).
It should be remembered that the French franc (and other
currencies of the European Monetary System) will be replaced by
the euro, sole European currency, in application of the Treaty of
the European Union.
As provided by the general principles of currency law, references
to francs (or other EMS currencies) will then be automatically
considered references to the euro.
This substitution will not in itself amend the terms of the
agreement or waive its execution or give one PARTY the right
unilaterally to amend or terminate it. It will occur on the date
and in the conditions defined by community regulations.
9
8.4 Where no commercial transaction is performed, BIOSPHERE MEDICAL
INC must nevertheless send CNRS within 30 (thirty) days of the
date that BIOSPHERE MEDICAL INC closes its books each year
indicated in 8.1 above, a statement attesting to the absence of
any operation during that year and indicating the causes of the
absence of sales.
8.5 Any amount not paid by BIOSPHERE MEDICAL INC within the times
given above will result in interest charged on sums overdue,
calculated pro rated according to the rules applicable to French
Public Institutions (which, at the DATE OF COMING INTO FORCE, was
the current legal interest rate increased by 2 points) without
prejudice to the right of the INSTITUTIONS to cancel this
agreement in application of section 14, Cancellation.
8.6 The sums due by BIOSPHERE MEDICAL INC to CNRS on behalf of the
INSTITUTIONS will be increased by the legal taxes in force on the
date they are due, in particular the V.A.T. if applicable.
8.7 Any accounting will be deemed available to the INSTITUTIONS or a
representative authorized by them until the date of expiration of
this agreement extended by 1 (one) year. The INSTITUTIONS will
have the right to check the accuracy of the royalty accounts of
BIOSPHERE MEDICAL INC During such a check a public accountant will
be designated by the INSTITUTIONS and his fees and expenses will
be paid by the INSTITUTIONS except if there is an adjustment of
more than 5% (five percent) of the amount of the sums actually
paid by BIOSPHERE MEDICAL INC as the result of this check, in
which case the expenses and fees of the public accountant will be
paid by BIOSPHERE MEDICAL INC.
8.8 The sums collected by CNRS on behalf of the INSTITUTIONS under
this agreement in any case belong to it definitively and
irremediably, and may in no case be restored to BIOSPHERE MEDICAL
INC. Moreover, any sums remaining due by BIOSPHERE MEDICAL INC on
the date of expiration or cancellation of this agreement may be
paid to CNRS on behalf of the INSTITUTIONS.
Section 9 - NON-DISCLOSURE
9.1 Each PARTY agrees to keep confidential the scientific and
technical information belonging to the other PARTY and any
information of any kind relative to the other PARTY it may learn
during the pre-contractual negotiations or on the occasion of the
execution of this Agreement. Each PARTY will not publish or convey
any or all of the confidential information to third parties except
with the written consent of the other PARTY.
BIOSPHERE MEDICAL INC agrees in particular to keep confidential
and maintain confidential all the knowledge that is conveyed to it
as part of the KNOW-HOW OF THE AGREEMENT.
10
The PARTIES agree to have the same undertaking made by their
personnel and any person attached to their service in any
capacity.
The confidentiality agreements reciprocally binding on the PARTIES
as provided herein do not apply to the information for which the
PARTY that receives it can prove:
a) that it was disclosed them after obtaining prior written
authorization from the other PARTY or the disclosure was made
by the other PARTY;
b) that it was in the public domain at the time it was conveyed
by the other PARTY or that it fell into the public domain
after this release without its fault;
c) that it was received from a third party legitimately;
d) that at the date it was conveyed by the other PARTY, it was
already in its possession;
e) that its disclosure was imposed by the application of a legal
provision or required regulation or by the application of a
final court decision or an arbitration ruling.
The exceptions listed above are not cumulative.
9.2 Each PARTY agrees not to file an application for a patent or other
industrial property title including the confidential information
of the other PARTY without having obtained the other PARTY's prior
written authorization to do so.
9.3 This confidentiality requirement will remain in force throughout
this Agreement and for 5 (five) years after its expiration or
cancellation.
9.4 The stipulations of this section may not obstruct:
- the obligation on researchers of each of the PARTIES to this
agreement to produce a progress report to the organization to
which they report, this report not being a disclosure in the
meaning of the Industrial Property laws,
- the defense of theses by researchers whose scientific activity
is related to the subject of this Agreement;
- the dissemination by BIOSPHERE MEDICAL INC of documents
seeking to promote the marketing of the PRODUCTS OF THE
AGREEMENT.
