EXHIBIT 10.45
*Confidential portions have been omitted and filed separately with the
Commission.
INTERNATIONAL LICENSE AGREEMENT
THIS AGREEMENT is made as of the 7th day of February 1997 by and between
BIOMATRIX, INC., a Delaware corporation, having its principal office at ▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇.▇.▇. ("Biomatrix") and AMERICAN
HOME PRODUCTS CORPORATION, a Delaware corporation having its principal office at
Five Giralda Farms, Madison, New Jersey 07990, U.S.A., acting through its
unincorporated Wyeth-Ayerst Laboratories division (such entities are together
defined herein as "Wyeth").
WHEREAS, Biomatrix is engaged in the development and manufacture of the
Products (as hereinafter defined);
WHEREAS, Wyeth desires to enter into an exclusive (except as provided
herein) license to market and sell Products and Extended Products (as
hereinafter defined) in the Territory (as hereinafter defined), and Biomatrix is
willing to grant such rights to Wyeth;
WHEREAS, on the terms and subject to the conditions set forth in the Supply
Agreement (as hereinafter defined), Wyeth desires to purchase from Biomatrix,
and Biomatrix desires to sell to Wyeth, Wyeth's requirements of Products and
Extended Products in the Territory; and
WHEREAS, as of the date hereof, Biomatrix and Wyeth are entering into the
U.S. Agreement (as defined below), the Supply Agreement (as defined below) and
the Trademark Agreement (as defined below);
NOW, THEREFORE, in consideration of the premises and of the mutual
covenants of the parties hereto, it is hereby agreed as follows:
1. DEFINITIONS. In this Agreement, the following words and expressions
shall have the following meanings:
1.1. "Additional Period" shall mean that term as defined in Section 3.1.
1.2. "Affiliate" shall mean, with respect to any party, any Person that,
directly or indirectly, is controlled by, controls or is under common control
with such party, but only for so long as such relationship exists.
1.3. "Applicable Currency" shall mean, with respect to a country in the
Territory, the lawful currency of such country.
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1.4. "Commercial Sale" means that sales by Wyeth or its Affiliates to
non-affiliated third-party purchasers shall have commenced with defined prices
and are supported by normal sales promotion activities.
1.5. "Competing Product" shall mean any
*
1.6. "Confidential Information" shall mean that term as defined in Section
7.1.
1.7. "Contract Quarter" shall mean, with respect to a country in the
Territory, the three (3) month period commencing on the first day of the first
fiscal quarter beginning immediately after the Launch Date in such country
(unless the Launch Date is the first day of a fiscal quarter, in which case the
first Contract Quarter shall commence on such day) and ending on the last day of
the fiscal quarter and each fiscal quarter thereafter throughout the term of
this Agreement.
1.8. "Contract Year" shall mean, with respect to a country in the
Territory, the twelve (12) month period commencing on the first day of the first
fiscal quarter beginning immediately after the Launch Date in such country
(unless the Launch Date is the first day of a fiscal quarter, in which case the
first Contract Year shall commence on such day) and each separate successive
twelve (12) month period thereafter.
1.9. "Development Program" shall mean the development program as set forth
in the U.S. Agreement.
1.10. "Effective Date" shall mean the date of this Agreement.
1.11. "Employment Costs" shall mean, with respect to any employee of
Biomatrix, for any period, the aggregate amount of
*
1.12. "Extended Product" shall mean
*
1.13. "Field" shall mean the
*
*Confidential portions have been omitted and filed separately with
the Commission.
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1.14. "Improvements" shall mean
*
1.15. "Initial Product" shall mean hylan gel-fluid 20 (▇▇▇▇▇ ▇-▇ 20)
Synvisc currently approved as a device with a CE ▇▇▇▇ for the intra-articular
treatment by viscosupplementation of osteoarthritis of the knee, to be supplied
in pre-filled syringes packaged ready for use, complying with Product Approvals
in the Territory as a device.
1.16. "Initial Product Specifications" shall mean the specifications for
the Initial Product set forth in Exhibit A, as such specifications may be
modified from time to time by agreement of the parties to reflect Improvements.
1.17. "Launch Date" shall mean, with respect to a country in the Territory,
the date of national introduction for commercial sale of the Product by Wyeth or
an Affiliate of Wyeth in such country.
1.18. "Net Revenues" shall mean for a specified period the total gross
invoice price received from the sale of all Products and Extended Products by
Wyeth and its Affiliates in the Territory during such period to non-Affiliated
wholesalers, hospitals, retail pharmacies, patients and other third party
purchasers,
*
Such amounts shall be determined from the books and records of Wyeth and its
Affiliates maintained in accordance with generally accepted accounting
principles, consistently applied.
1.19. "Non-competition Period" shall mean the period commencing on the
Effective Date and continuing until
*
thereafter.
