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EXHIBIT 10.6
PATENT AND KNOW-HOW LICENSE
N(DEGREE) L99102
BY AND BETWEEN
The CENTRE NATIONAL DE RECHERCHE SCIENTIFIQUE, a French scientific and
technological public establishment, having a registered office at 0 xxx
Xxxxxx-Xxxx - 00000 XXXXX Xxxxx 00 - Xxxxxx represented by its General Manager,
Mrs. Xxxxxxxxx XXXXXXXXXX, hereinafter referred to as "CNRS"
ON ONE HAND
AND
GLOBAL OXYCELL INC., a US limited liability company whose registered office is
One East Broward Blvd, Suite 1701, Xxxx Xxxxxxxxxx, Xxxxxxx 00000 - USA
represented by its Chief Executive Officer, Xx. Xxxx XXXXXXX, hereinafter
referred to as "OXYCELL"
ON THE OTHER HAND
The CNRS and OXYCELL are hereinafter jointly referred to as "PARTIES".
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WHEREAS:
The LABORATORY and in particular, the group directed by Mr. Xxxx-Xxxxx XXXX has
been working for many years on the biological applications of supramolecular
chemistry.
Certain research performed in this LABORATORY and concerning the design and
evaluation of artificial vectors for gene transfer, has resulted in the filing
of the international PCT application on February 28, 1997, N(degree) PCT/ FR 97
00364 under priority of two French patent application N(degree) 96.02604 and
N(degree) 96.09557, in the name of the CNRS.
Moreover a US patent application N(degree) US/60-150,574 has been filed on
August 26, 1999 entitled "Enhanced oxygen delivery in mammals, methods and
reagents related thereto", in the name of OXYCELL and naming as inventors Xx.
Xxxxxx Xxxxxxx and Mr. Xxxx-Xxxxx XXXX.
OXYCELL has expressed an interest in obtaining an exclusive and worldwide patent
and know-how license from the CNRS for the research work mentioned herein in
certain therapeutic fields.
NOW, THEREFORE THE PARTIES AGREE AS FOLLOWS:
Preliminary Article - DEFINITIONS
AFFILIATES shall mean any legal entity which, at the time in question:
- directly or indirectly controls OXYCELL; or
- is under the same direct or indirect control as OXYCELL; or
- is directly or indirectly controlled by OXYCELL.
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 conducted.
CONTRACT FIELD shall mean the field of therapeutic, prophylactic
products for oxygen delivery into human and animal cells, including but
not limited to improvements in oxygen delivery following disease
impacted occurrences such as heart stroke and peripheral vascular
diseases, diabetes, and sickle cell anemia.
CONTRACT KNOW-HOW, shall mean all the scientific, technical or any
other knowledge in relation to the implementation of the invention
protected by the CONTRACT PATENTS and acquired by the LABORATORY during
its research until the EFFECTIVE DATE.
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CONTRACT PATENTS shall mean the PCT patent application N(degree)
PCT/FR/97/00364 filed on February 28, 1997 entitled "Composes
apparentes a la famille des amidiniums. Compositions pharmaceutiques
les contenant et leurs applications", in the name of CNRS and naming as
inventors Xxxx-Xxxxx XXXX, Xxxxxx XXXX and Xxxx-Xxxxxx XXXXXXXX, filed
under priority of the French patent application filed on March 1, 1996,
in the name of CNRS, N(degree) 96.02604, entitled "Composes apparentes
a la famille des amidiniums. Compositions pharmaceutiques les contenant
et leurs applications", and of the French patent application filed on
July 30, 1996, in the name of CNRS, N (degree) 96.09557, entitled
"Composes apparentes a la famille des amidiniums. Compositions
pharmaceutiques les contenant et leurs applications", as well as all
issued patents, in part or in full, whether based upon or claiming
priority to the above application and all rights resulting therefrom
including without limitation (i) any and all European and foreign
patent applications and patents resulting from the above-mentioned
French patent applications, which shall be listed under Exhibit A (ii)
the patents proceeding from such applications, and (iii) all
continuations, divisions, continuations-in-part, reissues,
re-examinations, and extensions thereof.
CONTRACT PRODUCTS, shall mean any products which (i) are covered by a
VALID CLAIM of CONTRACT PATENTS and/or the US PATENT in the
jurisdiction where the products are developed, manufactured and/or sold
(referred to hereafter as PATENTED CONTRACT PRODUCTS), (ii) would be
covered by a VALID CLAIM of CONTRACT PATENTS in countries not listed in
Exhibit A, had such CONTRACT PATENTS been filed in the jurisdiction
where the products are manufactured and sold and are developed on the
basis of the CONTRACT KNOW-HOW (referred to hereafter as KNOW-HOW
CONTRACT PRODUCTS). It is understood by the PARTIES the products which
would fall under the definition of CONTRACT PRODUCTS in the countries
where no CONTRACT PATENTS has been filed are necessarily the same
products that those covered by a VALID CLAIM of CONTRACT PATENTS in
countries where CONTRACT PATENTS are granted.
