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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q/A
Quarterly Report Under Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the Quarter Ended June 30, 1996 Commission File Number 0-19373
BIOMATRIX, INC.
(Exact name of registrant as specified in its charter)
Delaware 13-3058261
(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
65 Railroad Avenue, Ridgefield, N.J. 07657
(Address of principal executive offices) (Zip Code)
(201) 945-9550
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes X No
The number of shares outstanding of the issuer's common stock as of the latest
practicable date:
Class June 30, 1996
Common Stock, $0.0001 par value 10,437,197
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
A. EXHIBITS
10.1(1) Restated Distribution Agreement between Biomatrix, Inc.
and Syntex Pharmaceuticals International Limited, dated
April 9, 1996.
10.2(1)(2) First Amendment to Stock Purchase Agreement, dated April
17, 1996, between Biomatrix, Inc. and Syntex
Pharmaceuticals International Limited.
10.3(2) Agreement of Lease, dated April 18, 1996, between
Ridgefield Associates and Biomatrix, Inc.
10.4(1) International Distribution Agreement, dated June 14,
1996, between Biomatrix, Inc. and Collagen Corporation.
10.5(1) United States Distribution Agreement, dated June 14,
1996 between Biomatrix, Inc. and Collagen Corporation.
10.6(2) Employment Agreement, dated April 2, 1996, between
Biomatrix, Inc. and Rory B. Riggs.
10.7(2) Restricted Stock Purchase Agreement, dated April 2,
1996, between Biomatrix, Inc. and Rory B. Riggs.
10.8(2) Secured Promissory Note, dated April 2, 1996, by Rory
Riggs and Biomatrix, Inc.
10.9(2) Stock Pledge Agreement, dated April 2, 1996, between
Rory B. Riggs and Biomatrix, Inc.
10.10(2) Amendment dated March 31, 1996 to the Consulting
Agreement, dated June 1, 1993, between Biomatrix, Inc.
and Julius A. Vida.
27.1(2) Financial Data Schedule.
B. REPORT ON FORM 8-K
None.
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(1) Confidential treatment requested. Confidential portions
have been omitted and filed separately with the
Commission.
(2) Previously filed as an exhibit to registrant's quarterly
report on Form 10-Q, for the quarterly period ended June
30, 1996, filed with the Securities and Exchange
Commission on August 14, 1996.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this amended report to be signed on its behalf by the
undersigned thereunto duly authorized.
DATE: BIOMATRIX, INC.
----------------
By:/S/ Rory B. Riggs
------------------------
Name: Rory B. Riggs
Title: President
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EXHIBIT 10.1
RESTATED DISTRIBUTION AGREEMENT
By and Between
BIOMATRIX, INC.
and
SYNTEX PHARMACEUTICALS INTERNATIONAL LIMITED
Dated as of April 9, 1996
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INDEX
SECTION PAGE
1. Definitions 1
2. Appointment of Exclusive Distributor; 5
Initial Payment; No Additional Payments;
Best Efforts of Syntex
3. Term and Termination 6
4. Payments 10
5. Withholding 10
6. Competing Products 10
7. Improvements 11
8. Trademarks, Agreement Product Marking; 11
Promotional Information
9. Supply of Product 15
10. Indemnification 31
11. Representations of Biomatrix 34
12. Representations of Syntex 35
13. Insurance 36
14. Infringement 36
15. Regulatory Activities; Clinical Trials 37
16. Consolidation of Documents 39
17. Other Distribution Agreements 39
18. Further Assurances 39
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SECTION PAGE
19. Assignment 39
20. Governing Law; Arbitration; Injunctive Relief 40
21. Severability 41
22. Force Majeure 41
23. Interest 41
24. No Partnership or Agency 41
25. Notices 41
26. EU Regulations 42
27. Survival 42
28. Miscellaneous 42
Exhibits
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Exhibit A - Agreement Product Quality Control Procedures
Exhibit B - Agreement Product Specifications
Exhibit C - Patents and Trademarks
Exhibit D - Price and Quantities of Physicians' Samples
Exhibit E - Sales Forecasts
Exhibit F - Documents
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RESTATED DISTRIBUTION AGREEMENT
THIS RESTATED DISTRIBUTION AGREEMENT (this "Agreement") is made as of the
9th day of April 1996 by and between BIOMATRIX, INC., a corporation duly
organized and existing under the laws of the State of Delaware, having its
principal office at 65 Railroad Avenue, Ridgefield, New Jersey 07657, U.S.A.
("Biomatrix") and SYNTEX PHARMACEUTICALS INTERNATIONAL LIMITED, a Bermudan
corporation with its registered office at The Corner House, 20 Parliament
Street, Hamilton, HM 12, Bermuda ("Syntex").
WHEREAS, Biomatrix and Syntex have entered into a Distribution Agreement
dated 9 November 1993 (the "First Distribution Agreement"), and a Second
Distribution Agreement dated as of 23 June 1994 (the "Second Distribution
Agreement", and, collectively with the First Distribution Agreement, the "Prior
Agreements"); and
WHEREAS, Biomatrix and Syntex desire to amend and restate the Prior
Agreements in their entirety in accordance with the terms hereof.
NOW, THEREFORE, in consideration of the premises and of the mutual
covenants of the parties hereto, Syntex and Biomatrix hereby agree to amend and
restate the Prior Agreements in their entirety as set forth below, so that from
and after the date hereof the Prior Agreements shall be superseded in their
entirety by this Agreement:
1. DEFINITIONS AND RULES OF INTERPRETATION. In this Agreement, unless the
context otherwise requires, references to sections and exhibits are to be
construed as references to the sections and exhibits of this Agreement; and
references to (or to any specified provision of) this Agreement or any other
document shall be construed as references to this Agreement, that provision or
that document as in force from time to time and as amended, varied, substituted,
supplemented, restated or novated in accordance with the terms thereof. In
addition, in this Agreement, the following words and expressions shall have the
following meanings:
1.1. "Affiliate" shall mean, with respect to any party, any Person which,
directly or indirectly, is controlled by, controls or is under common control
with such party. For purposes of this definition, the term "control" (including
with correlative meanings, the terms
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"controlled by" and "under common control with") shall mean, with respect to any
Person, the direct or indirect ownership of more than fifty percent (50%) of the
voting or income interest in such Person or the possession otherwise, directly
or indirectly, of the power to direct the management or policies of such Person.
1.2. "Agreement Product" shall mean hylan gel-fluid 20 (hylan G-F 20) for
the intra-articular treatment of osteoarthritis by viscosupplementation, as
described in the Agreement Product Specifications, to be supplied by Biomatrix
in pre-filled 2.0ml syringes packaged ready for sale and use, together with any
Improvements. Agreement Product shall also include the syringe and any other
delivery device associated with the Agreement Product and supplied by Biomatrix
to Syntex therewith.
1.3. "Agreement Product Quality Control Procedures" shall mean the
procedures set forth in Exhibit A for determining conformance with the Agreement
Product Specifications, as such procedures shall be modified in accordance with
Product License Approvals.
1.4. "Agreement Product Specifications" shall mean the specifications for
the Agreement Product set forth in Exhibit B, as such specifications shall be
modified in accordance with Product License Approvals.
1.5. "Agreement Year" shall mean, (a) for South Africa, the twelve (12)
month period commencing on the first day of the nearest month preceding or
succeeding (as the case may be) the first to occur of (i) the date of first
commercial sale of the Agreement Product in the respective country, or (ii)
three (3) months after Product License Approval in the respective country, and
each separate successive twelve (12) month period thereafter during the Initial
Term or any renewal term of this Agreement; and (b) in Sweden, the twelve (12)
month period commencing on June 1, 1995, and each separate successive twelve
(12) month period thereafter during the Initial Term or any renewal term of this
Agreement.
1.6. "Contract Quarter" shall mean that term as defined in Section 9.2(c).
1.7. "Dollars" and "$" shall mean the lawful currency of the United States
of America.
1.8. "Effective Date" shall mean April 9, 1996.
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1.9. "Formula Price" shall mean that term as defined in Section 9.2(a).
1.10. "Good Manufacturing Practice" shall mean all generally accepted good
manufacturing practices in effect in the country in which the Agreement Product
is manufactured and in each country in the Territory in which the Agreement
Product is being sold by Syntex in accordance with this Agreement, including
without limitation good manufacturing practices set forth in Volume IV of the
Rules Governing Medicinal Products in the European Community.
1.11. "hylans" means hyaluronan * without any other chemical change in the
molecule.
1.12. "Improvements" shall mean extensions of the label claims for the
Agreement Product, in addition to line extensions, new dosage and presentation
forms and packaging improvements for the Agreement Product. For the avoidance of
doubt, any product that comes within the definition of Next Generation Product
shall not constitute an Improvement hereunder.
1.13. "Initial Term" shall mean that term as defined in Section 3.2.
1.14. "Minimum Price" shall mean, with respect to each country in the
Territory, * that for each calendar year (or partial calendar year, in the case
of the period immediately following the * commencing with the first Agreement
Year (or partial Agreement Year) after the second anniversary of the Effective
Date * .
1.15. "Net Revenues" shall mean the total gross invoice price from the
sale of all units of the Agreement Product by Syntex or any of its Affiliates to
non-Affiliated wholesalers, hospitals and other third party purchasers * . For
the avoidance of doubt, Syntex shall be entitled at all times, in its
discretion, to * used to calculate "Net Revenues".
1.16. "Next Generation Product" shall mean any product (other than the Agreement
Product) * .
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* Confidential portions have been omitted and filed separately with the
Commission.
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1.17. "Non-Compete Territory" shall mean Germany, Spain, Switzerland,
Belgium, Luxembourg, the Netherlands, South Africa, the United Kingdom, the
Republic of Ireland, Sweden, Norway, Denmark, Iceland, Finland, and the Republic
of France, including "DOM TOM". For the purpose of this Agreement, "DOM TOM"
shall mean French Guiana, Martinique, Reunion, Guadeloupe, St. Pierre and
Miquelon ("Departements d'Outre Mer" or "DOM"); and Mayotte, Wallis and Futuna,
New Caledonia and Dependencies and French Polynesia ("Territoires d'Outre Mer"
or "TOM").
1.18. "Patents" shall mean Letters Patent or similar statutory rights
relating to any Agreement Product (including any continuation-in-part,
continuation or division thereof or substitute thereof), and patent applications
which are pending as of the Effective Date, in each case as set forth in Exhibit
C attached hereto, together with any supplementary or complementary protection
certificates therefor if and when such are granted.
1.19. "Person" shall mean an individual, a corporation, a partnership, a
trust, an unincorporated organization or a government or any agency or political
subdivision thereof.
1.20. "Product License Approvals" shall mean with respect to each country
in the Territory, those regulatory approvals required for the promotion,
marketing and sale of the Agreement Product in such country; provided, however,
that, except as specifically provided to the contrary herein, Product License
Approval shall not include any approvals with regard to pricing.
1.21. "South Africa" shall mean the Republic of South Africa.
1.22. "Territory" shall mean Sweden and South Africa; provided that,
subject to the provisions of Section 3.3(b), upon termination of this Agreement
with respect to any country in accordance with the terms of this Agreement, such
country shall, upon the effectiveness of such termination, cease to be part of
the Territory.
1.23. "Trademarks" shall mean (i) the trademark "SYNVISC" that is owned by
Biomatrix and used by Syntex and its designated Affiliates in connection with
the promotion, marketing and sale of the Agreement Product in the Territory
under this Agreement, as further described in Exhibit C hereto, and (ii) any
other trademarks, in addition to "SYNVISC", as may be agreed upon in writing
from time to time by the parties hereto for use by Syntex and its Affiliates in
connection with the promotion, marketing and sale of the Agreement Product under
this Agreement.
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2. APPOINTMENT OF EXCLUSIVE DISTRIBUTOR; INITIAL PAYMENT; NO ADDITIONAL
PAYMENTS; BEST EFFORTS OF SYNTEX.
2.1. Appointment. Subject to the terms and conditions hereinafter set
forth, Biomatrix hereby appoints Syntex as its exclusive distributor for the
promotion, marketing, sale and distribution within the Territory of the
Agreement Product supplied by Biomatrix to Syntex pursuant to this Agreement.
Except as specifically provided to the contrary herein, the foregoing
appointment shall not be construed (a) to effect any sale of proprietary
Biomatrix technology, (b) to grant any license relating to Biomatrix's
proprietary methods of formulating, fabricating and manufacturing the Agreement
Product, or (c) to grant Syntex any rights in or to any Biomatrix proprietary
technology by implication, estoppel or otherwise. During the term of this
Agreement Syntex shall neither seek customers for the Agreement Product outside
the Territory nor establish any branch or maintain any distribution facilities
(other than the central distribution facility referred to in Section 9.13 below)
outside the Territory for the promotion, marketing, sale or distribution of the
Agreement Product, except that Syntex shall be permitted to distribute the
Agreement Product from Sweden and in Swedish packaging to Denmark and Iceland on
a "patient-name" basis pursuant to a physician's request and in accordance with
all applicable laws and regulations, but only until such time as Biomatrix has
entered into an agreement or agreements relating to the distribution of the
Agreement Product in Denmark and Iceland.
2.2. Initial Payments. Biomatrix acknowledges receipt from Syntex of
$1,100,000 on December 6, 1995, as a non-refundable partial payment in
consideration of the release of Syntex from its obligations under the Prior
Agreements. Within five (5) business days after the Effective Date, Syntex shall
pay to Biomatrix an additional one million nine hundred thousand Dollars
($1,900,000), as additional consideration of the release of Syntex from its
obligations under the Prior Agreements.
2.3. * Payments. Biomatrix and Syntex acknowledge and agree that * , and
(ii) all payments previously paid by Syntex to Biomatrix pursuant to either or
both of the Prior Agreements shall be non-refundable.
2.4. Best Efforts of Syntex. Syntex hereby accepts the appointment as
exclusive distributor for the promotion, marketing, sale and distribution within
the Territory of the
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* Confidential portions have been omitted and filed separately with the
Commission.
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Agreement Product and hereby agrees to use its best efforts at all times during
the term hereof to promote, market, sell and distribute the Agreement Product in
the Territory. Syntex's "best efforts" in this Section 2.4 shall mean *
3. TERM AND TERMINATION.
3.1. Effective Date. This Agreement shall take effect as of the Effective
Date.
3.2. Term. Unless this Agreement is sooner terminated in accordance with
the provisions of this Agreement, with respect to each country in the Territory
the term (the "Initial Term") of the appointment hereunder shall be ten (10)
years after the date of the receipt by either Biomatrix or Syntex (as the case
may be) of the first Product License Approval in such country (in the case of
South Africa), and shall be the ten-year period ending on May 31, 2005 for
Sweden, and shall thereafter be renewable by Syntex, at its option, on a
country-by-country basis upon written notice to Biomatrix received at least six
(6) months prior to the end of the Initial Term for such country, for an
additional term of five (5) years following the date of expiration of such
Initial Term, provided that Syntex shall only be entitled to exercise such
renewal option if as of the date of expiration of such Initial Term Syntex is
not in breach of any of its obligations under this Agreement such that Biomatrix
would be entitled to terminate this Agreement with respect to such country,
including without limitation (i) Syntex's minimum purchase obligations under
Section 9.12 below and (ii) Syntex's best efforts obligations under Section 2.4
above. Thereafter, this Agreement shall be renewable, on a country-by-country
basis, following the expiration of such additional five (5) year term, for
further additional renewal terms of five (5) years each upon the written
agreement of the parties hereto, provided that in the event that either party
does not wish to extend this Agreement beyond the end of any additional term,
such party agrees to so notify the other party hereto in writing twelve (12)
months prior to the end of such term. If either party gives such written notice
of its intent not to extend the Agreement with respect to any country beyond the
end of any additional term, the Agreement shall terminate with respect to such
country at the end of such additional term.
3.3. Inventory.
(a) Upon termination of this Agreement for any reason other than (i)
termination pursuant to Section 3.5 hereof resulting from a breach by Syntex of
its obligations under this Agreement and (ii) termination resulting from
Syntex's failure to renew the Agreement following
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* Confidential portions have been omitted and filed separately with the
Commission.
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the expiration of the Initial Term, * Notwithstanding the preceding sentence,
upon termination of this Agreement for any reason, Biomatrix shall have the
right (but not, except as specifically provided above, the obligation) to
repurchase all or part of the inventory of the Agreement Product held by Syntex
or its Affiliates.
(b) The price for inventory to be repurchased by Biomatrix pursuant to
Section 3.3 (a) above shall be * . With respect to any quantities not
repurchased by Biomatrix, Syntex and its Affiliates shall have the right to sell
such inventory of the Agreement Product, in their usual and customary manner, in
the ordinary course of business, for a period of * following termination of this
Agreement and notwithstanding such termination the terms and conditions of this
Agreement shall apply to such sales.
3.4. Insolvency. This Agreement may be immediately terminated by either
party, upon giving written notice to the other party, in the event that the
other party is declared insolvent or bankrupt by a court of competent
jurisdiction or shall be the subject of any reorganization (other than a
corporate reorganization effected in the ordinary course of business and not
arising out of any insolvency) or winding up, receivership or dissolution,
bankruptcy or liquidation proceeding, or any proceeding similar to one or more
of the above, in which case termination shall be effective upon such written
notice.
3.5. Breach. This Agreement may be terminated by either party if the other
party shall breach any of its payment obligations hereunder or shall commit a
material breach of any of its warranties, covenants, conditions, obligations or
agreements contained herein, provided that in the case of a payment breach such
breach shall continue for a period of thirty (30) days after written notice
thereof and in the case of any other breach such breach shall continue for a
period of sixty (60) days after written notice thereof and provided further that
such termination shall be immediately effective upon further written notice to
that effect to the breaching party after its failure to cure such breach within
such applicable notice period.
3.6. Certain Rights Upon Termination. Upon termination of this Agreement,
for any reason whatsoever:
(a) Biomatrix shall have the unrestricted right to review, access, use and
permit others to review, access and use, either directly or by cross-reference
or incorporation or otherwise, all information, data, investigations,
preclinical and clinical protocols (including
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* Confidential portions have been omitted and filed separately with the
Commission.
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without limitation, information relating to laboratory, animal and human
studies), and related regulatory approvals pertaining to the Agreement Product
(the "Information") which are possessed or controlled by Syntex or any of its
Affiliates, or to which Syntex or any of its Affiliates has a right to review,
access or use (to the extent that Syntex is not prevented by law or contract
from doing so, provided that Syntex shall endeavour in good faith to avoid being
bound by any contract which would limit Biomatrix's rights under this Section
3.6(a)) for the purpose of manufacturing, developing, marketing, promoting,
licensing, selling and/or otherwise advancing any Biomatrix product (whether as
manufacturer, inventor, developer, promoter, distributor or otherwise); except
that Confidential Information (as defined in Section 10.4) relating to a Syntex
product other than the Agreement Product shall be subject to the provisions of
Section 10.4 and Biomatrix shall not use or permit others to use any such
Information to the extent that it relates to a Syntex product other than the
Agreement Product without the prior written consent of Syntex, such consent not
to be unreasonably withheld. Syntex unconditionally agrees promptly to take any
action and to execute and deliver to Biomatrix any documents or instruments
reasonably requested by Biomatrix to permit Biomatrix to make full use of such
unrestricted right. Further, Biomatrix shall have exclusive ownership rights to
the Trademarks and to all other product specific logos, slogans and other
intangibles relating to the Agreement Product (including all registrations
relating thereto) possessed or controlled by Syntex or any of its Affiliates,
and Syntex unconditionally agrees, subject to the provisions of Section 3.3(b),
(i) immediately to cease using the Trademarks and any such logos, slogans, and
marketing rights of Biomatrix or any colorable imitations thereof and (ii)
immediately to execute and deliver to Biomatrix any documents or instruments
reasonably requested by Biomatrix to give full effect to the provisions of this
Section 3.6. In addition, Syntex unconditionally agrees, subject to the
provisions of Section 3.3(b), that it shall, upon the request of Biomatrix,
immediately inform all relevant regulatory authorities that Syntex is no longer
a distributor of the Agreement Product and shall take all action and execute and
deliver all documents and instruments necessary in order to transfer all
registrations and regulatory approvals for the Agreement Product in favour of
Biomatrix or any Person nominated by Biomatrix. For the avoidance of doubt,
Syntex's unconditional obligations under this Section 3.6(a) shall not otherwise
adversely affect its rights or remedies against Biomatrix arising out of a
breach by Biomatrix of its obligations under this Agreement, including without
limitation a wrongful termination of this Agreement by Biomatrix.
(b) Biomatrix hereby acknowledges that Syntex shall not be responsible for
any use by Biomatrix or any other Person whose use has been permitted by
Biomatrix of any Information provided to Biomatrix by Syntex pursuant to Section
3.6(a).
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(c) Except to the extent that any Information falls within the categories
described in clause (a) or (b) of Section 10.4, Syntex shall not use or permit
others to use any Information to the extent that it relates to the Agreement
Product without the prior written consent of Biomatrix, such consent not to be
unreasonably withheld.
3.7. Effect of Termination.
(a) Upon termination of this Agreement for any reason, Syntex shall
immediately discontinue making any representations regarding its status as a
distributor for Biomatrix and shall immediately cease conducting any activities
with respect to the marketing, promotion, sale or distribution of the Agreement
Product; provided, however, that Syntex shall be permitted to sell inventory not
repurchased by Biomatrix in accordance with Section 3.3 hereof.
(b) Termination of this Agreement shall not affect obligations of either
party that may have accrued prior to the effective date of termination.
Termination of this Agreement shall be in addition to, and shall not be
exclusive of or prejudicial to, any other grounds for termination or rights or
remedies at law or in equity which either party may have on account of any
default of the other party.
3.8. Waiver. Each of Biomatrix and Syntex hereby waives, to the extent it
is able to do so under the law of every country in the Territory and other
applicable law, any statutory rights it may have or acquire in respect of the
termination of the relationship established hereby pursuant to the terms hereof,
and agrees that the rights available to it hereunder in the event of such
termination are adequate and reflect the agreement of the parties. Neither
Syntex nor Biomatrix shall have any right to claim any indemnity for goodwill or
lost profits or any damages arising from the rightful termination of this
Agreement in accordance with the terms hereof.
3.9. Termination for Commercial Reasons. Syntex shall have the right, by
written notice to Biomatrix at least 12 months' prior to the proposed effective
date thereof, to terminate this Agreement if, in the exercise of its reasonable
business judgment, it determines for commercial reasons not to continue as
distributor for the Agreement Product in the Territory. Such termination shall
be effective on the first anniversary of the date of such notice, except that
Biomatrix at its sole discretion can accelerate the effective date of such
termination by giving sixty (60) days' prior written notice to Syntex of the
effective date. At all times prior to the effective date of such termination,
the parties shall continue to perform their respective obligations under this
Agreement.
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4. PAYMENTS. All payments hereunder shall be made in Dollars. Payments to
Biomatrix shall be wired to an account designated by Biomatrix at Bank of New
York or another financial institution designated by Biomatrix upon the date when
due and the costs of any such remittance shall be borne by Syntex. Payments (if
any) to Syntex shall be wired to a bank account designated by Syntex upon the
date when due and the costs of any such remittance shall be borne by Biomatrix.
5. WITHHOLDING. All payments to be made by Syntex under this Agreement
shall be made in full, free and clear of and without any deduction of or
withholding for or on account of any taxes levied in any country of the
Territory or elsewhere. If Syntex shall be required by law to make any deduction
or withholding from any payment to Biomatrix then:
(a) Syntex shall ensure that such deduction or withholding does not exceed
the minimum legal liability therefor and shall forthwith pay to Biomatrix such
additional amount as will result in the receipt by Biomatrix of the full amount
which would otherwise have been received hereunder had no such deduction or
withholding been made and shall remit the amount of such tax to the appropriate
taxation authority;
(b) not later than * after each deduction or withholding of any taxes,
Syntex shall forward to Biomatrix such documentary evidence as may be required
by Biomatrix in respect of the deduction, withholding or payment; and
(c) if and whenever Biomatrix determines in its discretion that it has
finally obtained a credit for any deduction or withholding as aforesaid against
its own liability for tax by setting the whole or part thereof against payments
made by it under deduction of tax, Biomatrix shall notify Syntex, and shall
simultaneously pay to Syntex, an amount such that Biomatrix retains, taking into
account the original payment from Syntex and the tax credit, such amount as it
should originally have received from Syntex but for the withholding or other
deduction.
6. COMPETING PRODUCTS. In recognition of the rights granted by Biomatrix
to Syntex and the other obligations of Biomatrix hereunder, Syntex agrees that
Syntex shall not (alone or with others) and it shall ensure that its Affiliates
shall not (alone or with others) (i) prior to the fifth anniversary of the
Effective Date manufacture, sell, market, distribute or promote a Competing
Product in the Non-Compete Territory, or (ii) during the term hereof
manufacture,
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* Confidential portions have been omitted and filed separately with the
Commission.
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sell, market, distribute or promote a Competing Product in the Territory.
"Competing Product" shall mean any product based upon or principally derived
from sodium hyaluronate or other glycosaminoglycans or any of their derivatives
used for the intra-articular treatment of arthritis by viscosupplementation or
drug delivery. Syntex acknowledges and agrees that, in the event of a breach or
threatened breach by Syntex of its obligations under this Section 6, Biomatrix
will have no adequate remedy at law, and accordingly, shall be entitled to
injunctive or other appropriate equitable remedies against such breach or
threatened breach in addition to any other remedies which Biomatrix may have.
7. IMPROVEMENTS. Biomatrix shall promptly communicate to Syntex any
Improvements to the Agreement Product that Biomatrix or any of its Affiliates
may acquire, discover, invent, originate, make or conceive. Such communication
shall include any relevant technical and clinical information relating thereto
(in reasonable detail) which is available to Biomatrix.
8. TRADEMARKS; AGREEMENT PRODUCT MARKING; PROMOTIONAL INFORMATION.
8.1. Trademarks. Subject to the provisions of Section 3.6 hereof and
except as otherwise provided in Section 9.1 hereof, Syntex and its Affiliates
shall have the exclusive right to use the Trademark in the Territory during the
term of this Agreement. Syntex warrants that, except as otherwise provided in
Section 2.1 above, it shall not use any of the Trademarks at any time outside
the Territory or use any of the Trademarks for any products other than the
Agreement Product within the Territory.
8.2. Registered User and Recorded Licensee. To the extent necessary under
the laws of any country in the Territory to enable Syntex to exercise its
exclusive rights hereunder, Biomatrix shall enter into appropriate registered
user agreements with Syntex or its designated Affiliates in the Territory, for
the duration of this Agreement, such that Syntex and its Affiliates have the
exclusive use of the Trademarks as provided in this Agreement. In addition, to
the extent required by the laws or regulations of any country in the Territory,
Biomatrix shall submit applications to the appropriate authorities to have
Syntex or its designated Affiliates recorded on the relevant registries as the
exclusive licensee of the Trademarks for the Territory, provided that (i) Syntex
shall bear all of Biomatrix's direct out-of-pocket expenses in connection
therewith and (ii) Syntex shall, at its own cost and expense, prepare or cause
to be prepared the necessary documentation relating thereto, such documentation
to be in form and substance satisfactory to Biomatrix, and shall cooperate to
the fullest extent necessary in connection with such applications and
registrations.
<PAGE> 15
-13-
8.3. Termination of Registered User Status. Upon termination of this
Agreement, the right of Syntex and its Affiliates to use the Trademarks in the
Territory will revert to Biomatrix, and Syntex unconditionally agrees promptly
to take all necessary action and execute and deliver to Biomatrix all necessary
documents and instruments to remove Syntex as a registered user and/or a
recorded licensee of the Trademarks. For the avoidance of doubt, Syntex's
unconditional obligations under this Section 8.3 shall not otherwise adversely
affect its rights or remedies arising out of a breach by Biomatrix of its
obligations under this Agreement, including without limitation a wrongful
termination of this Agreement by Biomatrix.
8.4. Registration of Trademarks. Biomatrix shall, at its cost and expense,
file in the Territory and use its best efforts to obtain and thereafter maintain
the registration of the Trademarks in the Territory. * Biomatrix shall keep
Syntex advised of the status of such trademark rights. If any Trademark cannot
be used in any country in the Territory, for whatever reason, the parties shall
attempt in good faith to agree on a new trademark to which the provisions of
this Agreement shall apply.
8.5. Notice. Each party hereto agrees promptly to notify the other in
writing of any infringements or imitations of the Trademarks by third parties
which may come to its attention.
8.6. Labelling and Promotional Materials. All labelling, packaging and
promotional material for the Agreement Product sold by Syntex and its Affiliates
hereunder shall have a typical Syntex label design developed by Syntex. Syntex
shall provide Biomatrix with labelling masters, instructions and specifications,
including product information accompanying the Agreement Product and printed
information on containers. All such labelling, packaging and promotional
material shall be consistent with the relevant Product License Approvals and
shall also be reviewed by Biomatrix prior to its use and the substance thereof
shall be reasonably acceptable to it, Biomatrix's acceptance of or objection to
such material to be communicated to Syntex within * of Biomatrix's receipt
thereof; provided that no such communication by Biomatrix within such * period
shall be deemed to be Biomatrix's acceptance of such material. Biomatrix shall
make no changes to such labelling except as otherwise agreed to in writing by
Syntex.
8.7. Legend. Subject to applicable laws and regulations in the Territory,
all relevant packaging and promotional material for the Agreement Product used
or sold by Syntex shall contain (i) all applicable markings needed to keep the
Trademarks enforceable throughout
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 16
-14-
the Territory as specified in writing by Biomatrix to Syntex and (ii) a legend
which shall be displayed in a reasonably conspicuous manner on all packaging of
such Agreement Product indicating that such product has been developed by
Biomatrix, Inc., 65 Railroad Avenue, Ridgefield, New Jersey 07657, United States
of America and manufactured by Biomatrix Medical Canada Inc., 275 Labrosse
Avenue, Pointe-Claire, Quebec, Canada H9R 1A3, or such other Affiliate of
Biomatrix, Inc. which manufactures the Agreement Product.
8.8. Promotional Support.
(a) Biomatrix shall provide Syntex with promotional support by * to
Syntex to be used by Syntex as * Biomatrix and Syntex shall each provide to one
another on an ongoing basis and without charge (to the extent not prevented by
law or contract from doing so) all medical information relating to the Agreement
Product (including summary data from studies, clinical trials and the like as
well as information regarding adverse events associated with the use of the
Agreement Product), the proceedings of all symposia on the Agreement Product and
all promotional information that is available to Syntex or Biomatrix or any of
their Affiliates anywhere in the world relating to the Agreement Product. In
addition, Biomatrix and Syntex shall each provide the other with access to (to
the extent that the disclosing party is not prevented by law or contract from
doing so) such primary data and information in its possession as the other may
reasonably request regarding the results of the studies contained in such
summary data referred to above.