1.20. "Patents" shall mean Letters Patent, or similar statutory rights
relating to any Products (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 B hereto,
together with any supplementary or complementary protection certificates
therefor if and when such are granted.
*Confidential portions have been omitted and filed separately with
the Commission.
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1.21. "Person" or "person" shall mean an individual, a corporation, a
partnership, a trust, an unincorporated organization or a government or any
agency or political subdivision thereof.
1.22. "Product Approvals" shall mean, for any country in the Territory,
those regulatory approvals required for importation, promotion, pricing,
marketing and sale of a Product or Extended Product in such country.
1.23. "Product(s)" shall mean the Initial Product, together with any
Improvements (as defined in Section 1.14) to the Initial Product.
1.24. "Product Specialist" shall mean that term as defined in Section 8.10.
1.25. "Reimbursement Approvals" shall mean any and all governmental and
other approvals necessary in any country in the Territory for the buyer of
Products or Extended Products to claim reimbursement for the purchase of the
Products or Extended Products from private or public health insurance
organizations in such country.
1.26. "Region" shall mean any one of the following groups of countries:
*
1.27. "Supply Agreement" shall mean the Supply Agreement of even date
herewith by and between Biomatrix (or one of its Affiliates) and Wyeth (or one
of its Affiliates) as the same may be amended, supplemented, modified or
restated and as in effect from time to time, and any replacement supply
agreement with respect to Products and Extended Products by and between
Biomatrix (or one of its Affiliates) and Wyeth (or one of its Affiliates).
1.28. "Territory" shall mean all of the countries set forth under Section
1.26 above, subject to adjustment as set forth in Section 2.1(d).
1.29. "Trademarks" shall mean (i) the trademark Synvisc(R) and each other
▇▇▇▇, trademark or service ▇▇▇▇ described on Exhibit B hereto, and (ii) any
other marks, trademarks or service marks, as may be agreed upon in writing from
time to time by the parties hereto for use by Wyeth in connection with the
promotion, marketing and sale of the Product under this Agreement.
1.30. "Trademark Agreement" shall mean the Trademark License Agreement of
even date herewith by and between Biomatrix and Wyeth as the same may be
amended, supplemented, modified or restated and as in effect from time to time,
and any replacement Trademark License Agreement by and between Biomatrix and
Wyeth.
*Confidential portions have been omitted and filed separately with
the Commission.
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1.31. "Unit" shall mean, with respect to the Initial Product, a 2.0ml
syringe of the Initial Product.
1.32. "U.S. Agreement" shall mean the agreement of even date herewith by
and between Biomatrix and Wyeth relating to the marketing of Products and
Extended Products in the United States, as the same may be amended,
supplemented, modified or restated and as in effect from time to time.
1.33. "U.S. Dollars" and "US$" shall mean the lawful currency of the United
States of America.
2. GRANT OF RIGHTS; ACCEPTANCE; EXCLUSIVITY; CERTAIN PAYMENTS.
2.1. Grant of License. (a) Subject to the terms and conditions hereinafter
set forth, Biomatrix hereby grants to Wyeth an exclusive (except as to
Biomatrix's right to promote, market and sell the Products and Extended Products
as set forth in Sections 2.3 and 8.10) license (without the right to appoint
sub-licensees, sub-agents or subdistributors) under the Patents to import,
promote, market, offer for sale and sell Products and Extended Products for use
in the Field within the Territory. Such Products and Extended Products shall be
packaged and supplied by Biomatrix or an Affiliate of Biomatrix to Wyeth
pursuant to the Supply Agreement.
(b) Except as specifically provided to the contrary herein, the foregoing
license shall not be construed (i) to effect any sale of proprietary Biomatrix
technology, (ii) to grant any license relating to Biomatrix's proprietary
methods of formulating, fabricating and manufacturing the Products and Extended
Products, (iii) to ▇▇▇▇▇ ▇▇▇▇▇ any rights in or to the use of any proprietary
technology or Patents, or Trademarks of Biomatrix by implication or otherwise.
During the term of this Agreement Wyeth shall neither seek customers for the
Products or Extended Products outside the Territory, nor establish any branch or
maintain any distribution facilities outside the Territory for the promotion,
marketing, sale or distribution of Products or Extended Products outside the
Territory.
(c) It is understood by the parties that through the Development Program
Improvements and Extended Products may be developed. The parties agree that the
provisions relating to the Development Program are hereby incorporated into this
Agreement and any rights relating to Improvements and Extended Products under
the Development Program shall be incorporated into this Agreement.
(d) The parties agree that Wyeth shall develop during the
*
period immediately following the Effective Date business plans for the
marketing and sale of Products in the Middle East Region and the ECE Region, and
during the
*
period following the Effective Date a business plan for the marketing and
sale of Products in Spain. After the delivery of such business plans to
Biomatrix:
*Confidential portions have been omitted and filed separately with
the Commission.