CONTRACT TERRITORY shall mean the entire world.
EFFECTIVE COMPETITION shall mean a situation in which one or more third
parties, in a country of the CONTRACT TERRITORY, is marketing a product
using the same chemical entity, which competes with a CONTRACT PRODUCT
in the CONTRACT FIELD and the third party's product's sales for a
calendar quarter are at least 15% (fifteen percent) 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 at least 15% (fifteen percent) 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. It is understood by the PARTIES that EFFECTIVE
COMPETITION shall only apply in countries where no CONTRACT PATENTS
have been granted.
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EFFECTIVE DATE, shall mean the last date of signature of the present
Agreement by the PARTIES.
LABORATORY shall mean the Unite Propre de Recherche CNRS n(degree) 285,
"Chimie des Interactions Moleculaires", which is (i) part of the CNRS
and (ii) legally represented by the CNRS.
NET SALES, shall mean the gross amount received by OXYCELL and its
AFFILIATES from their customers including distributors but excluding
SUBLICENSEES, for sales of CONTRACT PRODUCTS, less any normal trade
discounts and credit notes and refunds issued in respect of returned
CONTRACT PRODUCTS, purchase, sales, import, or value added taxes and
charges in respect to carriage, freight and delivery costs, discounts
or rebates accrued, incurred or paid to Federal Medicaid or State
Medicare or other payors and amounts exactly repaid or credited by
reason of rejections or the return of Contract Products (due to
recalls, dating or other reasons).
Should OXYCELL sell CONTRACT PRODUCTS to an AFFILIATE (or vice-versa)
which thereafter sell them to an unrelated third party, the sales
between the AFFILIATE (or OXYCELL) and the unrelated third party (and
not the sales between OXYCELL and its AFFILIATE) shall be considered
NET SALES.
In the event that a CONTRACT PRODUCT is sold as part of a combination
product, the NET SALES of the CONTRACT PRODUCT, for the purposes of
determining royalty payments, shall be determined by multiplying the
Net Sales (as defined in this Section) of the combination product by
the fraction, A/(A+B) where A is the average sale price of the CONTRACT
PRODUCT when sold separately in finished form and B is the average sale
price of the other active compound(s) sold separately in finished form.
In the event that such average sale price cannot be determined for both
the CONTRACT PRODUCT and other active compound(s) in combination, NET
SALES for purposes of determining royalty payments shall be calculated
by multiplying the net sales of the combination products by the
fraction C/(C+D) where C is OXYCELL's cost of goods of the CONTRACT
PRODUCT and D is OXYCELL's cost of goods of the other active
compound(s), determined in accordance with the method of accounting
normally employed by OXYCELL in computing cost of goods.
SUBLICENSEES, shall mean any third parties who may obtain a sublicense
from OXYCELL to develop and/or commercially exploit the CONTRACT
PRODUCTS in the CONTRACT FIELD.
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SUBLICENSE REVENUES, shall mean consideration of any kind received by
Oxycell or its AffiliateS, from their sublicenseeS for sales of
Contract Products, or for fees received, such as upfront fees or
milestone fees paid to Oxycell or an Affiliate in consideration for
such sublicense. However, not included in Sublicense Revenues are
amounts paid to Oxycell or an Affiliate by the sublicenseeS for product
development, research work, clinical studies and regulatory approvals
performed by or for the Oxycell or an Affiliate or third parties on
their behalf.
US PATENT, shall mean the US patent Application which has been filed
under n(degree) US/60-150,574 on August 26, 1999 entitled "Enhanced
oxygen delivery in mammals, methods and reagents related thereto" as
well as on any extensions in part or in full of the above application
and all rights resulting therefrom including but not only (i) any and
all European and non-US patent applications and patents based upon,
claiming priority to and/or resulting from the above mentioned US
PATENT application, (ii) the patents proceedings from such
applications, (iii) any US utility applications and (iv) all
continuations divisions, continuations-in-part, reissues,
reexaminations, and extensions thereof.
VALID CLAIM shall mean any claim of an issued and unexpired patent or a
claim of a pending patent application within the CONTRACT PATENTS, or
the US PATENT 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 such reversal.
All plurals may be read in the singular and vice versa.