Section 10 - MAINTAINING THE PATENTS OF THE AGREEMENT IN FORCE
10.1 The fees for maintaining in force of the PATENTS OF THE
AGREEMENT will be paid the responsibility of CNRS starting from
the DATE OF COMING INTO FORCE.
11
10.2 If for any reason CNRS decides to abandon one of the PATENTS OF
THE AGREEMENT, it must so inform BIOSPHERE MEDICAL INC, with
reasonable advance notice. BIOSPHERE MEDICAL INC may then take
over for CNRS in maintaining this PATENT OF THE AGREEMENT in
force.
If the PATENTS OF THE AGREEMENT are licensed to other licensees
than BIOSPHERE MEDICAL INC and if CNRS decides to stop paying
the Industrial Property expenses for some or all of the said
patents, it is agreed that section 10.2 of this agreement must
be adjusted through a supplementary agreement to allow a
distribution among all licensees of the Industrial Property
expenses not assumed by the INSTITUTIONS .
10.3 It will be up to BIOSPHERE MEDICAL INC to ask CNRS by registered
letter with acknowledgement of receipt to request a
complementary protection certificate with PATENTS OF THE
AGREEMENT OR ANY EQUIVALENT TITLE. BIOSPHERE MEDICAL INC will
take care of undertaking this step sufficiently in advance to
enable the delivery of the certificate or title. In any case,
this procedure will be done at the risks and expense of
BIOSPHERE MEDICAL INC. CNRS may not oppose this request except
for reasonable and detailed reasons. In no case may CNRS be held
responsible except for gross negligence on its part for the
failure of this procedure.
Section 13 - WARRANTIES
11.1 This Agreement is made with no other warranty than that of the
material existence of the PATENTS OF THE AGREEMENT and the
KNOW-HOW OF THE AGREEMENT. In application of this Section, the
INSTITUTIONS offer no warranty, explicit or implicit, concerning
the PATENTS OF THE AGREEMENT and the KNOW-HOW OF THE AGREEMENT,
in particular with respect to their usefulness or suitability
for any function.
11.2 Possible random events, risks and perils with respect to the
execution of this Agreement and any legal defects contained in
one or more of the PATENTS OF THE AGREEMENT are the
responsibility of BIOSPHERE MEDICAL INC alone, which accepts
them. Accordingly, in case of the rejection or cancellation of
one or more of the PATENTS OF THE AGREEMENT, the dependence of
the said patents on a prior dominating patent, in case where the
PRODUCTS OF THE AGREEMENT because of the use of the PATENTS OF
THE AGREEMENT or the KNOW-HOW OF THE AGREEMENT were declared
infringed by a final court decision, the INSTITUTIONS will not
be required either to return the sums already paid by BIOSPHERE
MEDICAL INC nor reduce those due until the date of the final
legal decision nor the payment of any damages to BIOSPHERE
MEDICAL INC in compensation for the harm caused by such
rejection, cancellation, dependence or infringement.
12
11.3 BIOSPHERE MEDICAL INC may not call the INSTITUTIONS in warranty
in case of damage or prejudice of any kind caused by the
PRODUCTS OF THE AGREEMENT, since BIOSPHERE MEDICAL INC is solely
responsible to its customers and/or any third parties for the
quality and performances of the PRODUCTS OF THE AGREEMENT.
11.4 BIOSPHERE MEDICAL INC is solely responsible for ensuring that
the PRODUCTS OF THE AGREEMENT are compliant with applicable laws
and regulations.
Section 12 - DISALLOWANCE - NULLITY
If in the TERRITORY OF THE AGREEMENT, an administrative decision
or a final court decision disallows wholly or in part and/or
nullifies wholly or in part one or more of the PATENTS OF THE
AGREEMENT and/or restricts the liberty of its working, BIOSPHERE
MEDICAL INC may not claim from the INSTITUTIONS any
compensation, reimbursement, reduction of sums due at the time
of the issuing of the administrative or final court decision.
Thereafter, BIOSPHERE MEDICAL INC:
- must, as long as no appreciable competition arises in this
country, continue to pay the INSTITUTIONS for the country
considered, in consideration for the KNOW-HOW OF THE
AGREEMENT, the compensation provided in section 7 of this
Agreement.
