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Translated from the French
EXHIBIT 10.108
Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
AGREEMENT
THIS AGREEMENT ENTERED INTO ON JANUARY 28, 1999 BY AND BETWEEN:
COLLAGEN AESTHETICS INTERNATIONAL, an American company organized under the laws
of Delaware, duly represented by Xx. Xxxx Xxxxxxxxxxx, acting to the extent
necessary in its name to the benefit of its subsidiaries and more generally of
all the Collagen group member companies (hereinafter referred to as "COLLAGEN"),
AND
BIOPHARMEX S.A., a Luxembourgeois company, having its registered office in
Luxemburg, 00 xxxxxx xx 00 Xxxxxxxxx, 0000 Xxxxxxxxx, duly represented by Xx.
Xxx Xxxxx, duly qualified for the purposes hereof, pursuant to the minutes dated
January, 20, 1999, a copy of which is enclosed (hereinafter referred to as
"BIOPHARMEX")
RECITALS
A. Biopharmex is the owner of an exclusive manufacturing and/or
distribution license for the BIO-PLA Product, more fully described in
Schedule 1 hereto (hereinafter "THE PRODUCT(S)"), granted by Biopharmex
Holding, the holder of all of the rights to the patent and trademark
relating to said Product. Pursuant to such license, Biopharmex is duly
authorized to grant sublicenses for authorizing the distribution of the
Product in the Territory.
B. Collagen is a company with experience and an international reputation in
the field of the distribution of products for the esthetic medical
markets.
C. Pursuant to the Memorandum of Understanding of January 11, 1999
(hereinafter "THE MEMORANDUM"), the parties have agreed to enter into an
agreement pursuant to which Collagen agrees to ensure the distribution
of the BIO-PLA product in the Territory.
D. This Agreement entails the express confirmation of the Memorandum
between the parties of January 11, 1999, and more specifically the
condition precedent for this Agreement entering into effect.
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
NOW, THEREFORE, THE PARTIES HERETO HAVE AGREED AS FOLLOWS:
1. GRANT
1.1 Biopharmex hereby grants to Collagen, which accepts, the exclusive right
to distribute and sell the Products in the Territory, directly or
indirectly through one of its subsidiaries or more generally any
Collagen group affiliated company, pursuant to the terms and conditions
below.
1.2 In enjoyment of its rights by virtue of this Agreement Collagen agrees
to make best efforts in a loyal, vigorous and diligent manner to promote
the sales of the Products in the Territory.
1.3 Each of the parties agrees to independently exercise the rights and
obligations conferred on it pursuant to this Agreement in good faith.
2. EXCLUSIVE NATURE
2.1 Pursuant to this Agreement Collagen shall have the exclusive right to
distribute the Product to doctors in the Territory. Biopharmex shall not
grant equivalent rights or rights of the same nature to any third
parties throughout the term of this Agreement with the exception of the
21 countries appearing in Article 2.2 below.
2.2 The exclusive distribution rights granted to Collagen shall be exercised
in the Territory which shall be the whole world with the exception of
the 21 following countries: Argentina, Belize, Bolivia, Brazil, Chile,
Costa Rica, Colombia, Cuba, Ecuador, Guatemala, Guyana, Honduras,
Mexico, Nicaragua, Panama, Paraguay, Peru, San Salvador, Surinam,
Uruguay, Venezuela.
Biopharmex shall maintain control of the distribution process of the
Products in each of these 21 countries; Biopharmex shall therefore be
free to appoint third-party distributors in these countries to the
extent that such appointment does not interfere with the rights granted
to Collagen hereunder. Consequently, Biopharmex agrees to not negotiate
or enter into any agreement granting exclusive rights before July 1,
1999.
The parties agree that beginning on * they shall negotiate in good faith
to attempt to enter into an agreement as of * extending this Agreement
to each of the 21 countries appearing above in Article 2.2, paragraph 1
of this Agreement.
3. CONDITION PRECEDENT
Pursuant to the terms and conditions of the Memorandum, the performance
of this Agreement is subject to the fulfillment of the condition
precedent of obtaining satisfactory technical and scientific information
and results with respect to the Product within the framework of the due
diligence mission in progress on the date of the execution of this
Agreement.
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The terms and conditions of the due diligence mission are described in
the Memorandum. This condition shall run in favor of Collagen, which
alone may rely on the non-fulfillment of this condition precedent.
Collagen shall notify its intention to Biopharmex by sending a facsimile
within the week following April 11, 1999 confirmed by certified letter,
xxxx of receipt requested.
(a) If this condition precedent has not been fulfilled and Collagen
notifies Biopharmex that it intends to rely thereon this Agreement shall
become void, subject to the provisions of article 18.4 of this
Agreement.
(b) If this condition precedent is fulfilled thereby allowing Collagen
to undertake the distribution of the Product in the Territory, without
modification of the quotas, the condition precedent shall be
acknowledged as having been fulfilled and this Agreement shall be deemed
retroactively entered into as of January 11, 1999. The Memorandum shall
automatically expire at the same time.
(c) If this condition precedent is fulfilled and Collagen is desirous of
exercising its right to revise the quotas proposed by Biopharmex on the
conditions provided for in Article 9 of this Agreement, the parties
shall negotiate the revision of these quotas in good faith within a
maximum time period of seven (7) business days as from expiration of the
due diligence as defined in the memorandum, or as from April 11, 1999,
at the latest; Biopharmex shall then have the right to refuse the quotas
proposed by Collagen. If Biopharmex does not agree to the revision of
these quotas, the Memorandum and the Distribution Agreement shall be
automatically terminated and shall not entitle either one of the parties
hereto to claim damages from the other party.
4. TERM
This Agreement shall be effective for an initial period of ten years
beginning retroactively on January 11, 1999 and automatically
terminating on January 10, 2009.
This Agreement may be tacitly and automatically renewed for successive
periods of three (3) years absent notice to terminate by either one of
the parties by certified letter, xxxx of receipt requested sent 12
months in advance. The renewal of this Agreement as from January 11,
2009 for an initial three-year period shall entail the parties'
obligation to revise the financial terms and conditions of this
Agreement in good faith by entering into a written addendum to be
appended to this Agreement.
The nonrenewal by Biopharmex of this Agreement at any one of its
expiration dates pursuant to the terms and conditions above:
(a) shall create a preferential right in favor of Collagen which shall
be valid for six consecutive months following the expiration date of
this Agreement, allowing Collagen to refuse or accept to distribute the
Products in the Territory (or in any country belonging to the Territory)
under terms and conditions identical to those proposed by Biopharmex to
a third party; and
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
(b) shall oblige the parties to negotiate the terms and conditions for
purchasing or clearing the inventory in Collagen's possession in good
faith.