Article 1 - OBJECT NATURE AND SCOPE
1.1 The CNRS hereby grant OXYCELL which accepts, subject to the terms and
conditions of the present Agreement, an exclusive license under the
CONTRACT PATENTS and CONTRACT KNOW-HOW to make, have made, sell, use,
import, market, offer for sale, have sold and otherwise commercially
exploit the CONTRACT PRODUCTS in the CONTRACT FIELD and the CONTRACT
TERRITORY.
1.2 The right to license granted to OXYCELL by the CNRS includes the right
to grant sublicenses.
1.3 By virtue of the present Agreement, OXYCELL (with respect to the
sublicensees' rights) will have the sole right to make, have made,
sell, use, import, market, offer for sale, have sold and otherwise
commercially exploit the CONTRACT PRODUCTS in the CONTRACT FIELD and
the CONTRACT TERRITORY.
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Article 2 - RENUNCIATION
CNRS hereby confirms that it waives all rights whatsoever, as of the
EFFECTIVE DATE, in the US PATENT in consideration of the payment of the
financial conditions in accordance with Article 6 of the present
Agreement.
Consequently, CNRS irrevocably and expressly waives any claim, law
suit, proceedings or other action which may have as purpose, reason or
consequence the ownership of, or the quiet and useful possession and
enjoyment of the US PATENT by OXYCELL or any other third party claiming
by or through OXYCELL.
The present Article shall remain in effect regardless of the expiration
or termination of the present Agreement.
Article 3 - TERM
Subject to the provisions of Article 2, 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 each country:
(a) In which VALID CLAIM exists, for the duration of the last
VALID CLAIM or for the duration of any extensions by a
Supplementary Protection Certificate or an equivalent
document.
(b) In which no VALID CLAIM exists, or no longer exists, for 10
(ten) years as of the date of the first commercialized
KNOW-HOW CONTRACT PRODUCT in such country.
It is expressly agreed that at the expiration of the term of the
present Agreement, OXYCELL shall have the continuing right to make,
have made, sell, use, import, market, offer for sale, have sold and
otherwise commercially exploit the CONTRACT PRODUCTS in the CONTRACT
FIELD and the CONTRACT TERRITORY without any further royalties.
Article 4 - SUBLICENSES
4.1 Pursuant to Article 1.2 herein, OXYCELL may grant sublicenses
to its AFFILIATES subject to providing prior written
notification to the CNRS of the identity of such Affiliate for
information purposes only.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
OXYCELL may also grant sublicenses to non Affiliates subject to prior
written approval from the CNRS of the name of any proposed SUBLICENSEE.
Such prior written approval may not be unreasonably withheld or
delayed. In the event OXYCELL desires to grant a sublicense to a non
AFFILIATE, it shall have the right to submit the form of the proposed
sublicense agreement to CNRS and within 30 (thirty) business days of
the receipt of that form CNRS shall issue a letter to OXYCELL stating
that the proposed agreement is in compliance with this Article 4 or, if
not, stating the changes required to make it compliant. If no such
response is received within such time period from CNRS, its approval
shall be deemed to have been given both as to the transaction and form
of sublicense.
It is expressly agreed by the PARTIES, that the Sublicense Agreement
may not contain any exchange in kind provision pursuant to which the
SUBLICENSEE will pay OXYCELL with its own products.
4.2 OXYCELL agrees, subject to the SUBLICENSEES approval, to include within
the terms of any sublicenses a clause which permits the CNRS to audit
the AFFILIATES and SUBLICENSEES accounts related to the present
Agreement.
4.3 OXYCELL shall include within the terms of any sublicense obligations of
confidentiality which are similar to those set out in Article 9 below.
Article 5 - TRANSFER
The present Agreement is granted intuitu personae. It is therefore
personal, non- transferable and non-assignable, except to an AFFILIATE,
without the prior written consent of the CNRS which shall not be
unreasonably withheld or delayed.
It is hereby understood that any company to which OXYCELL's rights and
obligations are assigned, shall be subject to the same obligations as
those of OXYCELL herein, unless the new contracting parties should
reach another mutual agreement.
Article 6 - FINANCIAL CONDITIONS
6.1 The present license is granted in exchange for payment by OXYCELL to
the CNRS of:
a) A lump sum payment of ([***] excluding tax) due upon the
EFFECTIVE DATE.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
b) A lump sum payment of ([***] excluding tax) due at each
anniversary date of the EFFECTIVE DATE, until the CONTRACT
PATENTS have been granted or until the payment of either of
the lump sums specified under Article 6.1 c) and 6.1 d) have
been made, whichever occurs first, and in any event, when the
lump sum payment specified under Article 6.1.e) has been paid.
c) A lump sum payment of ([***] excluding tax) due when the
European patent of the CONTRACT PATENTS is granted.
d) A lump sum payment of ([***] excluding tax) due when the first
US patent of the CONTRACT PATENTS is granted.
e) A lump sum payment of ([***] excluding tax) once OXYCELL has
obtained the FDA approval for the commercial use of the
CONTRACT PRODUCTS in humans. One third of the above [***] lump
sum shall be however paid in advance should OXYCELL obtain the
FDA approval for the commercial use of the CONTRACT PRODUCTS
in animals. The advance payment shall be made at the date of
such approval.