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*
2.2. Acceptance of Obligations;
*
(a) Wyeth hereby accepts the license granted in section 2.1 above and
hereby agrees to use
*
(as defined below), at all times during the term of this Agreement, to import,
promote, market, offer for sale and sell the Products and Extended Products in
the Territory.
*
Wyeth shall promote the sale of Products and Extended Products through its sales
force, which shall receive training and support and have skills and resources
commensurate with those of Wyeth's sales force for other products which are of a
similar nature as the Products and Extended Products. Wyeth has no authority to
appoint any subagent, subdistributor, or other person to promote the sale of the
Products or Extended Products or to otherwise perform any of Wyeth's obligations
hereunder and agrees to refrain from using any such subagents, subdistributors
or other persons.
(b) Subject to delivery to Wyeth by Biomatrix of Wyeth's (i) launch
quantities as set forth on Exhibit C to the Supply Agreement and (ii)
*
of the First Contract Year sample quantities of the Initial Product, each
ordered in accordance with the terms of this Agreement and the Supply Agreement,
the Launch Date with respect to each country in the Territory
*
of the later of (i) Effective Date or (ii) Product Approval date.
*
*Confidential portions have been omitted and filed separately with
the Commission.
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2.3. Conversion to Co-promotion or Co-exclusive License.
(a) Failure to Meet
*
Sales Goals. In the event that Wyeth's cumulative Net Revenues from sales of
Products in the
*
with respect to any Region set forth on Exhibit C shall fail to exceed the
*
set forth opposite such Region on Exhibit C, then Biomatrix may, at its option,
elect to co-promote the Products and Extended Products or any Improvement in
such Region either itself (or through an Affiliate) or with a designee (a
"Designee") selling for Wyeth's account. Such co-promotion may be either on a
fixed cost reimbursement or performance/incentive basis as agreed upon by the
parties. Biomatrix shall make any such elections within
*
after delivery to Wyeth of a notice of any such failure to meet such
*
The parties agree that they will in good faith adjust such amounts on Exhibit C
if Wyeth can demonstrate that parallel imports of Products or other factors such
as competitive products being introduced, lower than anticipated reimbursed
price approval and other material external market factors had a material adverse
impact on its ability to achieve such amounts in any such Region. If Biomatrix
elects to convert this Agreement to a co-promotional arrangement with respect to
one or more Regions pursuant to the provisions of this Section 2.3, then
Biomatrix (or an Affiliate) or its Designee shall be compensated as follows:
*
If Biomatrix elects to co-promote the Products and Extended Products in any
Region, then Biomatrix (or an Affiliate) or its Designee may co-promote under
the Trademark in such Region.
(b) Failure to Meet Marketing Plan Goals. In the event that Wyeth's Net
Revenue from sales of Products in any Region in the Territory during the
*
shall fail to exceed,
*
of the projected Net Revenue set forth in the marketing plan prepared in
accordance with Section 8.8 for such Region, then Biomatrix may elect (i) to
co-promote the Products and Extended Products under the Trademark for Wyeth's
account itself (or through an Affiliate) in such Region, and/or appoint one
Designee (other than Wyeth or any of its Affiliates) in such Region, or (ii) to
convert Wyeth's license rights in such Region to co-exclusive and co-market the
Products and Extended Products itself (or through an Affiliate) in such Region,
and/or appoint one Designee (other than Wyeth or any of its Affiliates) in such
Region, under a trademark that is not similar to the Trademark.
*Confidential portions have been omitted and filed separately with
the Commission.
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Biomatrix shall make any such election with respect to any such Region within
*
with respect to such Region. If Biomatrix elects to co-promote the Products or
Extended Products itself (or through an Affiliate or Designee) with respect to
one or more Regions pursuant to the provisions of this Section 2.3(b), then
Biomatrix (or an Affiliate or Designee) shall be compensated on one of the
following bases:
*
If Biomatrix elects to convert Wyeth's rights in such Region(s) to co-exclusive
and co-market the Products and Extended Products ) (or through an Affiliate)
itself or in conjunction with a Designee with respect to one or more Regions
pursuant to the provisions of this Paragraph 2.3(b), then neither party shall
have any financial obligations to the other in connection with any sales by
Biomatrix (or an Affiliate) or its Designee under such co-marketing arrangement
(other than any obligations under the Supply Agreement and/or the Trademark
Agreement).
2.4 [RESERVED]
2.5. Development Payments. As an inducement for and in consideration of the
agreement of Biomatrix to actively participate in and support the Development
Program as set forth in Section 6 of the U.S. Agreement, Wyeth hereby agrees to
make the following non-refundable payments to Biomatrix:
(a) On the Effective Date Wyeth shall pay Biomatrix the amount of Four
Million U.S. Dollars ($4,000,000).