(b) Subject to applicable laws and regulations in the Territory, Syntex
shall ensure that all trade literature, publications and promotional materials
relating to the Agreement Product produced by or on behalf of Syntex or any of
its Affiliates shall specify the concept of viscosupplementation and that such
concept has been conceived and introduced by Biomatrix. Biomatrix hereby
represents and warrants to Syntex that the concept of viscosupplementation was
conceived and introduced by scientists who are principals of Biomatrix.
8.9. Adverse Events.
Each party hereto shall keep the other informed of all reports of
serious adverse events which come to its attention with regard to the use of the
Agreement Product ("AEs"), regardless of the origin of such report. In addition,
each party hereto shall inform the other, on a quarterly basis, of all reports
of AEs which are not serious. The term "reports" shall include, without
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Commission.
<PAGE> 17
-15-
limitation, publications in journals or in other media and any other
communications coming to the attention of such party as a result of (i) a
clinical trial of the Agreement Product conducted by or on behalf of Syntex or
Biomatrix or any of their Affiliates and/or (ii) the marketing of the Agreement
Product anywhere in the world and/or (iii) the marketing of other hylan products
anywhere in the world. Reports of serious AEs received by either party shall be
forwarded to the other party without delay, and in the case of serious AEs
arising out of the activities referred to in (i) or (ii) of this Section 8.9 not
later than * after such report was received. Each party shall have the right to
request, to the extent that such request is reasonable in the circumstances,
professional evaluation and further information, if available, on any AEs
reported. All such reports and further information shall be transmitted and
receipt confirmed by telefax as follows:
In the case of Biomatrix, to:
Biomatrix, Inc.
65 Railroad Avenue
Ridgefield, N.J. 07657 U.S.A.
Attention: Head of Clinical and Regulatory Department
Telephone: (201) 945 9550
Telefax: (201) 945 0363
In the case of Syntex to:
Roche A.B.
Lilehomsstranden 5
P.O. Box 47327
10074 Stockholm
Sweden
Attention: Head of Registration Department
Telephone: (8) 726 1200
Telefax: (8) 744 0681
and to:
Roche Products (Proprietary) Limited
P.O. Box 4589
Johannesburg 2000
South Africa
Attention: Head of Registration Department
Telephone: (11) 974 5335
Telefax: (11) 392 2338
with a copy to:
F. Hoffman-La Roche Ltd.
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 18
-16-
Grenzacherstr. 124
4070 Basel
Switzerland
Attention: Head of Pharma Drug Safety (PDS)
Telefax: (4161) 688 93 91
Each party may change, by written notice to the other party, the address to
which such reports and other information should be sent.
8.10. Recalls of the Agreement Product.
(a) If either party in good faith determines that a recall of the
Agreement Product in any country in the Territory is warranted, such party shall
immediately notify the other party in writing and shall advise such other party
of the reasons underlying its determination that a recall is warranted. The
parties shall consult with each other as to any action to be taken in regard to
such a recall, but in any event if after consultations either party in good
faith still believes that such a recall should be undertaken, the parties shall
cooperate in carrying out such recall.
(b) Except as otherwise provided in (c) below, in the event of a recall of
the Agreement Product, Biomatrix shall correct any deficiency relating to its
manufacturing, packaging, testing, labelling, storing or handling of the
Agreement Product, if applicable, and shall at its cost replace the Agreement
Product recalled.
(c) *
9. SUPPLY OF PRODUCT.
9.1 General. Biomatrix agrees to sell the Agreement Product to Syntex, on
the terms and subject to the conditions set forth herein, on an exclusive basis
for resale by Syntex and its designated Affiliates within the Territory, and
Syntex shall obtain the Agreement Product for resale in the Territory only from
Biomatrix. The term "exclusive" shall mean that, to the extent permitted by
applicable law (including without limitation EU competition law), Biomatrix
shall not sell the Agreement Product itself or supply or license the manufacture
of the Agreement Product to any third party for resale within the Territory.
9.2 Price and Quantity.
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Commission.
<PAGE> 19
-17-
(a) The "Formula Price" per unit of the Agreement Product shall be
determined for each country as follows:
<PAGE> 20
-18-
Agreement Year Formula Price
* *
provided that (i) when the Net Revenues * from the sale of all units of the
Agreement Product by Syntex or any of its Affiliates to non-affiliated third
party purchasers in Sweden exceed * in any Agreement Year for such country, or
(ii) when the Net Revenues, * from the sale of all units of the Agreement
Product by Syntex or any of its Affiliates to non-affiliated third party
purchasers in South Africa exceed * in any Agreement Year in such country, then
in calculating the Formula Price the relevant percentage of Net Revenues in
respect of that portion of the sales of the Agreement Product over and above the
relevant threshold set forth above for such country for such Agreement Year
shall be * .
(b) With respect to each country in the Territory the price to be paid by
Syntex to Biomatrix for each unit of the Agreement Product shall be the greater
of (i) the Minimum Price in such country or (ii) the Formula Price in such
country.
(c) Not less than * prior to the first Contract Quarter (as hereinafter
defined) and not less than * prior to each Contract Quarter thereafter the
parties shall calculate and agree on an estimated Formula Price per unit for the
Agreement Product in each country in the Territory; provided that the estimated
Formula Price for any country shall not under any circumstances be less than the
Minimum Price for such country. Such estimated Formula Price shall be the price
payable by Syntex to Biomatrix for the Agreement Product during such Contract
Quarter (subject to the adjustments contemplated by Section 9.2(d) below). Such
estimated prices shall be based on the parties' best estimates of Syntex's
prices for the Agreement Product to non-Affiliated third parties in such
country. If the parties cannot agree upon an estimated Formula Price per unit to
be charged by Biomatrix to Syntex for the first Contract Quarter, then the
estimated Formula Price to be charged by Biomatrix to Syntex shall be * . If
with respect to any country the parties cannot agree upon an estimated Formula
Price per unit to be charged by Biomatrix to Syntex during any Contract Quarter
other than the first Contract Quarter, then the estimated Formula Price to be
charged by Biomatrix to Syntex shall be * . "Contract Quarter" shall mean the
three (3) month period commencing with Syntex's first commercial sale of the
Agreement Product in any country in the Territory and ending on the last day of
the third complete calendar month thereafter and each three (3) month period
thereafter throughout the term of this Agreement.
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Commission.
<PAGE> 21
-19-
(d) Within * after the close of each Contract Quarter the actual Formula
Price for the Agreement Product in each country of the Territory shall be
calculated in accordance with Section 9.2(a) above and an adjustment resulting
from *
(e) Except as otherwise provided in Section 9.2(d) above, all payments by
Syntex to Biomatrix hereunder shall be made within * of the invoice date
relating thereto. Net Revenues shall be converted to Dollars using the average
monthly rates of exchange for the relevant period as published in The Wall
Street Journal (or, if The Wall Street Journal shall no longer publish such
exchange rates, as determined by a method that is mutually agreed upon in
writing by the parties).
(f) Within * following the end of each Contract Quarter, Syntex shall
submit to Biomatrix written reports detailing Syntex's and its Affiliates' sales
of the Agreement Product during the immediately preceding Contract Quarter,
which reports shall contain the Net Revenues of the Agreement Product in the
Territory from sales to non-Affiliated thirty party purchasers during the
applicable quarter (including a country by country breakdown), and the aggregate
number of units of the Agreement Product sold in each country during the
applicable quarter.
(g) *
(h) Syntex shall not be obligated to pay for any shipment (or partial
shipment) of the Agreement Product which does not conform to the Agreement
Product Specifications as determined by using the Agreement Product Quality
Control Procedures pursuant to Section 9.16(a) below. If Syntex notifies
Biomatrix that the Agreement Product does not conform to the Agreement Product
Specifications, then payment for such shipment shall be delayed until resolution
of the discrepancy by consultation between the parties or, if necessary, an
independent determination by a laboratory as to the conformity of such shipment
to the Agreement Product Specifications in accordance with Section 9.16(a)
below. Any units of the Agreement Product that are determined by such laboratory
not to conform to the Agreement Product Specifications shall be returned to
Biomatrix in accordance with Section 9.16(a) and Biomatrix shall bear the costs
and expenses incurred with respect to such units of the Agreement Product as a
result of such laboratory testing. If any units of the Agreement Product are
determined by such laboratory to conform to the Agreement Product
Specifications, then Syntex shall immediately (i) make full
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 22
-20-
payment to Biomatrix for such Agreement Product, together with interest on such
amount calculated in accordance with Section 23 hereof from the original payment
date until the date upon which Biomatrix actually receives payment and (ii) pay
all costs and expenses incurred with respect to such units of the Agreement
Product as a result of such laboratory testing.
(i) Biomatrix and its Affiliates shall sell to Syntex such quantities of
the Agreement Product as Syntex may, pursuant to the provisions hereof, order
from time to time (provided that Biomatrix and its Affiliates shall have no
obligation to supply Syntex with quantities of the Agreement Product in excess
of * in the then current estimates by Syntex for the relevant quarter under
Section 9.12(a) hereof) and Biomatrix shall use its best efforts to supply the
Agreement Product in line with Syntex's requirements. * Except for delays
resulting from a force majeure pursuant to Section 22 hereof, the purchase price
for any shipment of the Agreement Product shall be * if such shipment is
delivered to Syntex * and by * .
(j) (A) If Biomatrix is unable to supply the Agreement Product ordered by
Syntex in a timely manner, or if the Agreement Product consistently fails to
comply with the Agreement Product Specifications or if the regulatory
authorities in the Territory prevent importation of the Agreement Product in the
Territory because Biomatrix has failed to manufacture the Agreement Product in
accordance with applicable regulations, then Biomatrix shall use all
commercially reasonable efforts to remedy the problem or secure an alternative
source of supply within a reasonable time (which in any event shall not be
longer than * after receipt of written notice thereof from Syntex). If Biomatrix
is unable to remedy the problem or secure an alternative source of supply within
such * , then Biomatrix shall consult with Syntex and the parties shall work
together at Biomatrix's premises to remedy the problem. If the parties are
unable to remedy the problem after a period of * commencing with the date upon
which such consultations began, then either party may at its option terminate
this Agreement with respect to each country affected thereby.
(B) Until such time as the parties agree otherwise in writing, Biomatrix
shall, in an effort to * for the periods set forth below * with respect to each
country in the Territory * and (ii) * with respect to each country in the
Territory *
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Commission.
<PAGE> 23
-21-
<TABLE>
<CAPTION>
Percentage for Percentage for
Period Finished Units Components
- ------ -------------- ----------
<S> <C> <C> <C> <C>
Date of First Commercial - First Year Anniversary * *
Sale of the Agreement of Commencement Date
Product in such country
("Commencement Date")
First Year Anniversary - Second Year Anniversary * *
of Commencement Date of Commencement Date
Second Year Anniversary - Third Year Anniversary * *
of Commencement Date of Commencement Date
</TABLE>
* *
(C) The parties hereto agree that * , they shall discuss the Minimum Price
then in effect and whether, in view of then current sales volumes, forecasts,
product promotion and marketing and manufacturing efficiencies, any adjustment
in the Minimum Price (either upward or downward) should be made, provided that
no such change shall be made unless it is agreed to in writing by each of the
parties hereto.
9.3. Facility Visits. Prior to Biomatrix commencing supply of the
Agreement Product to Syntex * , Syntex or its representatives shall have the
right, at Syntex's expense and on reasonable notice to Biomatrix, during regular
business hours, to visit the facilities where the Agreement Product is
manufactured, packaged, quality control tested and stored for the purposes of
inspecting and auditing such facilities and the documentation systems,
operations and equipment that are used in the manufacture, packaging, quality
assurance, inventory control, handling or storage of the Agreement Product (and
Biomatrix shall procure such access on behalf of Syntex). Such audits shall be
scheduled, whenever practicable, during the manufacture of the Agreement Product
by Biomatrix or its Affiliate and such audits may include the observation of the
manufacturing process by Syntex or its representatives. In connection with such
inspections and audits, Syntex shall have access to the Master Files or
equivalent documentation standards relating to Biomatrix's activities concerning
the Agreement Product. Should Syntex, in the course of its inspections and
audits, discover that Biomatrix's methods and procedures for
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Commission.
<PAGE> 24
-22-
producing the Agreement Product are not in compliance with the Agreement Product
Specifications or Product License Approvals for the Agreement Product in the
Territory or Good Manufacturing Practices, then Syntex shall notify Biomatrix to
that effect and Biomatrix shall either (i) promptly correct, at Biomatrix's
expense, such deficiencies or (ii) promptly provide Syntex with evidence
indicating that the methods and procedures for producing the Agreement Product
are in compliance with the Agreement Product Specifications, the Product License
Approvals and Good Manufacturing Practices.
9.4. Regulatory Authorities. Biomatrix agrees that the regulatory
authorities of the countries where the Agreement Product is marketed by Syntex
or its designated Affiliates, or where applications have been made for Product
License Approvals (hereinafter the "Regulatory Authorities") shall be able to
inspect, during regular business hours, the facilities, documentation systems,
operations and equipment as set forth in Section 9.3 above, as the same relate
to the Agreement Product that is to be shipped to such countries. Biomatrix
shall notify Syntex in advance, whenever feasible, of inspections by any
Regulatory Authority. * Biomatrix shall provide to Syntex a written summary of
the inspection as it pertains to the Agreement Product, together with a copy of
the actual report (if any) relating thereto as provided to Biomatrix by such
Regulatory Authority. Biomatrix shall notify Syntex of any Good Manufacturing
Practice deficiencies affecting or relating to the Agreement Product discovered
during the course of any such inspections by the Regulatory Authorities * of
such deficiency being brought to Biomatrix's attention. Biomatrix shall promptly
comply, at its own expense, with requests and requirements of the Regulatory
Authorities relating to the Agreement Product, such that the Agreement Product
supplied hereunder will be manufactured in compliance therewith.
9.5. Shipment Samples. * to the expected date of the first commercial sale
of any Agreement Product in the Territory, Biomatrix and Syntex shall agree upon
a procedure for pre-shipment sampling (including without limitation the methods
of analysis for such sampling, Biomatrix's monitoring rights relating thereto
and the quantities of such pre-shipment samples to be sent to Syntex), which
procedure shall be at Syntex's cost, except that Biomatrix shall bear its own
costs in connection with exercising its monitoring rights. Unless otherwise
agreed in writing by Syntex, Biomatrix shall, prior to shipment of the Agreement
Product to Syntex hereunder, submit to Syntex or its nominee samples of each
batch of the Agreement Product in accordance with such agreed upon procedures.
Such samples shall be subject to the acceptance procedure described in 9.16
hereof and pursuant thereto Syntex or its nominee shall notify
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Commission.
<PAGE> 25
-23-
Biomatrix whether or not to proceed with delivery of such batch * of its receipt
of the samples relating thereto.
9.6. Certificates of Analysis, etc. Biomatrix shall furnish to Syntex,
with each shipment of the pre-shipment samples, a signed copy of the certificate
of analysis, together with a compliance statement and such non-confidential
manufacturing data as agreed by Biomatrix and Syntex, relating to such shipment
demonstrating that the pre-shipment samples and the Agreement Product
represented thereby conform in all respects to the applicable process controls
specified in the relevant product licenses and to the Agreement Product
Specifications, as determined in accordance with the Agreement Product Quality
Control Procedures.
9.7. [intentionally omitted].
9.8. Retention of Records. Biomatrix shall maintain and retain its
shipment records and reserve samples for each shipment of the Agreement Product
for * after the expiration date for the Agreement Product or for a period of *
after shipment to Syntex of the Agreement Product represented by such shipment
records or such other periods as may be required by Good Manufacturing
Practices, whichever is longer, and Syntex shall have the right, at its own
expense, to inspect such shipment records at the facilities where such Agreement
Product was manufactured during regular business hours and upon reasonable
notice to Biomatrix.
9.9. Waste Treatment. Syntex shall not be held responsible for the
treatment, management and/or disposal of waste and waste-related products
derived in any manner from the manufacture of the Agreement Product by
Biomatrix. Under no circumstances shall Syntex be considered a generator of
solid or hazardous waste with respect to the Agreement Product and Syntex shall
not be responsible for the management of such solid and hazardous wastes.
Furthermore, Biomatrix agrees that Syntex shall not be responsible for the
health and safety of Biomatrix's employees, agents and contractors in the
manufacture of the Agreement Product.
9.10. Compliance with Laws. Biomatrix warrants that it and its Affiliates
shall manufacture the Agreement Product in accordance with Good Manufacturing
Practices and shall comply in all material respects, with all applicable laws,
regulations, rules, ordinances, injunctions, orders and decrees and shall
maintain in effect all required governmental permits, licenses and orders
(including without limitation its Master File or the equivalent thereof) and
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Commission.
<PAGE> 26
-24-
approvals regarding the Agreement Product and the use of its facilities (or the
facilities of its Affiliates) to manufacture the Agreement Product.
9.11. Manufacturing Facilities. Biomatrix warrants that to the best of its
knowledge the facilities used for the manufacture and storage of the Agreement
Product have not at any time prior to the Effective Date and, unless otherwise
agreed in writing by Syntex, shall not at any time during the term of this
Agreement be used for the storage and/or manufacture of penicillin or penicillin
derivatives, cephalosporin or cephalosporin derivatives, cytotoxic or
antineoplastic compounds, or any other drug which, according to Good
Manufacturing Practice, it would be inappropriate to manufacture or store in the
aforesaid facilities. Biomatrix shall promptly inform Syntex of any facility
change which has an impact upon the manufacture, labelling, packaging, quality
control testing and/or storage of the Agreement Product.
9.12. Product Requirements; Sales Forecasts; Minimum Quantity Levels.
(a) *
(b) Exhibit E sets forth a forecast of sales of units of the Agreement
Product in each country within the Territory for each of the * with respect to
such country. * after the expiration of the * for such country and * after the
expiration of each Agreement Year thereafter the parties shall agree upon a
forecast of sales of units of the Agreement Product in such country for the *
beginning with the Agreement Year following such expired Agreement Year. Each
such forecast described above is referred to herein as a "Sales Forecast". If
the parties cannot agree upon any such Sales Forecast, such Sales Forecast shall
be calculated by taking * in the case of calculations for the * in the case of
calculations for the * in the case of calculations for the * in the case of
calculations for the * in the case of calculations for the * .
(c) Syntex shall be required to purchase minimum quantities of the
Agreement Product in each Agreement Year for sale in each country in the
Territory, commencing * applicable to such country, equal to * If Syntex fails
to purchase the Minimum Quantity for sale in any country * applicable to such
country, * applicable to such country, then Biomatrix may at its option upon *
In the case of a failure to purchase the Minimum Quantity in the third Agreement
Year in any country, such prior written notice shall be given by Biomatrix *
Notwithstanding the foregoing, Syntex's minimum
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Commission.
<PAGE> 27
-25-
purchase obligation under this Section 9.12(c) shall be subject to: (A) events
of force majeure pursuant to Section 22 hereof, (B) a failure by Biomatrix to
supply Syntex with sufficient quantities of the Agreement Product conforming to
the warranties set forth in this Agreement to enable Syntex to meet its minimum
purchase obligations and (C) patent and trademark infringements by Biomatrix
which prevent Syntex from meeting its minimum purchase obligations.
(d)(i) In addition to the requirements in Section 9.12(c) to purchase the
Minimum Quantities described therein, Syntex shall be obligated to make the
minimum purchases described in this Section 9.12(d) (the "Minimum Purchase
Requirements"). If during any Agreement Year following the * for any of the
countries set forth below Syntex fails to purchase at least * of the number of
units of the Agreement Product set forth opposite such country in the applicable
column, *
Country Minimum Units
- ------- -------------
A B C D
*
For the Minimum Purchase Requirements applicable to Sweden, Column D shall
apply at all times after Syntex has purchased at least * of Agreement Product in
Sweden in any calendar year, Column C shall apply at all times after Syntex has
purchased at least * but less than * in Sweden in any calendar year, Column B
shall apply at all times after Syntex has purchased at least * but less than *
in Sweden in any calendar year and column A shall apply at all other times.
For the Minimum Purchase Requirements applicable to South Africa, Column D
shall apply at all times after Syntex has purchased at least * of Agreement
Product in South Africa in any calendar year, Column C shall apply at all times
after Syntex has purchased at least * but less than * in South Africa in any
calendar year, Column B shall apply at all times after Syntex has purchased at
least * but less than * in South Africa in any calendar year, and column A shall
apply at all other times.
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Commission.
<PAGE> 28
-26-
(ii) Notwithstanding the foregoing, the provisions of Section 9.12(d)(i)
shall be *
(iii) If in any of the countries in the Territory the initial Product
Licence Approval is obtained on the basis of a label claim permitting hospital
use only and/or a single course of treatment only or if a third party launches a
Competing Product (as defined in Section 6 hereof) which has a material adverse
effect upon the market for the Agreement Product in such country, then the
parties hereto shall negotiate in good faith to adjust the quantities set forth
in Section 9.12(d)(i) for such country.
(e) Syntex shall maintain books of account with respect to its sale of the
Agreement Product in each country within the Territory. Biomatrix shall have the
right to have an independent public accountant selected and retained by
Biomatrix and reasonably acceptable to Syntex to inspect and examine such books
of Syntex during regular business hours and not more than twice per calendar
year for the purpose of verifying the statements of the aggregate Net Revenues
of the Agreement Product and determining the correctness of the Formula Prices.
The cost of each such audit shall be borne by Biomatrix unless a material error
is discovered in the course of such audit, in which case the cost shall be borne
by Syntex. For purposes of this 9.12(e), a material error shall be defined as an
understatement of five percent (5%) or more of such aggregate Net Revenues. Any
additional payments required as a result of such inspection and examination
shall be immediately paid to Biomatrix and shall bear interest from the date
such amount would otherwise have been paid until the date of actual payment at
the rate per annum set forth in Section 23 hereof. Such independent accounting
firm shall conduct such inspections and examinations under conditions of
confidentiality.
9.13. Shipment and Delivery; Packaging.
(a) Biomatrix shall arrange for shipment to Syntex of the Agreement
Product ordered by Syntex via common carrier. All shipments of Agreement Product
shall, unless otherwise instructed by Syntex, be delivered to Syntex's central
distribution facilities at Antwerp, Belgium or to such other central
distribution facility notified to Biomatrix by Syntex in writing from time to
time. All freight costs, insurance costs, customs charges and duties arising in
connection with any such shipment *
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Commission.
<PAGE> 29
-27-
(b) Syntex shall submit a purchase order setting forth the quantities,
delivery date, country for sale and shipping instructions with respect to each
shipment of the Agreement Product, such purchase orders to be received by
Biomatrix at least * prior to the stipulated delivery date. If at any time
Syntex desires to sell any units of the Agreement Product in a country in the
Territory other than the country specified in the purchase order relating
thereto, it shall immediately notify Biomatrix in writing thereof and Biomatrix
shall issue a new invoice with respect to such units of the Agreement Product
(containing appropriately revised terms including, without limitation, the
purchase price) and Biomatrix and Syntex shall (at Syntex's cost) cooperate with
each other to implement all necessary labelling and other changes so that such
units of the Agreement Product can be sold in such other country; provided that
at all times Syntex shall continue to bear the risk of loss of, or damage to,
all such units of the Agreement Product.
9.14. Title. Legal title to all quantities of the Agreement Product sold
hereunder shall remain in Biomatrix until the agreed price therefor has been
paid in full, and upon such payment the title to such Agreement Product shall,
without further action, be transferred to and vested in Syntex.
9.15. Risk of Loss. Biomatrix shall bear all risk of loss of, or damage
to, all units of the Agreement Product to the extent the same is in its
possession or the possession of its Affiliates, nominees or agents. Syntex shall
bear all risk of loss of, or damage to, all units of the Agreement Product after
delivery to a common carrier for shipment to Syntex in accordance with Section
9.13.
9.16. Acceptance.
(a) Should Syntex notify Biomatrix within * of the receipt of any shipment
of the Agreement Product, that the Agreement Product does not conform to the
Agreement Product Specifications therefor, Biomatrix and Syntex agree to consult
with each other in order to resolve the discrepancy between each other's
determinations. If such consultation does not resolve the discrepancy, the
parties agree to nominate an independent reputable laboratory, acceptable to
both parties (the "Laboratory"), that shall carry out the tests on
representative samples taken from such shipment using the Agreement Product
Quality Control Procedures, and the results of such tests shall be binding on
the parties for the purposes hereof. The costs of such tests shall be borne in
accordance with Section 9.2(h). Upon request by Syntex, Biomatrix shall promptly
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 30
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send a new shipment of the Agreement Product to Syntex (of similar quantity as
the batch of the Agreement Product being analysed pursuant to this Section
9.16(a), and at the selling price and on such other terms and conditions as set
forth herein) so as to enable Syntex to continue to supply the Agreement Product
to its customers; provided that if the Biomatrix test results are upheld by the
Laboratory, Syntex shall be obligated to accept the shipment of the Agreement
Product which was the subject of such tests at the selling price and on such
other terms and conditions as set forth herein. Any non-conforming shipment
shall be returned, at Biomatrix's expense, by Syntex to Biomatrix in accordance
with Biomatrix's instructions, accompanied by a reasonable detailed statement of
the claimed defect or non-conformity and proof of date of purchase.
(b) Prior to the initial commercial sale of the Agreement Product all
initial master copies of batch documentation and test methods for the Agreement
Product, to the extent they are not included in the Agreement Product Quality
Control Procedures, shall be agreed upon in writing by Biomatrix and Syntex in
accordance with Product License Approvals in order to establish a baseline for
future changes by Biomatrix. Biomatrix shall not make any changes to any
facilities, manufacturing processes, batch documentation or test methods which
impact upon the Agreement Product without written notification to Syntex
reasonably in advance of such changes. Biomatrix shall demonstrate to Syntex
that the changes are being made in accordance with all applicable laws and
regulations. Syntex shall acknowledge any such changes in writing and shall
fully cooperate with Biomatrix and use all commercially reasonable efforts in
order to obtain or assist in obtaining (as the case may be) the approval and
agreement (if needed) of all relevant regulatory authorities in the Territory
for all such changes. Subject to the notification and consultation described
above, Biomatrix shall determine the strategy, implementation and regulatory
process (with the full cooperation of Syntex) relating to such changes.
9.17. Purchase Orders. The provisions of this Agreement shall prevail over
any inconsistent statement or provisions contained in any document related to
this Agreement passing between the parties hereto including, but not limited to,
any purchase order, acknowledgement, confirmation or notice.
9.18 Limited Warranty; Limitation on Liability.
Biomatrix represents and warrants that the Agreement Product supplied to
Syntex hereunder shall:
(a) conform to the Agreement Product Specifications;
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(b) with respect to any particular country in the Territory, have a
minimum shelf life at the time of shipment by Biomatrix of * of the
approved shelf life as indicated in the Product License Approval for such
country; provided that such approved shelf life is at least * and subject
to the Agreement Product being kept at all times within the temperature
range specified by Biomatrix in the Agreement Product label; and
(c) be manufactured, labelled, packaged, tested and stored (while in the
possession or control of Biomatrix) in accordance with then-current Good
Manufacturing Practices, all applicable Product License Approvals therefor
and all applicable laws and regulations in the Territory relating to the
manufacture, labelling, packaging, testing, and storage of the Agreement
Product.
THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY
BIOMATRIX WITH RESPECT TO THE AGREEMENT PRODUCT, AND BIOMATRIX GIVES AND MAKES
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE
FOREGOING. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, NO IMPLIED WARRANTY
OF MERCHANTABILITY, NO IMPLIED WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE,
AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR COURSE
OF PERFORMANCE IS GIVEN OR MADE BY BIOMATRIX OR SHALL ARISE BY OR IN CONNECTION
WITH ANY SALE OR PROVISION OF THE AGREEMENT PRODUCT BY BIOMATRIX, OR SYNTEX'S
USE OR SALE OF THE AGREEMENT PRODUCT, OR BIOMATRIX'S AND/OR SYNTEX'S CONDUCT IN
RELATION THERETO OR TO EACH OTHER. NO REPRESENTATIVE OF BIOMATRIX IS AUTHORIZED
TO GIVE OR MAKE ANY OTHER REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING
WARRANTY IN ANY WAY.
The limited warranty set forth in this Section 9.18 does not apply to any
non-conformity of the Agreement Product resulting from (a) repair or alteration
by any party other than Biomatrix, (b) misuse, negligence, abuse, accident,
mishandling or storage in an improper environment by any party other than
Biomatrix, or (c) use, handling, storage or maintenance other than in accordance
with instructions and recommendations provided by Biomatrix.
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 32
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Biomatrix's obligation with respect to units of the Agreement Product
which do not meet the warranty contained herein is limited exclusively to
replacement, or, at Biomatrix's option, to a refund of the actual landed cost to
Syntex of such units of the Agreement Product, provided that such units of the
Agreement Product are returned to Biomatrix in the manner set forth in this
Section 9.18, and only if, upon examination by Biomatrix, such units of the
Agreement Product are determined to have been defective under the terms of this
Agreement. In the event of a dispute regarding a possible defect in the
Agreement Product, the parties shall resolve such dispute in accordance with the
procedures set forth in Section 9.16(a).
All such units of the Agreement Product shall be returned to Biomatrix
at the address set forth in Section 25 of this Agreement, accompanied or
preceded by a reasonably detailed statement of the claimed defect or
non-conformity and proof of date of purchase, and packed and shipped according
to instructions provided by Biomatrix. The shipping costs of any such returned
units of the Agreement Product shall be borne by Biomatrix, unless such units
are determined not to be defective under the terms of this Agreement, in which
case such shipping costs shall be borne by Syntex.