OXYCELL shall inform the CNRS in writing of the dates of each
event described herein, within two months after it occurs.
f) Royalty payments of (i) [***] of NET SALES of the PATENTED
CONTRACT PRODUCTS (other than those based on the US PATENT)
covered by a VALID CLAIM of the CONTRACT PATENTS or (ii) [***]
of NET SALES of the PATENTED CONTRACT PRODUCTS covered by a
VALID CLAIM of the US PATENT and/or KNOW-HOW CONTRACT
PRODUCTS, received by OXYCELL and/or its AFFILIATES.
For the avoidance of doubt, the royalty rate of [***] as set
out in (ii) is applicable only if there is no VALID CLAIM of
CONTRACT PATENTS (other than those based on the US PATENT)
covering the PATENTED CONTRACT PRODUCTS.
g) A percentage of sublicense revenues received by OXYCELL or an
affiliate, as calculate hereunder depending on the date of
execution of the relevant sublicense contracts:
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
- [***] of the above SUBLICENSE REVENUES for PATENTED
CONTRACT PRODUCTS (other than those based on the US
PATENT) covered by a VALID CLAIM of the CONTRACT
PATENTS or [***] of the above SUBLICENSE REVENUES for
the PATENTED CONTRACT PRODUCTS covered by a VALID
CLAIM of the US PATENT and/or KNOW-HOW CONTRACT
PRODUCTS, for payment received pursuant a sublicense
contract executed before the experimentation on the
first patient; or
- [***] of the above SUBLICENSE REVENUES for PATENTED
CONTRACT PRODUCTS (other than those based on the US
PATENT) covered by a VALID CLAIM of the CONTRACT
PATENTS or [***] of the above SUBLICENSE REVENUES for
PATENTED CONTRACT PRODUCTS covered by a VALID CLAIM
of the US PATENT and/or KNOW-HOW CONTRACT PRODUCTS,
for payment received pursuant a sublicense contract
executed after the experimentation on the first
patient but before the first FDA approval for the
commercial use of the CONTRACT PRODUCTS; or
- [***] of the above SUBLICENSE REVENUES for PATENTED
CONTRACT PRODUCTS (other than those based on the US
PATENT) covered by a VALID CLAIM of the CONTRACT
PATENTS or [***] of the above SUBLICENSE REVENUES for
PATENTED CONTRACT PRODUCTS covered by a VALID CLAIM
of the US PATENT and/or KNOW-HOW CONTRACT PRODUCTS,
for payment received pursuant a sublicense contract
executed after the first FDA approval for the
commercial use of the CONTRACT PRODUCTS.
h) No royalties or sublicenses fees shall be payable on Contract
PRODUCT sales between OXYCELL and any AFFILIATE, in which
event the royalty or sublicenses fees shall be based upon the
NET SALES of the AFFILIATE.
i) No multiple royalties or sublicenses fees shall be due and
payable because any CONTRACT PRODUCT are covered by more than
one patent which is within the definition of ContracT PATENTS.
In the event OXYCELL, any AFFILIATE, or any sublicensee does
not have freedom to operate and therefore is obliged to pay an
additional amount to third parties on Contract PRODUCTS,
(other than payments to ULP pursuant to a sponsored research
agreement executed by OXYCELL and ULP) in order to make, have
made, sell, use, import, market, offer for sale, have sold and
otherwise commercially exploit such CONTRACT PRODUCT, the
royalties due to CNRS hereunder shall be reduced by 50% (fifty
percent) of the amount due to said third parties but in no
event shall the effective royalty rate due CNRS be less than
one-half of the stated amount due as provided in paragraph
6.1(f) and (g) above.
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j) CNRS agrees that no royalties or sublicenses fees shall be due
for the internal use of the Contract PRODUCTS for research and
commercial development purposes by Oxycell and AFFILIATES or
for use by third parties providing research and development
activities on behalf of OXYCELL or AFFILIATES in seeking
governmental and professional approvals, certifications or
endorsements, or for training purposes, except where Oxycell
or any AFFILIATES receives revenues for the sale of the
CONTRACT PRODUCTS to the organization using the device for
such stated proposes.