(b)
*
payable within five (5) days of
*
(c)
*
payable within five (5) days after the last day of the month in which
*
in the Territory exceed
*
in the aggregate.
2.6. Payments. In consideration for its license rights hereunder Wyeth will
compensate Biomatrix for the use of its Trademarks, and the Patent and know-how
components of the Products as follows:
(a) Initial Term. During the Initial Term (as defined in the Supply
Agreement), Wyeth will pay Biomatrix for Products according to the provisions of
the Supply Agreement.
*Confidential portions have been omitted and filed separately with
the Commission.
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(b) Exclusive Additional Period. During any Additional Period in which
*
Wyeth will pay Biomatrix for Products for sale in such country according to the
provisions of the Supply Agreement
*
(c)
*
2.7. Nature of Payments. Each of the payments referred to in Sections 2.4,
2.5 and 2.6 hereof are independent of each other payment hereunder and shall not
be deemed satisfied by the making of any other payment hereunder. All payments
to be made pursuant to Sections 2.5 and 2.6 or under the Supply Agreement shall
be made in U.S. Dollars. Net Revenues denominated in an Applicable Currency used
in determining whether a payment is due shall be converted to U.S. Dollars in
accordance with Section 4.
2.8. Operations and Expenses. Except as otherwise set forth in this
Agreement, the operations of Wyeth under this Agreement are subject to the sole
control and management of Wyeth. Wyeth shall be responsible for all of its own
expenses and employees. Wyeth shall provide, at its own expense, such office
space and facilities, and hire and train such personnel, as may be required to
carry out its obligations under this Agreement. Wyeth agrees that it shall incur
no expense chargeable to Biomatrix, except as may be specifically authorized in
advance in writing in each case by Biomatrix.
2.9 Independent Purchaser and Seller. Neither party shall be considered an
agent or legal representative of the other party for any purpose, and neither
party nor any director, officer, agent or employee thereof shall be, or be
considered, an agent or employee of the other party. Neither party is granted
nor shall exercise the right or authority to assume or create any obligation or
responsibility, including without limitation contractual obligations and
obligations based on warranties or guarantees, on behalf of or in the name of
the other party.
3. TERM AND TERMINATION.
3.1. Term.
(a) Initial Term. Unless this Agreement is sooner terminated in accordance
with the provisions of this Agreement, this Agreement shall commence on the
Effective Date and shall end with respect to Products, on a country-by-country
basis, on the later to
*Confidential portions have been omitted and filed separately with
the Commission.
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occur of (i) the
*
of the Launch Date in such country or (ii) the date of the expiration of the
last to expire of the Patents in such country (the "Initial Term"); provided,
however, that payments on account of the Trademark Royalty under Section 2.6(c)
shall continue at all times when Wyeth is utilizing the Trademark under the
terms set forth in the Trademark Agreement.
(b) Additional Periods. This license shall be renewable following the
expiration of the Initial Term for further additional
*
under the provisions of either Section 2.6(b) or Section 2.6(c) (each such
additional term, an "Additional Period"). The parties shall agree in writing
upon whether the Additional Period shall be
*
at least
*
prior to the commencement of any such Additional Period. Biomatrix shall
continue to supply Products,
*
as mutually agreed, until such time as Wyeth elects not to renew this license.
3.2.
*
3.3. Insolvency. This Agreement may be immediately terminated by either
party, upon giving written notice to the other party, in the event that the
other party shall become insolvent or be declared bankrupt by a court of
competent jurisdiction or shall be the subject of any reorganization (other than
a corporate reorganization effected in the ordinary course of business and not
arising out of any insolvency) or winding up, receivership or dissolution,
bankruptcy or liquidation proceeding, or any proceeding or action similar to one
or more of the above, in which case termination shall be effective upon such
written notice. The failure of either party to give notice of termination upon
obtaining knowledge of any such event shall not be interpreted as a waiver of
such party's rights under this Section 3.3, and such party reserves the right to
exercise any such rights at any time after the occurrence of any such event.
3.4. Breach. This Agreement may be terminated by either party if the other
party shall commit a material breach of any provision hereof and shall not cure
such breach within
*
after a written notice by the other party to cure the breach; provided, that in
the case of a payment breach such cure period shall be equal to
*
*Confidential portions have been omitted and filed separately with
the Commission.
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after written notice.
*
3.5.