BIOMATRIX'S LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE
SALE OR USE OF THE AGREEMENT PRODUCT (WHETHER BASED ON CONTRACT, NEGLIGENCE,
BREACH OF WARRANTY, STRICT LIABILITY OR ANY OTHER LEGAL THEORY), SHALL BE
STRICTLY LIMITED TO BIOMATRIX'S OBLIGATIONS AS SPECIFICALLY AND EXPRESSLY
PROVIDED IN THIS SECTION 9.18 AND IN SECTION 10 BELOW. EXCEPT AS SPECIFICALLY
PROVIDED IN THIS SECTION 9.18 AND IN SECTION 10 BELOW, BIOMATRIX SHALL HAVE NO
LIABILITY, OBLIGATION OR RESPONSIBILITY OF ANY KIND, IN ANY WAY OR TO ANY
EXTENT, FOR ANY DAMAGES, LOSSES, COSTS, EXPENSES OR LIABILITIES FOR ANY
REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE AGREEMENT PRODUCT OR
THE PERFORMANCE THEREOF, OR ARISING IN ANY WAY IN CONNECTION WITH THE PURCHASE
OR USE OR INABILITY TO USE THE AGREEMENT PRODUCT, EVEN IF BIOMATRIX HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT WHATSOEVER SHALL
BIOMATRIX HAVE ANY LIABILITY, OBLIGATION OR RESPONSIBILITY FOR ANY INDIRECT,
INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES ARISING IN ANY WAY IN
CONNECTION WITH THE AGREEMENT PRODUCT OR ITS SALE OR USE.
<PAGE> 33
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9.19. Next Generation Products. During the term hereof, *
10. INDEMNIFICATION
10.1. Indemnification from Biomatrix. Subject to the provisions of
Section 10.3, Biomatrix shall defend, indemnify and hold Syntex and its
Affiliates and their respective directors, officers, agents and employees
harmless from and against any and all liabilities, claims, damages and expenses
(including without limitation actual court costs and reasonable attorneys' fees
regardless of outcome) resulting from:
*
provided, however, that upon Syntex being advised of any assertions of any third
party claims or suits or upon the bringing or filing of such claims or suits by
any third party against Syntex, Syntex will promptly notify Biomatrix thereof
and, at Biomatrix's cost, permit Biomatrix's attorneys to handle and control the
defence of such claims or suits and will co-operate with Biomatrix in the
defence thereof. The parties agree that there shall be no settlements, whether
agreed to in court or out of court, without the prior written consent of the
indemnifying party.
10.2. Indemnification from Syntex. Subject to the provisions of Section
10.3, Syntex shall defend, indemnify and hold Biomatrix and its Affiliates and
their respective directors, officers, agents and employees harmless from and
against any and all liabilities, claims, damages and expenses (including without
limitation actual court costs and reasonable attorneys' fees regardless of
outcome) resulting from:
(a) any failure by Syntex to act in accordance with applicable laws and
regulations in the Territory in connection with the Agreement Product; and/or
(b) any negligence or wilful misconduct on the part of Syntex or its
Affiliates in connection with the Agreement Product;
provided, however, that upon Biomatrix being advised of any assertions of any
third party claims or suits or upon the bringing or filing of such claims or
suits by any third party against Biomatrix, Biomatrix will promptly notify
Syntex thereof and, at Syntex's cost, permit Syntex's attorneys to handle and
control the defence of such claims or suits and will co-operate with
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 34
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Syntex in the defence thereof. The parties agree that there shall be no
settlements, whether agreed to in court or out of court, without the prior
written consent of the indemnifying party.
10.3. LIMITATION ON LIABILITY. NOTWITHSTANDING ANY PROVISION TO THE
CONTRARY IN SECTIONS 10.1 AND 10.2 ABOVE, OR ANY OTHER PROVISION OF THIS
AGREEMENT, IN NO EVENT (INCLUDING THE FAULT, NEGLIGENCE OR STRICT LIABILITY OF
EITHER PARTY) SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INDIRECT,
INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES OTHER THAN TO THE EXTENT
NECESSARY TO REIMBURSE SUCH OTHER PARTY FOR DAMAGES ACTUALLY PAID TO A
NON-AFFILIATED THIRD PARTY, PROVIDED THAT SUCH DAMAGES ARE OTHERWISE COVERED BY
THE PROVISIONS OF SECTION 10.1 OR SECTION 10.2, AS THE CASE MAY BE.
10.4. Confidential Information. All information acquired by either party
(the "Recipient") from the other party or any of its Affiliates (the
"Discloser") during the term of this Agreement or prior to the Effective Date,
relating directly or indirectly to the present or potential business,
operations, corporate, technical or financial situation of the Discloser, or to
manufacturing know-how, patents, data, test results, techniques, processes,
procedures, raw materials, dealer, supplier and customer lists, pre-clinical and
clinical protocols or any improvements thereof of the Discloser ("Confidential
Information") is confidential, and shall be held in trust by the Recipient for
the exclusive benefit of the Discloser. Unless otherwise agreed to in writing by
the Discloser, the Recipient shall not at any time, either during or subsequent
to the term of this Agreement, use for itself (other than in accordance with the
terms of this Agreement) or any other Person, or disclose or divulge to any
Person, other than to those of its employees and advisors and Affiliates who
require the same for the purposes hereof and who are bound by the same
obligations of confidentiality, non-disclosure and non-use as set forth herein,
any Confidential Information or any other confidential or proprietary
information of the Discloser of which the Recipient may acquire knowledge;
provided, however, that the confidentiality, non-disclosure and non-use
provisions contained in this Section 10.4 shall not apply to any information or
data to the extent that the Recipient:
(a) shall demonstrate by written evidence that such information or data
is known generally to persons in the trade through no act or omission of
the Recipient or any of its Affiliates;
<PAGE> 35
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(b) is required by any government authority to disclose such information
or data, including without limitation for the purposes of obtaining and
maintaining any Product License Approvals under this Agreement; or
(c) shall demonstrate by its written records was disclosed to or created
by it or its Affiliates on a non-confidential basis from a source other
than the Discloser or its Affiliates and that such disclosure or creation
did not constitute a breach of any applicable confidentiality
obligations.
Confidential Information shall be immediately returned to the Discloser upon
termination of this Agreement, along with any copies, reproductions, digests,
abstracts or the like of all or any part thereof in the Recipient's possession
or under the Recipient's control, and upon such return any computer entries or
the like relating thereto shall, to the extent legally permissible, be
destroyed; provided, however, that the legal department of Syntex shall be
entitled to retain in its files a reasonably detailed schedule of all such
returned and/or destroyed Confidential Information. Such return (and
destruction) will not affect the Recipient's obligations hereunder which shall
survive indefinitely. Notwithstanding anything herein to the contrary, the
provisions of this Section 10.4 shall be subject to Biomatrix's rights under
Section 3.6.
10.5. Prior Confidentiality Agreement. Notwithstanding the written
Confidentiality Agreement between the parties dated 3 December 1992, all
information disclosed by Biomatrix to Syntex and/or its Affiliates at any time
relating to the subject matter hereof shall be governed by this Agreement.
10.6. Public Announcement. Except as shall be necessary for governmental
notification purposes or to comply with applicable laws and regulations, and
except as otherwise agreed to by the parties hereto in writing, the parties
agree to keep the existence of this Agreement, and the transactions contemplated
hereby, strictly confidential. Neither party shall issue any initial public
announcement regarding this Agreement, the First Amendment to Stock Purchase
Agreement dated the date hereof between Biomatrix and Syntex or the relationship
of the parties under such agreements unless and until Biomatrix and Syntex shall
mutually agree in writing upon the text of such announcement. Any subsequent
public announcements regarding this Agreement or the transactions contemplated
herein shall also be agreed upon in writing between the parties prior to any
release thereof.
11. REPRESENTATIONS OF BIOMATRIX. Biomatrix represents, warrants and
covenants as follows:
<PAGE> 36
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11.1. It is a corporation duly organized and validly existing under the
laws of the State of Delaware with the full power to conduct its affairs as
currently conducted and contemplated hereunder. All necessary action has been
taken to enable it to execute and deliver this Agreement and perform its
obligations hereunder.
11.2. This Agreement is a valid and binding obligation of Biomatrix
enforceable in accordance with its terms. Biomatrix has the unencumbered right
to enter into this Agreement and to fulfil its duties hereunder. It is not and
will not become a party to any agreement in conflict herewith. Accordingly,
Biomatrix has the right to appoint Syntex as the exclusive distributor of the
Agreement Product in the Territory in accordance with the terms of this
Agreement and such appointment will not constitute a breach of any pre-existing
contractual or other arrangements between Biomatrix and any Affiliated or
non-Affiliated third party, nor shall it infringe the rights of any Affiliated
or non-Affiliated third party.
11.3 No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to, any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by Biomatrix and the performance by Biomatrix of its
obligations hereunder.
12. REPRESENTATIONS OF SYNTEX. Syntex represents, warrants and covenants
as follows:
12.1. It is a corporation duly organized and validly existing under the
laws of Bermuda with full power to conduct its affairs as currently conducted
and contemplated hereunder. All necessary action has been taken to enable it to
execute and deliver this Agreement and perform its obligations hereunder.
12.2. This Agreement is Syntex's valid and binding obligation
enforceable in accordance with its terms. Syntex has the unencumbered right to
enter into this Agreement and to fulfil its obligations hereunder. It is not and
will not become a party to any agreement in conflict herewith. Accordingly,
Syntex has the right to act as the exclusive distributor of the Agreement
Product in the Territory in accordance with the terms of this Agreement and the
performance of its obligations hereunder will not constitute a breach of any
pre-existing contractual or other arrangements between Syntex and any Affiliated
or non-Affiliated third party, nor shall it infringe the rights of any
Affiliated or non-Affiliated third party.
<PAGE> 37
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12.3. No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by Syntex and the performance by Syntex of its obligations
hereunder.
12.4. It is a wholly owned subsidiary of Roche Holding Ltd., Switzerland
(the "Ultimate Parent Company"). Syntex hereby acknowledges that Biomatrix is
relying upon the representation contained in this Section 12.4 in lieu of a
guarantee by the Ultimate Parent Company, and undertakes to promptly notify
Biomatrix in writing if Syntex shall cease to be a wholly-owned subsidiary of
the Ultimate Parent Company, and in such circumstances further undertakes to
discuss with Biomatrix in good faith the giving of appropriate assurances,
guarantees and/or additional representations.
13. INSURANCE.
(a) Biomatrix shall obtain and maintain no less than * of
product liability insurance covering third party claims arising out of the
manufacture and sale of the Agreement Product pursuant hereto. Such policy shall
name Syntex as an additional insured and shall be primary with respect to other
insurance or self-insurance carried by or available to Syntex. Such insurance
shall be issued with carriers reasonably acceptable to Syntex and in any event
carrying a rating of "A" or better by Best's or a similar rating service. A
certificate of insurance evidencing such policy shall be provided to Syntex
within * of execution of this Agreement by Biomatrix. A * notice of cancellation
or material change shall be required, with provision that any such notice of
cancellation or material change shall be notified in writing to Syntex in
accordance with Section 25 below.
(b) Syntex shall maintain, at its own expense, a comprehensive
program of risk retention and excess insurance which adequately covers its
obligations hereunder.
14. INFRINGEMENT. Each of Syntex and Biomatrix will promptly notify the
other party in writing of any infringement of a Patent or Trademark or
unauthorized disclosure or use of any Confidential Information, of which it
becomes aware in the Territory. Biomatrix shall have the exclusive right to take
all legal action in the Territory it deems necessary or advisable to eliminate
or minimize the consequences of such infringement of a Patent or Trademark in
the Territory. For the purpose of taking any such legal action, Biomatrix shall
have the right to use
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 38
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the name of Syntex as plaintiff, either solely or jointly in accordance with the
applicable rules of procedure. Syntex shall promptly furnish Biomatrix with
whatever written authority may be required in order to enable Biomatrix to use
Syntex's name in connection with any such legal action, and shall otherwise
cooperate fully and promptly with Biomatrix in connection with any such action,
provided that Biomatrix shall promptly reimburse Syntex's direct out-of-pocket
expenses incurred in connection therewith. All proceeds realized upon any
judgment or settlement regarding such action (net of all direct out-of-pocket
expenses relating thereto) shall be shared * Notwithstanding the foregoing, if
Biomatrix (i) notifies Syntex in writing that it does not intend to exercise its
rights to take legal action in the Territory to eliminate or minimize the
consequences of an infringement of a Patent or Trademark in the Territory or
(ii) fails to commence such action * following either party's notification to
the other party of such infringement, then Syntex shall be entitled, at its own
cost and expense, to take such legal action, and Biomatrix shall cooperate with
Syntex in connection therewith to the same extent and upon the same terms as
Syntex is required to cooperate with Biomatrix when Biomatrix exercises its
rights under this Section 14; provided, however, that Biomatrix shall be
entitled to an amount equal to * of the amount (net of Syntex's direct
out-of-pocket expenses in prosecuting such action) of any judgement award or
settlement payable to Syntex.
15. REGULATORY ACTIVITIES; CLINICAL TRIALS.
15.1. General. Subject to Biomatrix's approval rights as set forth in
Section 15.2(g), Syntex shall use its best efforts (as defined below) to obtain
and maintain at its expense all regulatory approvals required for the marketing
and sale by Syntex of the Agreement Product in each country in the Territory,
including all Product License Approvals and pricing and reimbursement approvals
where applicable. "Best efforts" in this context shall mean *
15.2. Product Approvals.
(a) All regulatory approvals required for the marketing and sale of the
Agreement Product in the Territory shall be held in the name of Syntex or its
designated Affiliate or, in the case of South Africa, its nominee. All Product
License Approvals held by Syntex or its designated Affiliate or nominee shall be
maintained by Syntex at its cost throughout the term of this Agreement.
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 39
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(b) For all phases of registration for Product License Approvals, and
pricing approval where applicable, Biomatrix shall provide such information,
including the results of ongoing pharmacological and preclinical studies,
technical support and assistance to Syntex as may be necessary to obtain and
maintain Product License Approvals for the Agreement Product.
(c) Except to the extent necessary to give effect to the provisions of
Section 3.3(b), Product License Approvals and pricing approvals relating to the
Agreement Product in all countries in the Territory in the name of Syntex or any
of its Affiliates or nominees shall be transferred to Biomatrix immediately upon
termination of the Agreement.
(d) If the government in any country in the Territory cancels the
Product License Approval for the Agreement Product, neither party will have any
liability whatsoever to the other party as a result of such cancellation.
(e) Syntex shall, at its cost, use its best efforts to obtain all
necessary pricing and reimbursement approvals required in the Territory with
respect to the Agreement Product, and to obtain and maintain at all times the
optimum price for the Agreement Product in all countries in the Territory. "Best
efforts" in this context shall have the meaning assigned to it in Section 15.1.
(f) During the term of this Agreement, each party shall immediately
notify the other in writing in the event that such party becomes aware of any
failure of the Agreement Product to comply with any of the requirements therefor
specified in the Product License Approval.
(g) Each party shall keep the other advised of regulatory interactions,
activities and correspondence and the registration status of the Agreement
Product on a regular basis. Except as specifically provided to the contrary in
Sections 15.1 and 15.2 (inclusive), Syntex shall not make any direct contact
with any regulatory authorities with respect to the Agreement Product without
the prior written consent of Biomatrix, such consent not to be unreasonably
withheld or delayed. In addition, Biomatrix shall be entitled generally to
oversee the strategy and content of all applications for Product License
Approvals and the content of all such applications shall be subject to
Biomatrix's prior written approval, such approval or disapproval to be given by
Biomatrix within * of its receipt thereof, such approval not to be unreasonably
withheld.
(h) Syntex shall, at its cost and with the cooperation of Biomatrix, use
its best efforts to obtain and maintain all necessary Product License Approvals
for Improvements in all countries
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 40
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in the Territory where Product License Approvals are held by Syntex or a Syntex
designated Affiliate or nominee. "Best efforts" in this context shall have the
meaning assigned to it in Section 15.1.
15.3. Clinical Trials; Publication of Results.
(a) Syntex shall complete on a timely basis * and shall also conduct, in
cooperation with Biomatrix, * Biomatrix shall have the right to review and
approve all protocols for all clinical trials, and all amendments to such
protocols. Syntex shall continue, under the supervision of Biomatrix, to report
to and to notify all regulatory authorities and ethical committees as may be
required in connection with such clinical trial activities. Biomatrix will
provide reasonable technical support to Syntex free of charge for all clinical
trials conducted in accordance with this Section 15.3. *
(b) Syntex shall provide the completed data resulting from * to
Biomatrix for analysis, and Biomatrix shall prepare the final reports relating
to such clinical trial data supplied by Syntex.
(c) Syntex shall provide the completed data resulting from the * to
Biomatrix for analysis, and in cooperation with the principal investigator
Biomatrix will analyze the data and prepare the final reports. Syntex shall not
publish the results of such trials without the written consent of Biomatrix,
such consent not to be unreasonably withheld. If Biomatrix has consented to
publication, Biomatrix and the principal investigator shall jointly prepare the
manuscript and select the journal for publication. The authors of such paper
shall be exclusively the clinical investigators conducting the trial.
(d) Biomatrix and its Affiliates shall be free to use the results of any
or all such clinical trials in the promotion, marketing and product licensing of
the Agreement Product outside the Territory.
16. CONSOLIDATION OF DOCUMENTS. As soon as practicable after the
Effective Date, Syntex shall consolidate all "Documents" (as defined below in
this Section 16) and limit its subsequent use of the Documents to purposes
connected with the distribution of the Agreement Product in Sweden and South
Africa. Syntex shall promptly return to Biomatrix all of the Documents listed on
Exhibit F hereto. "Documents" shall mean all originals, copies, digests and
summaries of all written or otherwise recorded documents, writings, materials,
items or information of any kind,
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* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 41
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concerning any matters relating to the Agreement Product that have resulted from
the shared or joint efforts of Biomatrix and Syntex, except for original copies
of any documents relating to Syntex's legal obligations ensuing from clinical
trial activities, copies of which shall be provided by Syntex to Biomatrix upon
its request.
17. OTHER DISTRIBUTION AGREEMENTS. Biomatrix may at any time discuss,
negotiate and execute binding agreements with parties other than Syntex relating
to the promotion, marketing, sale and distribution of the Agreement Product in
any country outside of the Territory.
18. FURTHER ASSURANCES. The parties hereto agree to execute such further
or other documents and assurances as are necessary from time to time in order to
give effect to the provisions of this Agreement.
19. ASSIGNMENT. The rights and obligations of the parties hereto shall
inure to the benefit of and shall be binding upon the authorized successors and
permitted assigns of each party. Neither party may assign its rights or
obligations under this Agreement or may designate another person to perform all
or part of its obligations under this Agreement, or to have all or part of its
rights and benefits under this Agreement without the prior written consent of
the other party, except to a successor of the business, by merger or otherwise,
to which this Agreement relates. It is acknowledged and understood that each of
the parties hereto may from time to time perform some or all of its obligations
hereunder through one or more of its Affiliates. In that regard, each of the
parties agrees (i) not to permit a person that is not an Affiliate to perform
any of its obligations hereunder, (ii) to notify the other party in writing
prior to the participation of the Affiliate in this Agreement, describing the
Affiliate and its expected involvement hereunder, (iii) to ensure that its
Affiliates comply with all of the provisions hereof, (iv) that the other party
hereto will not be in a direct contractual relationship with such Affiliate and
(v) that the party involving such Affiliate shall be responsible to the other
party hereto, both as primary obligor and as guarantor, for the performance of
all of its obligations hereunder, and for the conduct of its Affiliates.
20. GOVERNING LAW; ARBITRATION; INJUNCTIVE RELIEF.
20.1. This Agreement shall be governed by and construed in accordance
with the internal and substantive laws of the State of New York, United States
of America, excluding the United Nations Convention on Contracts for the
International Sales of Goods. In the event of any dispute touching or concerning
this Agreement, the parties hereby agree to submit such dispute to their
respective presidents by notice delivered in accordance with the provisions of
Section 25
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hereof, and if within thirty (30) days, or such other period as is agreed upon
in writing by the parties hereto, following such reference the dispute remains
unresolved, to submit the dispute for arbitration in New York City under the
Rules of the American Arbitration Association in effect on the date of this
Agreement (the "Rules") by arbitrators appointed in accordance with said Rules.
Any decision of such arbitrators shall be final and binding upon the parties. In
any arbitration pursuant to this Section the award shall be rendered by a
majority of three (3) arbitrators, one (1) of whom shall be appointed by each
party and the third of whom shall be appointed by mutual agreement of the two
(2) party-appointed arbitrators. In the event of failure of a party to appoint
an arbitrator within thirty (30) days after commencement of the arbitration
proceeding or in the event of failure of the two (2) party-appointed arbitrators
to agree upon the appointment of the third arbitrator within sixty (60) days
after commencement of the arbitration proceeding, such arbitrator shall be
appointed by the American Arbitration Association in accordance with the Rules.
The arbitrators shall apply the governing law set forth in this Section.
Judgment upon an award rendered by the arbitrators may be entered in any court
having jurisdiction thereof.
20.2. Each of the parties hereto acknowledges and agrees that damages
will not be an adequate remedy for any material breach or violation of this
Agreement if such material breach or violation would cause immediate and
irreparable harm (an "Irreparable Breach"). Accordingly, notwithstanding the
provisions of Section 20.1 hereof to the contrary, in the event of a threatened
or ongoing Irreparable Breach, each party hereto shall be entitled to seek, in
any state or federal court in the State of New York, equitable relief of a kind
appropriate in light of the nature of the ongoing threatened Irreparable Breach,
which relief may include, without limitation, specific performance or injunctive
relief. Such remedies shall not be the parties' exclusive remedies, but shall be
in addition to all other remedies provided in this Agreement.
21. SEVERABILITY. In the event that any provision of this Agreement
shall be held by a court of competent jurisdiction or by any governmental body
to be invalid or unenforceable, such provision shall be deemed severable and the
remaining parts and provisions of this Agreement shall remain in full force and
effect.
22. FORCE MAJEURE. Each of the parties shall be excused from the
performance of its obligations hereunder in the event such performance is
prevented by force majeure, and such excuse shall continue as long as the
condition constituting such force majeure continues. For the purpose of this
Agreement, force majeure is defined as contingencies beyond the reasonable
control of either party, including, without limitation, acts of God, judicial or
regulatory action, war, civil commotion, destruction of production facilities or
materials by fire, earthquake or
<PAGE> 43
-41-
storm and labor disturbances (whether or not any such labor disturbance is
within the power of the affected party to settle).
23. INTEREST. Any overdue amounts payable by either party hereunder
shall bear interest compounded monthly at the prime lending rate for Dollars
published from time to time in The Wall Street Journal plus * , or, if lower,
the highest rate permissible by applicable law, from the due date until the date
of payment.
24. NO PARTNERSHIP OR AGENCY. This Agreement and the relations hereby
established by and between Biomatrix and Syntex do not constitute a partnership,
joint venture, agency or contract of employment between them.
25. NOTICES. All communications in connection with this Agreement shall
be in writing and sent by postage prepaid first class mail, courier, or telefax,
and if relating to default, late payment or termination, by certified mail,
return receipt requested, telefax or courier, addressed to each party at the
address above, in the case of Biomatrix, Attn: Chief Executive Officer and
President, with a copy to Biomatrix Europe, 21 Boulevard Saint Germain 75005
Paris, France Attn: John Feilders, and with a copy to: Justin P. Morreale, Esq.,
Bingham, Dana & Gould, 150 Federal Street, Boston, Massachusetts 02110, U.S.A.,
and in the case of Syntex, Attn: Head of Business Development and Strategic
Marketing, F. Hoffman-La Roche Ltd., 4070 Basel, Switzerland, or to such other
address as the addressee shall last have designated by notice to the
communicating party. The date of giving any notice shall be the date of its
actual receipt.
26. EU REGULATIONS. It is the intention of the parties hereto that this
Agreement shall at all times qualify for the exemption from the provisions of
Article 85(1) of the Treaty of Rome dated 25 March, 1957, as amended, which
either (a) is available under EEC Regulation Number 1983/83, or (b) may
subsequently be available under any successor regulation or regulations thereto.
In the event that any provision of this Agreement is deemed to violate the
conditions for qualifying for the exemption, set out in whichever of those
regulations may be in effect at the relevant time, or if any such regulation is
amended after the date of this Agreement so as to cause this Agreement to fail
to qualify for the exemption, the parties hereto agree that they will, as soon
as it is practicable to do so, enter into good faith negotiations to amend this
Agreement as necessary in order to re-qualify for the exemption. If those
negotiations are not successfully concluded within a reasonable time (not to
exceed ninety (90) days, or such other period as is
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 44
-42-
agreed upon in writing by the parties hereto, after the relevant regulation is
amended), either party may terminate this Agreement upon written notice to the
other party.
27. SURVIVAL. The provisions of Sections 2.2, 2.3, 3.3, 3.6, 8.3, 10.1,
10.2, 10.3, and 10.4 of this Agreement shall survive the termination or
expiration of this Agreement (as the case may be) and shall remain in full force
and effect. The provisions of this Agreement that do not survive termination or
expiration hereof (as the case may be) shall, nonetheless, be controlling on,
and shall be used in construing and interpreting the rights and obligations of
the parties hereto with regard to any dispute, controversy or claim which may
arise under, out of, or in connection with this Agreement.
28. MISCELLANEOUS. This Agreement, together with the Stock Purchase
Agreement dated 23 June 1994 between Biomatrix and Syntex, as amended by the
First Amendment to Stock Purchase Agreement dated the date hereof between
Biomatrix and Syntex, and the trademark consent agreement dated 16 June 1987 and
amended as of 4 November 1993 between Biomatrix and Syntex Corporation, sets
forth the entire agreement between the parties with respect to the transactions
and arrangements contemplated hereby and supersedes all prior oral or written
arrangements, including without limitation the Prior Agreements and the Heads of
Agreement dated 27 November 1995 among Biomatrix, Syntex and F. Hoffman La Roche
Ltd. For the avoidance of doubt, the rights and obligations of the parties with
respect to the promotion, marketing, sale and distribution of the Agreement
Product in the "Territory" (as such term is defined in each of the Prior
Agreements) under each of the Prior Agreements have been superseded in all
respects by the terms of this Agreement. This Agreement may be modified or
amended only by a written instrument executed and delivered by both parties.
None of the provisions of this Agreement shall be deemed to have been waived by
any act or acquiescence on the part of either party except by an instrument in
writing signed and delivered by the party executing the waiver. This Agreement
may be executed in several identical counterparts, each of which shall be an
original, but all of which constitute one instrument, and in making proof of
this Agreement it shall not be necessary to produce or account for more than one
such counterpart.
<PAGE> 45
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date and year first above written.
SYNTEX PHARMACEUTICALS
INTERNATIONAL LIMITED
By: /s/ John Brough
------------------------
Name: John Brough
Title: President
BIOMATRIX, INC.
By: /s/ Endre A. Balazs
------------------------
Name: Endre A. Balazs
Title: Chief Executive Officer
<PAGE> 46
EXHIBITS
Exhibit A - Agreement Product Quality Control Procedures
Exhibit B - Agreement Product Specifications
Exhibit C - Patents and Trademarks
Exhibit D - Price and Quantities of Physicians' Samples
Exhibit E - Sales Forecasts
Exhibit F - Documents
<PAGE> 47
EXHIBIT A
*
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 48
EXHIBIT B
*
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 49
EXHIBIT C
Patents
U.K.
*
Germany
*
France
*
Italy
*
Netherlands
*
Belgium
*
Sweden
*
Switzerland
*
European Patent Applications
*
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 50
EXHIBIT C
Trademarks
U.K.
*
Ireland
*
Germany
*
France
*
Benelux
*
Sweden
*
Finland *
Iceland *
Denmark
*
Norway
*
Switzerland
*
Spain *
South Africa
*
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 51
EXHIBIT D
PRICE AND QUANTITY OF PHYSICIANS' SAMPLES
Price of Synvisc(R) samples to Syntex: **
Quantities (syringes/units)
*
- - The price and amount of any additional samples to be mutually agreed in
writing by both parties.
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 52
EXHIBIT E
SYNTEX SALES FORECAST
12 MONTHS PERIOD
(Units/Syringes)
================================================================================
Years from launch I II III
================================================================================
South Africa * * *
- --------------------------------------------------------------------------------
Sweden * * *
- --------------------------------------------------------------------------------
- ----------
* Confidential portions have been omitted and filed separately with the
Commission.
<PAGE> 53
EXHIBIT F
Documents
1. Synvisc(R) file as submitted to UK regulatory authorities.
2. Synvisc(R) File as submitted to FDA in May 1994.
3. File prepared for submission to regulatory authorities in France.
4. Documents prepared for submission for viral committee in France.
5. Documents prepared for submission for clinical trial registration in France
<PAGE> 1
EXHIBIT 10.4
INTERNATIONAL
DISTRIBUTION AGREEMENT
THIS AGREEMENT is made as of the 14th day of June 1996 by and between
BIOMATRIX, INC., a corporation duly organized and existing under the laws of the
State of Delaware, having its principal office at 65 Railroad Avenue,
Ridgefield, New Jersey 07657, U.S.A. ("Biomatrix") and COLLAGEN CORPORATION, a
corporation duly organized and existing under the laws of the State of Delaware,
having its principal office at 2500 Faber Place, Palo Alto, California 94303,
U.S.A. (the "Distributor").
WHEREAS, Biomatrix is engaged in the development and manufacture of the
Agreement Product (as hereinafter defined);
WHEREAS, the Distributor desires to enter into a distribution agreement
and be appointed the exclusive distributor (even to Biomatrix) of the Agreement
Product and any Improved Agreement Product(s) in the Territory (as such terms
are hereinafter defined), and Biomatrix is willing to so appoint the Distributor
on the terms and subject to the conditions set forth herein; and
WHEREAS, the Distributor desires to purchase from Biomatrix, and
Biomatrix desires to sell to the Distributor, the Distributor's orders of the
Agreement Product and any Improved Agreement Product(s) in the Territory on the
terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and of the mutual
covenants of the parties hereto, it is hereby agreed as follows:
1. DEFINITIONS AND INTERPRETATION.
1.1. In this Agreement, the following words and expressions shall have
the following meanings:
"Affiliate" shall mean, with respect to any party, any Person which,
directly or indirectly, is controlled by, controls or is under common
control with such party. For purposes of this definition, the term
"control" (including with correlative meanings, the terms "controlled
by" and "under common control with") shall mean, with respect to any
Person, the direct or indirect ownership of more than fifty percent
(50%) of the voting or income interest in such Person or the possession
otherwise, directly or indirectly, of the power to direct the
management or policies of such Person.
<PAGE> 2
-2-
"Agreement Product" shall mean the one product made of hylan B and
called by Biomatrix Hylaform(R), the specifications for which are set
forth on Exhibit A, for use in the correction of wrinkles and depressed
scars.