6.2 If OXYCELL justifies the existence of EFFECTIVE COMPETITION in any of
the countries of the CONTRACT TERRITORY in which there is no VALID
CLAIM, the PARTIES shall meet and negotiate in good faith new financial
conditions, for said countries, to be mutually agreed by the PARTIES.
6.3 The NET SALES and Sublicense Revenues used for computing the royalties
or sublicenses fees payable to CNRS thereunder shall be computed, and
royalties or sublicenses fees shall be paid in US dollars.
Article 7 - RECORD KEEPING AND AUDIT RIGHTS
7.1 OXYCELL shall keep accounts which shall include all the elements
necessary to precisely calculate the NET SALES and Sublicense Revenues.
7.2 No later than January 31st of every year, OXYCELL shall provide the
CNRS with a sale report setting out NET SALES and Sublicense Revenues
by country for the year ending on the previous December 31st.
7.3 Should there be no sale or sublicense revenues, OXYCELL shall
nevertheless send the CNRS a sales report in the month of January of
each year stating the absence of any sales during the year under
consideration and indicating the cause for this lack of sales or
SUBLICENSE REVENUES and the difficulties encountered.
7.4 All sales reports shall be sent to the Service Financier de la
Delegation du Siege du CNRS, 0 xxx Xxxxxx-Xxxx - 00000 XXXXX Cedex 16.
Said reports shall include the number of the present agreement.
7.5 The amounts due by OXYCELL to the CNRS must be paid within 35
(thirty-five) days following issuance of an invoice by CNRS to the
person and bank address indicated in Article 7.6 below.
7.6 Payments shall be made to the CNRS by check to the order l'Agent
Comptable Secondaire du CNRS, Delegation Paris Xxxxxx Xxxx, Paierie
Generale PARIS - Code Banque 30091 - Code Guichet N(degree) 75200 -
Compte N(degree) 20003000505 - Cle 69.
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Checks shall be addressed to the attention of: Agent Comptable
Principal du CNRS - 0 xxx Xxxxxx-Xxxx - 00000 XXXXX Cedex 16.
7.7 Any sums which remain unpaid by OXYCELL to the CNRS within the periods
set out hereunder shall be subject to interest at the rate determined
according to the rules applicable to the French Public Establishments
(prevailing legal interest rate + 2 points), without prejudice to the
right of CNRS to initiate termination proceedings pursuant to Article
13 below.
7.8 No more frequently than once every calendar year, OXYCELL shall permit
an expert accountant hired by the CNRS to inspect the records and
invoices of OXYCELL during normal working hours and upon providing
reasonable notice, and shall permit said accountant to take copies and
extracts for the sole purpose of verification of the reports sent to
the CNRS hereunder. The CNRS shall keep secret and shall procure its
expert accountant to keep secret any information relating to the
activities of OXYCELL or any AFFILIATE obtained pursuant to such
inspections. The expense of all such inspections shall be for the CNRS,
except in the case of back royalties of 5% (five percent) being due by
OXYCELL as a result of said audit.
Article 8 - EXPLOITATION
8.1 OXYCELL agrees to exploit the present license and to make its best
efforts in a commercially reasonable manner to develop, make, have
made, sell, use, and otherwise commercially exploit the CONTRACT
PRODUCTS.
8.2 OXYCELL agrees to provide annual reports describing the development and
exploitation of the CONTRACT PRODUCTS. If on the basis of such annual
report it appears that OXYCELL has not pursued the development of the
CONTRACT PRODUCTS, the CNRS may notify OXYCELL and request for further
information within 30 days of the reception of the annual report.
OXYCELL shall within 60 days of such notification inform CNRS of its
intention to pursue the development of CONTRACT PRODUCTS. Should
OXYCELL decide not to develop the CONTRACT PRODUCTS, CNRS may terminate
the Agreement pursuant to Article 13.2 below.
8.3 Except as provided in Article 9.5 below OXYCELL, its subsidiaries,
AFFILIATES, or SUBLICENSEES agree not to use the names "Centre National
de la Recherche Scientifique" or "CNRS" or any trademark, distinctive
sign or adaptations thereof which belongs to the CNRS or the names of
the CNRS inventors, for commercial purposes, without receiving prior
written approval from the CNRS or the natural person concerned, as the
case may be. Consent from CNRS will be promptly considered and not be
unreasonably withheld.
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8.4 OXYCELL, its subsidiaries, AFFILIATES, or SUBLICENSEES shall
commercialize the CONTRACT PRODUCTS under their own trademarks or under
trademarks for which they have obtained a license. The CNRS shall have
no rights to such trademarks. All administrative authorizations
obtained by OXYCELL for the purpose of manufacturing and/or
commercializing the CONTRACT PRODUCTS shall be obtained for OXYCELL or
for any party which it shall have designated and subject to Article 8.6
hereunder, the CNRS shall claim no rights thereto.