*
3.6. Certain Rights Upon Termination. Upon termination of this Agreement
for any reason whatsoever, other than pursuant to Section 3.1,
(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 without
limitation, marketing information and information relating to laboratory, animal
and human studies), and related regulatory approvals pertaining to the Products
(the "Information") which are possessed or controlled by Wyeth or any of its
Affiliates, or which Wyeth or any of its Affiliates has a right to review,
access or use. Wyeth 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
rights In addition, Wyeth agrees that it shall, upon the request of Biomatrix,
immediately inform all relevant regulatory authorities that Wyeth is no longer a
licensee of the Products and shall take all action and execute and deliver all
documents and instruments necessary in order to transfer all Product Approvals,
*Confidential portions have been omitted and filed separately with
the Commission.
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Reimbursement Approvals and price approvals and other relevant documents
relating to the Products to Biomatrix or any Person designated by Biomatrix.
(b) Notwithstanding the provisions of Section 3.6(a), both parties in good
faith shall take whatever action necessary to clarify the relationship between
Wyeth and Biomatrix during an Additional Period.
3.7. Effects of Termination.
(a) Subject to Wyeth's rights set forth in Section 3.2(a), upon termination
of this Agreement for any reason, other than pursuant to Section 3.1, Wyeth
shall discontinue using the Trademarks or making any representations regarding
its status as a licensee of Biomatrix and shall cease conducting any activities
with respect to the marketing, promotion, sale or distribution of the Products
in the Territory and shall take such action as is necessary to terminate Wyeth's
registration as Biomatrix's licensee with any governmental authority.
(b) Termination of this Agreement shall not affect obligations of either
party that may have accrued prior to the effective date of termination or any
obligation specifically stated to survive termination. Except to the extent
limited by Section 3.8, 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. Wyeth and Biomatrix hereby waive, to the extent they are able
to do so under applicable law, any statutory rights they may have or acquire
under the laws of any country in the Territory in respect of the termination of
the relationship established hereby pursuant to the terms hereof, and agree that
the rights available to them hereunder in the event of such termination are
adequate and reflect the agreement of the parties. Neither Wyeth nor Biomatrix
nor any of their respective Affiliates shall have any right to claim any
indemnity for goodwill or loss thereof, lost profits, loss of prospective
compensation, expenditures, investments, leases or any type of commitment made
in connection with the business of such party in reliance on the existence of
this Agreement or any damages arising from the termination of this Agreement by
the other party in accordance with the terms hereof.
4. PAYMENTS; EXCHANGE RATE.
(a) All payments hereunder shall be made in U.S. Dollars and at the
exchange rates set forth in this Section 4. Payments to Biomatrix shall be wired
to an account in a bank designated by Biomatrix and the costs of any such
remittance shall be borne by Wyeth.
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(b) All amounts denominated in an Applicable Currency shall be converted to
U.S. Dollars using the consistently applied method of conversion utilized by
Wyeth at the corporate level for financial reporting purposes, which method
shall be in accordance with generally accepted accounting principles.
5. WITHHOLDING. All payments to be made by Wyeth under this Agreement shall
be made in full, free and clear of and without any deduction of or withholding
for or on account of any taxes levied in any country of the Territory or
elsewhere; provided that if Wyeth shall be required by law to make any deduction
or withholding from any payment to Biomatrix then:
(i) Wyeth shall ensure that such deduction or withholding does not exceed
the minimum legal liability therefor;
(ii) at least thirty (30) days prior to the first deduction or withholding,
Wyeth shall notify Biomatrix thereof, and the parties shall negotiate in good
faith adjustments to the payments hereunder in order to minimize or eliminate
such deduction or withholding, provided that the total payments by Wyeth shall
not increase; and
(iii) Wyeth shall forward to Biomatrix such documentary evidence as may be
available in respect of each deduction, withholding or payment together with
each payment or promptly thereafter.
6. COMPETING PRODUCTS.
6.1. Non-competition by Wyeth. In recognition of the rights granted by
Biomatrix to Wyeth and the other obligations of Biomatrix hereunder, Wyeth
agrees that it shall not, directly or indirectly (alone or with others), and it
shall ensure that its Affiliates shall not, directly or indirectly (alone or
with others), during the Non-competition Period, manufacture, sell, market,
distribute or promote a Competing Product in the Territory;
*
If Wyeth
*
Wyeth agrees that (a) it shall not expand the market where it sells such
Competing Product into any country in the Territory in which such Competing
Product is not currently sold at the time of any such acquisition and (b) Wyeth
shall
*
Wyeth acknowledges and agrees that, in the event of a breach or threatened
breach by Wyeth of its obligations under this Section 6.1, Biomatrix will have
no adequate remedy at law, and accordingly shall be entitled to injunctive or
*Confidential portions have been omitted and filed separately with
the Commission.
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other appropriate equitable remedies against such breach or threatened breach in
addition to any other remedies which Biomatrix may have.
6.2.
*
7. CONFIDENTIAL INFORMATION; PUBLIC ANNOUNCEMENTS.
7.1. 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
*Confidential portions have been omitted and filed separately with
the Commission.