(c) shall oblige Biopharmex to purchase the promotional material in
Collagen's possession, for up to [*], provided said material may be
reused (if necessary, by Biopharmex adding an adhesive).
Non renewal by Collagen of this Agreement on any one of its expiration
date on the conditions specified above with respect to form and
deadlines shall trigger the consequences provided for in Article 8.3
(vii), shall prohibit Collagen for exercising its preferential rights
and shall not give rise to the purchase of the promotional material in
Collagen's possession.
5. APPROVALS
5.1 European approval
European approval of the Products includes the authorization of the "EC"
marking of the Products as well as the vetting of the clinical studies
which form an integral part thereof pursuant to the provisions of EU
Directive No. 93/42 of June 14, 1993, in its most recent version in
force on the date of the request for approval of the Products.
European approval of the Products shall be carried out by Biopharmex in
its name and at its expense and shall be available, by September 1, 1999
at the latest, in order to allow for the marketing of the Products in
Europe. However, this deadline may be extended until January 1, 2000 in
the event of requests for additional information by the competent
authorities.
Biopharmex shall keep Collagen informed in writing, on a monthly basis,
of the progress in obtaining European approval.
The absence of European approval of the Products shall entail Collagen's
right, on the one hand, to terminate this Agreement on the terms and
conditions provided in Article 8 of this Agreement and, on the other, to
be immediately reimbursed for all amounts paid in the form of a loan on
the conditions provided in Article 6 of this Agreement.
5.2 Approvals outside of Europe
5.2.1 The parties agree that the approval requests for countries outside
of the European Union shall be carried out by Collagen in the name of
Biopharmex to the extent permitted by the laws and national and
international regulations.
Failing this, the parties agree to proceed with the approval of the
Products in the following order of priority:
(i) approval carried out jointly in the names of Biopharmex and
Collagen, at Collagen's expense,
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
(ii) approval carried out in the name of Collagen at Collagen's expense,
(iii) approval carried out in the name of the subdistributor appointed
by Collagen, at Collagen's expense.
5.2.2. Approvals in the United States and in Japan
The approval process for the Product in the United States and in Japan
will be carried out by Collagen, in its own name and at its own expense.
By mutual agreement of the parties, on the date upon which Collagen
receives the final notice of approval for the Product in each of these
countries:
(i) Biopharmex undertakes to reimburse Collagen for all of the external
expenses met by the latter. The expression `external expenses' refers to
all expenses relating to the involvement of third party to this
Agreement, with proof provided in the form of corresponding invoices, a
copy of which Collagen shall submit to Biopharmex, should the latter so
request;
(ii) the period of validity of the distribution rights granted to Collagen in
the United States and Japan under this Agreement, and of all the rights
and obligations arising therefrom, is extended automatically and with
full legality for an additional term of (5) five years, i.e. until
January 11th 2014;
(iii) the rate of royalties applicable for the sale of the Product in the
United States and Japan is as defined in Article 7.4 of this Agreement.
5.3 Effects of approval
Approval shall entail Collagen's automatic authorization to distribute
the Products in the Territory.
5.3.1 The parties agree that the Products shall be marketed in France
according to the following timetable:
- In France: within [*] as from the date on which Collagen
receives notice of the European approval of the Products;
- In Belgium, Spain and Italy: within [*] as from the date on
which Collagen receives notice of the European approval of the
Products;
- In the other member states of the European Union: within [*] as
from the date on which Collagen receives notice of the European
approval of the Products;
5.3.2 Collagen shall distribute the products outside the European Union
within [*] as from the final approval date in each country in question.
5.4 Ownership of the approvals
The approvals shall remain the property of Biopharmex. Consequently, in
the event of early termination of this Agreement, Collagen shall make
its best efforts in order to ensure the transfer to Biopharmex of the
approvals obtained by Collagen or by one of
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
its subdistributors to the extent permitted by national laws and/or
regulations.. The costs connected to such transfers shall be borne by
Biopharmex alone.
6. FINANCIAL CONDITIONS
6.1 Representations
Biopharmex represents and warrants to Collagen that it is a resident
company of Luxembourg within the meaning of Article II of the Double
Taxation Treaty between the United States and Luxembourg of December 18,
1962. Biopharmex also represents and warrantees
(i) that Biopharmex is not a "holding company" within the meaning of
Article XV of said treaty,
(ii) that it has the certificates and documents attesting to the fact
that it is entitled to the application of this treaty and shall furnish
said certificates and documents to Collagen by January 27, 1999 at the
latest and periodically thereafter in accordance with the regulatory
requirements in force.
6.2 Marketing (entrance)
In consideration for the distribution rights to the Products in the
Territory granted to Collagen by virtue of this Agreement, Collagen
shall pay Biopharmex compensation for a total amount of [*]. Such
compensation shall be payable in three installments: the first
installment shall be for a total amount of [*], which shall be at first
granted in the form of a loan, a second installment for a total amount
of [*], also granted in the form of a loan together with a conversion
option on the conditions provided in Article 6.4 and lastly a third and
last installment for a total amount of [*] payable on the conditions
provided in Article 6.6.
Given that Collagen's consent is conditioned, on the one hand, on the
satisfactory results of the due diligence mission and, on the other, by
the actual granting of a European approval which is indispensable for
the marketing of the Products, the compensation payable to Biopharmex
shall not be due pursuant to this Agreement before the actual
fulfillment of these two conditions. Consequently, on the one hand, the
two first installments shall be payable in the form of a loan together
with a conversion option on the conditions specified below in Article
6.4 and, on the other, the last installment shall not be due to
Biopharmex unless the Products are lawfully marketed in France by
Collagen, on the conditions specified in Article 6.6 below.
6.3 Loan
6.3.1 Pursuant to the terms and conditions of the Memorandum and, more
specifically, Schedule 2 and, in consideration for the rights
granted to Collagen pursuant to the due diligence mission,
Collagen has granted Biopharmex a loan for a total amount of [*].
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
6.3.2 The parties agree that on the date of execution of this
Agreement, provided that Collagen has previously obtained the
personal security from Xx. Xxxxxxx-Xxxxxxxx pursuant to the terms
and conditions of Schedule 3 to this Agreement, Collagen shall
grant to Biopharmex a second loan for a total amount of [*]. The
terms and conditions for the granting of this new loan are set
forth in Schedule 3 to this Agreement.