"Agreement Product Specifications" shall mean the specifications for
the Agreement Product set forth in Exhibit A, as such specifications
may be modified or supplemented by Biomatrix from time to time in
accordance with Product License Approvals or to reflect any Improved
Agreement Product(s).
"Agreement Year" shall mean, with respect to a country or Region, as
applicable, in the Territory, the twelve (12) month period commencing
on the date of first commercial sale of the Agreement Product in such
country or Region, as applicable, and each separate successive twelve
(12) month period thereafter.
"Contract Quarter" shall mean, for sales of Agreement Product in a
country or Region, as applicable in the Territory, the period
commencing with the Distributor's first commercial sale of the
Agreement Product in such country or Region, as applicable, and ending
on the first to occur of March 31, June 30, September 30 and December
31, as applicable, and each three (3) month period thereafter
throughout the term of this Agreement.
"Dermal Tissue Augmentation Products" shall mean biomaterial(s) that
are [ *** ].
"Dollars" and "$" shall mean the lawful currency of the United States
of America.
"Effective Date" shall mean June 17, 1996.
"EU Countries" shall mean, collectively, Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the
Netherlands, Portugal, Spain, Sweden and the United Kingdom.
"European Territory" shall mean, collectively, the EU Countries,
Switzerland, Norway, Liechtenstein and Iceland.
"Formula Price" shall mean an amount equal to [ *** ] of the
Agreement Product by Distributor or an Affiliate of Distributor,
calculated on a [ *** ] basis, provided that if the [ *** ] the
Agreement Product in a Region [ *** ], then the Formula Price for
such Region shall mean an amount equal to [ *** ] of the
Agreement Product on a [ *** ] basis by Distributor or an
Affiliate of Distributor in such Region. [ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 3
-3-
[ *** ] the Formula Price shall mean an amount equal to [ *** ] by
Distributor or an Affiliate of Distributor, [ *** ], for or an
[ *** ,] including without limitation [ *** .]
"Improved Agreement Product(s)" shall mean (i) any modification of the
Agreement Product (made entirely from hylan B) regarding the
formulation of hylan B in the Agreement Product, that is changes of
concentration of the polymer or other changes in the Agreement Product
Specifications, whether or not requiring new regulatory approval in the
EU Countries or in the United States, and (ii) any modifications or
changes related to the packaging of the Agreement Product, including
the syringe used, mode of application or dosage.
"Incremental Royalties" shall mean that term as defined in Section 8.2.
"Initial Term" shall mean that term as defined in Section 3.2.
"Launch" shall mean, with respect to a country in the Territory, the
commencement by Distributor of sales of the Agreement Product in
commercial quantities for use in such country. Such Launch shall be
made with respect to each country in the Territory in accordance with
the dates set forth on Exhibit B.
"Minimum Price" shall mean an amount equal to [ *** ] for each
Treatment Syringe, [ *** ,] then the Minimum Price payable in such
Region [ *** ] Agreement Years immediately following such [ *** ]
shall equal [ *** ,] and [ *** ] Agreement Years following such
[ *** ] shall equal [ *** ] for each Treatment Syringe.
"Net Retail Sales" shall mean, with respect to sales of a Dermal Tissue
Augmentation Product in a country in the Territory, the aggregate gross
price invoiced for retail sales of such product during a period in such
country to unaffiliated third-party purchasers [ *** .] It is
Biomatrix's understanding that the foregoing definition is consistent
with how the Distributor reports its sales in its audited financial
statements.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 4
-4-
"New Products" shall mean [ *** ]
"Patents" shall mean Letters Patent or similar statutory rights
relating to any Agreement Product and any Improved Agreement Product(s)
(including any continuation-in-part, continuation or division thereof
or substitute thereof), and patent applications which are pending as of
the Effective Date, in each case as set forth in Exhibit C, together
with any supplementary or complementary protection certificates
therefor if and when such are granted.
"Person" shall mean an individual, a corporation, limited liability
company, a partnership, a trust, an unincorporated organization or a
government or any agency or political subdivision thereof.
"Product License Approvals" shall mean those regulatory approvals
required for the importation, promotion, marketing and sale of the
Agreement Product and any Improved Agreement Product(s) in the
Territory (including any reimbursement or pricing approvals).
"Region" shall mean any one of the following countries or groups of
countries: (i) the United Kingdom and Ireland; (ii) Germany; (iii)
France; (iv) Italy; (v) Spain and Portugal; (vi) Denmark, Finland,
Sweden, Norway and Iceland; (vii) Belgium, Luxembourg and the
Netherlands; (viii) Japan; (ix) Austria, Liechtenstein and Switzerland;
(x) Australia and New Zealand; (xi) Greece and Israel; (xii) Argentina,
(xiii) Brazil, (xiv) Chile, (xv) Mexico, (xvi) Canada, (xvii) Columbia,
(xviii) Cyprus, (xix) Lebanon, and (xx) Turkey.
"Supply Forecast" shall mean that term as defined in Section 7.3(b).
"Territory" shall mean, collectively, the EU Countries, Switzerland,
Norway, Liechtenstein, Iceland, Australia, New Zealand, Japan, Israel,
Argentina, Brazil, Mexico, Chile, Columbia, Cyprus, Lebanon, Turkey and
Canada and any countries added hereto pursuant to Section 2.4.
"Trademarks" shall mean (i) the trademark Hylaform(R), the details of
which are described in Exhibit C, and (ii) any other trademarks, as may
be agreed upon in writing from time to time by the parties hereto for
use by the Distributor in connection with the promotion, marketing and
sale of the Agreement Product and any Improved Agreement Product(s)
under this Agreement.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 5
-5-
"Treatment Syringe" shall mean a ready-for-injection 1.0cc syringe of
the Agreement Product.
"United States Consumer Price Index" shall mean the Consumer Price
Index, All Items, United States, as published by the Bureau of Labor
Statistics.
1.2. In this Agreement, unless the context otherwise requires:
(a) clause headings are inserted for convenience of reference only and
have no legal effect;
(b) references to sections, exhibits and schedules are to be construed
as references to the sections of, and exhibits and schedules to, this Agreement
and references to this Agreement include its exhibits and schedules.
(c) references to (or to any specified provision of) this Agreement or
any other document shall be construed as references to this Agreement, that
provision or that document as in force for the time being and as amended,
varied, substituted, supplemented, restated or novated in accordance with the
terms thereof or, as the case may be, with the agreement of the relevant parties
and (where such consent is, by the terms of this Agreement or the relevant
document, required to be obtained as a condition to such amendment being
permitted) the prior written consent of Biomatrix;
(d) words importing the plural shall include the singular and vice
versa;
(e) references to a person shall be construed as including references
to an individual, firm, consortium, company, corporation, unincorporated body of
persons or any State or any agency thereof; and
(f) references to statutory provisions shall be construed as references
to those provisions as replaced, amended or re-enacted from time to time.
2. APPOINTMENT; BEST EFFORTS; EXCLUSIVITY.
2.1. Appointment.
(a) Subject to the terms and conditions hereinafter set forth,
Biomatrix hereby appoints the Distributor as its exclusive [ *** ] (except to
the extent set forth in Section 2.3) distributor for the registration (other
than in the European Territory), promotion, marketing, sale and distribution
within the Territory of the Agreement Product and any Improved Agreement
Product(s) supplied by Biomatrix or an Affiliate of Biomatrix to the Distributor
pursuant to this Agreement. Such appointment does not include the right to
sublicense or appoint subdistributors except to an Affiliate of Distributor or a
Subdistributor of Distributor set forth on Exhibit E hereto (each a
"Subdistributor") without
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 6
-6-
the approval of Biomatrix; (and only for such time as such an Affiliate remains
an Affiliate or Subdistributor of Distributor).
(b) Except as specifically provided to the contrary herein, the
foregoing appointment shall not be construed, by implication or otherwise, (i)
to effect any sale of proprietary Biomatrix technology, (ii) to grant any
license relating to Biomatrix's proprietary methods of formulating, fabricating
and manufacturing the Agreement Product or any Improved Agreement Product(s), or
(iii) to grant the Distributor any rights in or to any proprietary technology or
Patents or Trademarks of Biomatrix.
(c) During the term of this Agreement the Distributor shall neither
seek customers for the Agreement Product or any Improved Agreement Product(s)
outside the Territory nor establish any branch or maintain any distribution
facilities outside the Territory for the registration, promotion, marketing,
sale or distribution of the Agreement Product or any Improved Agreement
Product(s).
(d) [ *** ] to enter into subdistribution arrangements [ *** ]
hereto and no Subdistributor shall have any further right to sublicense any
rights or appoint additional subdistributors. The rights of Subdistributors to
maintain a sublicense hereunder shall be subject to the following:
(i) Each Subdistributor shall agree with Distributor that its
rights to sell the Agreement Product and Improved Agreement
Product(s) are subject to the terms of this Agreement,
including without limitation Distributor's or Biomatrix's
rights to terminate or convert this Agreement into a
non-exclusive arrangement;
(ii) [ *** ]
(iii) [ *** ]
(iv) Without the prior written consent of Biomatrix, Distributor
shall not waive any default or breach of any Subdistributor
which would adversely affect Biomatrix; and
(v) Upon any termination of this Agreement (or with respect to any
country), all subdistributor arrangements shall automatically
terminate; provided that Biomatrix may, in its sole
discretion, negotiate a license directly with any terminated
Subdistributor.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 7
-7-
2.2. Acceptance of Obligations; Best Efforts. The Distributor hereby
accepts the appointment described in Section 2.1 and hereby agrees to use its
best efforts at all times during the term hereof to register, promote, market,
sell and distribute the Agreement Product and any Improved Agreement Product(s)
in the Territory. [ *** ]
2.3. Conversion to Non-Exclusive Distributorship. In the event that (i)
in any Agreement Year after and including the third Agreement Year or (ii) from,
after and including the first year of the Distributor acquiring and/or
commercializing a New Product pursuant to Section 10.1(b) (and so long as (i) no
force majeure condition of the Distributor exists at such time pursuant to
Section 20, (ii) Biomatrix has met its supply obligations under Section 7.4 and
(iii) Distributor is able to lawfully sell the Agreement Product and any
Improved Agreement product(s) in each of the countries within any such Region)
the Distributor's (or its Affiliates' or Subdistributors', as applicable) Net
Retail Sales of the Agreement Product and any Improved Agreement Product(s) in a
Region comprise less than [ *** ] of its Net Retail Sales of [ *** ,] including
the Agreement Product and any Improved Agreement Product(s), [ *** ] Upon
conversion of Distributor's rights to a
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 8
-8-
non-exclusive distribution arrangement in any Region, Biomatrix shall have the
right to distribute the Agreement Product and Improved Agreement Product and/or
engage another distributor for such Region. Biomatrix will give Distributor [
*** ] days notice prior to appointing a third party distributor for such Region.
From and after the date of a conversion to a non-exclusive distribution
arrangement within a Region, the Distributor shall lose its rights hereunder to
register, promote, market, sell and distribute within such Region any Improved
Agreement Product(s) commercialized on or after such date. Notwithstanding the
foregoing, the Distributor shall retain the exclusive rights in all trademarks
under which the Distributor launched the Agreement Product or any Improved
Agreement Product(s) in such Region. Upon conversion of Distributor's rights to
a non-exclusive distribution arrangement in any Region in the European
Territory, the arrangements between the parties under this Agreement shall no
longer be governed by this Agreement and such Region shall no longer be deemed a
part of the Territory, but rather, such Region shall become the subject of a new
agreement between the parties upon the same terms and conditions set forth in
this Agreement. Upon such conversion to a non-exclusive arrangement, the parties
agree to execute such further documents and agreements as are necessary in order
to give effect to the provisions of this Section.
2.4. Expansion of Territory. One or more countries may be added to the
Territory from time to time after the Effective Date by mutual written agreement
of the parties hereto, conditional upon the satisfactory completion of the
necessary due diligence in such country and the satisfaction of Biomatrix with
the proposed arrangements for the registration, promotion, marketing, sale and
distribution of the Agreement Product and any Improved Agreement Product(s) by
the Distributor in such country. Biomatrix agrees to discuss the appointment of
Distributor or one of its subdistributors prior to appointing a third party
distributor of the Agreement Product in any additional country.
3. TERM AND TERMINATION.
3.1. Effective Date. This Agreement shall take effect as of the
Effective Date.
3.2. Term.
(a) Unless this Agreement is sooner terminated, in its entirety or as
to a country or Region in the Territory in accordance with the provisions of
this Agreement, the term of the appointment hereunder for a country in the
Territory shall commence on the first day of the first Agreement Year for such
country and shall end on the last day of the tenth (10th) Agreement Year for
such country (the "Initial Term").
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 9
-9-
(b) Unless this Agreement is sooner terminated, in its entirety or as
to any Region in the Territory in accordance with the provisions of this
Agreement, the appointment of the Distributor hereunder as exclusive distributor
of the Agreement Product for each Region in the Territory shall be renewable by
the Distributor, at its option, upon written notice to Biomatrix received at
least ninety (90) days prior to the end of the Initial Term for such Region, for
an additional consecutive term of five (5) years following the date of
expiration of the Initial Term for such Region, provided that the Distributor
shall only be entitled to exercise such renewal option with respect to any
Region if as of the date of expiration of the Initial Term for such Region the
Distributor is not in material breach of any of its obligations under this
Agreement with respect to any Region (it being understood that any payment
default by Distributor under this Agreement will be deemed a default as to the
entire Territory). Thereafter, the appointment of the Distributor as exclusive
distributor of the Agreement Product for such Region shall be renewable upon the
expiration of such additional five (5) year term, upon written notice to
Biomatrix received at least ninety (90) days prior to the end of such term for
such Region, for one additional consecutive renewal term of five (5) years,
provided that, as of the date of expiration of the first renewal term for such
Region, the Distributor is not in material breach of any of its obligations
under this Agreement with respect to any Region (it being understood that any
payment default by Distributor under this Agreement will be deemed a default as
to the entire Territory). For the avoidance of any doubt, the Distributor's
rights with respect to any Improved Agreement Product(s) commercialized after
the tenth anniversary of the Effective Date shall terminate upon the tenth
anniversary of the Effective Date. Subject to the terms of this Agreement,
Distributor shall have the right to continue to sell the Agreement Product and
any Improved Agreement Products it is then currently selling.
(c) This Agreement may be terminated with respect to any country in the
Territory by either party, by written notice to the other party, in the event
that (i) a mutual decision not to Launch the Agreement Product in such country
is reached or (ii) a Launch is not commenced with respect to such country within
thirty (30) days after the time period set forth on Exhibit B.
(d) In the event that in any Agreement Year commencing with the third
Agreement Year (and so long as (i) no force majeure condition of the Distributor
exists at such time pursuant to Section 20, (ii) Biomatrix has met its supply
obligations under Section 7.4, and (iii) Distributor is able to lawfully sell
the Agreement product and any Improved Agreement Product(s) in each of the
countries within any such Region), the Distributor's (and its Affiliates' or
Subdistributors', as applicable) Net Retail Sales of the Agreement Product and
any Improved Agreement Product(s) in any Region comprise less than seven and
one-half percent (7-1/2%) of its Net Retail Sales in such Region of all Dermal
Tissue Augmentation Products, including the Agreement Product and any Improved
Agreement Product(s), the Distributor's distribution rights (including, without
limitation, its right to use the Trademarks) under this Agreement for the
Agreement Product and any Improved Agreement Product(s) in such Region shall
terminate upon 90 days notice, but in any event no later than 120 days after the
end of the applicable Agreement Year, to Distributor from Biomatrix; provided,
however, that Distributor may within thirty (30) days after receipt of any such
notice from Biomatrix, cure a shortfall of Net Retail Sales with respect to a
Region in the Territory, other than Regions in the European Territory, Australia
and Canada, for an Agreement Year by paying to Biomatrix an amount equal to
twenty-five percent (25%) of the total dollar amount of any such shortfall of
Net Retail Sales in such Agreement Year for such Region (such amount the "Cure
Amount"); further provided that with respect to any Region in the Territory, at
Biomatrix's election, Biomatrix may refuse to allow such cure if Distributor has
taken advantage of such cure provision with respect to such Region in each of
the two preceding Agreement Years.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 10
-10-
By way of example, if Distributor's Net Retail Sales of all Dermal Tissue
Augmentation Products in a Region in a given Agreement Year [$10,000,] and
Distributor's Net Retail Sales of the Agreement Product in such Region in such
Agreement Year were $500, then Distributor could cure such shortfall and prevent
termination by paying Biomatrix $62.50. Distributor may cure a shortfall of Net
Retail Sales with respect to Regions in the European Territory, Australia or
Canada in an Agreement Year by paying the Cure Amount to Biomatrix with respect
to any such Region for such Agreement Year as provided above; provided, however,
that in exchange for such Cure Amount Biomatrix will supply Distributor with an
amount of units of the Agreement Product purchasable for such Cure Amount at the
applicable Minimum Price or Formula Price for the applicable Agreement Year for
such Region; further provided that with respect to any such Region, at
Biomatrix's election, Biomatrix may refuse to allow such cure if Distributor has
taken advantage of such cure provision w/respect to such Region in each of the
two preceding Agreement Years. Upon any such termination of the Distributor's
distribution rights in a Region, the Distributor's obligation to pay any
royalties pursuant to Sections 8.1 and 8.2 for any sales in such Region after
such termination shall cease, but the Distributor shall remain obligated to pay
all such royalties for sales in such Region accrued prior to such termination.
(e) If the Distributor's rights to distribute the Agreement Product and
any Improved Agreement Product(s) in any country in the European Territory shall
terminate solely pursuant to subsection (d) above, Biomatrix agrees to sell the
Agreement Product and any Improved Agreement Product(s) developed before the
date of such termination to the Distributor a price not greater than the price
paid by another distributor appointed in such country in the European territory,
for the period of time equal to the period that would have remained in the
Initial Term in such country had the Distributor's distribution rights not
terminated.
3.3. Inventory.
(a) Upon termination of this Agreement for any reason, Biomatrix shall
have the right (but not the obligation) to repurchase all or part of the
inventory of the Agreement Product and any Improved Agreement Product(s) held by
the Distributor or its Affiliates or Subdistributors.
(b) The price for inventory to be repurchased by Biomatrix pursuant to
Section 3.3(a) above shall be the landed cost thereof actually paid by the
Distributor to Biomatrix. With respect to any quantities not repurchased by
Biomatrix, the Distributor shall have the
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 11
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right to sell such inventory of the Agreement Product and any Improved Agreement
Product(s), in its usual and customary manner, in the ordinary course of
business, for a period of six (6) months following termination of this Agreement
and notwithstanding such termination the terms and conditions of this Agreement
shall apply to such sales.
3.4. Insolvency. This Agreement may be immediately terminated as to the
entire Territory by either party, upon giving written notice to the other party,
in the event that the other party shall become insolvent or be declared bankrupt
by a court of competent jurisdiction or shall be the subject of any
reorganization (other than a corporate reorganization effected in the ordinary
course of business and not arising out of any insolvency) or winding up,
receivership or dissolution, bankruptcy or liquidation proceeding, or any
proceeding or action similar to one or more of the above, in which case
termination shall be effective upon such written notice. The failure of either
party to give notice of termination upon obtaining knowledge of any such event
shall not be interpreted as a waiver of such party's rights under this Section
3.4, and such party reserves the right to exercise any such rights at any time
after the occurrence of any such event.
3.5. Breach. This Agreement may be terminated as to the entire
Territory by either party if the other party shall breach any of its payment
obligations hereunder or with respect to any Region if Distributor (or its
Affiliates or Subdistributors, as applicable) shall commit a material breach of
any of its warranties, covenants, conditions, obligations or agreements
contained herein with respect to such Region, provided that such breach shall
continue for a period of thirty (30) days after written notice thereof and
provided further that such termination shall be immediately effective upon
further written notice to that effect to the breaching party after its failure
to cure such breach within such applicable notice period. For avoidance of
doubt, the parties agree that if a Launch is not reached with respect to a
country within thirty days after the time period set forth on Exhibit B, then
either party may terminate this Agreement with respect to such country (provided
that such failure to reach a Launch is not caused by a force majeure condition
of the Distributor or Biomatrix's failure to meet its supply obligations under
Section 7.4).
3.6. Certain Rights Upon Termination. Upon termination of this
Agreement for any reason whatsoever, Biomatrix shall have the following rights,
or if such termination is as to a country in the Territory in accordance with
the provisions of this Agreement, Biomatrix shall have the following rights in
such country:
(a) Biomatrix shall have the unrestricted right to review, access, use
and permit others to review, access and use, either directly or by
cross-reference or incorporation or otherwise, all information, data,
investigations, preclinical and clinical protocols, marketing information
disseminated by Distributor publicly to customers and patients and all
information required to be provided to Biomatrix by law, information relating to
laboratory, animal and human studies, and related regulatory approvals
pertaining to the Agreement Product or any Improved Agreement Product(s) (the
"Information") which are possessed or controlled by the Distributor or any of
its Affiliates or Subdistributors, or to which the Distributor or any of its
Affiliates or Subdistributors has a right to review, access or use.
<PAGE> 12
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The Distributor unconditionally agrees promptly to take any action and
to execute and deliver to Biomatrix any documents or instruments reasonably
requested by Biomatrix to permit Biomatrix to make full use of such unrestricted
right.
(b) Further, Biomatrix shall have exclusive ownership rights to the
Trademarks and to all other product specific logos, slogans and other
intangibles used by the Distributor solely in association with the independent
sale of the Agreement Product and any Improved Agreement Product(s) (including
all registrations relating thereto) possessed or controlled by the Distributor
or any of its Affiliates or Subdistributors, and the Distributor unconditionally
agrees, subject to the provisions of Section 3.3(b), (i) immediately upon
termination to cease using the Trademarks and any such logos, slogans, and
marketing rights of Biomatrix or any imitations thereof and (ii) immediately to
execute and deliver to Biomatrix any documents or instruments reasonably
requested by Biomatrix to give full effect to the provisions of this Section
3.6; provided, however, if the Distributor maintains a license to distribute the
Agreement Product(s) in (a) two Regions, (b) one Region in the European
Territory or (c) in the United States, then Distributor shall retain the
exclusive rights in the Trademarks in the entire Territory.
(c) In addition, the Distributor unconditionally agrees, subject to the
provisions of Section 3.3(b), that it shall, upon the request of Biomatrix,
immediately inform all relevant regulatory authorities that the Distributor (or
its Affiliate or Subdistributor) is no longer a distributor of the Agreement
Product or the Improved Agreement Product(s) and shall take all action and
execute and deliver all documents and instruments necessary in order to transfer
to the fullest extent permitted under applicable law all registrations and
Product License Approvals, or applications therefor, for the Agreement Product
or any Improved Agreement Product(s) to Biomatrix or any Person nominated by
Biomatrix.
3.7. Effects of Termination.
(a) Upon termination of this Agreement for any reason, the Distributor
shall immediately discontinue making any representations regarding its status as
a distributor for Biomatrix and shall immediately cease conducting any
activities with respect to the marketing, promotion, sale or distribution of the
Agreement Product and any Improved Agreement Product(s), provided, however, that
the Distributor shall be permitted to sell inventory not repurchased by
Biomatrix in accordance with Section 3.3.
(b) Termination of this Agreement shall not affect obligations of
either party that may have accrued prior to the effective date of termination.
Subject to Clause 3.8 below, termination of this Agreement shall be in addition
to, and shall not be exclusive of or prejudicial to, any other grounds for
termination or rights or remedies at law or in equity which either party may
have on account of any default of the other party.
3.8. Waiver. The Distributor (for itself and on behalf of its
Affiliates and Subdistributors) hereby waives, to the extent it is able to do so
under the law of
<PAGE> 13
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every country in the Territory and other applicable law, any statutory rights it
may have or acquire in respect of the termination of the relationship
established hereby pursuant to the terms hereof, and agrees that the rights
available to it hereunder in the event of such termination are adequate and
reflect the agreement of the parties. The Distributor shall not have any right
to claim any indemnity for goodwill or lost profits or any damages arising from
the rightful termination of this Agreement in accordance with the terms hereof.
4. PAYMENTS. All payments hereunder shall be made in Dollars. Payments
to Biomatrix shall be wired to an account designated by Biomatrix and the costs
of any such remittance shall be borne by the Distributor. All amounts (except
for the Minimum Price, which shall be denominated in Dollars) denominated in
another currency shall be converted to Dollars using the average month-end rates
of exchange for the relevant period as published in The Wall Street Journal (or,
if The Wall Street Journal shall no longer publish such exchange rates, as
determined by a method that is mutually agreed upon in writing by the parties).
5. WITHHOLDING. All payments to be made by the Distributor under this
Agreement shall be made in full, free and clear of and without any deduction of
or withholding for or on account of any taxes levied in any country of the
Territory or elsewhere; provided that if the Distributor shall be required by
law to make any deduction or withholding from any payment to Biomatrix then:
(a) the Distributor shall ensure that such deduction or withholding
does not exceed the minimum legal liability therefor; and
(b) not later than five (5) days before each deduction or withholding
of any taxes, the Distributor shall forward to Biomatrix such documentary
evidence as may be required by Biomatrix in respect of the proposed deduction,
withholding or payment; and
(c) prior to any deduction or withholding the parties shall attempt in
good faith to agree upon revised mutually acceptable pricing and/or payment
terms.
6. TRADEMARKS; AGREEMENT PRODUCT MARKING; PROMOTIONAL INFORMATION.
6.1. Trademarks. Subject to the provisions of Section 3.6, Biomatrix
hereby licenses to the Distributor the right to use, and hereby requires solely
in association with the independent sale by the Distributor of the Agreement
Product and any Improved Agreement Products the use of, the Trademarks in the
Territory during the term of this Agreement. The Distributor warrants that it
shall not use any of the Trademarks at any time outside the Territory or use any
of the Trademarks for any products other than the Agreement Product and any
Improved Agreement Product(s) within the Territory. The Distributor shall not
use a trademark or other mark (other than a Trademark) in connection with its
distribution of the Agreement Product and any Improved Agreement Products unless
and until it has been agreed upon in writing by each of the parties and become a
Trademark as defined herein.
<PAGE> 14
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Biomatrix shall prosecute, maintain and defend the Trademarks throughout the
Term of this Agreement in all countries in the Territory in which the
Distributor, any of its Affiliates or any Subdistributor is selling the
Agreement Product and/or any Improved Agreement Product. The parties shall
execute a short form Trademark assignment agreement to the extent that it is
necessary to record the Trademark license under this Section 6.1 in any country
whose laws require any such registration.
6.2. Termination of Right to Use Trademarks. Subject to the sell-out
right of Section 3.3(b) and except as otherwise provided in Section 3.6, upon
termination of this Agreement, the license to use the Trademarks in the
Territory shall terminate, and the Distributor unconditionally agrees promptly
to take all necessary action and execute and deliver to Biomatrix all necessary
documents and instruments to remove the Distributor as a registered user and/or
a recorded licensee of the Trademarks. In the event that the Distributor fails
promptly upon written request by Biomatrix to comply with any of its agreements
in the preceding sentence of this Section 6.2, the Distributor hereby
irrevocably consents to Biomatrix's taking any action necessary to give effect
to such agreements.
6.3. Notice. Each party hereto agrees promptly to notify the other in
writing of any infringements or imitations of the Trademarks by third parties
which may come to its attention.
6.4. Labelling and Promotional Materials; Approved Use of Product.
(a) The Distributor shall provide Biomatrix with labelling masters,
instructions, specifications and copies of all marketing, labelling and
promotional material it intends to use relating to the Agreement Product and any
Improved Agreement Product(s). All such labelling, packaging and promotional
material shall be consistent with the relevant Product License Approvals and all
labelling and packaging materials shall be reviewed by Biomatrix and shall be
subject to its written approval prior to use, such approval not to be
unreasonably withheld. Biomatrix shall communicate its acceptance or rejection
of such labelling, packaging and any major promotional materials that include
claims or items impacting regulatory approvals within [ *** ] of its receipt
thereof and if no such communication is received by Distributor from Biomatrix
within such [ *** ] Biomatrix shall be deemed to have accepted. Distributor
shall provide Biomatrix with all major promotional materials for launches and
subsequent promotions within a reasonable time prior to their use in order to
allow Biomatrix to comment on such materials. Distributor shall provide
Biomatrix with copies of all other promotional materials at or prior to their
use.
(b) The Distributor agrees that its (and its Affiliates' and
Subdistributors') promotion, marketing, sale and distribution of the Agreement
Product and any Improved Agreement Product(s) in the Territory, and the
promotional materials and labelling used in connection therewith, shall be
strictly in accordance with the approved use of the Agreement Product and any
Improved Agreement Product(s) as specified in the Product License Approvals and
as further provided in this Agreement. Specifically, for purposes of this
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 15
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Agreement, the Distributor (and its Affiliates and Subdistributors) agrees
[ *** ,] or unless agreed to in writing by Biomatrix.
6.5. Legend. Subject to applicable laws and regulations in the
Territory, all relevant packaging and promotional material for the Agreement
Product and any Improved Agreement Product(s) used or sold by the Distributor
(and its Affiliates and Subdistributors) shall contain (i) all applicable
markings needed to keep the Trademarks enforceable throughout the Territory as
reasonably specified by Biomatrix to the Distributor and (ii) a legend which
shall be displayed in a reasonably conspicuous manner on all packaging of such
Agreement Product and any Improved Agreement Product(s) containing the corporate
identification logo of Biomatrix and indicating that such product has been
developed and manufactured by Biomatrix, Inc., and its affiliates, 65 Railroad
Avenue, Ridgefield, New Jersey, 07657 U.S.A.
6.6. Promotional Support. Biomatrix and the Distributor (and its
Affiliates and Subdistributors) shall provide to each other on an ongoing basis
and without charge (to the extent not prevented by law or contract from doing
so) all medical information relating to the Agreement Product and any Improved
Agreement Product(s) (including summary data from studies, clinical trials and
the like as well as information regarding adverse events associated with the use
of the Agreement Product), the proceedings of all symposia on the Agreement
Product and any Improved Agreement Product(s) and all promotional information
that is available to such party relating to the Agreement Product and any
Improved Agreement Product(s). In addition, Biomatrix and the Distributor (and
its Affiliates and Subdistributors) shall provide each other with access to such
primary data and information in its possession as the other may reasonably
request regarding the results of the studies contained in such summary data
referred to above.