- may, starting from the time where appreciable competition
appears in this country, negotiate a new compensation due from
BIOSPHERE MEDICAL INC to the INSTITUTIONS, it being understood
that all other stipulations of this Agreement will continue in
any case to apply for the PATENTS OF THE AGREEMENT still in
force.
Section 13 - INFRINGEMENTS
13.1 The INSTITUTIONS and BIOSPHERE MEDICAL INC will inform each
other as soon as possible of any case of infringement by a third
party of which they learn and/or of any claim or action for
infringement that targets them.
13.2 a)If in the case of infringement of one or more of the
PATENTS OF THE AGREEMENT by a third party, the INSTITUTIONS
may take action at their expense against the infringing party,
it being understood that any compensation and damages awarded
by the court will completely and irrevocably belong to the
INSTITUTIONS.
13
This stipulation will not obstruct BIOSPHERE MEDICAL INC from
intervening in the case, at its expense, to obtain
compensation for its own injury. The compensation and damages
that may be awarded at the outcome of such a suit will then be
completely and irrevocably theirs.
b)If the INSTITUTIONS take no action, BIOSPHERE MEDICAL INC
may, if it so desires, after formal notice of action addressed
to CNRS - by registered mail with acknowledgement of receipt
-- that has been more than one month without response, file
xxx for infringement on its own initiative and on its own
behalf. In this case, the cost of the proceedings will be paid
solely by it, and any compensation and damages awarded by the
court will then be completely and irrevocably theirs.
c)The stipulations of 13.2 b) above are applicable subject to
the compulsory legal provisions applicable in the country
where the infringement takes place.
d)The stipulations of 13.2 do not apply to cases of
infringement of the PATENTS OF THE AGREEMENT outside the
DOMAIN OF THE AGREEMENT and the TERRITORY OF THE AGREEMENT and
the PRODUCTS OF THE AGREEMENT, which are under the
jurisdiction of the INSTITUTIONS alone or of any third party
they so designate.
13.3 If suits for infringement are filed against BIOSPHERE MEDICAL
INC or any of its SUB-LICENSEES or DISTRIBUTORS on the occasion
of the working of the PRODUCTS OF THE AGREEMENT, because of the
use of the PATENTS OF THE AGREEMENT and/or the KNOW-HOW OF THE
AGREEMENT, the INSTITUTIONS will convey to BIOSPHERE MEDICAL INC
the elements they have available for its defense or for the
defense of its SUB-LICENSEES or DISTRIBUTORS. If at the outcome
of such a suit for infringement, the said companies are found
guilty, BIOSPHERE MEDICAL INC will hold the INSTITUTIONS safe;
as provided in section 11, BIOSPHERE MEDICAL INC is not allowed
to call them in guarantee or claim from the INSTITUTIONS any
compensation, reimbursement of sums of any kind already paid to
the INSTITUTIONS or any reduction of sums already due at the
time of the final court decision. In case of the cancellation of
one of the PATENTS OF THE AGREEMENT, the provisions of sections
11 and 12 will be applied without being overridden.
13.4 The PARTIES agree to provide each other with all documents and
elements it may need on the occasion of such proceedings as
described above.
14
Section 14 - CANCELLATION - EXPIRATION
14.1 This Agreement will be automatically cancelled in case of
cessation of activity, dissolution or bankruptcy of BIOSPHERE
MEDICAL INC.
If BIOSPHERE MEDICAL INC becomes the object of bankruptcy
proceedings and the INSTITUTIONS want to cancel this Agreement,
the INSTITUTIONS will so inform BIOSPHERE MEDICAL INC by
registered mail with acknowledgement of receipt. Subject to the
compulsory legal provisions applicable in the case of class
action proceedings in force in the United States in the State of
Massachusetts, this Agreement will be cancelled automatically 3
(three) months after the sending by CNRS of a registered letter
with acknowledgement of receipt setting out the reasons for the
cancellation.
14.2 This Agreement may be cancelled by either of the PARTIES in case
of failure of the other PARTY to execute one or more of the
obligations contained in its various clauses, in particular
Section 6 (Working) and Section 7 (Financial Terms and
Conditions). This cancellation will take effect only 3 (three)
months after the complaining PARTY has sent a registered letter
with acknowledgement of receipt setting out the reasons for the
complaint unless within that time, the defaulting PARTY has
satisfied its obligations or provided proof of its being
prevented from doing so as the result of a case of force
majeure. The exercise of this cancellation option does not
relieve the defaulting party from satisfying the obligations
contracted until the date the cancellation takes effect, without
prejudice to the payment of damages due by the defaulting PARTY
in compensation for the prejudice experienced by the complaining
PARTY from the early cancellation of this Agreement.