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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, the Information described in Section 3.5, 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 7.1 shall not apply to any information or
data to the extent that the Recipient:
(i) 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;
(ii) is required by any government authority to disclose such information
or data, including without limitation for the purposes of obtaining and
maintaining any Product Approvals under this Agreement; or
(iii) shall demonstrate by its written records that such information or
data 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.
All 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. The Recipient shall then attest to the Discloser in writing as to the
return and/or destruction of the Confidential Information. Such return (and
destruction) will not affect the Recipient's obligations hereunder, which shall
survive indefinitely or, if a definite period is required under applicable law,
until five (5) years after termination or expiration of this Agreement.
Notwithstanding anything herein to the contrary, the provisions of this Section
7.1 shall be subject to Biomatrix's rights under Section 3.5.
7.2. Public Announcement. Except as shall be necessary for governmental
notification purposes or to comply with applicable laws and regulations, and
except as
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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. The parties shall agree upon the text of an initial
public announcement relating to the transactions contemplated by this Agreement
as soon as possible after the Effective Date. 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.
8. INTELLECTUAL PROPERTY; AGREEMENT PRODUCT MARKING; PROMOTIONAL
INFORMATION; REGULATORY MATTERS.
8.1. PATENTS. (a) Biomatrix shall be responsible, at its cost and expense,
for prosecuting to issuance in the Territory all patent applications, for filing
and prosecuting all patent reissues and reexaminations, for applying for and
obtaining any Supplementary Protection Certificates, and for paying all
annuities, on all patents, and all such applications and patents shall
constitute Patents under this Agreement.
(b) Upon request of Wyeth, Biomatrix shall provide Wyeth with a copy of the
prosecution file wrapper histories of each patent and application constituting
Patents under this Agreement.
8.2. Trademarks. The Trademark Agreement sets forth the terms and
conditions of Wyeth's use of the Trademarks. Upon termination of this Agreement,
all rights set forth herein with respect to the Trademarks shall terminate and
the rights and obligations set forth in the Trademark Agreement shall govern the
use of the Trademarks.
8.3. Notice of Infringement. Each party hereto agrees to notify the other
in writing promptly (but not later than thirty (30) days) after obtaining
knowledge of any infringements or imitations of the Trademarks or Patents by
third parties. Further, Wyeth agrees to notify Biomatrix immediately after it
becomes aware that any of the Products or Extended Products sold in the
Territory are thereafter sold or transported outside the Territory.
8.4. Labelling and Promotional Materials. Wyeth shall provide Biomatrix
with labelling masters, instructions, specifications and copies of all
marketing, labelling and promotional material it intends to use relating to the
Products or Extended Products. All such labelling, packaging and promotional
material that include claims or items impacting regulatory approvals shall be
consistent with all relevant regulatory requirements and shall be reviewed by
Biomatrix and shall be subject to its written approval prior to use. All other
major promotional materials for launches and subsequent promotions shall be
provided by Wyeth to Biomatrix within a reasonable time prior to their use in
order to allow Biomatrix to comment on such materials. Wyeth shall provide
Biomatrix with all other promotional materials as promptly as practicable.
-16-
8.5. Legend. Subject to applicable laws and regulations in the Territory,
all relevant packaging and promotional material for the Products and Extended
Products used or sold by Wyeth shall contain (i) all applicable markings needed
to keep the Trademarks enforceable throughout the Territory as specified in
writing by Biomatrix to Wyeth, and (ii) a legend which shall be displayed in a
reasonably conspicuous manner on all packaging of such Products and Extended
Products containing the corporate identification logo of Biomatrix in at least
equal prominence as that of Wyeth, and indicating that such Product or Extended
Product has been developed and manufactured by Biomatrix, Inc., and its
affiliates, ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇.▇.▇. or similar
statement in such form as is consistent with Biomatrix's practices in
distributing the Agreement Product through other distribution arrangements in
other territories.
8.6. Promotional Support.
(a) Samples. Wyeth will be allowed to purchase up to a maximum of
*
respectively, solely for the purposes of promotion of the Initial Product in the
Territory. Biomatrix agrees to sell such samples to Wyeth for a price equal to
*
for each such Unit.
(b) Exchange of Information. Biomatrix and Wyeth shall provide to each
other on an ongoing basis and without charge (to the extent not prevented by law
or contract from doing so) all marketing, medical, scientific and other
information relating to the Products and Extended Products (including summary
data from studies, clinical trials and the like as well as information regarding
adverse events associated with the use of the Products and Extended Products),
the proceedings of all symposia on the Products and Extended Products and all
promotional information that is available to such party relating to the Products
and Extended Products. In addition, Biomatrix and Wyeth shall provide each other
with access to such primary data and information in its possession as the other
may reasonably request regarding the results of the studies contained in such
summary data referred to above. Each party shall have the right to use the
marketing, promotional, medical, scientific and other information of the other
party as long as such use is not restricted or limited by any other provision in
this Agreement.