6.7 Joint Coordinating Committee. Upon the execution of this Agreement,
Biomatrix and the Distributor shall establish a joint coordinating committee
(the "Committee") to review all matters relating to product labelling, product
claims, regulatory matters or clinical trials. The Committee shall consist of an
equal number, not to [ *** ,] of voting representatives from each of Biomatrix
and the Distributor and shall meet [ *** .] In the event of a dispute between
representatives of Biomatrix and the Distributor on the Committee, a senior
representative of each such party shall be appointed to resolve such dispute,
and in the event such senior representatives are unable to resolve the matter,
Biomatrix's view shall prevail over the Distributor's.
6.8 Recalls of the Agreement Product.
(a) If either party in good faith determines that a recall of the
Agreement Product in any country in the Territory is warranted, such party shall
immediately notify the other party in writing and shall advise such other party
of the reasons underlying its determination that a recall is warranted. The
parties shall consult with each other as to any action to be
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 16
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taken in regard to such a recall, but in any event if after consultations either
party in good faith still believes that such a recall should be undertaken, the
parties shall cooperate in carrying out such recall.
(b) Except as otherwise provided in (c) below, in the event of a recall
of the Agreement Product, Biomatrix shall correct any deficiency relating to its
manufacturing, packaging, testing, labelling, storing or handling of the
Agreement Product for which it is responsible, if applicable, and shall at its
cost replace the Agreement Product recalled.
(c) Biomatrix shall reimburse Distributor for all direct costs and
expenses (including without limitation shipping, quality control testing and
notification costs) incurred by Distributor and its Affiliates as a result of
any recall, except where such recall (i) is the result of the failure of
Distributor or its Affiliates or Subdistributors to comply with their
obligations under this Agreement and/or (ii) was opposed by Biomatrix and proved
to be unwarranted, in which case Distributor shall reimburse Biomatrix for all
direct costs and expenses (including without limitation shipping, quality
control testing and notification costs) incurred by Biomatrix and its Affiliates
as a result of such recall.
6.9. Product Vigilance System. The Distributor shall be responsible for
maintaining medical device vigilance systems, as established for the Agreement
Product by Biomatrix, and shall promptly provide Biomatrix with notice of all
product complaints, including medical complaints. Biomatrix shall be solely
responsible for processing, analyzing and, if necessary, reporting medical
complaints to regulatory authorities. The Distributor shall provide all
necessary support to Biomatrix for carrying out such activities.
7. SUPPLY OF AGREEMENT PRODUCT.
7.1. General; Fee.
(a) Biomatrix agrees to sell the Agreement Product and any Improved
Agreement Product(s) to the Distributor, on the terms and subject to the
conditions set forth herein, for resale by the Distributor within the Territory,
and the Distributor shall obtain the Agreement Product and any Improved
Agreement Product(s) for resale in the Territory only from Biomatrix or its
Affiliates. Biomatrix shall not sell the Agreement Product or any Improved
Agreement Product(s) itself or supply or license the manufacture of the
Agreement Product or any Improved Agreement Product(s) to any third party for
resale within the Territory, provided that Biomatrix's obligations under this
sentence shall be subject to (i) applicable law, including without limitation EU
competition law and, in particular, EEC Regulation 1983/83 (as amended or
succeeded) and (ii) the provisions of this Agreement, including Section 2.3.
(b) [ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 17
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[ *** ,] the Distributor shall pay to Biomatrix a fee in the amount of five
million Dollars (US$5,000,000) in cash or by wire transfer on the execution of
this Agreement by the parties hereto. Such fee shall not be refundable in whole
or part.
7.2. Price; Adjustment; Reports; Payment.
(a) The parties shall attempt in good faith to agree in writing, prior
to the Launch in each country, upon mutually acceptable supply pricing for the
Distributor's purchase of the Agreement Product and any Improved Agreement
Product(s), but such pricing in any event shall not be less than the greater of
(i) the Minimum Price, or (ii) the Formula Price, except as provided in
subsection (b) below. The parties shall attempt in good faith to agree in
writing upon mutually acceptable minimum pricing for the Agreement Product in
sizes other than the 1.0cc Treatment Syringe and for any Improved Agreement
Product(s). For any syringe with a fill volume of greater than one cc (1cc), the
Minimum Price shall be the amount calculated as [ *** ] plus the dollar amount
which equals [ *** ] of such product with a larger fill volume [ *** ] of the
one cc(1cc) syringe. In the event that Biomatrix's actual incremental Cost of
Goods Sold exceeds such dollar amount, the Minimum Price shall be the amount
calculated as [ *** .] Subject to the general commercial availability of
appropriate syringes for the Agreement Product, the [ *** ] for a one and
one-half (1.5)cc syringe, [ *** ] for a two (2.0)cc syringe, and [ *** ] for a
two and one-half (2.5)cc syringe.
(b) If Biomatrix has appointed a new distributor for a country in the
Territory pursuant to Section 2.3 and the Distributor has the right to
distribute the Agreement Product and any Improved Agreement Product(s) in such
country, the supply pricing for the Distributor's purchase of the Agreement
Product and any Improved Agreement Product(s) for resale in such country
[ *** .]
(c) The price initially payable by the Distributor to Biomatrix for
each unit of the Agreement Product during each month of each Agreement Year
shall be the Minimum Price applicable to sales in such country (subject to
adjustment at the close of each applicable Contract Quarter and Agreement Year
in accordance with Section 7.2(e) below).
(d) Within [ *** ] after the end of each month of each
Agreement Year for each country in the Territory, the Formula Price for the
Agreement Product in such
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 18
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country shall be calculated, and, to the extent that such Formula Price exceeds
the applicable Minimum Price for such Agreement Year for such country, an
adjustment resulting from the [ *** ] with respect to all units of the
Agreement Product sold by the Distributor (and its Affiliates and
Subdistributors) in such country during such monthly period, such payment to be
made [ *** ] after the end of the month following such monthly period.
(e) Within [ *** ] after the end of each Contract Quarter and Agreement
Year for each country, the Formula Price for the Agreement Product in such
country shall be calculated and an adjustment resulting from the [ *** ,] as
appropriate, to the other party with respect to all units of the Agreement
Product sold by the Distributor in such country during such Contract Quarter and
Agreement Year, such payment to be made within [ *** ] after the end of such
[ *** ] period following the end of such Contract Quarter and Agreement Year.
The price calculated annually in this manner shall be the final price payable
for all units of the Agreement Product sold by the Distributor, any Affiliates
or Subdistributors of Distributor during such Agreement Year. For the avoidance
of doubt, the aggregate amount payable by Distributor for the Agreement
Product(s) and any Improved Agreement Product(s) in any country for any
Agreement Year shall in no event be lower than the Minimum Price multiplied by
the total units sold in such Agreement Year in such country.
(f) Within [ *** ] following the end of each calendar month in each
Agreement Year, the Distributor shall submit to Biomatrix written reports
detailing the units and value of the Distributor's, Affiliates' and
Subdistributors' Net Retail Sales and aggregate number of units sold of the
Agreement Product and any Improved Agreement Product(s) in each country in the
Territory during the immediately preceding calendar month.
(g) Within [ *** ] following the end of each Agreement Year, the
Distributor shall submit to Biomatrix written reports detailing the
Distributor's and its Affiliates' and Subdistributors' sales of the Agreement
Product and any Improved Agreement Product(s) during the immediately preceding
Agreement Year, which reports shall contain the Net Retail Sales of the
Agreement Product and any Improved Agreement Product(s) in each country in the
Territory, and the aggregate number of units of the Agreement Product and any
Improved Agreement Product(s) sold in each country in the Territory during the
applicable Agreement Year.
(h) All purchases of the Agreement Product and any Improved Agreement
Product(s) hereunder shall be billed and paid in Dollars within [ *** ] after
the later of the date of delivery or the date of the Distributor's receipt of
the invoice for each shipment of same to the Distributor.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 19
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7.3. Sales and Supply Forecasts; Accounts.
(a) Exhibit D, which shall be supplied by the Distributor within
[ *** ] of the Effective Date, sets forth a sales forecast of units of the
Agreement Product in the Territory for the first year after the Effective Date.
(b) Within [ *** ] after the end of each month, the Distributor shall
provide to Biomatrix an updated rolling twelve (12) month monthly supply
forecast for all unit sizes of the Agreement Product in the Territory. Each such
supply forecast described in this subsection (b) is referred to herein as a
"Supply Forecast"; provided, that updated Supply Forecasts shall not vary
(whether up or down) from the immediately preceding Supply Forecast by more than
[ *** ] with respect to each month covered by such preceding Supply Forecast.
(c) The Distributor shall maintain, and shall require its Affiliates and
Subdistributors to maintain, books of account with respect to sales of the
Agreement Product in the Territory by it and its Affiliates and Subdistributors.
Biomatrix shall have the right, not more than once during each calendar year, to
have an independent accountant selected and retained by Biomatrix (reasonably
acceptable to the Distributor, provided that any "big six" accounting firm shall
be deemed reasonable) to inspect and examine such books of the Distributor, its
Affiliates and Subdistributors during regular business hours for the purpose of
verifying the statements of the aggregate Net Retail Sales of all Dermal Tissue
Augmentation Products for all purposes hereunder, including verification of
Formula Price and the royalties described in Section 8. The cost of each such
audit shall be borne by Biomatrix unless a material error is discovered in the
course of such audit, in which case the cost shall be borne by the Distributor.
For purposes of this Section 7.3(d), a material error shall be defined as an
understatement of five percent (5%) or more of the aggregate amount owed to
Biomatrix with respect to sales of Dermal Tissue Augmentation Products in a
country in the Territory. Any additional payments required as a result of such
inspection and examination shall be immediately paid to Biomatrix and shall bear
interest from the date such amount would otherwise have been paid until the date
of actual payment at the rate per annum set forth in Section 20. Such
independent accounting firm shall conduct such inspections and examinations
under conditions of confidentiality.
7.4. Shipment and Delivery; Packaging.
(a) Biomatrix or an Affiliate of Biomatrix shall arrange for shipment
to the Distributor of the Agreement Product and any Improved Agreement
Product(s) ordered by the Distributor [ *** ]. The Distributor shall
pay all customs duties, sales taxes and other governmental charges relating to
the Agreement Product and any Improved Agreement Product(s), and shall be solely
responsible for clearing such products through customs throughout the Territory.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 20
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(b) The Distributor shall submit a firm purchase order setting forth
the quantities, delivery date and shipping instructions with respect to each
shipment of the Agreement Product and any Improved Agreement Product(s), such
purchase orders to be received by Biomatrix at least [ *** ] prior to the
requested delivery date; provided that the Distributor shall not submit any
purchase order for fewer than [ *** ] units of the Agreement Product or the
Improved Agreement Product(s) (although multiple delivery sites for purchase
orders shall be allowed). Biomatrix shall use commercially reasonable efforts
but shall have no obligation to supply Distributor with quantities of the
Agreement Product(s) and Improved Agreement Product(s) in excess of the amounts
in the then current Supply Forecast for the relevant monthly period. For
avoidance of doubt, so long as Biomatrix supplies Distributor with quantities of
the Agreement Product and Improved Agreement Product(s) as set forth in the
Supply Forecast, then Biomatrix shall not be deemed to be in default under this
section or any other provision of this Agreement relating to Biomatrix's supply
obligations. In addition to the foregoing, within [ *** ,] in consideration
for which units the Distributor shall pay to Biomatrix a price of [ *** ] per
unit.
(c) Biomatrix agrees that with respect to languages for packaging for
the European Territory three separate forms of packaging shall be made
available, as applicable, as follows:
(i) Northern Europe - English, Dutch, French, German and
Italian;
(ii) Southern Europe - English, Italian, Spanish, Portuguese
and Greek; and
(iii) Scandinavia - English, Swedish, Norwegian, Danish and
Finnish.
(d) Each unit of the Agreement Product and any Improved Agreement
Products shipped to the Distributor shall have, as of the time of delivery, a
remaining shelf life of no less than [ *** ] less than the maximum shelf life
for such product, as approved by the United States Food and Drug Administration.
Biomatrix shall continually use its best efforts at all times during the term
hereof to lengthen to [ *** ] the shelf life of the Agreement Product and any
Improved Agreement Products to the extent supported by stability data.
Biomatrix' "best efforts" in this section shall mean that Biomatrix shall use
such methods, exercise such degree of effort and diligence, and adhere to such
standards as are commercially reasonable.
7.5. Title. Legal title to all quantities of the Agreement Product and
any Improved Agreement Product(s) sold hereunder shall remain in Biomatrix until
delivery of the Agreement Product and any Improved Agreement Product(s) to
Distributor or its agent and acceptance thereof and upon such delivery and
acceptance the title to such Agreement
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 21
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Product and any Improved Agreement Product(s) shall, without further action, be
transferred to and vested in the Distributor.
7.6. Risk of Loss. Biomatrix shall bear all risk of loss of, or damage
to, all units of the Agreement Product and any Improved Agreement Product(s) to
the extent the same is in its possession or the possession of its Affiliates,
nominees or agents. The Distributor shall bear all risk of loss of, or damage
to, all units of the Agreement Product and any Improved Agreement Product(s)
after delivery to a common carrier for shipment to the Distributor in accordance
with Section 7.4.
7.7. Acceptance. [ *** .] All units of the Agreement Product and
Improved Agreement Products delivered to Distributor pursuant to this Agreement
shall be [ *** ,] the specifications listed in Exhibit A. Any non-conformity
which arises after acceptance by Distributor directly associated with product
specification shall be the responsibility of Biomatrix unless such
non-conformity is due to improper storage conditions subsequent to delivery of
the Agreement Product. All other non-conformities of the Agreement Product shall
be the responsibility of the Distributor. Biomatrix and the Distributor agree to
consult with each other in order to resolve the discrepancy between each other's
determinations. If such consultation does not resolve the discrepancy, the
parties agree to nominate a reputable independent laboratory, acceptable to both
parties, that shall carry out tests on representative samples taken from such
shipment, and the results of such tests shall be binding on the parties.
Biomatrix shall at its expense replace any such shipment to the extent that it
does not conform to the Agreement Product Specifications. All defective units of
the Agreement Product or any Improved Agreement Product(s) shall be returned to
Biomatrix at the address set forth in Section 23 of this Agreement, accompanied
or preceded by a reasonably detailed statement of the claimed defect or
non-conformity and proof of date of purchase, and packed and shipped according
to instructions provided by Biomatrix. The shipping costs of any such returned
units shall be borne by Biomatrix, unless such units are determined not to be
defective under the terms of this Agreement, in which case such shipping costs
shall be borne by the Distributor.
7.8. Purchase Orders. The provisions of this Agreement shall prevail
over any inconsistent statement or provisions contained in any document related
to this Agreement passing between the parties hereto including, but not limited
to, any purchase order, acknowledgment, confirmation or notice.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 22
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7.9. Limited Warranty; Limitation on Liability.
Biomatrix represents and warrants that the Agreement Product and any
Improved Agreement Product(s) supplied to the Distributor hereunder shall:
(a) conform to the Agreement Product Specifications; and
(b) be manufactured, labelled, packaged and tested (while in the
possession or control of Biomatrix) in accordance with the applicable Product
License Approvals therefor and all applicable laws and regulations in the
Territory relating to the manufacture, labelling, packaging and testing of the
Agreement Product, and shall be manufactured for use for the indications
specified in the applicable Product License Approvals therefor.
THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY
BIOMATRIX WITH RESPECT TO THE AGREEMENT PRODUCT, AND BIOMATRIX GIVES AND MAKES
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE
FOREGOING. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, NO IMPLIED WARRANTY
OF MERCHANTABILITY, NO IMPLIED WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE,
AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR COURSE
OF PERFORMANCE IS GIVEN OR MADE BY BIOMATRIX OR SHALL ARISE BY OR IN CONNECTION
WITH ANY SALE OR PROVISION OF THE AGREEMENT PRODUCT BY BIOMATRIX, OR THE
DISTRIBUTOR'S (OR ITS AFFILIATES' OR SUBDISTRIBUTORS') USE OR SALE OF THE
AGREEMENT PRODUCT, OR BIOMATRIX'S AND/OR THE DISTRIBUTOR'S (OR ITS AFFILIATES'
OR SUBDISTRIBUTORS') CONDUCT IN RELATION THERETO OR TO EACH OTHER. NO
REPRESENTATIVE OF BIOMATRIX IS AUTHORIZED TO GIVE OR MAKE ANY OTHER
REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY WAY.
The limited warranty set forth in this Section 7.9 does not apply to
any non-conformity of the Agreement Product or any Improved Agreement Product(s)
resulting from (a) repair or alteration by any party other than Biomatrix or its
Affiliates, (b) misuse, negligence, abuse, accident, mishandling or storage in
an improper environment by any party other than Biomatrix or its Affiliates, or
(c) use, handling, storage or maintenance other than in accordance with
instructions and recommendations provided by Biomatrix or its Affiliates.
Biomatrix's obligation with respect to units of the Agreement Product
and any Improved Agreement Product(s) which do not meet the warranty contained
herein is limited to replacement of such units of the Agreement Product or
Improved Agreement Product(s) as applicable, provided that such units are
returned to Biomatrix accompanied by a reasonably detailed statement of the
claimed defect or non-conformity and proof of date of purchase, and packed and
shipped according to instructions provided by Biomatrix, and only
<PAGE> 23
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if, upon examination by Biomatrix, such units of the Agreement Product or the
Improved Agreement Product(s) are determined to have been defective under the
terms of this Agreement.
BIOMATRIX'S LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE
SALE OR USE OF THE AGREEMENT PRODUCT AND ANY IMPROVED AGREEMENT PRODUCT(S)
(WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF WARRANTY, STRICT LIABILITY OR
ANY OTHER LEGAL THEORY), SHALL BE STRICTLY LIMITED TO BIOMATRIX'S OBLIGATIONS AS
SPECIFICALLY AND EXPRESSLY PROVIDED IN THIS SECTION 7.9 AND IN SECTION 9 BELOW.
EXCEPT AS SPECIFICALLY PROVIDED IN THIS SECTION 7.9 AND IN SECTION 9 BELOW,
BIOMATRIX SHALL HAVE NO LIABILITY, OBLIGATION OR RESPONSIBILITY OF ANY KIND, IN
ANY WAY OR TO ANY EXTENT, FOR ANY DAMAGES, LOSSES, COSTS, EXPENSES OR
LIABILITIES FOR ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE
AGREEMENT PRODUCT AND ANY IMPROVED AGREEMENT PRODUCT(S) OR THE PERFORMANCE
THEREOF, OR ARISING IN ANY WAY IN CONNECTION WITH THE PURCHASE OR USE OR
INABILITY TO USE THE AGREEMENT PRODUCT OR ANY IMPROVED AGREEMENT PRODUCT(S),
EVEN IF BIOMATRIX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO
EVENT WHATSOEVER SHALL BIOMATRIX HAVE ANY LIABILITY, OBLIGATION OR
RESPONSIBILITY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY
DAMAGES ARISING IN ANY WAY IN CONNECTION WITH THE AGREEMENT PRODUCT OR ANY
IMPROVED AGREEMENT PRODUCT(S) OR THEIR SALE OR USE.
<PAGE> 24
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8. ROYALTY PAYMENTS BY DISTRIBUTOR.
8.1. Royalties for Sales of Dermal Tissue Augmentation Products. The
Distributor shall pay to Biomatrix a royalty of [ *** ] of the Net Retail
Sales by the Distributor and its Affiliates and Subdistributors of all Dermal
Tissue Augmentation Products (other than sales of the Agreement Product and any
Improved Agreement Product(s)) in all countries in the Territory on a
country-by-country basis, including any countries that are added to the
Territory after the Effective Date, [ *** .] Such royalty shall commence with
respect to each country in the Territory at the earlier of (a) the Launch of the
Agreement Product in such country or (b) the Launch date for such country set
forth on Exhibit B; provided that if a Launch is delayed due to Biomatrix's
failure to meet its supply obligations under Section 7.4, due to a force majeure
condition of Distributor or if the Distributor is not able to lawfully sell the
Agreement product in such country, such royalty with respect to any such country
shall not commence until Biomatrix meets its supply obligations, Distributor is
able to lawfully sell the Agreement Product in such country, or until such force
majeure condition ceases. Such royalty shall be paid by not later than [ *** ]
after the end of each Contract Quarter.
8.2. Incremental Royalties. The Distributor shall pay to Biomatrix the
following annual royalties (the "Incremental Royalties") on the Distributor's
and its Affiliates' and Subdistributors' total incremental increases in Net
Retail Sales of all Dermal Tissue Augmentation Products (including the Agreement
Product and any Improved Agreement Product(s)), in each country in the Territory
based on the incremental increases, if any, in Net Retail Sales of all Dermal
Tissue Augmentation Products in such country in each Agreement Year over a base
year amount comprised of Net Retail Sales of Dermal Tissue Augmentation Products
in the twelve (12) months immediately preceding the first commercial sale of
either the Agreement Product or any Improved Agreement Product(s) in such
country:
<TABLE>
<CAPTION>
Increase in Total
Sales Over Base Royalty on Total
Year Amount Incremental Sales
----------- -----------------
<S> <C> <C>
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
</TABLE>
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 25
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The Distributor's obligation to pay the Incremental Royalties shall cease with
respect to a country in the Territory in the event that the Distributor's rights
to sell, distribute, market and promote the Agreement Product and any Improved
Agreement Product have become non-exclusive with respect to such country
pursuant to Section 2.3 or have terminated pursuant to Section 3.2(d). The
Incremental Royalty shall be paid by not later than [ *** ] after the end of
each Agreement Year. For the avoidance of doubt, if the Distributor had no sales
of any Dermal Tissue Augmentation Products in a country prior to the first
commercial sale of either the Agreement Product or any Improved Agreement
Product in such country, the Distributor shall be obligated to pay a [ *** ]
royalty on Net Retail Sales of all Dermal Tissue Augmentation products sold
after such first commercial sale.
9. INDEMNIFICATION; CONFIDENTIALITY; PUBLIC ANNOUNCEMENT
9.1. Indemnification from the Distributor. Subject to the provisions of
Section 9.3, the Distributor shall defend, indemnify and hold Biomatrix and its
Affiliates and their respective directors, officers, agents and employees
harmless from and against any and all liabilities, claims, damages and expenses
(including without limitation actual court costs and reasonable attorneys' fees
regardless of outcome) resulting from claims of third parties or arising out of:
(a) any failure by the Distributor, its Affiliates or Subdistributors
to act in accordance with the terms of this Agreement and/or any applicable laws
and regulations in the Territory in connection with the Agreement Product and
any Improved Agreement Product(s), including without limitation any unauthorized
representations, warranties or guarantees given by the Distributor, its
Affiliates or Subdistributors;
(b) any unauthorized use of an unapproved label on the Agreement
Product or any Improved Agreement Product(s); and/or
(c) any activities of the Distributor, its Affiliates or
Subdistributors relating to the promotion, marketing, sale and distribution of
the Agreement Product and any Improved Agreement Product(s);
provided, however, that upon Biomatrix being advised of any assertions
of any such third party claims or suits or upon the bringing or filing of such
claims or suits by any third party against Biomatrix, Biomatrix will promptly
notify the Distributor thereof and Biomatrix may, at its option, permit the
Distributor's attorneys to handle and control the defense of such claims or
suits at the Distributor's cost and Biomatrix will co-operate with the
Distributor in the defense thereof. The parties agree that there shall be no
settlements, whether agreed to in court or out of court, without the prior
written consent of the indemnifying party.
9.2. Indemnification from Biomatrix. Subject to the provisions of
Section 9.3, Biomatrix shall defend, indemnify and hold the Distributor and its
Affiliates and their
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 26
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respective directors, officers, agents and employees harmless from and against
any and all liabilities, claims, damages and expenses (including without
limitation actual court costs and reasonable attorneys' fees regardless of
outcome) resulting from claims of third parties arising out of:
(a) any failure by Biomatrix to act in accordance with applicable laws
and regulations in the Territory in connection with the Agreement Product and
any Improved Agreement Product(s) (including changing a jointly agreed upon
label without the consent of Distributor);
(b) a product or manufacturing defect in the Agreement Product or any
Improved Agreement Product(s); and
(c) any infringement of the patent rights of third parties resulting
from the use or sale of the Agreement Product in the Territory in accordance
with this Agreement.
provided, however, that upon the Distributor being advised of any assertions of
any such third party claims or suits or upon the bringing or filing of such
claims or suits by any third party against the Distributor, the Distributor will
promptly notify Biomatrix thereof and, at Biomatrix's cost, permit Biomatrix's
attorneys to handle and control the defense of such claims or suits and will
co-operate with Biomatrix in the defense thereof. The parties agree that there
shall be no settlements, whether agreed to in court or out of court, without the
prior written consent of the indemnifying party.
9.3. Limitation on Liability.
NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN SECTIONS 9.1 AND 9.2
ABOVE, OR ANY OTHER PROVISION OF THIS AGREEMENT, IN NO EVENT (INCLUDING THE
FAULT, NEGLIGENCE OR STRICT LIABILITY OF EITHER PARTY) SHALL EITHER PARTY BE
LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR
EXEMPLARY DAMAGES OTHER THAN TO THE EXTENT NECESSARY TO REIMBURSE SUCH OTHER
PARTY FOR DAMAGES ACTUALLY PAID TO A NON-AFFILIATED THIRD PARTY, PROVIDED THAT
SUCH DAMAGES ARE OTHERWISE COVERED BY THE PROVISIONS OF SECTION 9.1 OR SECTION
9.2, AS THE CASE MAY BE.
9.4. Confidential Information. All information acquired by either party
(the "Recipient") from the other party or any of its Affiliates (the
"Discloser") during the term of this Agreement or prior to the Effective Date,
relating directly or indirectly to the present or potential business,
operations, corporate, technical or financial situation of the Discloser, or to
manufacturing know-how, patents, data, test results, techniques, processes,
procedures, raw materials, dealer, supplier and customer lists, pre-clinical and
clinical protocols or any improvements thereof of the Discloser ("Confidential
Information") is confidential, and shall be held in trust by the Recipient for
the exclusive benefit of the Discloser. Unless otherwise
<PAGE> 27
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agreed to in writing by the Discloser, the Recipient shall not at any time,
either during or subsequent to the term of this Agreement, use for itself (other
than in accordance with the terms of this Agreement) or any other Person, or
disclose or divulge to any Person, other than to those of its employees and
advisors and Affiliates who require the same for the purposes hereof and who are
bound by the same obligations of confidentiality, non-disclosure and non-use as
set forth herein, any Confidential Information or any other confidential or
proprietary information of the Discloser of which the Recipient may acquire
knowledge; provided, however, that the confidentiality, non-disclosure and
non-use provisions contained in this Section 9.4 shall not apply to any
information or data to the extent that the Recipient:
(a) shall demonstrate by clear and convincing evidence that such
information or data is known generally to persons in the trade through no act or
omission of the Recipient or any of its Affiliates;
(b) is required by any government authority to disclose such
information or data, including without limitation for the purposes of obtaining
and maintaining any Product License Approvals under this Agreement; or
(c) shall demonstrate by its written records was disclosed to or
created by it or its Affiliates on a non-confidential basis from a source other
than the Discloser or its Affiliates and that such disclosure or creation did
not constitute a breach of any applicable confidentiality obligations.
Confidential Information shall be immediately returned to the Discloser upon
termination of this Agreement, along with any copies, reproductions, digests,
abstracts or the like of all or any part thereof in the Recipient's possession
or under the Recipient's control, and upon such return any computer entries or
the like relating thereto shall, to the extent legally permissible, be
destroyed. Such return (and destruction) will not affect the Recipient's
obligations hereunder which shall survive indefinitely. Notwithstanding anything
herein to the contrary, the provisions of this Section 9.4 shall be subject to
Biomatrix's rights under Section 3.6.
9.5. Public Announcement. Except as shall be necessary for governmental
notification purposes or to comply with applicable laws and regulations, and
except as otherwise agreed to by the parties hereto in writing, the parties
agree to keep the existence of this Agreement, and the transactions contemplated
hereby, strictly confidential. In the event that a party must file this document
or otherwise disclose any of its subject matter pursuant to public filing
requirements, such party shall seek confidential treatment of those portions of
the Agreement as the parties shall mutually agree upon; provided, however, that
the Distributor must provide written notice to Biomatrix no later than June 30,
1996 of those portions of the Agreement for which the Distributor requests
confidential treatment. The parties shall agree upon the text of an initial
public announcement relating to the transactions contemplated by this Agreement
as soon as
<PAGE> 28
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possible. Any subsequent public announcements regarding this Agreement or the
transactions contemplated herein shall also be agreed upon in writing between
the parties prior to any release thereof.
10. NEW PRODUCTS.
10.1 [ *** ,] Distributor shall not commercialize nor begin the
commercialization process with respect to or acquire any New Product anywhere in
the Territory or the United States, either independently or in conjunction with
one or more third parties, unless and until the following conditions have been
satisfied:
(a) Distributor has made a commercially reasonable written offer to
Biomatrix to participate with Distributor in the development and
commercialization of such New Product; and
(b) Biomatrix has failed to accept such written offer within [ *** ]
of its receipt of such offer.
In the event that Biomatrix fails to accept any written offer made by
Distributor pursuant to this Section 10.1 within [ *** ] of Biomatrix's
receipt thereof, then Distributor, subject to the terms of this Agreement, shall
have the right to independently or with other parties develop and/or
commercialize any New Product to which such written offer relates; provided,
however, that any such New Product does not infringe upon any of the
intellectual property rights of Biomatrix. Distributor shall not be required to
make the written offer to Biomatrix set forth in Section 10.1(a) above only in
the event and to the extent that it is prevented from doing so due to patented
proprietary rights of a third party.
(c) At all times during the term of this Agreement, Distributor shall
notify Biomatrix in writing within [ *** ] of each occurrence of one or more of
the following:
(i) Distributor's entering into an agreement with one or
more third parties with regard to the development,
acquisition and/or commercialization of any New
Product, and Distributor shall provide to Biomatrix
notice of such agreement and any and all agreements
relating thereto and a non-confidential summary of
such agreements; or
(ii) Distributor's commencing a clinical trial (either
alone or in conjunction with a third party) with
respect to any New Product, together with notice of
the commencement of such clinical trial and a list of
all countries where such clinical trial will take
place; or
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 29
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(iii) Distributor's filing of an application (either alone
or in conjunction with a third party) for marketing
approval with the United States Food and Drug
Administration or an equivalent regulatory agency in
any country with respect to any New Product stating
in which countries any such filings have been made.