8.5 CNRS shall do its best reasonable efforts to assist OXYCELL, directly
or through the LABORATORY in obtaining any administrative
authorizations which may be required for the purpose of manufacturing
and/or commercializing the CONTRACT PRODUCTS.
8.6 Without prejudice to the terms of Article 10.4 hereunder, OXYCELL
agrees to provide the CNRS with a copy 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 3 (three) months after obtaining such final
authorizations.
8.7 OXYCELL has a general knowledge in respect of (i) the CONTRACT FIELD
and (ii) developing, making, selling, using, and otherwise commercially
exploiting the CONTRACT PRODUCT should such exploitation be reasonably
possible.
Article 9 - CONFIDENTIALITY
9.1 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.
9.2 The PARTIES shall assure that their personnel and others in their
service are bound by the same obligations of confidentiality described
hereunder. Moreover, OXYCELL shall include confidentiality obligations
no less onerous than the present Article 9 in any sublicenses it may
grant to SUBLICENSEES.
9.3 The confidentiality obligations between the PARTIES in the present
Article 9 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
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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; or
f) Was disclosed after obtaining the prior authorization of the
owning PARTY; or
g) Was independently developed by or on behalf of the receiving
PARTY without use of any confidential information received
from the owning PARTY; or
h) Was disclosed in the course of exercising its rights to
validly exploit VALID CLAIMS including its rights to defend
such exploitation against third parties.
9.4 The present Article 9 shall remain in effect until the expiration of
the last of the CONTRACT PATENTS, the expiration or termination of the
present Agreement notwithstanding.
9.5 OXYCELL shall have the right to use and disclose the names of CNRS and
the inventors and other information otherwise restricted in use and
disclosure under the present Agreement to the extent necessary to
comply with applicable governmental orders and governing laws and
regulations.
Article 10 - INTELLECTUAL PROPERTY
10.1 Any and all decisions concerning the prosecution and maintenance of the
intellectual property necessary to the validity of the CONTRACT PATENTS
in the Contract territory shall belong exclusively to the CNRS which
shall be responsible for the prosecution and maintenance fees of said
CONTRACT PATENTS. CNRS shall provide copies of the main relevant
prosecution and maintenance documents to OXYCELL, and keep OXYCELL
informed of the status of the CONTRACT PATENTS at OXYCELL formal
request.
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10.2 Should the CNRS wish to either not initiate or abandon the prosecution
or maintenance of the CONTRACT PATENTS in any country within the
CONTRACT TERRITORY, it shall notify OXYCELL 2 (two) months prior to the
next deadline for filing the necessary documents or making the
necessary payment of maintenance fees of said patent applications or
patent(s). OXYCELL may take over the prosecution and maintenance of
said CONTRACT PATENTS subject to notifying the CNRS no later than 1
(one) month prior to such deadline. In this case the terms of the
present Agreement shall remain in effect and OXYCELL shall be
responsible for the prosecution and maintenance fees for said CONTRACT
PATENTS and no royalties shall be due to the CNRS in any such country
as long as OXYCELL shall continue to support the prosecution or
maintenance of the CONTRACT PATENTS.
Article 11 - INFRINGEMENT
11.1 The PARTIES shall inform each other within the shortest possible delay
of any third party infringement of which they may become aware and/or
of any infringement claims or actions, which may be taken against it.
11.2 The CNRS may take action at its own expense against any third party
infringement to the CONTRACT PATENTS, with the understanding that any
indemnification awarded by court decision as a result of said action
shall irrevocably and entirely be the property of the CNRS. Moreover
CNRS shall inform any other beneficiary of a license in respect of the
CONTRACT PATENTS in order to organize any possible common action
against any third party infringement.
This shall not prevent OXYCELL from taking action against third party
infringement at its own expense to obtain indemnification for damages
which it alone has incurred and any indemnification awarded by court
decision from said action shall be irrevocably and entirely the
property of OXYCELL.
11.3 Subject to Article 11.2 OXYCELL shall have right to enforce any VALID
CLAIMS within the CONTRACT FIELD against any infringement or alleged
infringement thereof, and shall at all times keep CNRS informed as to
the status thereof. OXYCELL may, in its sole judgment and at its own
expense, institute suit against any such infringer or alleged infringer
and control, settle, and defend such suit in a manner consistent with
the terms and provisions hereof and recover, for its account, any
damages, awards or settlements resulting therefrom, subject to Article
11.4. This right to xxx for infringement shall not be used in an
arbitrary or capricious manner. CNRS shall reasonably cooperate in any
such litigation at OXYCELL's expense.