6.4 Conversion
The approval date of the Product in Europe under the conditions provided
for in Article 5.1 of this Agreement shall entail the conversion of the
two first installments paid in the form of a loan into compensation in
favor of Biopharmex. The conversion shall become effective within seven
(7) days as from the date of the receipt by Collagen of the notification
by Biopharmex of the European approval of the Product by the competent
authorities as defined in Article 5.1 of this Agreement.
The tax consequences related, more particularly, to withholding tax
liable to be claimed by virtue of the conversion of the two installments
paid in the form of a loan into compensation in favor of Biopharmex
shall be borne by Biopharmex, which alone shall be liable therefor.
6.5 Non-conversion
6.5.1 Pursuant to the terms and conditions of Article 3(a) of the
Memorandum, Collagen shall have the full and unrestricted right
to place on record the non-fulfillment of the condition precedent
of obtaining satisfactory technical and scientific results with
respect to the Product within the framework of the due diligence,
and to not distribute the Product.
Such decision shall automatically entail:
(a) the rescission of the Memorandum without either party being
liable therefor nor entitling either one of the parties
hereto to claim damages from the other party.
(b) this Agreement becoming void ab initio for non-fulfillment
of the aforementioned condition precedent, without either
party being liable therefor nor entitling either one of the
parties hereto to claim damages from the other party.
(c) the non-conversion of the two loan agreements corresponding
to the two installments for a total amount of [*]. The terms
and conditions for the repayment of these two (2) loans
within one (1) year, i.e., on January 11, 2000 for the first
loan and on January 27, 2000 for the second loan are those
set forth in Schedule 3 to this Agreement.
6.5.2 Likewise, the absence of final approval of the Product shall
result in Biopharmex's obligation to repay the first two
installments paid by Collagen
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
within 12 months as from the date on which each of these loans
has been granted, i.e., respectively, January 11, 2000 and
January 27, 2000.
6.6 Third installment
The date of the first marketing of the Product in France by Collagen
shall give right to payment of the third installment to Biopharmex. The
third installment shall be payable within twelve (12) months as from the
date of the first French marketing of the Product by Collagen.
7. INVOICING - PAYMENTS
For the purpose of this Agreement, "sales price" refers to the price of the
Product sold by Biopharmex to Collagen and "resale price" refers to the price of
the Product sold by Collagen to its clientele comprised exclusively of doctors.
7.1 Biopharmex's sales price per Product unit to Collagen is [*], ex-VAT,
payable upon invoicing, 60 days following delivery, on the conditions
set forth in Article 10 of this Agreement.
This price may be revised by mutual agreement between the parties once a
year in order to meet cost developments, the request of customers, the
economic conjuncture or where monetary circumstances would adversely
affect the original equilibrium of the Agreement.
7.2 Collagen may freely set the resale price of the Product to its customers
(i.e. exclusively in this case to doctors) in the Territory.
7.3 In order to ensure the proper distribution of the Products and in light
of its knowledge of the potential market for the Products in certain
European countries, Biopharmex recommends that for its launching the
maximum unit price for Products sold in Belgium, Italy, Spain and France
by Collagen be approximately [*], ex-VAT. Biopharmex also recommends
that Collagen not exceed this maximum resale price during approximately
three years in the absence of a significant evolution in the market for
the Product.
In all other countries in the Territory, Collagen shall evaluate an
optimal maximum price for launching the Products in light of the markets
involved on the basis of its international experience.
7.4 During the initial term of the Agreement (i.e. ten years), if Collagen
resells the Product to the final customer in all or part of the
Territory at the maximum recommended price of [*], the parties agree
that the following terms shall apply:
- Collagen shall pay Biopharmex for each sale of the Product made
outside of the United States and Japan a royalty at the rate
of [*] applied to the fraction of the price exceeding [*], i.e.:
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9
Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
(Collagen resale price, [*]) x [*]
- Taking into account the approval costs incurred by Collagen in
the United States and Japan, the rate in these countries shall be
[*], i.e.:
(Collagen resale price, [*]) x [*]
7.5 Collagen shall, on the one hand, keep Biopharmex informed on a quarterly
basis of the sales made by country in the Territory and, on the other,
shall ensure the annual certification of Collagen's accounts by a
Statutory Auditor.
Biopharmex may, if necessary, audit Collagen's accounts relative to the
sale of the Products at its expense, provided that it has previously
notified its intent to carry out such audit to Collagen in writing
making reference to this article.
8. VOIDING OF AGREEMENT - TERMINATION
8.1 Voiding of Agreement
This Agreement shall be automatically void with immediate effect for any
one of the reasons described in Article 3 or Article 5.1 upon receipt of
notice sent by Collagen by certified letter, xxxx of receipt requested
and shall not entitle either one of the parties hereto to claim damages
or compensation from the other party.
This Agreement shall also be void in accordance with the same terms and
conditions in the event of the permanent withdrawal of approval of the
"EC" marking of the Products, by the competent authorities.
8.2 Early termination
Absent a contrary provision appearing in Article 8.1, either one of the
parties may terminate this Agreement forthwith in the event of a
material breach by the other party of any one of its obligations
pursuant to this Agreement.
Termination shall be made by prior notice to the other party which shall
be deemed validly given by certified letter, xxxx of receipt requested
containing a description of the alleged breach, making reference to this
article. Termination shall become effective only upon expiration of a
period of ninety (90) days as from receipt of such notice during which
the other party must cure such breach.
If the defaulting party fails to cure such breach upon expiration of
this 90-day period, and the termination of this Agreement shall become
immediately effective without any other notice.
8.3 Termination of this Agreement shall entail:
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
(i) the immediate discontinuation of deliveries, excepting deliveries
corresponding to orders accepted by Biopharmex before notice of breach;
(ii) the complete return by Collagen of the approval files, the promotional
materials and the available samples of the Products belonging to
Biopharmex and the return of the results of the clinical tests conducted
on the Product on the conditions described in Article 12 of this
Agreement;
(iii) the repayment of any amounts due by Biopharmex to Collagen (in principal
and interest), and more specifically, the repayment of the loans made in
the conditions provided in Article 6.5.1 and Schedule 3 hereof only if
such termination occurs before their conversion pursuant to Article 6.4.