14.3 In case of cancellation of this Agreement, the sub-licensing
agreements entered into with the SUB-LICENSEES before the
cancellation date of this Agreement may only remain in force
subject to a written agreement, negotiated in good faith,
between the INSTITUTIONS and the said SUB-LICENSEES.
14.4 If this Agreement expires or is cancelled, BIOSPHERE MEDICAL INC
agrees:
- to no longer work and not to allow the direct or indirect
working of the PATENTS OF THE AGREEMENT until they expire;
- not to disclose and not to work or let work directly or
indirectly the KNOW-HOW OF THE AGREEMENT as long as the
KNOW-HOW OF THE AGREEMENT has not become a matter of the
public record;
- to restore to the INSTITUTIONS within the month following the
expiration or the cancellation of this Agreement, all
documents and materials that the INSTITUTIONS may have sent it
without being able to keep copies.
15
Moreover, in case of early cancellation of this license, BIOSPHERE
MEDICAL INC agrees to send to the INSTITUTIONS all the results
obtained on the invention covered by the PATENTS OF THE AGREEMENT or
by using the KNOW-HOW OF THE AGREEMENT and authorizes the
INSTITUTIONS to communicate them to third parties subject to the
signature by the said third parties of a non-disclosure agreement and
to work, directly or indirectly, the said results.
Section 15 - INVENTORIES
If BIOSPHERE MEDICAL INC or its SUB-LICENSEES has PRODUCTS OF THE
AGREEMENT in stock on the date of the expiration or cancellation of
this Agreement, they will be authorized to sell these PRODUCTS OF THE
AGREEMENT within 6 (six) months after the expiration or cancellation
date of this Agreement, subject first to sending the INSTITUTIONS on
the date of expiration or cancellation of this Agreement an inventory
list and send to respecting the conditions of Section 7 herein with
respect to the financial terms and conditions.
Section 16 - TOTALITY AND LIMITS OF THE AGREEMENT
16.1 This Agreement expresses all of the obligations of the PARTIES
relative to its object. No general or specific conditions
appearing in the documents sent or given to the PARTIES may be
included in this Agreement.
16.2 This Agreement may not be amended or renewed except by a
Complementary Agreement signed by the duly authorized
representatives of the PARTIES.
16.3 It is stipulated that the relationships being established
between the PARTIES under this Agreement confer no right other
than those mentioned herein. It is understood that this
Agreement does not contain, in particular, assignment for the
benefit of BIOSPHERE MEDICAL INC of any right outside the DOMAIN
OF THE AGREEMENT and the TERRITORY OF THE AGREEMENT and the
PRODUCTS OF THE AGREEMENT nor any right on the patents other
than the PATENTS OF THE AGREEMENT or any know-how other than the
KNOW-HOW OF THE AGREEMENT.
Section 17 - HEADINGS
In case of problems in interpretation between any of the headings of
the clauses and any of the clauses, the headings are declared
non-existent.
16
Section 18 - NULLITY OF ONE CLAUSE
If one or more stipulations of this Agreement are considered invalid
or declared so by application of a law, a regulation - and in
particular the law of the European Union - or after a final decision
of a competent jurisdiction, the other stipulations will retain all
their force and scope, and the PARTIES will proceed without delay to
make the necessary modifications while respecting, wherever possible,
the meeting of the minds present at the time this Agreement is
signed.
Section 19 - WAIVER
The fact that one of the PARTIES is unable to act on the failure by
the other PARTY to satisfy one of the obligations contained herein
may not be construed for the future as being a waiver of the
obligation involved.
Section 20 - DISPUTES - APPLICABLE LAW
20.1 In case of a disagreement involving the validity, interpretation
or execution of this Agreement, the PARTIES will attempt to
resolve their differences out of court.
20.2 In case of persistent disagreement, the dispute will be brought
before the competent French jurisdictions and this Agreement
will be subject to French laws and regulations.
20.3 This Section will remain in force notwithstanding the expiration
or cancellation of this Agreement.