10.2 So long as either [ *** ] Agreement Product and any Improved
Agreement Product [ *** ] and/or (b) Distributor [ *** ,] either independently
or in conjunction with one or more third parties, [ *** ,] Biomatrix shall not
[ *** ] until the following conditions have been satisfied:
(i) Biomatrix has made a commercially reasonable
[ *** ] to Distributor to[ *** ;] and
(ii) Distributor has [ *** .]
In the event that Distributor [ *** ] by Biomatrix pursuant to this
Section 10.2 [ *** ] then Biomatrix [ *** ] by this Agreement [ *** ;] provided,
however, that Biomatrix shall not have the right to commercialize any such New
Products within [ *** ] so long as either of the conditions set forth in Section
10.2(a) or 10.2(b) is satisfied. Specifically, once one of the conditions in
Section 10.2(a) or 10.2(b) is not satisfied, Distributor shall (subject to the
terms of this Agreement) [ *** ,] however, after such date it shall [ *** .]
10.3. Nothing in this Section 10 shall be construed, by implication or
otherwise, (i) to effect any sale or license of proprietary Biomatrix technology
(including any New Products), (ii) to grant any license relating to Biomatrix's
proprietary methods of formulating, fabricating and manufacturing the Agreement
Product, Improved Agreement
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 30
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Products or New Products, or (iii) to grant Distributor any rights in or to any
proprietary technology or Patents or Trademarks of Biomatrix.
11. REPRESENTATIONS OF BIOMATRIX. Biomatrix represents, warrants and
covenants as follows:
11.1. It is a corporation duly organized and validly existing under the
laws of the State of Delaware with the full power to conduct its affairs as
currently conducted and contemplated hereunder. All necessary action has been
taken to enable it to execute and deliver this Agreement and perform its
obligations hereunder.
11.2. This Agreement is a valid and binding obligation of Biomatrix
enforceable in accordance with its terms. Biomatrix has the unencumbered right
to enter into this Agreement and to fulfill its duties hereunder. It is not and
will not become a party to any agreement in conflict herewith. Accordingly,
Biomatrix has the right to appoint the Distributor as the exclusive distributor
of the Agreement Product in the Territory in accordance with the terms of this
Agreement and such appointment will not constitute a breach of any existing
contractual or other arrangements between Biomatrix and any Affiliated or
non-Affiliated third party, nor shall it infringe the rights of any Affiliated
or non-Affiliated third party.
11.3 No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to, any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by Biomatrix and the performance by Biomatrix of its
obligations hereunder.
12. REPRESENTATIONS OF THE DISTRIBUTOR. The Distributor represents,
warrants and covenants as follows:
12.1 It is a corporation duly organized and validly existing under the
laws of Delaware with full power to conduct its affairs as currently conducted
and contemplated hereunder. All necessary action has been taken to enable it to
execute and deliver this Agreement and perform its obligations hereunder.
12.2. This Agreement is the Distributor's valid and binding obligation
enforceable in accordance with its terms. The Distributor has the unencumbered
right to enter into this Agreement and to fulfill its obligations hereunder. It
is not and will not become a party to any agreement in conflict herewith.
Accordingly, the Distributor has the right to act as the exclusive distributor
of the Agreement Product in the Territory in accordance with the terms of this
Agreement and the performance of its obligations hereunder will not constitute a
breach of any existing contractual or other arrangements between the Distributor
and any Affiliated or non-Affiliated third party, nor shall it infringe the
rights of any Affiliated or non-Affiliated third party.
<PAGE> 31
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12.3. No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by the Distributor and the performance by the Distributor of
its obligations hereunder.
13. INSURANCE. Each party hereto shall (a) obtain and maintain such
insurance policies as are adequate to cover its respective obligations hereunder
and which are consistent with normal business practices of prudent companies
similarly situated and (b) provide the other party, upon request, with
certificates of insurance confirming the existence of such insurance policies.
14. INFRINGEMENT. Each of the Distributor and Biomatrix will promptly
notify the other party in writing of any infringement of a Patent or Trademark
or unauthorized disclosure or use of any Confidential Information, of which it
becomes aware in the Territory. Biomatrix shall have the exclusive right at its
own cost to take all legal action in the Territory it deems necessary or
advisable to eliminate or minimize the consequences of such infringement of a
Patent or Trademark in the Territory. For the purpose of taking any such legal
action, Biomatrix shall have the right, subject to the Distributor's consent
which consent shall not be unreasonably withheld or delayed, to use the name of
the Distributor as plaintiff, either solely or jointly in accordance with the
applicable rules of procedure; provided that Biomatrix shall give the
Distributor prior notice of such use of the Distributor's name. The Distributor
shall promptly furnish Biomatrix with whatever written authority may be required
in order to enable Biomatrix to use the Distributor's name in connection with
any such legal action, and shall otherwise cooperate fully and promptly with
Biomatrix in connection with any such action. All proceeds realized upon any
judgment or settlement regarding such action shall belong to Biomatrix.
15. REGULATORY ACTIVITIES; CLINICAL TRIALS AND MARKETING STUDIES.
15.1. General.
(a) Biomatrix shall be responsible for maintaining at its cost the
Product License Approvals required for the marketing and sale of the Agreement
Product and any Improved Agreement Product(s) in the European Territory
throughout the term of this Agreement. The Distributor shall use its best
efforts to obtain and maintain at its cost any Product License Approvals and to
conduct at its cost any clinical trials required for the marketing and sale of
the Agreement Product and any Improved Agreement Product(s) in each country in
the Territory, except for the European Territory, throughout the term of this
Agreement. "Best efforts" in this context shall mean such that Distributor shall
generally use the same methods, exercise the same degree of effort and
diligence, and adhere to the same standards as Distributor and its Affiliates
would apply to their own actively promoted pharmaceutical products in the
Territory, and shall be as are commercially reasonable.
(b) Biomatrix shall assist the Distributor in submitting applications
for Product License Approvals, provided that (i) Biomatrix shall be entitled
generally to oversee the
<PAGE> 32
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strategy and content of regulatory approval applications (in their original form
whether in English or any other language) and (ii) the content of all such
applications shall be subject to Biomatrix's prior written approval, such
approval or disapproval to be given by Biomatrix within [ *** ] of its receipt
thereof. The timing of such applications shall be mutually agreed in writing by
the parties. Biomatrix shall hold in its name all regulatory approvals required
for the marketing and sale of the Agreement Product and any Improved Agreement
Product(s) in the Territory, except to the extent that applicable law requires
that such regulatory approvals be held in the name of the Distributor.
(c) The Distributor and Biomatrix shall provide reasonable advice and
assistance to each other as may be necessary to obtain and maintain Product
License Approvals.
(d) Except to the extent necessary to give effect to the provisions of
Section 3.3(b), the Product License Approvals relating to the Agreement Product
and any Improved Agreement Product(s) in the Territory in the name of the
Distributor or any of its Affiliates shall be transferred to Biomatrix
immediately upon termination of the Agreement.
(e) During the term of this Agreement, each party shall immediately
notify the other in writing in the event that such party becomes aware of any
failure of the Agreement Product and any Improved Agreement Product(s) to comply
with any of the requirements therefor specified in any Product License
Approvals.
(f) Each of the Distributor and Biomatrix shall keep the other advised
of regulatory interactions, activities and correspondence and the registration
status of the Agreement Product and any Improved Agreement Product(s) on at
least a quarterly basis, and any matters requiring immediate attention shall be
communicated as soon as practicable.
15.2. Clinical Trials and Marketing Studies.
(a) The Distributor shall be responsible at its own cost for conducting
and managing any clinical trials which the Distributor or Biomatrix may be
required to undertake in order to obtain Product License Approvals in the
Territory, except in the European Territory. The protocols for any such clinical
trials will be developed jointly by Biomatrix and the Distributor, and Biomatrix
shall have the right to audit the performance of any clinical studies performed
by or on behalf of the Distributor in respect of the Agreement Product and any
Improved Agreement Product(s). The Distributor shall provide Biomatrix with the
results of all such clinical trials, and Biomatrix and its Affiliates shall be
free to use the results of such clinical trials.
(b) The parties agree that if any marketing-related studies are deemed
necessary, such studies will not delay the Launch in any country in the European
Territory. The protocols for any marketing-related studies requested by the
Distributor will be developed jointly by Biomatrix and the Distributor, and the
Distributor will be responsible for conducting and managing such studies at its
own expense. Biomatrix shall have the right to
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 33
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audit the performance of any marketing-related studies performed by or on behalf
of the Distributor. The results of such studies will not be published or
publicized in any way without the prior written approval of Biomatrix.
16. FURTHER ASSURANCES. The parties hereto agree to execute such
further or other documents and assurances as are necessary from time to time in
order to give effect to the provisions of this Agreement.
17. ASSIGNMENT. The rights and obligations of the parties hereto shall
inure to the benefit of and shall be binding upon the authorized successors and
permitted assigns of each party. Neither party may assign its rights or
obligations under this Agreement or may designate another person to perform all
or part of its obligations under this Agreement, or to have all or part of its
rights and benefits under this Agreement without the prior written consent of
the other party, except to an Affiliate or to a successor of the business, by
merger or otherwise, to which this Agreement relates, provided that in the case
of an assignment to an Affiliate the assigning party shall promptly notify the
other party in writing of such assignment and shall remain liable (both directly
and as guarantor) with respect to all obligations so assigned. In the event of
any assignment or in the event that an Affiliate of either party shall exercise
rights and/or perform obligations hereunder pursuant to the terms of this
Agreement, the assignee or Affiliate, as the case may be, shall specifically
assume and be bound by the provisions of the Agreement by executing and agreeing
to an assumption agreement satisfactory to the other party hereto.
18. GOVERNING LAW; ARBITRATION; INJUNCTIVE RELIEF.
(a) This Agreement shall be governed by and construed in accordance
with the internal and substantive laws of the State of New York, United States
of America. The parties hereby agree that the United Nations Convention on
Contracts for the International Sale of Goods shall not apply to this Agreement
or any other document contemplated hereby. In the event of any dispute touching
or concerning this Agreement, the parties hereby agree to submit such dispute to
their respective presidents by notice delivered in accordance with the
provisions of Section 23, and if within [ *** ,] or such other period as is
agreed upon in writing by the parties hereto, following such reference the
dispute remains unresolved, to submit the dispute for arbitration in Boston,
Massachusetts under the Rules of the American Arbitration Association in effect
on the date of this Agreement (the "Rules") by arbitrators appointed in
accordance with said Rules. Any decision of such arbitrators shall be written
and shall be final and binding upon the parties. In any arbitration pursuant to
this Section the award shall be rendered by a majority of three (3) arbitrators,
one (1) of whom shall be appointed by each party and the third of whom shall be
appointed by mutual agreement of the two (2) party-appointed arbitrators. In the
event of failure of a party to appoint an arbitrator within thirty (30) days
after commencement of the arbitration proceeding or in the event of failure of
the two (2) party-appointed arbitrators to agree upon the appointment of the
third arbitrator within sixty (60) days after commencement of the arbitration
proceeding, such arbitrator shall be appointed by the American Arbitration
Association in accordance with the Rules. The arbitrators shall apply
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 34
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the governing law set forth in this Section. Judgment upon an award rendered by
the arbitrators may be entered in any court having jurisdiction thereof.
(b) Each of the parties hereto acknowledges and agrees that damages
will not be an adequate remedy for any material breach or violation of this
Agreement if such material breach or violation would cause immediate and
irreparable harm (an "Irreparable Breach"). Accordingly, notwithstanding the
provisions of Section 18(a) to the contrary, in the event of a threatened or
ongoing Irreparable Breach, each party hereto shall be entitled to seek, in any
state or federal court in the State of New York, equitable relief of a kind
appropriate in light of the nature of the ongoing threatened Irreparable Breach,
which relief may include, without limitation, specific performance or injunctive
relief; provided, however, that if the party bringing such action is
unsuccessful in obtaining the relief sought, the moving party shall pay the
non-moving party's reasonable costs, including attorney's fees, incurred in
connection with defending such action. Such remedies shall not be the parties'
exclusive remedies, but shall be in addition to all other remedies provided in
this Agreement.
19. SEVERABILITY. In the event that any provision of this Agreement
shall be held by a court of competent jurisdiction or by any governmental body
to be invalid or unenforceable, such provision shall be deemed severable and the
remaining parts and provisions of this Agreement shall remain in full force and
effect.
20. FORCE MAJEURE. Each of the parties shall be excused from the
performance of its obligations hereunder in the event such performance is
prevented by force majeure, and such excuse shall continue as long as the
condition constituting such force majeure continues. For the purpose of this
Agreement, force majeure is defined as contingencies beyond the reasonable
control of either party, including, without limitation, acts of God, judicial or
regulatory action, war, civil commotion, destruction of production facilities or
materials by fire, earthquake or storm and labor disturbances (whether or not
any such labor disturbance is within the power of the affected party to settle).
21. INTEREST. Any overdue amounts payable by either party hereunder
shall bear interest compounded monthly at the prime lending rate for Dollars
published from time to time in The Wall Street Journal plus [ *** ] per annum,
or, if lower, the highest rate permissible by applicable law, from the due date
until the date of payment.
22. NO PARTNERSHIP OR AGENCY. This Agreement and the relations hereby
established by and between Biomatrix and the Distributor do not constitute a
partnership, joint venture, agency or contract of employment between them.
23. NOTICES. All communications in connection with this Agreement shall
be in writing and sent by postage prepaid first class mail, courier, or telefax,
and if relating to default, late payment or termination, by certified mail,
return receipt requested, telefax or courier, addressed to each party at the
address set forth at the beginning of this Agreement, in the case of Biomatrix,
Attn: Chief Executive Officer, with a copy to: Justin P. Morreale, Esq.,
Bingham, Dana & Gould LLP, 150 Federal Street, Boston, Massachusetts 02110,
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 35
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U.S.A., and in the case of the Distributor, Attn: President, with a copy to
Kimberlie L. Cerrone, Esq., Venture Law Group, 2800 Sand Hill Road, Menlo Park,
California 94025, or to such other address as the addressee shall last have
designated by notice to the communicating party. The date of giving any notice
shall be the date of its actual receipt.
24. EU REGULATIONS. It is the intention of the parties hereto that this
Agreement shall at all times qualify for the exemption from the provisions of
Article 85(1) of the Treaty of Rome dated 25 March, 1957, as amended, which
either (a) is available under EEC Regulation Number 1983/83, or (b) may
subsequently be available under any successor regulation or regulations thereto.
In the event that any provision of this Agreement is deemed to violate the
conditions for qualifying for the exemption, set out in whichever of those
regulations may be in effect at the relevant time, or if any such regulation is
amended after the date of this Agreement so as to cause this Agreement to fail
to qualify for the exemption, the parties hereto agree that they will, as soon
as it is practicable to do so, enter into good faith negotiations to amend this
Agreement as necessary in order to re-qualify for the exemption or to notify the
Agreement. If those negotiations are not successfully concluded within a
reasonable time (not to exceed ninety (90) days, or such other period as is
agreed upon in writing by the parties hereto, after the relevant regulation is
amended), either party may terminate this Agreement upon written notice to the
other party.
25. SURVIVAL. The provisions of Sections 3.3, 3.6, 3.7, 3.8, 6.2, 9.1,
9.2, 9.3, 9.4 and 9.5 of this Agreement shall survive the termination or
expiration of this Agreement (as the case may be) and shall remain in full force
and effect. The provisions of this Agreement that do not survive termination or
expiration hereof (as the case may be) shall, nonetheless, be controlling on,
and shall be used in construing and interpreting the rights and obligations of
the parties hereto with regard to, any dispute, controversy or claim which may
arise under, out of, or in connection with this Agreement.
26. MISCELLANEOUS. This Agreement sets forth the entire agreement
between the parties with respect to the transactions and arrangements
contemplated hereby and supersedes all prior oral or written arrangements. This
Agreement may be modified or amended only by a written instrument executed and
delivered by both parties. None of the provisions of this Agreement shall be
deemed to have been waived by any act or acquiescence on the part of either
party except by an instrument in writing signed and delivered by the party
executing the waiver. This Agreement may be executed in several identical
counterparts, each of which shall be an original, but all of which constitute
one instrument, and in making proof of this Agreement it shall not be necessary
to produce or account for more than one such counterpart.
[The remainder of this page is intentionally left blank.]
<PAGE> 36
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date and year first above written.
COLLAGEN CORPORATION
By: /s/ HOWARD D. PALEFSKY
-------------------------------------
Name: HOWARD D. PALEFSKY
Title: CHAIRMAN & CEO
BIOMATRIX, INC.
By: /s/ ENDRE A. BALAZS
-------------------------------------
Name: ENDRE A. BALAZS
Title: CEO
<PAGE> 37
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EXHIBITS
<TABLE>
<S> <C> <C>
Exhibit A - Agreement Product Specification and Approval Documents
Exhibit B - Launch Schedule
Exhibit C - Patents and Trademarks
Exhibit D - Sales Forecasts
Exhibit E - Subdistributors
</TABLE>
<PAGE> 38
EXHIBIT A
Agreement Product Specification and Approval Documents
TESTS PROCEDURES SPECIFICATIONS
[ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 39
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EXHIBIT B
Launch Schedule
<TABLE>
<CAPTION>
Country: Date of Launch
-------- --------------
<S> <C> <C>
1. Australia [ *** ]
2. Austria [ *** ]
3. Belgium [ *** ]
4. Denmark [ *** ]
5. Finland [ *** ]
6. France [ *** ]
7. Germany [ *** ]
8. Greece [ *** ]
9. Iceland [ *** ]
10. Ireland [ *** ]
11. Italy [ *** ]
12. Japan [ *** ]
13. Liechtenstein [ *** ]
14. Luxembourg [ *** ]
15. The Netherlands [ *** ]
16. New Zealand [ *** ]
17. Norway [ *** ]
18. Portugal [ *** ]
</TABLE>
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 40
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<TABLE>
<S> <C>
19. Spain [ *** ]
20. Sweden [ *** ]
21. Switzerland [ *** ]
22. United Kingdom [ *** ]
23. Israel [ *** ]
24. Argentina [ *** ]
25. Brazil [ *** ]
26. Mexico [ *** ]
27. Canada [ *** ]
28. Chile [ *** ]
</TABLE>
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 41
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EXHIBIT C
Patents and Trademarks
Patents(1)/
[ *** ]
- ----------
1 All numbers given are for issued patents except [ ***,] and [ ***.]
2 This [ *** ] has been allowed and will issue in the next few months
under the same number.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 42
-42-
[ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 43
-43-
[ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 44
-44-
Trademark - Hylaform*
Country and Status Ser Nos. or Reg. Nos.
- ------------------ ---------------------
[ *** ]
- ----------
* Filed in International Classes 5 and 10
Legend: [ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 45
-45-
EXHIBIT D
Sales Forecasts(1)
(Units)
First Agreement Year
(1) The parties acknowledge that in the event of the addition of other
syringe sizes this forecast is subject to adjustment to incorporate
such new sizes.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 46
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EXHIBIT E
Collagen Subdistributors
<TABLE>
<CAPTION>
Country Subdistributor
- ------- --------------
<S> <C>
Argentina New Pharma S.A.
Brazil Magistral
Chile Prater Laboratorios
Mexico Bard Mexico SA
Israel T.C. Technocare Ltd.
Japan Lederle (Japan) K.K. Ltd.
Columbia Consumed
Cyprus Charitonos Enterprises
Lebanon Pharmed S.A.L.
Turkey Assos Pharmaceuticals
</TABLE>
<PAGE> 1
EXHIBIT 10.5
UNITED STATES
DISTRIBUTION AGREEMENT
THIS AGREEMENT is made as of the 14th day of June 1996 by and between
BIOMATRIX, INC., a corporation duly organized and existing under the laws of the
State of Delaware, having its principal office at 65 Railroad Avenue,
Ridgefield, New Jersey 07657, U.S.A. ("Biomatrix") and COLLAGEN CORPORATION, a
corporation duly organized and existing under the laws of the State of Delaware,
having its principal office at 2500 Faber Place, Palo Alto, California 94303,
U.S.A. (the "Distributor").
WHEREAS, Biomatrix is engaged in the development and manufacture of the
Agreement Product (as hereinafter defined);
WHEREAS, the Distributor desires to enter into a distribution agreement
and be appointed the exclusive distributor (even to Biomatrix) of the Agreement
Product and any Improved Agreement Product(s) in the Territory (as such terms
are hereinafter defined), and Biomatrix is willing to so appoint the Distributor
on the terms and subject to the conditions set forth herein; and
WHEREAS, the Distributor desires to purchase from Biomatrix, and
Biomatrix desires to sell to the Distributor, the Distributor's orders of the
Agreement Product and any Improved Agreement Product(s) in the Territory on the
terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and of the mutual
covenants of the parties hereto, it is hereby agreed as follows:
1. DEFINITIONS AND INTERPRETATION.
1.1. In this Agreement, the following words and expressions shall have
the following meanings:
"Affiliate" shall mean, with respect to any party, any Person which,
directly or indirectly, is controlled by, controls or is under common
control with such party. For purposes of this definition, the term
"control" (including with correlative meanings, the terms "controlled
by" and "under common control with") shall mean, with respect to any
Person, the direct or indirect ownership of more than fifty percent
(50%) of the voting or income interest in such Person or the possession
otherwise, directly or indirectly, of the power to direct the management
or policies of such Person.
<PAGE> 2
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"Agreement Product" shall mean the one product made of hylan B and
called by Biomatrix Hylaform(R), the specifications for which are set
forth on Exhibit A, for use in the correction of wrinkles and depressed
scars.
"Agreement Product Specifications" shall mean the specifications for the
Agreement Product set forth in Exhibit A, as such specifications may be
modified or supplemented by Biomatrix from time to time in accordance
with Product License Approvals or to reflect any Improved Agreement
Product(s).
"Agreement Year" shall mean the twelve (12) month period commencing on
the date of first commercial sale of the Agreement Product in the United
States and each separate successive twelve (12) month period thereafter.
"Contract Quarter" shall mean, for sales of Agreement Product, the
period commencing with the Distributor's first commercial sale of the
Agreement Product in the United States and ending on the first to occur
of March 31, June 30, September 30 and December 31, as applicable, and
each three (3) month period thereafter throughout the term of this
Agreement.
"Dermal Tissue Augmentation Products" shall mean biomaterial(s) that are
[ *** ]
"Dollars" and "$" shall mean the lawful currency of the United States of
America.
"Effective Date" shall mean June 17, 1996.
"EU Countries" shall mean, collectively, Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the
Netherlands, Portugal, Spain, Sweden and the United Kingdom.
"European Territory" shall mean, collectively, the EU Countries,
Switzerland, Norway, Liechtenstein and Iceland.
"Formula Price" shall mean an amount equal to [ *** ] of the Agreement
Product, provided that if the [ *** ] the Agreement Product in the
Territory [ *** ] then the Formula Price shall mean an amount equal to
[ *** ] of the Agreement Product [ *** ].
"Improved Agreement Product(s)" shall mean (i) any modification of the
Agreement Product (made entirely from hylan B) regarding the formulation
of hylan B in the
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 3
-3-
Agreement Product, that is changes of concentration of the polymer or
other changes in the Agreement Product Specifications, whether or not
requiring new regulatory approval in the EU Countries or in the United
States, and (ii) any modifications or changes related to the packaging
of the Agreement Product, including the syringe used, mode of
application or dosage.
"Incremental Royalties" shall mean that term as defined in Section 8.2.
"Initial Term" shall mean that term as defined in Section 3.2.
"International Agreement" means the Distribution Agreement between
Biomatrix and Distributor, dated as of the date hereof, relating to the
sale of the Agreement Product in the EU Countries, Switzerland, Norway,
Liechtenstein, Iceland, Australia, New Zealand, Canada, Israel,
Argentina, Mexico, Chile and Brazil.
"International Territory" shall mean, collectively, the EU Countries,
Switzerland, Norway, Liechtenstein, Iceland, Australia, New Zealand and
Japan, Israel, Argentina, Brazil, Chile, Mexico and Canada.
"Launch" shall mean the commencement by the Distributor of sales of the
Agreement Product in commercial quantities in the Territory for use in
the Territory.
"Minimum Price" shall mean an amount equal to [ *** ] for each Treatment
Syringe, [ *** ] then the Minimum Price payable [ *** ] Agreement Years
immediately following such [ *** ] shall equal , and [ *** ] Agreement
Years following such [ *** ] shall equal [ *** ] for each Treatment
Syringe.
"Net Retail Sales" shall mean, with respect to sales of a Dermal Tissue
Augmentation Product in the Territory, the aggregate gross price
invoiced for retail sales of such product during a period in such
country to unaffiliated third-party purchasers [ *** ] It is Biomatrix's
understanding that the foregoing definition is consistent with how the
Distributor reports its sales in its audited financial statements.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 4
-4-
"New Products" shall mean [ *** ]
"Patents" shall mean Letters Patent or similar statutory rights relating
to any Agreement Product and any Improved Agreement Product(s)
(including any continuation-in-part, continuation or division thereof or
substitute thereof), and patent applications which are pending as of the
Effective Date, in each case as set forth in Exhibit C, together with
any supplementary or complementary protection certificates therefor if
and when such are granted.
"Person" shall mean an individual, a corporation, limited liability
company, a partnership, a trust, an unincorporated organization or a
government or any agency or political subdivision thereof.
"Product License Approvals" shall mean those regulatory approvals
required for the importation, promotion, marketing and sale of the
Agreement Product and any Improved Agreement Product(s) in the United
States (including any reimbursement or pricing approvals).
"Region" shall mean any one of the following countries or groups of
countries: (i) the United Kingdom and Ireland; (ii) Germany; (iii)
France; (iv) Italy; (v) Spain and Portugal; (vi) Denmark, Finland,
Sweden, Norway and Iceland; (vii) Belgium, Luxembourg and the
Netherlands; (viii) Japan; (ix) Austria, Liechtenstein and Switzerland;
(x) Australia and New Zealand; (xi) Greece and Israel; and (xii)
Argentina, (xiii) Brazil, (xiv) Chile, (xv) Mexico; (xvi) Canada, (xvii)
Columbia, (xviii) Cyprus, (xix) Lebanon, and (xx) Turkey.
"Supply Forecast" shall mean that term as defined in Section 7.3(b).
"Territory" shall mean the United States.
"Trademarks" shall mean (i) the trademark Hylaform(R), the details of
which are described in Exhibit C, and (ii) any other trademarks, as may
be agreed upon in writing from time to time by the parties hereto for
use by the Distributor in connection with the promotion, marketing and
sale of the Agreement Product and any Improved Agreement Product(s)
under this Agreement.
"Treatment Syringe" shall mean a ready-for-injection 1.0cc syringe of
the Agreement Product.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 5
-5-
"United States Consumer Price Index" shall mean the Consumer Price
Index, All Items, United States, as published by the Bureau of Labor
Statistics.
1.2. In this Agreement, unless the context otherwise requires:
(a) clause headings are inserted for convenience of reference only and
have no legal effect;
(b) references to sections, exhibits and schedules are to be construed
as references to the sections of, and exhibits and schedules to, this Agreement
and references to this Agreement include its exhibits and schedules.
(c) references to (or to any specified provision of) this Agreement or
any other document shall be construed as references to this Agreement, that
provision or that document as in force for the time being and as amended,
varied, substituted, supplemented, restated or novated in accordance with the
terms thereof or, as the case may be, with the agreement of the relevant parties
and (where such consent is, by the terms of this Agreement or the relevant
document, required to be obtained as a condition to such amendment being
permitted) the prior written consent of Biomatrix;
(d) words importing the plural shall include the singular and vice
versa;
(e) references to a person shall be construed as including references to
an individual, firm, consortium, company, corporation, unincorporated body of
persons or any State or any agency thereof; and
(f) references to statutory provisions shall be construed as references
to those provisions as replaced, amended or re-enacted from time to time.
2. APPOINTMENT; BEST EFFORTS; EXCLUSIVITY.
2.1. Appointment.
(a) Subject to the terms and conditions hereinafter set forth, Biomatrix
hereby appoints the Distributor as its exclusive [ *** ] (except to the extent
set forth in Section 2.3) distributor for the promotion, marketing, sale and
distribution within the Territory of the Agreement Product and any Improved
Agreement Product(s) supplied by Biomatrix or an Affiliate of Biomatrix to the
Distributor pursuant to this Agreement. Such appointment does not include the
right to sublicense or appoint subdistributors except to an Affiliate of
Distributor without the approval of Biomatrix; (and only for such time as such
an Affiliate remains an Affiliate of Distributor).
(b) Except as specifically provided to the contrary herein, the
foregoing appointment shall not be construed, by implication or otherwise, (i)
to effect any sale of proprietary Biomatrix technology, (ii) to grant any
license relating to Biomatrix's proprietary
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 6
-6-
methods of formulating, fabricating and manufacturing the Agreement Product or
any Improved Agreement Product(s), or (iii) to grant the Distributor any rights
in or to any proprietary technology or Patents or Trademarks of Biomatrix.
2.2. Acceptance of Obligations; Best Efforts. The Distributor hereby
accepts the appointment described in Section 2.1 and hereby agrees to use its
best efforts at all times during the term hereof to promote, market, sell and
distribute the Agreement Product and any Improved Agreement Product(s) in the
Territory. [ *** ]
2.3. Conversion to Non-Exclusive Distributorship. In the event that (i)
in any Agreement Year after and including the third Agreement Year or (ii) from,
after and including the first year of the Distributor acquiring and/or
commercializing a New Product pursuant to Section 10.1(b) (and so long as (i) no
force majeure condition of Distributor exists at such time pursuant to Section
20, (ii) Biomatrix has met its supply obligations under Section 7.4 and (iii)
Distributor is able to lawfully sell the Agreement Product and any Improved
Agreement Product(s) in the Territory) the Distributor's Net Retail Sales of the
Agreement Product and any Improved Agreement Product(s) in the Territory,
comprise less than [ *** ] of its Net Retail Sales of [ *** ] including the
Agreement Product and any Improved Agreement Product(s), [ *** ] within [ *** ]
days after receipt of any such notice from Biomatrix, a shortfall of [ *** ]
with respect to the Territory for an Agreement Year by [ *** ] Biomatrix shall
have the right to distribute the Agreement Product and Improved Agreement
Product and/or engage another distributor for the Territory. From and after
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 7
-7-
the date of a conversion to a non-exclusive distribution arrangement within the
Territory, the Distributor shall lose its rights hereunder to promote, market,
sell and distribute within the Territory any Improved Agreement Product(s)
commercialized on or after such date. Notwithstanding the foregoing, the
Distributor shall retain the exclusive right to use all trademarks under which
the Distributor launched the Agreement Product or any Improved Agreement
Product(s) in the Territory.