(iv) the accounting and rapid payment of all money credits of either one of
the parties;
(v) Collagen shall thereafter refrain from adopting, using, registering or
otherwise relying on or holding rights to and over the trademarks,
drawings or models for the packaging or labels for the Products
belonging to Biopharmex, its parent company or affiliated companies, in
the Territory;
(vi) the early termination of this Agreement by Biopharmex shall entail
Biopharmex's obligation to purchase the inventory of the Products in the
possession of Collagen or its subdistributors on the effective date of
termination, at landed cost, as well as the promotional materials in
Collagen's possession, up to [*], provided said material may be reused
(if necessary by Biopharmex adding an adhesive);
(vii) the early termination of this Agreement by Collagen shall entail
Collagen's express authorization to sell the Products until the clearing
of the inventory in its possession, but shall not give rise to the
purchase of the promotional material in Collagen's possession.
9. QUOTAS
9.1 Collagen agrees to comply with the following minimum sales quotas for
the first three sales years for the Products in the Territory:
- 1st year: [*]
- 2nd year: [*]
- 3rd year: [*]
However, if in the 1st year sales by Collagen exceed more than 50% of
the minimum quotas set for this 1st year, the minimum for the 2nd year
shall be equal to the sales for the 1st year. The same principle shall
apply for the 2nd year.
The fact that Collagen does not attain these quotas shall constitute a
legitimate reason for the loss of territorial exclusivity in its favor.
The loss of territorial exclusivity shall be notified to Collagen by
certified letter, xxxx of receipt requested and shall become
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
effective upon expiration of a 90-day period as from the date of receipt
of advice of the notification.
9.2 The above quotas are not final. The parties agree that Collagen may
revise such quotas within the week following the expiration of the due
diligence and propose new quotas to Biopharmex. Biopharmex may refuse
the revision of the quotas as proposed by Collagen. The failure by the
parties to agree on the final quotas shall automatically and immediately
entail termination of all agreements between the parties on the
conditions provided in Article 3 (c) of this Agreement.
9.3 Failing an Agreement by the parties with respect to the quotas, the two
loans made to Biopharmex on the conditions provided for in Article 6 and
Schedule 3 shall become automatically due and owing, within one (1) year
as from the date on which each loan was made, i.e., respectively January
11, 2000 for the first loan and January 27, 2000 for the second.
10. INVENTORY - DELIVERY
10.1 Inventory (minimum - Product specifications)
10.1.1 Minimum inventory
During the first three years of this Agreement Biopharmex shall maintain
a minimum volume of "buffer" inventory as follows:
- during the first year: the greater of [*] of Collagen forecast
orders or [*];
- during the second year: the greater of [*] of Collagen forecast
orders or [*]; or half of the units sold by Collagen during the
first year;
- during the third year: the greater of [*] of Collagen forecast
orders or [*], or half of the units sold by Collagen during the
second year.
10.1.2 Product Specifications
Biopharmex agrees to deliver Products to Collagen whose remaining shelf
life shall be equal to or greater than three-quarters of its total shelf
life.
10.1.3 Manufacture
The manufacture of the Products shall be carried out under the
responsibility and control of Biopharmex and shall give rise to a
warranty on the conditions provided for below in Article 14 of this
Agreement.
In order to ensure the availability of inventory of the Products,
Biopharmex and Collagen shall, within six months as from the date of the
European approval of the Products, identify a second potential
manufacturer who shall be duly certified by the FDA, and more
particularly for its GMP. This second manufacturer shall be used by
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Biopharmex under its control and responsibility, in order to ensure the
continuity of manufacture of the Products in the event of the failure of
the present manufacturer.
10.2 Delivery
The products shall be made available to Collagen at Biopharmex's
warehouse (Luxembourg), located at the following address: 00, xxxxxx xx
00 xxxxxxxxx, 0000 Xxxxxxxxxx.
The risks shall be transferred to Collagen upon taking of delivery by
Collagen or by a third party appointed by Collagen in accordance with
the ex-warehouse conditions which are identical to the ex-works
conditions of the Incoterms, (ICC), 1990 publication.
The Products shall remain Biopharmex's property until full payment of
the price by Collagen on the due date appearing on the invoice.
10.3 Storing of the Product
Biopharmex shall continuously maintain the necessary services for the
storage of a volume of adequate inventory in order to meet Collagen's
product orders. Consequently, the closing of Biopharmex's warehouse for
any reason whatsoever shall be notified in advance to Collagen within
two (2) months before the actual closing date. Biopharmex shall then
take all necessary measures in order to ensure the continuous storage
service for the Products under its responsibility and at its expense.
Pursuant to this Agreement, Collagen may make all necessary inspections
of Biopharmex's warehouse at any time during the term of this Agreement,
provided that it has previously informed Biopharmex within a reasonable
period of its intention to make such inspection.
11. NON-COMPETITION
Collagen's non-competition commitments shall be those which are
limitatively described below in this article.
11.1 Manufacturing
During a period of three (3) years following the date of expiration of
this Agreement for any reason whatsoever, Collagen agrees to neither
manufacture nor use any and all of the intellectual property rights
belonging to Biopharmex including, more particularly, the rights
relating to Biopharmex's patents and know-how covering: another product,
if said product could reasonably be considered as being both competing
with and similar to the Product. It is precised that the Product refers
to: polylactid acid in the form of microspheres, microparticles, or
fragments suspended in a gel or in a gel of synthetic or natural origin
whose reabsorbability is time controlled and whose durability is at
least 18 months.
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13
Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
For the purpose of this Agreement, by way of example (without limit),
the following products shall not be considered as similar and competing
with the Product: injectable Collagen - Zyderm; Zyplast; Collagen;
Hylaform gel; Botulinum Toxine; Softform implant.
11.2 Distribution
The distribution non-competition commitment (prohibiting Collagen from
distributing products which compete with and are similar to the product
as defined in Article 11.1 above) shall be deemed nonexistent in any one
of the following cases:
(a) Final approval refusal of the Product in Europe by the competent
governmental authorities; in such case, Collagen shall not be bound by
any non-competition obligation.
(b) Upon expiration of the distribution agreement on its expiration
date, Collagen shall not be bound by any non-competition obligation for
the distribution of the Product.
(c) In the case of termination for serious fault by Biopharmex, Collagen
shall not be bound by any non-competition obligation relating to the
distribution of the Product.
Nevertheless Collagen agrees to not distribute products which are both
competing with and similar to the Product as defined in Article 11.1
above during 24 months in the two following cases:
(d) In the event that Collagen decides to not continue the project
following due diligence as from the placing on record of the
non-fulfillment of the condition precedent.
(e) In the event that Biopharmex refuses the modified quotas proposed by
Collagen, in accordance with the time periods and conditions provided in
Article 3(c) .