Section 21 - REGISTRATION IN THE NATIONAL REGISTER OF PATENTS
21.1 This Agreement may be registered in the National Register of
Patents, kept by the Institut National de la Propriete
Industrielle (National Institute of Industrial Property) and the
national registers of patents kept by the national offices of
Industrial Property concerned by the PATENTS OF THE AGREEMENT at
the case and expense of BIOSPHERE MEDICAL INC.
21.2 Any tax registration required for this Agreement will be done by
BIOSPHERE MEDICAL INC at its expense.
Section 22 - LANGUAGES
This Agreement has been established only in the French language.
17
Section 23 - NOTICE
Any notice required for this Agreement will be sent by registered
mail with acknowledgment of receipt, to the PARTY concerned at the
following address:
For the INSTITUTIONS
CNRS
Delegation aux Entreprises
0 xxx Xxxxxx Xxxx
00000 XXXXX Cedex 16
for BIOSPHERE MEDICAL INC
BIOSPHERE MEDICAL INC
Attention: Xx. Xxxx-Xxxxx XXXXX
000 Xxxxx Xxxxxx
Xxxxxxxxxxx, XX
00000 Xxxxxx Xxxxxx
Done in three original copies, one for CNRS, one for UNIVERSITE and one
for BIOSPHERE MEDICAL INC.
Done in Paris JULY 15, 1999 signed in MARLBOROUGH
JUNE 6, 1999
For the Directeur General
and per
Assistant to the Delegue aux Entreprise
Xxxxxx BAIXERDAS
[signature] [signature]
Xxxxxxxxx XXXXXXXXXX Xxxx-Xxxxx XXXXX
Directeur General du CNRS President, CEO of
BIOSPHERE MEDICAL INC
[signed]
President of ULP
J.Y. MERINDOL
per JULY 2, 1999
Vice President, Research and Doctoral Training
X. XXXXXXXXX
Xxxx-Xxxx MERINDOL
President of the UNIVERSITE XXXXX XXXXXXX STRASBOURG 1
18
SCHEDULE 1
LIST OF PATENTS OF THE AGREEMENT
19
LIST OF LIPOPOLYAMINE PATENTS
COUNTRY TYPE HOLDERS FILED PUBLICATION AGREEMENT EXPIRATION PROCEDURE
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
GERMANY EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
AUSTRIA EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
BELGIUM EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
CANADA NP CNRS 12 APR 1990 12 APR 2016 Examination
18 MAR 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
DENMARK EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
SPAIN EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
UNITED STATES NP CNRS 17 APR 1990 15 DEC 1992 17 APR 2010 Agreement
15 DEC 1992
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
UNITED STATES CNT CNRS 31 JUL 1992 Abandoned
03 FEB 1994
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
UNITED STATES CNTI CNRS 03 FEB 1994 19 DEC 1995 19 DEC 2012 Agreement
19 DEC 1995
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
UNITED STATES DIV1 CNRS 07 JUN 1995 01 APR 1997 01 APR 2014 Agreement
01 APR 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
FRANCE CNRS 17 APR 1989 19 OCT 1990 15 JUL 1991 17 APR 2009 Agreement
05 JUL 1991
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
FRANCE EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
GREECE EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
20
COUNTRY TYPE HOLDERS FILED PUBLICATION AGREEMENT EXPIRATION PROCEDURE
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
ISRAEL CNRS 12 APR 1990 30 MAR 1997 12 APR 2010 Agreement
30 mar 1993
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
ITALY EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
JAPAN CNRS 17 APR 1990 29 OCT 1997 17 APR 2016 Agreement
29 OCT 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
LUXEMBOURG EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010 Agreement
04 JUN 1997
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
NETHERLANDS EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
EUROPEAN PROC. EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
UNITED KINGDOM EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
SWEDEN EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
SWITZERLAND EPO CNRS 13 APR 1990 24 OCT 1990 04 JUN 1997 13 APR 2010
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
COUNTRY TYPE HOLDERS FILED PUBLICATION AGREEMENT EXPIRATION PROCEDURE
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
FRANCE DIVI CNRS 24 JUL 1989 26 OCT 1990 05 JUL 1991 12 APR 2009 Agreement
05 JUL 1991
-------------------- ---------- ------------ ---------------- ----------------- --------------- ------------------- ----------------
21