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11.4 Any recovery by OXYCELL under Articles 11.2 and 11.3 shall be deemed to
reflect loss of commercial sales, and OXYCELL shall pay to CNRS the
same percent of the recovery net of all reasonable costs and expenses
associated with each suit or settlement as if such net constituted
SUBLICENSE REVENUES. If the cost and expenses exceed the recovery, then
one-half (1/2) of the excess shall be credited against royalties
payable by OXYCELL to CNRS hereunder in connection with sales or
services in the country of such legal proceedings, provided, however,
that any such credit under the present Article 11.4 shall not exceed
fifty percent (50%) of the royalties otherwise payable to CNRS with
regard to sales or services in the country of such action in any one
calendar year, with any excess credit being carried forward to future
calendar years.
11.5 Should OXYCELL, or its AFFILIATES, become the object of infringement
claims as a result of the commercialization of the CONTRACT PRODUCTS
which have been identified or developed by the use of the CONTRACT
PATENTS and the CONTRACT KNOW HOW, the CNRS shall provide OXYCELL with
any documents or information which it may have in its possession which
may be necessary to assist in the defense of OXYCELL or its AFFILIATES.
11.6 The present article shall not in any way be considered to constitute a
waiver by the CNRS to take any action or intervention.
Article 12 - WARRANTIES
12.1 CNRS declares and warrants that it is the sole owner of the CONTRACT
PATENTS.
12.2 CNRS declares and warrants that the CONTRACT PATENTS with respect to
the CONTRACT FIELD are not subject to any pledge, security, license,
authorization to use, right of preference, rights of first refusal or
right of preemption nor more generally to any right or restriction or
covenant in whatever form in any country on behalf or in favor of any
third party which might affect the quiet and useful possession and
enjoyment of the CONTRACT PATENTS by OXYCELL.
12.3 Subject to Article 12.2 OXYCELL shall not call on the CNRS in guarantee
for any damages or prejudice of any nature caused by the CONTRACT
PRODUCTS. OXYCELL is solely responsible to its clients and/or any third
parties for the quality and performance of the CONTRACT PRODUCTS.
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Article 13 - TERMINATION
13.1 Should OXYCELL cease business operations or be the object of a
liquidation procedure, the CNRS may terminate the present Agreement if
it so wishes subject to notifying OXYCELL. After 1 (one) month without
a response to this notification by Oxycell, the judicial administrator
or liquidator as the case may be, and subject to the applicable and
legal regulations in the United States, the present Agreement shall be
immediately terminated by right.
13.2 The present Agreement may be terminated as of right, without any
judicial formalities, by either of the PARTIES in the event that the
other PARTY fails to perform one or more of the material obligations
contained in the various clauses of the present Agreement, including
Article 6. 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.
13.3 Subject to the obtaining by OXYCELL of the administrative
authorizations to use the CONTRACTS PRODUCTS for commercial use in
humans, if after 5 (five) years from the EFFECTIVE DATE, OXYCELL has
not taken the necessary steps for the commercialization of the CONTRACT
PRODUCTS, and cannot provide any reasonable justification for such
failure the CNRS may terminate the present Agreement in accordance with
the procedure set out in Article 13.2 above.
13.4 Oxycell may terminate as of right without any judicial formalities, the
present Agreement at each anniversary date of the EFFECTIVE DATE,
subject to a prior written notification to CNRS, at least 3 month
before the above anniversary date. OXYCELL shall be liable for a
payment of any monies due prior to the termination date.
13.5 Should the present Agreement expire or be terminated OXYCELL agrees not
to use or allow any direct or indirect use of the Valid Claims for
CONTRACT PATENTS until the expiration of the last of the VALID CLAIMS
for such patents. However, OXYCELL shall have the right to dispose of
existing inventory for 180 (one hundred and eighty) days following any
such expiration or termination. Furthermore, each PARTY agrees to
return or destroy all proprietary or confidential information,
material, and documents that it has received from the other PARTY and
not to conserve any copies for any purposes whatsoever.
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13.6 Upon termination of the present Agreement and subject to the provisions
of Article 2 all rights in and to the Contract Products shall revert to
CNRS at no cost to CNRS, provided that CNRS shall enter into a direct
license agreement with the SUBLICENSEE in the event the sublicensee
cures any payment defaults and agrees to directly assume the
obligations of Oxycell or any Affiliate under the present Agreement and
to make all payments directly to CNRS. In this connection CNRS agrees
to promptly issue, from time to time, upon written request, estoppel
certificates in favor of Oxycell, AFFILIATES, sublicensees or potential
sublicensees setting forth the status of the present Agreement and, if
in default, the conditions required to cure the same.