11.3 "Similar and competing Product"
Collagen's decision to distribute a product which is similar and
competing with the Product as defined in Article 11.1 above during the
term of this Agreement may give rise, at Biopharmex's election, to
either (i) withdrawal of the exclusivity for the distribution of the
Product for the remainder of the term of this Agreement; or (ii) the
granting of royalties in an amount of [*] of the sales of this other
product during the remainder of the term of this Agreement.
12. CLINICAL TRIALS
12.1 For the purpose of this Agreement, Collagen is expressly authorized, on
the one hand, to conduct clinical trials for a total number of two
hundred (200) patients identified by Collagen and, on the other, to
constitute an objective clinical database relating to the Product
capable of being used for ensuring the proper promotion of the Product.
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These clinical trials shall be conducted in accordance with the
conditions to be determined by Collagen in its own protocol. Biopharmex
shall supply all Products necessary for conducting these trials, free of
charge.
This Agreement shall become effective before the date that these trials
are completed.
12.2 In the event any defect whatsoever in the Product is notified to
Collagen within the framework of these tests, Collagen shall immediately
inform Biopharmex thereof Biopharmex shall thereafter take all necessary
and useful measures.
12.3 In the event of the early termination of this Agreement, Biopharmex
shall have access to the results of the clinical tests conducted by
Collagen according to Collagen's protocol on the conditions set forth in
Article 12 of this Agreement.
13. INDUSTRIAL AND INTELLECTUAL PROPERTY
Biopharmex represents that it is the sole owner of all the industrial
and intellectual property rights to the Product on the date of execution
of this Agreement. Biopharmex undertakes to indemnify and hold harmless
Collagen against any claims by third parties with respect to the extent
or lawfulness of all of these rights.
13.1 Trademarks
Collagen's right to distribute the Products pursuant to this Agreement
entails the right and obligation to use the "BIO-PLA" trademark
belonging to Biopharmex relating to the Product exclusively for the
purposes of its distribution and marketing.
The parties agree that Collagen may market the Product under a trademark
other than "BIO-PLA", with Biopharmex's prior consent; it is agreed,
however, that the identification of this new trademark shall be made by
mutual agreement of the parties.
The filing of the new trademark shall be carried out by Collagen and
shall be its exclusive property. The parties agree that in event of
termination of non renewal of this Agreement, Collagen shall transfer
ownership of the new trademark to Biopharmex.
In accordance with the laws of the Territory, Collagen and Biopharmex
shall make reference to the registration of the trademarks on all the
promotional material and documents involved related to the Products.
Furthermore, Collagen shall inform Biopharmex of any act of which it is
aware liable to infringe or otherwise interfere with Biopharmex's rights
to the trademarks, the brand names of the Products or their packaging
and shall immediately inform Biopharmex of any infringement of said
trademark of which it is aware. The defense of Biopharmex's trademarks
before the court shall be freely decided by Biopharmex; Collagen shall
apply its assistance for said defense in the manner requested by
Biopharmex.
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Biopharmex represents that it has all the intellectual property rights
allowing it to validly enter into the Distribution Agreement. Biopharmex
shall indemnify and hold harmless Collagen against any claims liable to
be made by third parties for patent infringement resulting from the
marketing of the Product in the Territory and to provide it with all
necessary assistance in order to defend its interests.
13.2 Patents
Biopharmex represents that Biopharmex is the lawful owner and lawfully
exploits the patent rights for the Product. Throughout the term of this
agreement, Biopharmex shall indemnify and hold harmless Collagen against
any claim liable to be made by a third party for patent infringement
resulting from the marketing of the Product in the Territory by Collagen
or any one of its subdistributors.
14. PRODUCT LIABILITY
Biopharmex shall be liable in its capacity as manufacturer of the
Products. Biopharmex shall justify that its activities are duly covered
by an insurance policy at the latest on the date of the marketing of the
Product.
As manufacturer, Biopharmex warrants that the Products conform to the
specifications and their approval file and that the Products are free of
any manufacturing and material defects or latent defects on the date of
their delivery and shall indemnify and hold harmless Collagen in this
regard.
Collagen shall assume liability resulting from the warehousing and
distribution of the Product for which Collagen has taken out an
insurance policy.
The parties agree to keep each other mutually informed in writing of any
"undesirable effects" of which they are aware. In the event that the
Product must be withdrawn from any one of the markets in the Territory
due to inherent defects in the Product, Biopharmex shall bear all costs
and expenses resulting from such withdrawal.
Biopharmex shall be responsible for its "material post marketing
monitoring" duties in the European union.
15. PERSONAL NATURE OF THE AGREEMENT/ASSIGNABILITY
15.1 This Agreement is personal in nature. Neither one of the parties may
assign its rights, duties or obligations arising from this Agreement to
any third party whatsoever without the prior written consent of the
other party.
15.2 The assignment of all of Biopharmex's rights and obligations by virtue
of this Agreement to any third party, whether for consideration or free
of charge, shall first give right to an exclusive right in favor of
Collagen to exercise a preferential right on conditions which are
identical to those provided in Article 4 (a) of this Agreement.
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
Collagen's decision to not exercise its preferential right shall
constitute the condition precedent authorizing Biopharmex to assign all
of its rights and obligations hereunder in favor of a third party.
Biopharmex shall guarantee to Collagen that the assignee shall assume
all of the obligations incumbent upon Biopharmex pursuant to this
Agreement.
15.3 Any change liable to alter Biopharmex's control and, more particularly,
any transfer of shares or change in the stated capital liable to confer
on any third party other than the persons specified at Article 15.4 of
this Agreement the right to [*] of Biopharmex's stated capital, (whether
in one or successive transactions), shall be subject to Collagen's prior
written consent.
15.4 The transfers of shares inuring exclusively to the members of Xx.
Xxxxxxx-Xxxxxxxx'x direct family, that is, in a limited manner, in favor
of her spouse and/or children, may be freely made without Collagen's
prior approval. Biopharmex shall keep Collagen informed of any such
transfers throughout the term of this Agreement.
16. PACKAGING - PROMOTION - PROMOTIONAL MATERIAL
16.1 Packaging
The packaging, labeling and directions for use of the Products for their
marketing in the European Union shall be performed under Biopharmex's
exclusive responsibility.
The packaging, labeling and directions for use of the Products for their
marketing outside of the European Union shall be performed by
Biopharmex, at its own expense in accordance with the written
recommendations transmitted by Collagen. Collagen shall therefore
transmit to Biopharmex information relating to the applicable laws and
regulations in the countries involved.
16.2 Promotional activities
In order to support Collagen's promotional policy, Xx. Xxxxxxx-Xxxxxxxx
agrees to be available thirty (30) business days per year at a date
mutually determined by the parties, taking into account Xx.