3. TERM AND TERMINATION.
3.1. Effective Date. This Agreement shall take effect as of the
Effective Date.
3.2. Term.
(a) Unless this Agreement is sooner terminated in accordance with the
provisions of this Agreement, the term of the appointment hereunder for shall
commence on the first day of the first Agreement Year and shall end on the last
day of the tenth (10th) Agreement Year (the "Initial Term").
(b) Unless this Agreement is sooner terminated in accordance with the
provisions of this Agreement, the appointment of the Distributor hereunder as
exclusive distributor of the Agreement Product shall be renewable by the
Distributor, at its option, upon written notice to Biomatrix received at least
ninety (90) days prior to the end of the Initial Term, for an additional
consecutive term of five (5) years following the date of expiration of the
Initial Term, provided that the Distributor shall only be entitled to exercise
such renewal option if as of the date of expiration of the Initial Term the
Distributor is not in material breach of any of its obligations under this
Agreement. Thereafter, the appointment of the Distributor as exclusive
distributor of the Agreement Product shall be renewable upon the expiration of
such additional five (5) year term, upon written notice to Biomatrix received at
least ninety (90) days prior to the end of such term for one additional
consecutive renewal term of five (5) years provided that, as of the date of
expiration of the first renewal term, the Distributor is not in material breach
of any of its obligations under this Agreement. For the avoidance of any doubt,
Distributor's rights with respect to any Improved Agreement Product(s)
commercialized after the tenth anniversary of the Effective Date shall terminate
upon the tenth anniversary of the Effective Date. Subject to the terms of this
Agreement, Distributor shall have the right to continue to sell the Agreement
Product and any Improved Agreement Products it is then currently selling.
(c) This Agreement may be terminated by either party, by written notice
to the other party, in the event that (i) a mutual decision not to Launch the
Agreement Product in such country is reached or (ii) a Launch is not commenced
within the time period set forth on Exhibit B.
(d) In the event that in any Agreement Year after and including the
third Agreement Year (and so long as (i) no force majeure condition of
Distributor exists at such time pursuant to Section 20, (ii) Biomatrix has met
its supply obligations under Section 7.4,
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 8
-8-
and (iii) Distributor is able to lawfully sell the Agreement Product and any
Improved Agreement Product(s) in the Territory), the Distributor's Net Retail
Sales of the Agreement Product and any Improved Agreement Product(s) in the
Territory comprise less than seven and one-half percent (7-1/2%) of its Net
Retail Sales in the Territory of all Dermal Tissue Augmentation Products,
including the Agreement Product and any Improved Agreement Product(s), the
Distributor's distribution rights (including, without limitation, its right to
use the Trademarks) under this Agreement for the Agreement Product and any
Improved Agreement Product(s) in the Territory shall terminate upon ninety (90)
days notice, but in any event not later than one hundred and twenty (120) days
after the end of the applicable Agreement Year, at the election of Biomatrix;
provided, however, that Distributor may cure a shortfall of Net Retail Sales for
an Agreement Year by paying to Biomatrix an amount equal to twenty-five percent
(25%) of the total dollar amount of such shortfall of Net Retail Sales in such
Agreement Year; further provided that, at Biomatrix's election, Biomatrix may
refuse to allow such cure if Distributor has taken advantage of such cure
provision in each of the two preceding Agreement Years. By way of example, if
Distributor's Net Retail Sales of all Dermal Tissue Augmentation Products in the
Territory in a given Agreement Year were $10,000, and Distributor's Net Retail
Sales of the Agreement Product in the Territory in such Agreement Year were
$500, then Distributor could cure such shortfall and prevent termination by
paying Biomatrix $62.50. Upon any such termination of the Distributor's
distribution rights in the Territory, the Distributor's obligation to pay any
royalties pursuant to Sections 8.1 and 8.2 for any sales in the Territory after
such termination shall cease, but the Distributor shall remain obligated to pay
all such royalties for sales in the Territory accrued prior to such termination.
(e) Notwithstanding any other provision of this Agreement to the
contrary, Biomatrix may terminate this Agreement at any time prior to receipt of
the Approved Letter (as defined hereafter) from the U.S. Food and Drug
Administration if Distributor is in material breach of the International
Agreement, which material breach has not been cured within thirty (30) days
after written notice of such breach is received by Distributor. The parties
expressly agree that Distributor's failure to meet or adhere to the launch
schedule for the Agreement Product for each country as set forth in the
International Agreement shall be deemed a material breach of the International
Agreement except to the extent that Distributor's failure to meet such launch
schedule is due to (i) Biomatrix's failure to meet its supply obligations under
the International Agreement, (ii) a force majeure condition of the Distributor,
or (iii) it being unlawful for the Distributor to sell the Agreement Product or
any Improved Agreement Product in the Territory, provided that such unlawfulness
is not the result of any act or failure to act of the Distributor.
(f) Notwithstanding any other provision in this Agreement to the
contrary, the Distributor may terminate this Agreement upon notice to Biomatrix
of the Distributor's decision not to pay the fee called for in Section 7.1(b).
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 9
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3.3. Inventory.
(a) Upon termination of this Agreement for any reason, Biomatrix shall
have the right (but not the obligation) to repurchase all or part of the
inventory of the Agreement Product and any Improved Agreement Product(s) held by
the Distributor or its Affiliates.
(b) The price for inventory to be repurchased by Biomatrix pursuant to
Section 3.3(a) above shall be the landed cost thereof actually paid by the
Distributor to Biomatrix. With respect to any quantities not repurchased by
Biomatrix, the Distributor shall have the right to sell such inventory of the
Agreement Product and any Improved Agreement Product(s), in its usual and
customary manner, in the ordinary course of business, for a period of six (6)
months following termination of this Agreement and notwithstanding such
termination the terms and conditions of this Agreement shall apply to such
sales.
3.4. Insolvency. This Agreement may be immediately terminated by either
party, upon giving written notice to the other party, in the event that the
other party shall become insolvent or be declared bankrupt by a court of
competent jurisdiction or shall be the subject of any reorganization (other than
a corporate reorganization effected in the ordinary course of business and not
arising out of any insolvency) or winding up, receivership or dissolution,
bankruptcy or liquidation proceeding, or any proceeding or action similar to one
or more of the above, in which case termination shall be effective upon such
written notice. The failure of either party to give notice of termination upon
obtaining knowledge of any such event shall not be interpreted as a waiver of
such party's rights under this Section 3.4, and such party reserves the right to
exercise any such rights at any time after the occurrence of any such event.
3.5. Breach. This Agreement may be terminated by either party if the
other party shall breach any of its payment obligations hereunder or if
Distributor shall commit a material breach of any of its warranties, covenants,
conditions, obligations or agreements contained herein, provided that such
breach shall continue for a period of thirty (30) days (ten (10) days in the
event that such breach is the failure of the Distributor to pay the fee called
for in Section 7.1(b)) after written notice thereof and provided further that
such termination shall be immediately effective upon further written notice to
that effect to the breaching party after its failure to cure such breach within
such applicable notice period. For avoidance of doubt, the parties agree that if
a Launch is not reached within thirty days after the time period set forth on
Exhibit B, then either party may terminate this Agreement (provided that such
failure to reach a Launch is not due to (i) a force majeure condition of the
Distributor, (ii) Biomatrix's failure to meet its supply obligations under
Section 7.4, or (iii) it being unlawful for the Distributor to sell the
Agreement Product or any Improved Agreement Product in the Territory, provided
that such unlawfulness is not the result of any act or failure to act of the
Distributor).
3.6. Certain Rights Upon Termination. Upon termination of this Agreement
for any reason whatsoever, Biomatrix shall have the following rights:
<PAGE> 10
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(a) Biomatrix shall have the unrestricted right to review, access, use
and permit others to review, access and use, either directly or by
cross-reference or incorporation or otherwise, all information, data,
investigations, preclinical and clinical protocols, marketing information
disseminated by Distributor publicly to customers and patients and all
information required to be provided to Biomatrix by law, information relating to
laboratory, animal and human studies, and related regulatory approvals
pertaining to the Agreement Product or any Improved Agreement Product(s) (the
"Information") which are possessed or controlled by the Distributor or any of
its Affiliates, or to which the Distributor or any of its Affiliates has a right
to review, access or use. The Distributor unconditionally agrees promptly to
take any action and to execute and deliver to Biomatrix any documents or
instruments reasonably requested by Biomatrix to permit Biomatrix to make full
use of such unrestricted right.
(b) Further, Biomatrix shall have exclusive ownership rights to the
Trademarks and to all other product specific logos, slogans and other
intangibles used by the Distributor solely in association with the independent
sale of the Agreement Product and any Improved Agreement Product(s) (including
all registrations relating thereto) possessed or controlled by the Distributor
or any of its Affiliates, and the Distributor unconditionally agrees, subject to
the provisions of Section 3.3(b), (i) immediately upon termination to cease
using the Trademarks and any such logos, slogans, and marketing rights of
Biomatrix or any imitations thereof and (ii) immediately to execute and deliver
to Biomatrix any documents or instruments reasonably requested by Biomatrix to
give full effect to the provisions of this Section 3.6.
(c) In addition, the Distributor unconditionally agrees, subject to the
provisions of Section 3.3(b), that it shall, upon the request of Biomatrix,
immediately inform all relevant regulatory authorities that the Distributor is
no longer a distributor of the Agreement Product or the Improved Agreement
Product(s) and shall take all action and execute and deliver all documents and
instruments necessary in order to transfer to the fullest extent permitted under
applicable law all registrations and Product License Approvals, or applications
therefor, for the Agreement Product or any Improved Agreement Product(s) to
Biomatrix or any Person nominated by Biomatrix.
3.7. Effects of Termination.
(a) Upon termination of this Agreement for any reason, the Distributor
shall immediately discontinue making any representations regarding its status as
a distributor for Biomatrix and shall immediately cease conducting any
activities with respect to the marketing, promotion, sale or distribution of the
Agreement Product and any Improved Agreement Product(s), provided, however, that
the Distributor shall be permitted to sell inventory not repurchased by
Biomatrix in accordance with Section 3.3.
(b) Termination of this Agreement shall not affect obligations of either
party that may have accrued prior to the effective date of termination. Subject
to Clause 3.8 below, termination of this Agreement shall be in addition to, and
shall not be exclusive of or
<PAGE> 11
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prejudicial to, any other grounds for termination or rights or remedies at law
or in equity which either party may have on account of any default of the other
party.
3.8. Waiver. The Distributor hereby waives, to the extent it is able to
do so under the laws of the United States and other applicable law, any
statutory rights it may have or acquire in respect of the termination of the
relationship established hereby pursuant to the terms hereof, and agrees that
the rights available to it hereunder in the event of such termination are
adequate and reflect the agreement of the parties. The Distributor shall not
have any right to claim any indemnity for goodwill or lost profits or any
damages arising from the rightful termination of this Agreement in accordance
with the terms hereof.
4. PAYMENTS. All payments hereunder shall be made in Dollars. Payments
to Biomatrix shall be wired to an account designated by Biomatrix and the costs
of any such remittance shall be borne by the Distributor.
5. WITHHOLDING. All payments to be made by the Distributor under this
Agreement shall be made in full, free and clear of and without any deduction of
or withholding for or on account of any taxes levied in any country of the
Territory or elsewhere; provided that if the Distributor shall be required by
law to make any deduction or withholding from any payment to Biomatrix then:
(a) the Distributor shall ensure that such deduction or withholding does
not exceed the minimum legal liability therefor; and
(b) not later than five (5) days before each deduction or withholding of
any taxes, the Distributor shall forward to Biomatrix such documentary evidence
as may be required by Biomatrix in respect of the proposed deduction,
withholding or payment; and
(c) prior to any deduction or withholding the parties shall attempt in
good faith to agree upon revised mutually acceptable pricing and/or payment
terms.
6. TRADEMARKS; AGREEMENT PRODUCT MARKING; PROMOTIONAL INFORMATION.
6.1. Trademarks. Subject to the provisions of Section 3.6, Biomatrix
hereby licenses to the Distributor the right to use, and hereby requires solely
in association with the independent sale by the Distributor of the Agreement
Product and any Improved Agreement Products the use of, the Trademarks in the
Territory during the term of this Agreement. The Distributor warrants that it
shall not use any of the Trademarks at any time outside the Territory or use any
of the Trademarks for any products other than the Agreement Product and any
Improved Agreement Product(s) within the Territory. The Distributor shall not
use a trademark or other mark (other than a Trademark) in connection with its
distribution of the Agreement Product and any Improved Agreement Products unless
and until it has been agreed upon in writing by each of the parties and become a
Trademark as defined herein. Biomatrix shall prosecute, maintain and defend the
Trademarks throughout the Term of this Agreement in the Territory. The parties
shall execute a short form Trademark assignment
<PAGE> 12
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agreement to the extent that it is necessary to record the Trademark license
under this Section 6.1.
6.2. Termination of Right to Use Trademarks. Subject to the sell-out
right of Section 3.3(b) and except as otherwise provided in Section 3.6, upon
termination of this Agreement, the license to use the Trademarks in the
Territory shall terminate, and the Distributor unconditionally agrees promptly
to take all necessary action and execute and deliver to Biomatrix all necessary
documents and instruments to remove the Distributor as a registered user and/or
a recorded licensee of the Trademarks. In the event that the Distributor fails
promptly upon written request by Biomatrix to comply with any of its agreements
in the preceding sentence of this Section 6.2, the Distributor hereby
irrevocably consents to Biomatrix's taking any action necessary to give effect
to such agreements.
6.3. Notice. Each party hereto agrees promptly to notify the other in
writing of any infringements or imitations of the Trademarks by third parties
which may come to its attention.
6.4. Labelling and Promotional Materials; Approved Use of Product.
(a) The Distributor shall provide Biomatrix with labelling masters,
instructions, specifications and copies of all marketing, labelling and
promotional material it intends to use relating to the Agreement Product and any
Improved Agreement Product(s). All such labelling, packaging and promotional
material shall be consistent with the relevant Product License Approvals and all
labelling and packaging materials shall be reviewed by Biomatrix and shall be
subject to its written approval prior to use, such approval not to be
unreasonably withheld. Biomatrix shall communicate its acceptance or rejection
of such labelling packaging and any major promotional materials that include
claims or items impacting regulatory approvals within [ *** ] of its receipt
thereof and if no such communication is received by Distributor from Biomtrix
within such [ *** ] Biomatrix shall be deemed to have accepted. Distributor
shall provide Biomatrix with all other major promotional materials for launches
and subsequent promotions within a reasonable time prior to their use in order
to allow Biomatrix to comment on such materials. Distributor shall provide
Biomatrix with copies of all other promotional materials at or prior to their
use.
(b) The Distributor agrees that its promotion, marketing, sale and
distribution of the Agreement Product and any Improved Agreement Product(s) in
the Territory, and the promotional materials and labelling used in connection
therewith, shall be strictly in accordance with the approved use of the
Agreement Product and any Improved Agreement Product(s) as specified in the
Product License Approvals and as further provided in this Agreement.
Specifically, for purposes of this Agreement, the Distributor agrees [ *** ] or
unless agreed to in writing by Biomatrix.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 13
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6.5. Legend. Subject to applicable laws and regulations in the Territory,
all relevant packaging and promotional material for the Agreement Product and
any Improved Agreement Product(s) used or sold by the Distributor shall contain
(i) all applicable markings needed to keep the Trademarks enforceable throughout
the Territory as reasonably specified by Biomatrix to the Distributor and (ii) a
legend which shall be displayed in a reasonably conspicuous manner on all
packaging of such Agreement Product and any Improved Agreement Product(s)
containing the corporate identification logo of Biomatrix and indicating that
such product has been developed and manufactured by Biomatrix, Inc., and its
affiliates, 65 Railroad Avenue, Ridgefield, New Jersey, 07657 U.S.A.
6.6. Promotional Support. Biomatrix and the Distributor shall provide to
each other on an ongoing basis and without charge (to the extent not prevented
by law or contract from doing so) all medical information relating to the
Agreement Product and any Improved Agreement Product(s) (including summary data
from studies, clinical trials and the like as well as information regarding
adverse events associated with the use of the Agreement Product), the
proceedings of all symposia on the Agreement Product and any Improved Agreement
Product(s) and all promotional information that is available to such party
relating to the Agreement Product and any Improved Agreement Product(s). In
addition, Biomatrix and the Distributor shall provide each other with access to
such primary data and information in its possession as the other may reasonably
request regarding the results of the studies contained in such summary data
referred to above.
6.7 Joint Coordinating Committee. Upon the execution of this Agreement,
Biomatrix and the Distributor shall establish a joint coordinating committee
(the "Committee") to review all matters relating to product labelling, product
claims, regulatory matters or clinical trials. The Committee shall consist of an
equal number, not to [ *** ], of voting representatives from each of Biomatrix
and the Distributor and shall meet [ *** ]. In the event of a dispute between
representatives of Biomatrix and the Distributor on the Committee, a senior
representative of each such party shall be appointed to resolve such dispute,
and in the event such senior representatives are unable to resolve the matter,
Biomatrix's view shall prevail over the Distributor's.
6.8. Recalls of the Agreement Product.
(a) If either party in good faith determines that a recall of the
Agreement Product in the Territory is warranted, such party shall immediately
notify the other party in writing and shall advise such other party of the
reasons underlying its determination that a recall is warranted. The parties
shall consult with each other as to any action to be taken in regard to such a
recall, but in any event if after consultations either party in good faith still
believes that such a recall should be undertaken, the parties shall cooperate in
carrying out such recall.
(b) Except as otherwise provided in (c) below, in the event of a
recall of the Agreement Product, Biomatrix shall correct any deficiency relating
to its manufacturing,
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 14
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packaging, testing, labelling, storing or handling of the Agreement Product for
which it is responsible, if applicable, and shall at its cost replace the
Agreement Product recalled.
(c) Biomatrix shall reimburse Distributor for all direct costs
and expenses (including without limitation shipping, quality control testing and
notification costs) incurred by Distributor and its Affiliates as a result of
any recall, except where such recall (i) is the result of the failure of
Distributor or its Affiliates to comply with their obligations under this
Agreement and/or (ii) was opposed by Biomatrix and proved to be unwarranted, in
which case Distributor shall reimburse Biomatrix for all direct costs and
expenses (including without limitation shipping, quality control testing and
notification costs) incurred by Biomatrix and its Affiliates as a result of such
recall.
6.9 Product Vigilance System. The Distributor shall be responsible for
maintaining medical device vigilance systems, as established for the Agreement
Product by Biomatrix, and shall promptly provide Biomatrix with notice of all
product complaints, including medical complaints. Biomatrix shall be solely
responsible for processing, analyzing and, if necessary, reporting medical
complaints to regulatory authorities. The Distributor shall provide all
necessary support to Biomatrix for carrying out such activities.
7. SUPPLY OF AGREEMENT PRODUCT.
7.1. General; Fee.
(a) Biomatrix agrees to sell the Agreement Product and any Improved
Agreement Product(s) to the Distributor, on the terms and subject to the
conditions set forth herein, for resale by the Distributor within the Territory,
and the Distributor shall obtain the Agreement Product and any Improved
Agreement Product(s) for resale in the Territory only from Biomatrix or its
Affiliates. Biomatrix shall not sell the Agreement Product or any Improved
Agreement Product(s) itself or supply or license the manufacture of the
Agreement Product or any Improved Agreement Product(s) to any third party for
resale within the Territory, provided that Biomatrix's obligations under this
sentence shall be subject to (i) applicable law and (ii) the provisions of this
Agreement, including Section 2.3.
(b) In consideration of the costs and expenses that have been incurred
by Biomatrix in connection with the Agreement Product, including, without
limitation, the incurrence of costs and expenses of research and development,
developing manufacturing capability, prosecuting and maintaining patents and
trademarks, obtaining regulatory approvals, conducting clinical trials, making
regulatory filings and taking other actions, as well as the legal, general and
administrative costs related thereto, the Distributor shall pay to Biomatrix a
fee in the amount of seven million Dollars (US$7,000,000) in cash or by wire
transfer within ten (10) days after notice to the Distributor by Biomatrix of
receipt by Biomatrix of an approval letter (the "Approved Letter") from the
United States Food and Drug Administration indicating the approval of the
Agreement Product for sale in the United States, with which notice Biomatrix
shall deliver a copy of such Approved Letter. Such fee shall not be refundable
in whole or part.
<PAGE> 15
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7.2. Price; Adjustment; Reports; Payment.
(a) The parties shall attempt in good faith to agree in writing, prior
to the Launch in each country, upon mutually acceptable supply pricing for the
Distributor's purchase of the Agreement Product and any Improved Agreement
Product(s), but such pricing in any event shall not be less than the greater of
(i) the Minimum Price, or (ii) the Formula Price, except as provided in
subsection (b) below. The parties shall attempt in good faith to agree in
writing upon mutually acceptable minimum pricing for the Agreement Product in
sizes other than the 1.0cc Treatment Syringe and for any Improved Agreement
Product(s). For any syringe with a fill volume of greater than one cc (1cc), the
Minimum Price shall be the amount calculated as [ *** ] plus the dollar amount
which equals [ *** ] of such product with a larger fill volume [ *** ] of the
one cc (1cc) syringe. In the event that Biomatrix's actual incremental Cost of
Goods Sold exceeds such dollar amount, the Minimum Price shall be the amount
calculated as [ *** ] Subject to the general commercial availability of
appropriate syringes for the Agreement Product, the [ *** ] for a one and
one-half (1.5)cc syringe, [ *** ] for a two (2.0)cc syringe, and [ *** ] for a
two and one-half (2.5)cc syringe.
(b) If Biomatrix has appointed a new distributor in the Territory
pursuant to Section 2.3 and the Distributor has the right to distribute the
Agreement Product and any Improved Agreement Product(s) in the Territory, the
supply pricing for the Distributor's purchase of the Agreement Product and any
Improved Agreement Product(s) for resale in the Territory [ *** ]
(c) The price initially payable by the Distributor to Biomatrix for each
unit of the Agreement Product during each month of each Agreement Year shall be
the Minimum Price (subject to adjustment at the close of each applicable
Contract Quarter and Agreement Year in accordance with Section 7.2(e) below).
(d) Within [ *** ] after the end of each month of each Agreement Year,
the Formula Price for the Agreement Product shall be calculated, and, to the
extent that such Formula Price exceeds the applicable Minimum Price for such
Agreement Year, an adjustment resulting from the [ *** ] with respect to all
units of the Agreement Product sold by the Distributor in the Territory during
such monthly
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 16
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period, such payment to be made [ *** ] after the end of the month following
such monthly period.
(e) Within [ *** ] after the end of each Contract Quarter and Agreement
Year, the Formula Price for the Agreement Product shall be calculated and an
adjustment resulting from the [ *** ] as appropriate, to the other party with
respect to all units of the Agreement Product sold by the Distributor in the
Territory during such Contract Quarter and Agreement Year, such payment to be
made within [ *** ] after the end of such [ *** ] period following the end of
such Contract Quarter and Agreement Year. The price calculated annually in this
manner shall be the final price payable for all units of the Agreement Product
sold by the Distributor or any Affiliate during such Agreement Year. For the
avoidance of doubt, the aggregate amount payable by Distributor for the
Agreement Product(s) and any Improved Agreement Product(s) for any Agreement
Year shall in no event be lower than the Minimum Price multiplied by the total
units sold in such Agreement Year in the Territory.
(f) Within [ *** ] following the end of each calendar month in each
Agreement Year, the Distributor shall submit to Biomatrix written reports
detailing the units and value of the Distributor's and its Affiliates' Net
Retail Sales and aggregate number of units sold of the Agreement Product and any
Improved Agreement Product(s) in the Territory during the immediately preceding
calendar month.
(g) Within [ *** ] following the end of each Agreement Year, the
Distributor shall submit to Biomatrix written reports detailing the
Distributor's and its Affiliates' sales of the Agreement Product and any
Improved Agreement Product(s) during the immediately preceding Agreement Year,
which reports shall contain the Net Retail Sales of the Agreement Product and
any Improved Agreement Product(s) in the Territory, and the aggregate number of
units of the Agreement Product and any Improved Agreement Product(s) sold in the
Territory during the applicable Agreement Year.
(h) All purchases of the Agreement Product and any Improved Agreement
Product(s) hereunder shall be billed and paid in Dollars within [ *** ] after
the later of the date of delivery or the date of the Distributor's receipt of
the invoice for each shipment of same to the Distributor.
7.3. Sales and Supply Forecasts; Accounts.
(a) Exhibit D, which shall be supplied by the Distributor within [ *** ]
of the Distributor's receipt of notice from Biomatrix of [ *** ] shall set forth
a sales forecast of units of the Agreement Product in the Territory for the
first Agreement Year.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 17
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(b) Within [ *** ] after the end of each month of each Agreement
Year in the Territory, the Distributor shall provide to Biomatrix an updated
rolling twelve (12) month monthly supply forecast for all unit sizes of the
Agreement Product. Each such supply forecast described in this subsection (b) is
referred to herein as a "Supply Forecast"; provided, that updated Supply
Forecasts shall not vary (whether up or down) from the immediately preceding
Supply Forecast by more than [ *** ] with respect to each month
covered by such preceding Supply Forecast.
(c) The Distributor shall maintain books of account with respect to its
sales of the Agreement Product in the Territory. Biomatrix shall have the right,
not more than once during each calendar year, to have an independent accountant
selected and retained by Biomatrix (reasonably acceptable to Distributor,
provided that any "big six" accounting firm shall be deemed reasonable) to
inspect and examine such books of the Distributor during regular business hours
for the purpose of verifying the statements of the aggregate Net Retail Sales of
all Dermal Tissue Augmentation Products for all purposes hereunder, including
verification of Formula Price and the royalties described in Section 8. The cost
of each such audit shall be borne by Biomatrix unless a material error is
discovered in the course of such audit, in which case the cost shall be borne by
the Distributor. For purposes of this Section 7.3(d), a material error shall be
defined as an understatement of five percent (5%) or more of the aggregate
amount owed to Biomatrix with respect to sales of Dermal Tissue Augmentation
Products in the Territory. Any additional payments required as a result of such
inspection and examination shall be immediately paid to Biomatrix and shall bear
interest from the date such amount would otherwise have been paid until the date
of actual payment at the rate per annum set forth in Section 20. Such
independent accounting firm shall conduct such inspections and examinations
under conditions of confidentiality.
7.4. Shipment and Delivery; Packaging; Shelf Life.
(a) Biomatrix or an Affiliate of Biomatrix shall arrange for shipment to
the Distributor of the Agreement Product and any Improved Agreement Product(s)
ordered by the Distributor [ *** ] The Distributor shall pay all customs duties,
sales taxes and other governmental charges relating to the Agreement Product and
any Improved Agreement Product(s), and shall be solely responsible for clearing
such products through customs throughout the Territory.
(b) The Distributor shall submit a firm purchase order setting forth the
quantities, delivery date and shipping instructions with respect to each
shipment of the Agreement Product and any Improved Agreement Product(s), such
purchase orders to be received by Biomatrix at least [ *** ] prior to
the requested delivery date; provided that the Distributor shall not submit any
purchase order for fewer than [ *** ] units of the Agreement Product or the
Improved Agreement Product(s) (although multiple delivery site for purchase
orders shall be allowed). Biomatrix shall have no obligation to supply
Distributor with quantities of the Agreement Product(s) and Improved Agreement
Product(s) in excess of the amounts in the then current Supply Forecast for the
relevant monthly period.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 18
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(c) Each unit of the Agreement Product and any Improved Agreement
Products shipped to the Distributor shall have, as of the time of delivery, a
remaining shelf life of no less than [ *** ] less than the maximum shelf life
for such product, as approved by the U.S. Food and Drug Administration.
Biomatrix shall continually use its best efforts at all times during the term
hereof to lengthen to [ *** ] the shelf life of the Agreement Product and any
Improved Agreement Products to the extent supported by stability data.
Biomatrix' "best efforts" in this section shall mean that Biomatrix shall use
such methods, exercise such degree of effort and diligence, and adhere to such
standards as are commercially reasonable.
7.5. Title. Legal title to all quantities of the Agreement Product and
any Improved Agreement Product(s) sold hereunder shall remain in Biomatrix until
delivery of the Agreement Product and any Improved Agreement Product(s) to
Distributor or its agent and acceptance thereof, and upon such delivery and
acceptance the title to such Agreement Product and any Improved Agreement
Product(s) shall, without further action, be transferred to and vested in the
Distributor.
7.6. Risk of Loss. Biomatrix shall bear all risk of loss of, or damage
to, all units of the Agreement Product and any Improved Agreement Product(s) to
the extent the same is in its possession or the possession of its Affiliates,
nominees or agents. The Distributor shall bear all risk of loss of, or damage
to, all units of the Agreement Product and any Improved Agreement Product(s)
after delivery to a common carrier for shipment to the Distributor in accordance
with Section 7.4.
7.7. Acceptance. [ *** ]All units of the Agreement Product and Improved
Agreement Products delivered to Distributor pursuant to this Agreement shall be
[ *** ] the specification listed in Exhibit A. Any non-conformity which arises
after acceptance by Distributor directly associated with Product specification
shall be the responsibility of Biomatrix unless such non-conformity is due to
improper storage conditions subsequent to delivery of the Agreement Product. All
other non-conformities of the Agreement Product shall be the responsibility of
the Distributor. Biomatrix and the Distributor agree to consult with each other
in order to resolve the discrepancy between each other's determinations. If such
consultation does not resolve the discrepancy, the parties agree to nominate a
reputable independent laboratory, acceptable to both parties, that shall carry
out tests on representative samples taken from such shipment, and the results of
such tests shall be binding on the
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 19
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parties. Biomatrix shall at its expense replace any such shipment to the extent
that it does not conform to the Agreement Product Specifications. All defective
units of the Agreement Product or any Improved Agreement Product(s) shall be
returned to Biomatrix at the address set forth in Section 23 of this Agreement,
accompanied or preceded by a reasonably detailed statement of the claimed defect
or non-conformity and proof of date of purchase, and packed and shipped
according to instructions provided by Biomatrix. The shipping costs of any such
returned units shall be borne by Biomatrix, unless such units are determined not
to be defective under the terms of this Agreement, in which case such shipping
costs shall be borne by the Distributor.