(c) Reference to Viscosupplementation and Biomatrix. Subject to applicable
laws and regulations in the Territory, Wyeth shall ensure that all trade
literature, publications and promotional materials relating to the Products and
Extended Products produced by or on behalf of Wyeth or any of its Affiliates
shall, in a reasonably conspicuous manner, refer to viscosupplementation. In
major promotional materials, and other material where appropriate, Wyeth shall
in a reasonably conspicuous manner reference that the concept and the name
viscosupplementation have been conceived and introduced by the founders of
Biomatrix. The product positioning for the Initial Product shall be the same as
is currently used by Biomatrix, as redefined from time to time by Biomatrix
based upon current and new scientific, medical or marketing information
obtained.
*Confidential portions have been omitted and filed separately with
the Commission.
-17-
8.7. Customer Service. In connection with sales of Products and Extended
Products in the Territory, Wyeth shall carry out, at its expense, all order
entry, sales reporting, accounts receivable and collections and costs related
thereto.
8.8. Marketing Plan. Three months prior to the end of the
*
Agreement Year, Wyeth shall prepare at its own expense and deliver to Biomatrix
a
*
forecast of its sales of Products and Extended Products in the Territory on a
Region by Region basis (the "Marketing Plan") setting forth (i) its projections
of Net Revenues for each country in the Territory for each of the
*
(ii) its projected marketing efforts in the Territory during such
*
period, and its projections of the cost thereof, and (iii) its projected
marketing mix. Wyeth shall prepare the Marketing Plan in good faith and shall
use Commercially Reasonable Efforts in such preparation.
8.9. Development, Marketing and Sales Steering Committee. The parties shall
establish a development, marketing and sales steering committee (the
"Committee") comprised of three (3) voting representatives designated by each
party. The Committee will be administered by a chairman appointed from the
members, alternating yearly among representatives of Biomatrix and Wyeth. The
Committee will meet at least twice annually, or more often if necessary as
requested by either party, and written minutes of each meeting shall be kept. In
addition to any specific powers granted to the Committee in this Agreement and
the Supply Agreement, the Committee shall oversee the continued development of
the Improvements and Extended Products with respect to label extensions, product
reimbursement approvals, the marketing and sale of the Products and Extended
Products, and the development of promotional programs and the preparation of
marketing studies. The Committee shall not have the authority to change the
responsibilities of the parties under this Agreement. Decisions of the Committee
shall be made by consensus (a majority of the members designated by each party).
The Committee will have no control over the marketing and sales budget of either
party. If, after a period of thirty (30) days (or earlier at the election of
either party), a matter is still not resolved, it shall be referred to the CEO
of Biomatrix and the Executive Officer of American Home Products Corporation
responsible for its global pharmaceutical operations, or their designees, to
resolve in a period of thirty (30) days through good faith discussions, or if
still unresolved, to promptly agree upon a binding third party dispute
resolution mechanism intended to promptly and fairly resolve the matter in
dispute. The Committee will have no control over the marketing, sales or
development budget of either party.
8.10. Co-Promotion.
*
Biomatrix shall hire and train as employees of Biomatrix (at Wyeth's expense)
*
sales representatives for
*
active in marketing and sale of the Products (the "Product Specialists"). The
Product Specialists shall co-promote the
*Confidential portions have been omitted and filed separately with
the Commission.
-18-
Products and Extended Products in cooperation with Wyeth's marketing and sales
force in accordance with marketing plans approved by the Committee. All sales of
the Products in the Territory made by the Product Specialists during the term
hereof shall be
*
Beginning in the
*
Biomatrix shall have the right to require that the Product Specialists be
permitted to market, promote and sell other products manufactured by Biomatrix
for the account of Biomatrix. Subject to applicable
*
laws, Biomatrix shall consider for employment current employees of Wyeth as
Product Specialists. Biomatrix shall have the right to assign up to a total of
*
of the Product Specialists under this Agreement and the U.S. Agreement toward
the promotion of Products and Extended Products
*
8.11. Customer Lists. Wyeth shall maintain a master customer list
containing relevant information on sales of the Products and shall deliver
copies of such list to Biomatrix on a quarterly basis for Germany, Spain,
Portugal, Austria and Greece or promptly on the request of Biomatrix but not
more than annually with respect to other countries in the Territory.
8.12 Product Vigilance System. Wyeth shall be responsible for maintaining
medical device vigilance systems, as established for the Products and Extended
Products by applicable regulatory requirements, and shall promptly provide
Biomatrix with notice of all product related events and complaints, including
medical complaints. The parties shall develop a mutually agreed procedure to
comply with regulatory requirements and the policies of each party. Biomatrix
shall be solely responsible for processing, analyzing and, if necessary,
reporting medical complaints to regulatory authorities. Wyeth shall provide all
necessary support to Biomatrix for carrying out such activities.