Xxxxxxx-Xxxxxxxx'x availability. Xx. Xxxxxxx-Xxxxxxxx'x transportation
and lodging and meal costs shall be reimbursed by Collagen to Biopharmex
upon presentation of supporting documents.
Within the framework of specific promotional activities with large
injectors, Collagen shall deliver Products free of charge based on the
volume of orders to be mutually determined by the parties. These
Products shall be supplied free of charge by Biopharmex to Collagen.
Each introduction of the Products on a market in the Territory made by
visits to doctors shall give rise to the delivery by Collagen of free
samples to the doctors. Biopharmex shall make available to Collagen one
free sample unit per perspective customer.
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16.3 Promotional Material
The preparation of material necessary for the promotion of the Products
shall be carried out in accordance with a mutual agreement between the
parties in compliance with applicable laws and regulations.
In the event of the early termination of this Agreement by Biopharmex,
Biopharmex shall purchase the promotional material on the conditions set
forth in Article 8.3 (vi) of this Agreement. Early termination by
Collagen shall trigger the application of Article 8.3 (vii) of this
Agreement.
In the event of non renewal of this Agreement, the terms and conditions
of Article 4 (c) of this Agreement shall apply with regard to the
promotional material in the possession of Collagen.
17. SUBDISTRIBUTORS
Collagen is expressly authorized to appoint third-party subdistributors in all
the countries where Collagen does not have a permanent installation (branch,
permanent establishment or subsidiary) without prior authorization. Collagen
shall transmit to Biopharmex the list of subdistributors that it intends to
appoint in the Territory at the end of the due diligence at the latest. Collagen
shall keep Biopharmex informed of each new appointment of a third-party
subdistributor in the Territory.
18. CONFIDENTIALITY
18.1 The negotiations which have been held or which shall be held between the
parties are deemed confidential.
18.2 The parties acknowledge that within the framework of their discussions
and agreements they shall exchange information relating not only to the
Product but also to their activity, strategy, and technology, including
without limitation their know-how and all other industrial and/or
intellectual property rights, as well as scientific and technical
information, and industrial and business secrets which are confidential
per se and the disclosure of which to a third party would irremediably
affect the value thereof.
18.3 Consequently, the parties agree to keep strictly confidential and to not
use, copy or reproduce this information, whether directly or indirectly,
for any other purposes than those which are strictly necessary pursuant
to this Agreement without the prior written consent of the other party.
Moreover, each party shall make its best efforts in order to ensure
compliance with this confidentiality obligation by its employees,
agents, representatives or experts to which the disclosure of such
information is necessary.
18.4 The confidentiality of the information exchanged pursuant to this
Agreement shall survive for three (3) years as from the date of
expiration of this Agreement regardless of the reason.
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19. FORCE MAJEURE
The total or partial non performance by either one the parties of one of
its obligations hereunder, due to any cause beyond its control which is
insurmontable, shall excuse such performance to the extent of such
obstacle, difficulty or delay, for a duration equal to that of the case
of force xxxxxxx.Xx the event that the delay continues for one hundred
twenty (120) days or more, the other party (during this period that the
obstacle, difficulty or delay continues), may terminate this Agreement,
at its election, by giving sixty (60) days written notice to the
defaulting party.
Pursuant to this Agreement, any decision from competent authorities
liable to suspend authorization to manufacture, sell and/or distribute
the Products in any part of the Territory shall constitute a case of
force majeure.
20 TAX OBLIGATIONS
Each of the parties shall be solely liable for its own taxes.
Consequently, the parties agree that Biopharmex shall pay all the
withholdings which may be due as a result of payments made by Collagen
under this Agreement and any subsequent commercial transactions between
the parties.
21. LAW - JURISDICTION
21.1 The parties expressly agree that the provisions of the United Nations
Convention for the International Sales of Goods dated April 11, 1980
shall not be applicable to this Agreement. All the rights, obligations
and constructions resulting from this Agreement shall be governed
exclusively by the laws of France.
21.2 Any dispute relating to the performance, construction or termination of
this Agreement if not amicably settled between the parties shall be
submitted to ICC arbitration in Paris in accordance with the ICC rules
of arbitration.
22. LANGUAGE OF THE AGREEMENT
This Agreement is drawn up in the French language to which is attached
an official translation in the English language made by a firm of sworn
translators. The parties expressly agree that they shall not make any
claim resulting purely and simply from differences related to or
resulting from the use of the two different languages.
23. INDEPENDENCE OF PROVISIONS
In case any one of the provisions contained in this Agreement shall be
held to be void or unenforceable by an enforceable decision of a
tribunal, court or any other authority whose jurisdiction has not been
challenged, and which decision binds the party such invalidity or
unenforceability shall not affect any other provisions thereof nor
render
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
them unenforceable. Moreover, the parties agree to replace such void or
unenforceable provisions by provisions which shall allow to the extent
possible to obtain the economic and business objectives connected to the
provisions which have been held void or unenforceable.
24. ELECTION OF DOMICILE - NOTICES
24.1 Notices to the parties
All notices exchanged between the parties pursuant to this Agreement shall be
made in writing and sent:
[*] for Biopharmex, to the following address:
BIOPHARMEX
38, Avenue du 10 Septembre,
L2550 Luxembourg
A l'attention de : Monsieur Xxx Xxxxx
[*] for Collagen, to the following address:
COLLAGEN Aesthetics International
0000 Xxxxxxxxxxx Xxxx
Xxxx Xxxx, XX 00000, XXX
A l'attention de : Mme Xxxxxxxxx Xxxxxxxx
Such notice shall be effectively made or validly delivered in the case of a
facsimile or telex or similar transmission at the time of its receipt or in the
case of a certified letter, xxxx of receipt upon receipt of the postal advice.
Each party may change the aforementioned address by giving written and express
notice of its new address to the other party.
24.2 This Agreement includes four Schedules, numbered one (1) to four (4) and
constitutes the final and complete agreement between the parties on the date of
its execution. Consequently, with the exception of the Memorandum and its
schedules, this Agreement cancels and supersedes all prior written or oral
agreements between Biopharmex and Collagen. The terms and conditions of this
Agreement shall be the only terms and conditions applicable to the sale of the
Products, to the exclusion of any other terms and conditions which may, more
particularly, appear in Biopharmex's general conditions of sale.
All Schedules and documents attached hereto form an integral part of this
Agreement.
Executed in two original copies in the French language and two original copies
in the English language. Each of the parties acknowledges being in possession of
this Agreement in the French language and in the English language.