Article 14 - ENTIRE AGREEMENT
14.1 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.
14.2 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.
14.3 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 OXYCELL outside the CONTRACT FIELD, nor rights to
any patents other than the CONTRACT PATENTS or to any know how other
than the CONTRACT KNOW-HOW.
Article 15 - 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 16 - 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.
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Article 17 - 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 18 - DISPUTES - GOVERNING LAW
18.1 The laws of France shall govern the present Agreement.
18.2 In the event that a difficulty arises in the interpretation or
execution of the present Agreement, the PARTIES shall try to settle
their differences out of court within a limited period of 3 months as
from the issuance of a written notice by either party of a dispute.
18.3 In case of persistent disagreement after the 3 months settlement
period, the competent French courts shall have sole jurisdiction to
settle any disputes in respect of the interpretation and/or performance
of the Agreement.
18.4 The present Article shall remain in effect regardless of the expiration
or termination of the present Agreement.
Article 19 - REGISTRATION AT THE REGISTRE NATIONAL DES BREVETS - FISCAL
REGISTRATION
19.1 The present Agreement may be registered at the Registre National des
Brevets, which is controlled by the Institut National de Propriete
Industrielle, and each National Patent Office for the purpose of
registering the CONTRACT PATENTS; the fees of said registrations to be
paid by the OXYCELL.
19.2 Any fiscal registrations of the present Agreement shall be performed by
OXYCELL at its sole expense.
Article 20 - LANGUAGE
The present Agreement has been established in two versions, one in
French and one in English. In case of difficulties of interpretation,
the French version shall prevail.
Article 21 - NOTIFICATIONS
All notifications for the present Agreement shall be sent by registered
letter with acknowledgment of receipt to the PARTY for which the notice
is intended at the following address:
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For the CNRS:
CNRS
Delegation aux Entreprises
0 xxx Xxxxxx-Xxxx
00000 Xxxxx Cedex 16
France
For OXYCELL:
GLOBAL OXYCELL INC.
Xx. Xxxx XXXXXXX
0 Xxxx Xxxxxxx Xxxx.
Xxxxx 0000
Fort Lauderdale
Florida
3301
USA
In Paris In Fort Lauderdale
the 5th day of June, 2000 the 23rd day of May, 2000
In three copies including one for the Institut National de la Propriete
Industrielle and one for the contracting PARTIES.
--------------------------- ---------------------------
Mrs. Xxxxxxxxx XXXXXXXXXX Xx. Xxxx XXXXXXX
General Manager of CNRS Chief Executive Officer of GLOBAL
OXYCELL
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EXHIBIT A
CONTRACT PATENTS
------------------------------------------------------------------------------------------------------------
COUNTRY FILING FILING VIA PROC PUB. PUB ISSUE ISSUE EXP.
N(DEGREE) DATE DATE N(DEGREE) DATE N(DEGREE) DATE
------------------------------------------------------------------------------------------------------------
FR 96 09557 30/07/96 BN DLV 06/02/98 2751972 04/09/98 96 09557 30/07/16
------------------------------------------------------------------------------------------------------------
JP 97530677 28/02/97 PCT DEP
------------------------------------------------------------------------------------------------------------
CA 2248186 28/02/97 PCT DEP 28/02/17
------------------------------------------------------------------------------------------------------------
MX 986892 28/02/97 PCT DEP
------------------------------------------------------------------------------------------------------------
BR 28/02/97 PCT DEP 28/02/12
------------------------------------------------------------------------------------------------------------
NO 983691 28/02/97 PCT DEP 28/02/17
------------------------------------------------------------------------------------------------------------
KR 98706784 28/02/97 PCT DEP 28/02/12
------------------------------------------------------------------------------------------------------------
HU P9902465 28/02/97 PCT DEP 28/02/17
------------------------------------------------------------------------------------------------------------
XX 000000 28/02/97 PCT DEP 28/02/17
------------------------------------------------------------------------------------------------------------
EP 97907154.5 28/02/97 PCT DEP 28/02/17
------------------------------------------------------------------------------------------------------------
AU 9719304 28/02/97 PCT DEP 28/02/13
------------------------------------------------------------------------------------------------------------
US 09/125825 28/02/97 PCT DEP
------------------------------------------------------------------------------------------------------------
WO FR97/00364 28/02/97 PCT PUB 04/09/97 WO97/31935 28/10/99
------------------------------------------------------------------------------------------------------------
CZ 982772 28/02/97 PCT DEP
------------------------------------------------------------------------------------------------------------
SK 98 1182 28/02/97 PCT DEP
------------------------------------------------------------------------------------------------------------
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