7.8. Purchase Orders. The provisions of this Agreement shall prevail
over any inconsistent statement or provisions contained in any document related
to this Agreement passing between the parties hereto including, but not limited
to, any purchase order, acknowledgment, confirmation or notice.
7.9. Limited Warranty; Limitation on Liability.
Biomatrix represents and warrants that the Agreement Product and any
Improved Agreement Product(s) supplied to the Distributor hereunder shall:
(a) conform to the Agreement Product Specifications; and
(b) be manufactured, labelled, packaged and tested (while in the
possession or control of Biomatrix) in accordance with the applicable Product
License Approvals therefor and all applicable laws and regulations in the
Territory relating to the manufacture, labelling, packaging and testing of the
Agreement Product, and shall be manufactured for use for the indications
specified in the applicable Product License Approvals therefor.
THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY
BIOMATRIX WITH RESPECT TO THE AGREEMENT PRODUCT, AND BIOMATRIX GIVES AND MAKES
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE
FOREGOING. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, NO IMPLIED WARRANTY
OF MERCHANTABILITY, NO IMPLIED WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE,
AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR COURSE
OF PERFORMANCE IS GIVEN OR MADE BY BIOMATRIX OR SHALL ARISE BY OR IN CONNECTION
WITH ANY SALE OR PROVISION OF THE AGREEMENT PRODUCT BY BIOMATRIX, OR THE
DISTRIBUTOR'S (OR ITS AFFILIATES') USE OR SALE OF THE AGREEMENT PRODUCT, OR
BIOMATRIX'S AND/OR THE DISTRIBUTOR'S (OR ITS AFFILIATES') CONDUCT IN RELATION
THERETO OR TO EACH OTHER. NO REPRESENTATIVE OF BIOMATRIX IS AUTHORIZED TO GIVE
OR MAKE ANY OTHER REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY
IN ANY WAY.
<PAGE> 20
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The limited warranty set forth in this Section 7.9 does not apply to any
non-conformity of the Agreement Product or any Improved Agreement Product(s)
resulting from (a) repair or alteration by any party other than Biomatrix or its
Affiliates, (b) misuse, negligence, abuse, accident, mishandling or storage in
an improper environment by any party other than Biomatrix or its Affiliates, or
(c) use, handling, storage or maintenance other than in accordance with
instructions and recommendations provided by Biomatrix or its Affiliates.
Biomatrix's obligation with respect to units of the Agreement Product
and any Improved Agreement Product(s) which do not meet the warranty contained
herein is limited to replacement of such units of the Agreement Product or
Improved Agreement Product(s) as applicable, provided that such units are
returned to Biomatrix accompanied by a reasonably detailed statement of the
claimed defect or non-conformity and proof of purchase, and packed and shipped
according to instructions provided by Biomatrix, and only if, upon examination
by Biomatrix, such units of the Agreement Product or the Improved Agreement
Product(s) are determined to have been defective under the terms of this
Agreement.
BIOMATRIX's LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE
SALE OR USE OF THE AGREEMENT PRODUCT AND ANY IMPROVED AGREEMENT PRODUCT(S)
(WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF WARRANTY, STRICT LIABILITY OR
ANY OTHER LEGAL THEORY), SHALL BE STRICTLY LIMITED TO BIOMATRIX'S OBLIGATIONS AS
SPECIFICALLY AND EXPRESSLY PROVIDED IN THIS SECTION 7.9 AND IN SECTION 9 BELOW.
EXCEPT AS SPECIFICALLY PROVIDED IN THIS SECTION 7.9 AND IN SECTION 9 BELOW,
BIOMATRIX SHALL HAVE NO LIABILITY, OBLIGATION OR RESPONSIBILITY OF ANY KIND, IN
ANY WAY OR TO ANY EXTENT, FOR ANY DAMAGES, LOSSES, COSTS, EXPENSES OR
LIABILITIES FOR ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE
AGREEMENT PRODUCT AND ANY IMPROVED AGREEMENT PRODUCT(S) OR THE PERFORMANCE
THEREOF, OR ARISING IN ANY WAY IN CONNECTION WITH THE PURCHASE OR USE OR
INABILITY TO USE THE AGREEMENT PRODUCT OR ANY IMPROVED AGREEMENT PRODUCT(S),
EVEN IF BIOMATRIX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO
EVENT WHATSOEVER SHALL BIOMATRIX HAVE ANY LIABILITY, OBLIGATION OR
RESPONSIBILITY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY
DAMAGES ARISING IN ANY WAY IN CONNECTION WITH THE AGREEMENT PRODUCT OR ANY
IMPROVED AGREEMENT PRODUCT(S) OR THEIR SALE OR USE.
8. ROYALTY PAYMENTS BY DISTRIBUTOR.
8.1. Royalties for Sales of Dermal Tissue Augmentation Products. The
Distributor shall pay to Biomatrix a royalty of [ *** ] of the Net Retail Sales
by the
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 21
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Distributor and its Affiliates of all Dermal Tissue Augmentation Products (other
than sales of the Agreement Product and any Improved Agreement Product(s)) in
the Territory, including any countries that are added to the Territory after the
Effective Date, [ *** ]. Such royalty shall commence at the earlier of (a)
Launch of the Agreement Product in the Territory or (b) the Launch date set
forth on Exhibit B; provided that if a the Launch is delayed due to Biomatrix's
failure to meet its supply obligations under Section 7.4, due to a force majeure
condition of Distributor or if Distributor is not able to lawfully sell the
Agreement Product in the Territory, such royalty shall not commence until
Biomatrix meets its supply obligations, until Distributor is able to sell the
Agreement Product in the Territory, or until such force majeure condition
ceases. Such royalty shall be paid by not later than [ *** ] after the end of
each Contract Quarter.
8.2. Incremental Royalties. The Distributor shall pay to Biomatrix the
following annual royalties (the "Incremental Royalties") on the Distributor's
and its Affiliates' total incremental increases in Net Retail Sales of all
Dermal Tissue Augmentation Products (including the Agreement Product and any
Improved Agreement Product(s)), in the Territory based on the incremental
increases, if any, in Net Retail Sales of all Dermal Tissue Augmentation
Products in each Agreement Year over a base year amount comprised of Net Retail
Sales of Dermal Tissue Augmentation Products in the twelve (12) months
immediately preceding the first commercial sale of either the Agreement Product
or any Improved Agreement Product(s):
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 22
-22-
<TABLE>
<CAPTION>
Increase in Total
Sales Over Base Royalty on Total
Year Amount Incremental Sales
----------- -----------------
<S> <C> <C>
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
[ *** ] [ *** ]
</TABLE>
The Distributor's obligation to pay the Incremental Royalties shall cease in the
event that the Distributor's rights to sell, distribute, market and promote the
Agreement Product and any Improved Agreement Product have become non-exclusive
pursuant to Section 2.3 or have terminated pursuant to Sect ion 3.2(d). The
Incremental Royalty shall be paid by not later than [ *** ] after the end of
each Agreement Year. For the avoidance of doubt, if the Distributor had no sales
of any Dermal Tissue Augmentation Products prior to the first commercial sale of
either the Agreement Product or any Improved Agreement Product, the Distributor
shall be obligated to pay a [ *** ] royalty on Net Retail Sales of all Dermal
Tissue Augmentation products sold after such first commercial sale.
9. INDEMNIFICATION; CONFIDENTIALITY; PUBLIC ANNOUNCEMENT
9.1. Indemnification from the Distributor. Subject to the provisions of
Section 9.3, the Distributor shall defend, indemnify and hold Biomatrix and its
Affiliates and their respective directors, officers, agents and employees
harmless from and against any and all liabilities, claims, damages and expenses
(including without limitation actual court costs and reasonable attorneys' fees
regardless of outcome) resulting from claims of third parties or arising out of:
(a) any failure by the Distributor to act in accordance with the terms
of this Agreement and/or any applicable laws and regulations in the Territory in
connection with the Agreement Product and any Improved Agreement Product(s),
including without limitation any unauthorized representations, warranties or
guarantees given by the Distributor or its Affiliates;
(b) any unauthorized use of an unapproved label on the Agreement Product
or any Improved Agreement Product(s); and/or
(c) any activities of the Distributor or its Affiliates relating to the
promotion, marketing, sale and distribution of the Agreement Product and any
Improved Agreement Product(s);
provided, however, that upon Biomatrix being advised of any assertions of any
such third party claims or suits or upon the bringing or filing of such claims
or suits by any third party
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 23
-23-
against Biomatrix, Biomatrix will promptly notify the Distributor thereof and
Biomatrix may, at its option, permit the Distributor's attorneys to handle and
control the defense of such claims or suits at the Distributor's cost and
Biomatrix will co-operate with the Distributor in the defense thereof. The
parties agree that there shall be no settlements, whether agreed to in court or
out of court, without the prior written consent of the indemnifying party.
9.2. Indemnification from Biomatrix. Subject to the provisions of
Section 9.3, Biomatrix shall defend, indemnify and hold the Distributor and its
Affiliates and their respective directors, officers, agents and employees
harmless from and against any and all liabilities, claims, damages and expenses
(including without limitation actual court costs and reasonable attorneys' fees
regardless of outcome) resulting from claims of third parties arising out of:
(a) any failure by Biomatrix to act in accordance with applicable laws
and regulations in the Territory in connection with the Agreement Product and
any Improved Agreement Product(s) (including changing a jointly agreed upon
label without the consent of Distributor);
(b) a product or manufacturing defect in the Agreement Product or any
Improved Agreement Product(s); and
(c) any infringement of the patent rights of third parties resulting
from the use or sale of the Agreement Product in the Territory in accordance
with this Agreement.
provided, however, that upon the Distributor being advised of any assertions of
any such third party claims or suits or upon the bringing or filing of such
claims or suits by any third party against the Distributor, the Distributor will
promptly notify Biomatrix thereof and, at Biomatrix's cost, permit Biomatrix's
attorneys to handle and control the defense of such claims or suits and will
co-operate with Biomatrix in the defense thereof. The parties agree that there
shall be no settlements, whether agreed to in court or out of court, without the
prior written consent of the indemnifying party.
9.3. Limitation on Liability.
NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN SECTIONS 9.1 AND 9.2
ABOVE, OR ANY OTHER PROVISION OF THIS AGREEMENT, IN NO EVENT (INCLUDING THE
FAULT, NEGLIGENCE OR STRICT LIABILITY OF EITHER PARTY) SHALL EITHER PARTY BE
LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR
EXEMPLARY DAMAGES OTHER THAN TO THE EXTENT NECESSARY TO REIMBURSE SUCH OTHER
PARTY FOR DAMAGES ACTUALLY PAID TO A NON-AFFILIATED THIRD PARTY, PROVIDED THAT
SUCH DAMAGES ARE OTHERWISE COVERED BY THE PROVISIONS OF SECTION 9.1 OR SECTION
9.2, AS THE CASE MAY BE.
<PAGE> 24
-24-
9.4. Confidential Information. All information acquired by either party
(the "Recipient") from the other party or any of its Affiliates (the
"Discloser") during the term of this Agreement or prior to the Effective Date,
relating directly or indirectly to the present or potential business,
operations, corporate, technical or financial situation of the Discloser, or to
manufacturing know-how, patents, data, test results, techniques, processes,
procedures, raw materials, dealer, supplier and customer lists, pre-clinical and
clinical protocols or any improvements thereof of the Discloser ("Confidential
Information") is confidential, and shall be held in trust by the Recipient for
the exclusive benefit of the Discloser. Unless otherwise agreed to in writing by
the Discloser, the Recipient shall not at any time, either during or subsequent
to the term of this Agreement, use for itself (other than in accordance with the
terms of this Agreement) or any other Person, or disclose or divulge to any
Person, other than to those of its employees and advisors and Affiliates who
require the same for the purposes hereof and who are bound by the same
obligations of confidentiality, non-disclosure and non-use as set forth herein,
any Confidential Information or any other confidential or proprietary
information of the Discloser of which the Recipient may acquire knowledge;
provided, however, that the confidentiality, non-disclosure and non-use
provisions contained in this Section 9.4 shall not apply to any information or
data to the extent that the Recipient:
(a) shall demonstrate by clear and convincing evidence that such
information or data is known generally to persons in the trade through no act or
omission of the Recipient or any of its Affiliates;
(b) is required by any government authority to disclose such information
or data, including without limitation for the purposes of obtaining and
maintaining any Product License Approvals under this Agreement; or
(c) shall demonstrate by its written records was disclosed to or created
by it or its Affiliates on a non-confidential basis from a source other than the
Discloser or its Affiliates and that such disclosure or creation did not
constitute a breach of any applicable confidentiality obligations.
Confidential Information shall be immediately returned to the Discloser upon
termination of this Agreement, along with any copies, reproductions, digests,
abstracts or the like of all or any part thereof in the Recipient's possession
or under the Recipient's control, and upon such return any computer entries or
the like relating thereto shall, to the extent legally permissible, be
destroyed. Such return (and destruction) will not affect the Recipient's
obligations hereunder which shall survive indefinitely. Notwithstanding anything
herein to the contrary, the provisions of this Section 9.4 shall be subject to
Biomatrix's rights under Section 3.6.
9.5. Public Announcement. Except as shall be necessary for governmental
notification purposes or to comply with applicable laws and regulations, and
except as otherwise agreed to by the parties hereto in writing, the parties
agree to keep the existence of
<PAGE> 25
-25-
this Agreement, and the transactions contemplated hereby, strictly
confidential. In the event that a party must file this document or otherwise
disclose any of its subject matter pursuant to public filing requirements, such
party shall seek confidential treatment of those portions of the Agreement as
the parties shall mutually agree upon; provided, however, that the Distributor
must provide written notice to Biomatrix no later than June 30, 1996 of those
portions of the Agreement for which the Distributor requests confidential
treatment. The parties shall agree upon the text of an initial public
announcement relating to the transactions contemplated by this Agreement as soon
as possible. Any subsequent public announcements regarding this Agreement or the
transactions contemplated herein shall also be agreed upon in writing between
the parties prior to any release thereof.
10. NEW PRODUCTS.
10.1 [ *** ] Distributor shall not commercialize nor begin the
commercialization process with respect to or acquire any New Product anywhere in
the International Territory or the United States, either independently or in
conjunction with one or more third parties, unless and until the following
conditions have been satisfied:
(a) Distributor has made a commercially reasonable written offer to
Biomatrix to participate with Distributor in the development and
commercialization of such New Product; and
(b) Biomatrix has failed to accept such written offer within [ *** ] of
its receipt of such offer.
In the event that Biomatrix fails to accept any written offer made by
Distributor pursuant to this Section 10.1 within [ *** ] of Biomatrix's receipt
thereof, then Distributor, subject to the terms of this Agreement, shall have
the right to independently or with other parties develop and/or commercialize
any New Product to which such written offer relates; provided, however, that any
such New Product does not infringe upon any intellectual property rights of
Biomatrix. Distributor shall not be required to make the written offer to
Biomatrix set forth in Section 10.1(a) above only to the extent that it is
prevented from doing so due to the patented proprietary rights of a third party.
(c) At all times during the term of this Agreement, Distributor shall
notify Biomatrix in writing within [ *** ] of each occurrence of one or more of
the following:
(i) Distributor's entering into an agreement with one or more
third parties with regard to the development, acquisition
and/or commercialization of any New Product, and
Distributor shall provide to Biomatrix notice of such
agreement and any and all agreements relating thereto and
a non-confidential summary of such agreements; or
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 26
-26-
(ii) Distributor's commencing a clinical trial (either alone or
in conjunction with a third party) with respect to any New
Product, together with a notice of the commencement of
such clinical trial and a list of all countries where such
clinical trials will take place; or
(iii) Distributor's filing of an application (either alone or in
conjunction with a third party) for marketing approval
with the United States Food and Drug Administration or an
equivalent regulatory agency in any country with respect
to any New Product stating in which countries any such
filings have been made.
10.2 So long as either [ *** ] Agreement Product and any Improved
Agreement Product [ *** ] and/or (b) Distributor [ *** ] either independently or
in conjunction with one or more third parties, [ *** ] Biomatrix shall not
[ *** ] until the following conditions have been satisfied:
(i) Biomatrix has made a commercially reasonable [ *** ]
to Distributor to [ *** ]; and
(ii) Distributor has [ *** ]
In the event that Distributor [ *** ] by Biomatrix pursuant to this
Section 10.2 [ *** ] then Biomatrix [ *** ] by this Agreement [ *** ]; provided,
however, that Biomatrix shall not have the right to commercialize any such New
Products within [ *** ] so long as either of the conditions set forth in Section
10.2(a) or 10.2(b) is satisfied. Specifically, once one of the conditions in
Section 10.2(a) or 10.2(b) is not satisfied, Distributor shall, subject to the
terms of this Agreement, [ *** ] however, after such date it shall [ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 27
-27-
10.3. Nothing in this Section 10 shall be construed, by implication or
otherwise, (i) to effect any sale or license of proprietary Biomatrix technology
(including any New Products), (ii) to grant any license relating to Biomatrix's
proprietary methods of formulating , fabricating and manufacturing the Agreement
Product, Improved Agreement Products or New Products, or (iii) to grant
Distributor any rights in or to any proprietary technology or Patents or
Trademarks of Biomatrix.
11. REPRESENTATIONS OF BIOMATRIX. Biomatrix represents, warrants and
covenants as follows:
11.1. It is a corporation duly organized and validly existing under the
laws of the State of Delaware with the full power to conduct its affairs as
currently conducted and contemplated hereunder. All necessary action has been
taken to enable it to execute and deliver this Agreement and perform its
obligations hereunder.
11.2. This Agreement is a valid and binding obligation of Biomatrix
enforceable in accordance with its terms. Biomatrix has the unencumbered right
to enter into this Agreement and to fulfill its duties hereunder. It is not and
will not become a party to any agreement in conflict herewith. Accordingly,
Biomatrix has the right to appoint the Distributor as the exclusive distributor
of the Agreement Product in the Territory in accordance with the terms of this
Agreement and such appointment will not constitute a breach of any existing
contractual or other arrangements between Biomatrix and any Affiliated or
non-Affiliated third party, nor shall it infringe the rights of any Affiliated
or non-Affiliated third party.
11.3 No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to, any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by Biomatrix and the performance by Biomatrix of its
obligations hereunder.
12. REPRESENTATIONS OF THE DISTRIBUTOR. The Distributor represents,
warrants and covenants as follows:
12.1 It is a corporation duly organized and validly existing under the
laws of Delaware with full power to conduct its affairs as currently conducted
and contemplated hereunder. All necessary action has been taken to enable it to
execute and deliver this Agreement and perform its obligations hereunder.
12.2. This Agreement is the Distributor's valid and binding obligation
enforceable in accordance with its terms. The Distributor has the unencumbered
right to enter into this Agreement and to fulfill its obligations hereunder. It
is not and will not become a party to any agreement in conflict herewith.
Accordingly, the Distributor has the right to act as the exclusive distributor
of the Agreement Product in the Territory in accordance with the terms of this
Agreement and the performance of its obligations hereunder will not constitute a
<PAGE> 28
-28-
breach of any existing contractual or other arrangements between the Distributor
and any Affiliated or non-Affiliated third party, nor shall it infringe the
rights of any Affiliated or non-Affiliated third party.
12.3. No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by the Distributor and the performance by the Distributor of
its obligations hereunder.
13. INSURANCE. Each party hereto shall (a) obtain and maintain such
insurance policies as are adequate to cover its respective obligations hereunder
and which are consistent with normal business practices of prudent companies
similarly situated and (b) provide the other party, upon request, with
certificates of insurance confirming the existence of such insurance policies.
14. INFRINGEMENT. Each of the Distributor and Biomatrix will promptly
notify the other party in writing of any infringement of a Patent or Trademark
or unauthorized disclosure or use of any Confidential Information, of which it
becomes aware in the Territory. Biomatrix shall have the exclusive right at its
own cost to take all legal action in the Territory it deems necessary or
advisable to eliminate or minimize the consequences of such infringement of a
Patent or Trademark in the Territory. For the purpose of taking any such legal
action, Biomatrix shall have the right, subject to the Distributor's consent
which consent shall not be unreasonably withheld or delayed, to use the name of
the Distributor as plaintiff, either solely or jointly in accordance with the
applicable rules of procedure; provided that Biomatrix shall give the
Distributor prior notice of such use of the Distributor's name. The Distributor
shall promptly furnish Biomatrix with whatever written authority may be required
in order to enable Biomatrix to use the Distributor's name in connection with
any such legal action, and shall otherwise cooperate fully and promptly with
Biomatrix in connection with any such action. All proceeds realized upon any
judgment or settlement regarding such action shall belong to Biomatrix.
<PAGE> 29
-29-
15. Regulatory Activities; Clinical Trials and Marketing Studies.
15.1. General.
(a) Biomatrix shall be responsible for maintaining at its cost the
Product License Approvals required for the marketing and sale of the Agreement
Product and any Improved Agreement Product(s) in the Territory throughout the
term of this Agreement.
(b) Biomatrix shall hold in its name all regulatory approvals required
for the marketing and sale of the Agreement Product and any Improved Agreement
Product(s) in the Territory.
(c) The Distributor and Biomatrix shall provide reasonable advice and
assistance to each other as may be necessary to obtain and maintain Product
License Approvals.
(d) During the term of this Agreement, each party shall immediately
notify the other in writing in the event that such party becomes aware of any
failure of the Agreement Product and any Improved Agreement Product(s) to comply
with any of the requirements therefor specified in any Product License
Approvals.
(e) Each of the Distributor and Biomatrix shall keep the other advised
of regulatory interactions, activities and correspondence relating to the
Agreement Product and any Improved Agreement Product(s) on at least a quarterly
basis, and any matters requiring immediate attention shall be communicated as
soon as practicable. Notwithstanding the foregoing, within [ *** ]. Biomatrix
shall deliver a [ *** ] to the Distributor.
15.2. Marketing Studies. The parties agree that if any marketing-related
studies are deemed necessary, such studies will not delay the Launch in the
Territory. The protocols for any marketing-related studies requested by the
Distributor will be developed jointly by Biomatrix and the Distributor, and the
Distributor will be responsible for conducting and managing such studies at its
own expense. Biomatrix shall have the right to audit the performance of any
marketing-related studies performed by or on behalf of the Distributor. The
results of such studies will not be published or publicized in any way without
the prior written approval of Biomatrix.
16. FURTHER ASSURANCES. The parties hereto agree to execute such further
or other documents and assurances as are necessary from time to time in order to
give effect to the provisions of this Agreement.
17. ASSIGNMENT. The rights and obligations of the parties hereto shall
inure to the benefit of and shall be binding upon the authorized successors and
permitted assigns of each party. Neither party may assign its rights or
obligations under this Agreement or may designate another person to perform all
or part of its obligations under this Agreement, or to
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 30
-30-
have all or part of its rights and benefits under this Agreement without the
prior written consent of the other party, except to an Affiliate or to a
successor of the business, by merger or otherwise, to which this Agreement
relates, provided that in the case of an assignment to an Affiliate the
assigning party shall promptly notify the other party in writing of such
assignment and shall remain liable (both directly and as guarantor) with respect
to all obligations so assigned. In the event of any assignment or in the event
that an Affiliate of either party shall exercise rights and/or perform
obligations hereunder pursuant to the terms of this Agreement, the assignee or
Affiliate, as the case may be, shall specifically assume and be bound by the
provisions of the Agreement by executing and agreeing to an assumption agreement
satisfactory to the other party hereto.
18. GOVERNING LAW; ARBITRATION; INJUNCTIVE RELIEF.
(a) This Agreement shall be governed by and construed in accordance with
the internal and substantive laws of the State of New York, United States of
America. The parties hereby agree that the United Nations Convention on
Contracts for the International Sale of Goods shall not apply to this Agreement
or any other document contemplated hereby. In the event of any dispute touching
or concerning this Agreement, the parties hereby agree to submit such dispute to
their respective presidents by notice delivered in accordance with the
provisions of Section 23, and if within [ *** ], or such other period
as is agreed upon in writing by the parties hereto, following such reference the
dispute remains unresolved, to submit the dispute for arbitration in Boston,
Massachusetts under the Rules of the American Arbitration Association in effect
on the date of this Agreement (the "Rules") by arbitrators appointed in
accordance with said Rules. Any decision of such arbitrators shall be written
and shall be final and binding upon the parties. In any arbitration pursuant to
this Section the award shall be rendered by a majority of three (3) arbitrators,
one (1) of whom shall be appointed by each party and the third of whom shall be
appointed by mutual agreement of the two (2) party-appointed arbitrators. In the
event of failure of a party to appoint an arbitrator within thirty (30) days
after commencement of the arbitration proceeding or in the event of failure of
the two (2) party-appointed arbitrators to agree upon the appointment of the
third arbitrator within sixty (60) days after commencement of the arbitration
proceeding, such arbitrator shall be appointed by the American Arbitration
Association in accordance with the Rules. The arbitrators shall apply the
governing law set forth in this Section. Judgment upon an award rendered by the
arbitrators may be entered in any court having jurisdiction thereof.
(b) Each of the parties hereto acknowledges and agrees that damages will
not be an adequate remedy for any material breach or violation of this Agreement
if such material breach or violation would cause immediate and irreparable harm
(an "Irreparable Breach"). Accordingly, notwithstanding the provisions of
Section 18(a) to the contrary, in the event of a threatened or ongoing
Irreparable Breach, each party hereto shall be entitled to seek, in any state or
federal court in the State of New York, equitable relief of a kind appropriate
in light of the nature of the ongoing threatened Irreparable Breach, which
relief may include, without limitation, specific performance or injunctive
relief; provided, however, that if the party bringing such action is
unsuccessful in obtaining the relief sought, the moving party
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 31
-31-
shall pay the non-moving party's reasonable costs, including attorney's fees,
incurred in connection with defending such action. Such remedies shall not be
the parties' exclusive remedies, but shall be in addition to all other remedies
provided in this Agreement.
19. SEVERABILITY. In the event that any provision of this Agreement
shall be held by a court of competent jurisdiction or by any governmental body
to be invalid or unenforceable, such provision shall be deemed severable and the
remaining parts and provisions of this Agreement shall remain in full force and
effect.
20. FORCE MAJEURE. Each of the parties shall be excused from the
performance of its obligations hereunder in the event such performance is
prevented by force majeure, and such excuse shall continue as long as the
condition constituting such force majeure continues. For the purpose of this
Agreement, force majeure is defined as contingencies beyond the reasonable
control of either party, including, without limitation, acts of God, judicial or
regulatory action, war, civil commotion, destruction of production facilities or
materials by fire, earthquake or storm and labor disturbances (whether or not
any such labor disturbance is within the power of the affected party to settle).
21. INTEREST. Any overdue amounts payable by either party hereunder
shall bear interest compounded monthly at the prime lending rate for Dollars
published from time to time in The Wall Street Journal plus [ *** ] per annum,
or, if lower, the highest rate permissible by applicable law, from the due date
until the date of payment.
22. NO PARTNERSHIP OR AGENCY. This Agreement and the relations hereby
established by and between Biomatrix and the Distributor do not constitute a
partnership, joint venture, agency or contract of employment between them.
23. NOTICES. All communications in connection with this Agreement shall
be in writing and sent by postage prepaid first class mail, courier, or telefax,
and if relating to default, late payment or termination, by certified mail,
return receipt requested, telefax or courier, addressed to each party at the
address set forth at the beginning of this Agreement, in the case of Biomatrix,
Attn: Chief Executive Officer, with a copy to: Justin P. Morreale, Esq.,
Bingham, Dana & Gould LLP, 150 Federal Street, Boston, Massachusetts 02110,
U.S.A., and in the case of the Distributor, Attn: President, with a copy to
Kimberlie L. Cerrone, Esq., Venture Law Group, 2800 Sand Hill Road, Menlo Park,
California 94025, or to such other address as the addressee shall last have
designated by notice to the communicating party. The date of giving any notice
shall be the date of its actual receipt.
24. SURVIVAL. The provisions of Sections 3.3, 3.6, 3.7, 3.8, 6.2, 9.1,
9.2, 9.3, 9.4 and 9.5 of this Agreement shall survive the termination or
expiration of this Agreement (as the case may be) and shall remain in full force
and effect. The provisions of this Agreement that do not survive termination or
expiration hereof (as the case may be) shall, nonetheless, be controlling on,
and shall be used in construing and interpreting the rights and obligations of
the parties hereto with regard to, any dispute, controversy or claim which may
arise under, out of, or in connection with this Agreement.
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 32
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25. MISCELLANEOUS. This Agreement sets forth the entire agreement
between the parties with respect to the transactions and arrangements
contemplated hereby and supersedes all prior oral or written arrangements. This
Agreement may be modified or amended only by a written instrument executed and
delivered by both parties. None of the provisions of this Agreement shall be
deemed to have been waived by any act or acquiescence on the part of either
party except by an instrument in writing signed and delivered by the party
executing the waiver. This Agreement may be executed in several identical
counterparts, each of which shall be an original, but all of which constitute
one instrument, and in making proof of this Agreement it shall not be necessary
to produce or account for more than one such counterpart.
[The remainder of this page is intentionnaly left blank.]
<PAGE> 33
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the date and year first above written.
COLLAGEN CORPORATION
By: /s/ HOWARD D. PALEFSKY
---------------------------------------
Name: Howard D. Palefsky
Title: Chairman & CEO
BIOMATRIX, INC.
By: /s/ ENDRE A. BALAZS
---------------------------------------
Name: Endre A. Balazs
Title: CEO
<PAGE> 34
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EXHIBITS
<TABLE>
<S> <C> <C>
Exhibit A - Agreement Product Specification and Approval Documents
Exhibit B - Launch Schedule
Exhibit C - Patents and Trademarks
Exhibit D - Sales Forecasts
</TABLE>
<PAGE> 35
EXHIBIT A
Agreement Product Specification and Approval Documents
TESTS PROCEDURES SPECIFICATIONS
[ *** }
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 36
EXHIBIT B
Launch Schedule
Date of Launch
--------------
United States
[ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 37
EXHIBIT C
Patents and Trademarks
Patents
[ *** ]
Trademarks
[ *** ]
***Confidential portions have been omitted and filed separately with the
Securities and Exchange Commission.
<PAGE> 38
EXHIBIT D
Sales Forecasts(1)
(Units)
First Agreement Year
(1) The parties acknowledge that in the event of the addition of other syringe
sizes this forecast is subject to adjustment to incorporate such new sizes.