At ______, on January 28, 1999
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FOR BIOPHARMEX FOR COLLAGEN AESTHETICS INTERNATIONAL
Xx. Xxx Xxxxx Xx. Xxxx Xxxxxxxxxxx
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--------------------------------
SCHEDULE 1
--------------------------------
- The BIO PLA product is defined as follows (hereinafter the "Product"):
- Polyactid acid in the form of microspheres, microparticles, or fragments
suspended in a gel or in a gel of synthetic or natural origin whose
reabsorbability is time controlled and whose durability is at least 18
months.
- The Product unit is defined as the quantity necessary to be diluted in 3
cc of Product.
2. The Field of Application of the Product that is the object of the
present Contract is defined as follows:
2.1. Medicine and aesthetic surgery (as of now, smoothing out wrinkles and
cutaneous depressions over the entire human body), dermatology, plastic
surgery, maxillo-facial surgery.
2.2. Hence Biopharmex shall be free to make and market a product having the
same composition for any field of application other than the one defined
above (2.1.), as long as it sees to it that the said product is
exploited and/or marketed under some other name and trademark than
BIO-PLA.
2.3. In addition, Biopharmex undertakes, on one hand, not to exploit and/or
market the said product in one of the fields reserved for Collagen under
the present Contract, and on the other hand to refrain from any practice
of such nature as to create an economic disparity because of the
respective prices of each of the products in the Territory.
2.4. Starting on 1 July 1999, Biopharmex undertakes to negotiate in good
faith with Collagen on possible extension of the field of application of
the present Contract to the field of urology, with a view to reaching
agreement within a period of 6 months, or by 31 December 1999. The fact
that the parties do not conclude a contract in this field on the
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agreed date shall have no consequence for performance of the present
Contract and may not give rise to any request for indemnity whatsoever.
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--------------------------------
SCHEDULE 2
--------------------------------
MEMORANDUM EXECUTED BY THE PARTIES ON JANUARY 11, 1999
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--------------------------------
SCHEDULE 3
--------------------------------
3.1 LOAN AGREEMENT
3.2 SECURITY
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
LOAN CONTRACT
The present loan contract is signed this very day, 28 January 1999, between:
COLLAGEN Aesthetics International, a company operating under the laws of the
State of Delaware, having its principal establishment at 0000 Xxxxxxxxxxx Xxxx,
Xxxx Xxxx, XX 00000, Xxxxxx Xxxxxx of America,
Represented by Xx. Xxxx Xxxxxxxxxxx, its duly authorized legal representative,
(hereinafter the "Lender")
and:
BIOPHARMEX S.A., a company under Luxembourg law, having its registered office at
00, xxxxxx xx 00 xxxxxxxxx, X-0000 Xxxxxxxxxx,
Represented by Xx. Xxx Xxxxx, its duly authorized legal representative,
(hereinafter the "Borrower").
THE PARTIES SET FORTH THE FOLLOWING PREMISES:
The Lender wishes to make available to the Borrower, which accepts, a second
loan in an amount [*], in order to finance development of what are called
"BIO-PLA" products (hereinafter the "Products"), which the Lender plans to
distribute, by virtue of a distribution contract signed this very day between
the parties (hereinafter the "Distribution Contract".
NOW THEREFORE THE PARTIES HEREBY ENTER INTO THE FOLLOWING AGREEMENT:
ARTICLE 1 - LOAN
1.1. Amount
In the light of the rights granted to the Lender by virtue of the Distribution
Contract, the Lender grants a second loan (the "Loan") to the Borrower in an
amount of [*]. The Loan shall be made available all at once by means of a
transfer initiated within five (5) days following
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
signature of these presents. The date of availability of the funds shall be
called the "Effective Date".
1.2. Use
The Borrower shall have to use the amount of the Loan solely for financing
development of the Products.
1.3. Duration
The Loan is concluded for a duration of one (1) year starting with the Effective
Date, subject to the provisions of Article 5 below.
1.4. Interest
The interest rate applicable to the present Loan shall be equal to [*]. The
interest shall be calculated on the basis of the exact number of days elapsing
on the basis of a year of 365 days, and shall be paid quarterly.
The global effective rate ("TEG") of the present Loan is [*].
ARTICLE 2 - REPAYMENT
2.1. Repayment
The Loan amount shall be repaid all at once on the first anniversary of the
Effective Date (the "Repayment Date"), subject to the provisions of Articles 2.3
and 5 below.
2.2. Prepayment
The Borrower shall have the option of prepaying the entire Loan without
indemnity.
2.3. Offsetting
In case of European approval of the Product under the conditions of Article 5.1
of the Distribution Contract, the Loan shall be repaid by offsetting against the
first and the second admission fees ("first and second milestone payments"),
pursuant to the provisions of Article 6.4 of the Distribution Contract, the said
offsetting being effective seven days following the date on which COLLAGEN
receives the notification of the above-mentioned approval.
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ARTICLE 3 - PAYMENT
Any payment by the Borrower shall have to be made net of any deductions or
withholdings of any nature whatsoever. If the Borrower is required to make such
a deduction, withholding or subtraction, it shall have to pay any additional
amount to the Lender such that the said Lender receives a net amount equal to
the one it would have received in the absence of such deduction, withholding or
subtraction.
In addition, the Borrower shall have to supply the Lender with any justification
relating to the said deduction or withholding. If payment of such an additional
amount is not legally authorized, the Borrower shall have to repay the Loan
balance without delay, as well as all interest relating thereto.
ARTICLE 4 - CERTIFICATIONS AND GUARANTEES
The Borrower hereby certifies the following, to the Lender's benefit:
(i) it is validly constituted under Luxembourg law,
(ii) it is duly authorized to sign the present Loan, which constitutes valid
obligations for it which are fully applicable to it,
(iii) signature of these presents is not contrary to any legislative or
regulatory provision whatsoever or to the Borrower's Articles, or to any
other contract or undertaking to which the Borrower is a party,
(iv) any approvals required for purposes of signing the present Loan and
performing the obligations thereof have been duly obtained,
(v) the interest payable by virtue of these presents is not subject to
withholding in Luxembourg.
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ARTICLE 5 - PREPAYABILITY
Any amounts in terms of principal lent by virtue of these presents as well as
any interest relating thereto shall be payable by right in advance, and the Loan
shall be canceled, without any need for advance warning in case of occurrence of
one of the following events:
5.1. Non-performance by the Borrower of a substantial obligation resulting
from the present Loan or from the Distribution Contract, and inability
to remedy it within a period of two weeks starting with the date of a
warning sent by the Lender to that effect;
5.2. An amount due from the Borrower to the Lender is not paid at due date;
5.3. Insolvency or cessation of payments of the Borrower;
5.4. A procedure of court reorganization or liquidation filed against the
Borrower, as well as a search for or obtaining by court action or by its
creditors' agreement of a delay of due date or of a reduction of its
debts.
