1
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 ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇.▇.▇.
("Biomatrix") and SYNTEX PHARMACEUTICALS INTERNATIONAL LIMITED, a Bermudan
corporation with its registered office at The ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇, ▇▇▇▇▇▇▇ ("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 (▇▇▇▇▇ ▇-▇ 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 ▇▇▇". For the purpose of this Agreement, "DOM ▇▇▇"
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 "▇▇▇").
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.
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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.
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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., ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇
of America and manufactured by Biomatrix Medical Canada Inc., ▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇-▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇, 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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* Confidential portions have been omitted and filed separately with the
Commission.
17
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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.
▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇.▇. ▇▇▇▇▇ ▇.▇.▇.
Attention: Head of Clinical and Regulatory Department
Telephone: (▇▇▇) ▇▇▇ ▇▇▇▇
Telefax: (▇▇▇) ▇▇▇ ▇▇▇▇
In the case of Syntex to:
▇▇▇▇▇ ▇.▇.
▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇
▇.▇. ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇
Attention: Head of Registration Department
Telephone: (▇) ▇▇▇ ▇▇▇▇
Telefax: (▇) ▇▇▇ ▇▇▇▇
and to:
Roche Products (Proprietary) Limited
▇.▇. ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇
Attention: Head of Registration Department
Telephone: (▇▇) ▇▇▇ ▇▇▇▇
Telefax: (▇▇) ▇▇▇ ▇▇▇▇
with a copy to:
▇. ▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Ltd.
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* Confidential portions have been omitted and filed separately with the
Commission.
18
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▇▇▇▇▇▇▇▇▇▇▇▇▇. ▇▇▇
▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇
Attention: Head of Pharma Drug Safety (PDS)
Telefax: (▇▇▇▇) ▇▇▇ ▇▇ ▇▇
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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* Confidential portions have been omitted and filed separately with the
Commission.
19
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(a) The "Formula Price" per unit of the Agreement Product shall be
determined for each country as follows:
20
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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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* Confidential portions have been omitted and filed separately with the
Commission.
21
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(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.
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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* Confidential portions have been omitted and filed separately with the
Commission.
23
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Percentage for Percentage for
Period Finished Units Components
------ -------------- ----------
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
* *
(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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* Confidential portions have been omitted and filed separately with the
Commission.
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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* Confidential portions have been omitted and filed separately with the
Commission.
25
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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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* Confidential portions have been omitted and filed separately with the
Commission.
26
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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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* Confidential portions have been omitted and filed separately with the
Commission.
27
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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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* Confidential portions have been omitted and filed separately with the
Commission.
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(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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* Confidential portions have been omitted and filed separately with the
Commission.
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(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
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* Confidential portions have been omitted and filed separately with the
Commission.
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.
----------
* Confidential portions have been omitted and filed separately with the
Commission.
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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.
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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.
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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;
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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:
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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.
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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
----------
* Confidential portions have been omitted and filed separately with the
Commission.
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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.
----------
* Confidential portions have been omitted and filed separately with the
Commission.
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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
----------
* Confidential portions have been omitted and filed separately with the
Commission.
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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,
----------
* Confidential portions have been omitted and filed separately with the
Commission.
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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
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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, ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇ Attn: ▇▇▇▇ ▇▇▇▇▇▇▇▇, and with a copy to: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, Esq.,
▇▇▇▇▇▇▇, ▇▇▇▇ & ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, U.S.A.,
and in the case of Syntex, Attn: Head of Business Development and Strategic
Marketing, ▇. ▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ 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.
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 ▇. ▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇
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.
45
-43-
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/ ▇▇▇▇ ▇▇▇▇▇▇
------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇
Title: President
BIOMATRIX, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Chief Executive Officer
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
47
EXHIBIT A
*
----------
* Confidential portions have been omitted and filed separately with the
Commission.
48
EXHIBIT B
*
----------
* Confidential portions have been omitted and filed separately with the
Commission.
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.
50
EXHIBIT C
Trademarks
U.K.
*
Ireland
*
Germany
*
France
*
Benelux
*
Sweden
*
Finland *
Iceland *
Denmark
*
Norway
*
Switzerland
*
Spain *
South Africa
*
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* Confidential portions have been omitted and filed separately with the
Commission.
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.
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* Confidential portions have been omitted and filed separately with the
Commission.
52
EXHIBIT E
SYNTEX SALES FORECAST
12 MONTHS PERIOD
(Units/Syringes)
================================================================================
Years from launch I II III
▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇ * * *
--------------------------------------------------------------------------------
Sweden * * *
--------------------------------------------------------------------------------
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* Confidential portions have been omitted and filed separately with the
Commission.
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