Moreover, and without prejudice to the other provisions of the present Loan
Contract, the Borrower shall have to indemnify the Lender for all losses or
expenditures incurred because of the occurrence of one of the above-mentioned
events.
ARTICLE 6 - SURETY
In order to warrant proper performance of the present Contract and repayment of
the Loan in terms of principal, interest, expenses and incidentals, Xx.
XXXXXXX-XXXXXXXX agrees, in a separate document dated this very day, to be
answerable, as joint surety, for repayment of the Loan in terms of principal,
interest, expenses and incidentals.
ARTICLE 7 - MISCELLANEOUS PROVISIONS
7.1. Notification
Any notification, request or communication that can or must be made in
performance of these presents shall have to be made by registered mail with
receipt sent to the following addresses:
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For the Borrower:
BIOPHARMEX
Attention: Xx. Xxx Xxxxx
00, xxxxxx xx 00 xxxxxxxxx
X-0000 Xxxxxxxxxx
For the Lender:
COLLAGEN Aesthetics International
Attention: Xxx. Xxxxxxxx Xxxxxxxx
0000 Xxxxxxxxxxx Xxxx
Xxxx Xxxx, XX 00000
XXX
7.2. Inapplicability
Illegality or inapplicability of a provision of the Loan Contract under the
terms of law of a jurisdiction shall not affect its validity by virtue of the
law of another jurisdiction, and shall not affect the validity of the other
provisions of the Loan Contract.
7.3. Applicable law and competent courts
It is explicitly agreed that the present Contract is subject to French law. Any
dispute shall be subject to the sole jurisdiction of the Courts of Paris.
7.4. Contract Language
The present Contract is drawn up in the French language, and an official
translation into the English language is attached thereto, made by a sworn
translation firm. It is explicitly agreed that the parties shall refrain from
making any claim resulting purely and simply from differences connected with or
resulting from the use of two different languages.
Signed in ________ on 28 January 1999.
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In two originals in French and in two originals in English, each of the parties
acknowledging that it is in possession of the present Contract in the French
language and in the English language.
The Lender The Borrower
Represented by Xx. Xxxx Xxxxxxxxxxx Represented by Xx. Xxx Xxxxx
___________________________________ ___________________________________
Doctor LAUGIER-LAGLENNE
(as surety)
___________________________________
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SURETY
I the undersigned,
Xx. Xxxxxxxxx XXXXXXX-XXXXXXXX, residing at 00, xxx xx Xxxxxxxx, 00000 Xxxxx,
Xxxxxx,
hereby declare that I will act as personal, joint and indivisible surety
vis-a-vis the company COLLAGEN Aesthetics International (the "Beneficiary"),
having its main establishment at 0000 Xxxxxxxxxxx Xxxx, Xxxx Xxxx, XX 00000,
Xxxxxx Xxxxxx of America, for repayment by the BIOPHARMEX SA Company, a company
under Luxembourg law having its registered office at 00 xxxxxx xx 00 xxxxxxxxx,
X - 0000 Xxxxxxxxxx, of any amount due or to become due in terms of principal,
interest, expenditures and incidentals from BIOPHARMEX to the Beneficiary, by
virtue of a Loan Contract of which I am fully and entirely aware, concluded this
very day between BIOPHARMEX SA and the Beneficiary.
I commit myself up to an amount in terms of principal [*], to be increased by
any interest at a rate of [*], expenses and incidentals.
The present Surety may be called upon at any time. It shall become enforceable
by right and without warning as soon as the Beneficiary's claim against
BIOPHARMEX SA becomes payable. In case of default by BIOPHARMEX SA for any
reason whatsoever, I undertake to pay, to the Beneficiary, what BIOPHARMEX SA
owes it, including the amounts that have become prepayable. As surety, I may not
call upon any payment extensions that may be granted to BIOPHARMEX SA explicitly
or tacitly.
My assigns, particularly my heirs, shall be jointly and indivisibly liable
vis-a-vis the Beneficiary for performance of the present Surety.
I shall act as surety of BIOPHARMEX SA Company as long as it has not paid the
amounts due to the Beneficiary in full. In any event, the present surety is
granted for a maximum duration of two (2) years starting with the date of these
presents.
I explicitly waive beneficium excussionis and beneficium divisionis. Hence the
Beneficiary shall be entitled to apply to me for any payment in connection with
the present undertaking without first having to take proceedings against
BIOPHARMEX SA.
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Application for an order
granting confidential
treatment pursuant to Rule
24-b-2 of the Securities
Exchange Act of 1934 has been
or be timely made.
Confidential portions of this
document have been redacted
and marked with an [*] and
have been filed with the
Securities and Exchange
Commission separately with an
application.
To obtain payment in connection with the present undertaking, the Beneficiary
shall be entitled to take legal proceedings against all of my movables and
immovables, present or future.
It is understood that any total or partial payment made in connection with these
presents shall reduce my undertaking to that extent.
All of the provisions of the present undertaking shall retain their full effect,
whatever changes may occur in the financial or legal situation or the legal form
of BIOPHARMEX SA. I intend to personally monitor the situation of BIOPHARMEX SA,
and I dispense the Beneficiary from any notice of extension or of non-payment.
The Beneficiary shall have no obligation to supply me with information in
connection with these presents.
All of the expenses, the fees and penalties to which the present undertaking and
performance thereof give rise shall be paid by me, including the recording
expenses in case that formality is carried out.
The present Surety is drawn up in the French language, and an official
translation into the English language is attached thereto, made by a sworn
translation firm. It is explicitly agreed that the parties shall refrain from
making any claim resulting purely and simply from differences connected with or
resulting from the use of two different languages.
The present Surety is subject to French law. For any difficulty that may arise
from performance of these presents and/or from their construction, sole
jurisdiction is assigned to the competent Courts of Paris.
Signed in Paris on 28 January 1999
___________________________________
Doctor LAUGIER-LAGLENNE
Have the signature preceded by the following handwritten indication: "Read and
approved, accepted for personal, joint and individual surety in an amount [*] in
principal, to be increased by any interest at an annual rate of [*], expenses
and incidentals, with waiver of beneficium divisionis and beneficium
excussionis".
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SCHEDULE 4
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TIMETABLE OF APPROVALS BY COUNTRY
To be submitted by Collagen before April 11, 1999
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