*Confidential portions have been omitted and filed separately with
the Commission.
-19-
8.13.
*
8.14. Compliance. Wyeth shall, at its expense, obtain any and all import
licenses that may be necessary to permit the sale by Biomatrix and the purchase
by Wyeth of the Products and Extended Products hereunder, obtain such approvals
from the banking and other governmental authorities in the Territory for payment
of all amounts due hereunder to Biomatrix in U.S. Dollars, and comply with any
and all governmental laws, regulations, and orders that may be applicable to
Wyeth by reason of its execution of this Agreement including any requirement to
be registered as the Biomatrix's reseller of products with any governmental
authority, and including all laws, regulations or orders that govern or affect
the ordering, export, shipment, import, sale (including government procurement),
delivery, or redelivery of Products and Extended Products in the Territory.
Wyeth shall furnish Biomatrix with such documentation as Biomatrix may request
to confirm Wyeth's compliance with this Section 8.14 and agrees that it shall
not engage in any course of conduct that, in Biomatrix's reasonable belief,
would cause Biomatrix to be in violation of the laws of any jurisdiction.
*Confidential portions have been omitted and filed separately with
the Commission.
-20-
8.15. Local Laws. Each party shall notify the other party of the existence
and content of any provision of law in the Territory or any other applicable law
that conflicts with any provision of this Agreement at the time of its execution
or thereafter.
8.16. Questionable Payments. Wyeth shall not, directly or indirectly, in
the name of, on behalf of, or for the benefit of Biomatrix offer, promise or
authorize to pay, or pay any compensation or give anything of value to, any
official, agent or employee of any government or governmental agency, or to any
political party or officer, employee or agent thereof in connection with the
promotion or sale of Products and Extended Products.
9. SUPPLY OF PRODUCTS. The Supply Agreement sets forth the terms and
conditions for sale of Products by Biomatrix (or its Affiliates) to Wyeth.
10. INDEMNIFICATION; LIMITATION ON LIABILITY
10.1. Indemnification from Wyeth. Subject to the provisions of Section
10.3, Wyeth 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 or arising out of or in connection with:
*
10.2. Indemnification from Biomatrix. Subject to the provisions of Section
10.3, Biomatrix shall defend, indemnify and hold Wyeth 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 or arising out of or in connection with:
*Confidential portions have been omitted and filed separately with
the Commission.
-21-
*
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 OR THE SUPPLY AGREEMENT, IN NO
EVENT (INCLUDING THE FAULT, NEGLIGENCE OR STRICT LIABILITY OF EITHER PARTY)
SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY, INCLUDING
ANY PURCHASER OF PRODUCTS OR EXTENDED PRODUCTS, 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 Indemnification Procedure. The party claiming indemnification
("Indemnitee"), after being advised of any assertions of any such third party
claims or suits or upon the bringing or filing of such claims or suits by any
third party against the Indemnitee, shall promptly notify the party from which
indemnification is sought ("Indemnitor") thereof; provided, that the failure to
promptly notify shall not affect the Indemnitor's obligations hereunder except
to the extent the Indemnitor is prejudiced by the delay in notification. The
Indemnitee shall permit the Indemnitor's attorneys to handle and control the
defense of such claims or suits at the Indemnitor's cost. The Indemnitee shall
co-operate with the Indemnitor in the defense of such claims or suits. 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 Indemnitor.
*Confidential portions have been omitted and filed separately with
the Commission.
-22-
11. REPRESENTATIONS OF BIOMATRIX. Biomatrix represents, warrants and
covenants as follows:
11.1. Biomatrix is a corporation duly organized and validly existing under
the laws of the state of Delaware with the full power to conduct its affairs as
currently conducted and contemplated hereunder. All necessary action has been
taken to enable it to execute and deliver this Agreement and perform its
obligations hereunder.
11.2. This Agreement is a valid and binding obligation of Biomatrix
enforceable in accordance with its terms. Biomatrix has the unencumbered right
to enter into this Agreement and to fulfill its duties hereunder. It is not and
will not become a party to any agreement in conflict herewith. Accordingly,
Biomatrix has the right to ▇▇▇▇▇ ▇▇▇▇▇ the exclusive license granted hereunder
in the Territory in accordance with the terms of this Agreement and such grant
will not constitute a breach of any existing contractual or other arrangements
between Biomatrix and any Affiliated or non-Affiliated third party, nor shall it
infringe on 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, other than the Product Approvals contemplated herein.
12. REPRESENTATIONS OF WYETH. Wyeth represents, warrants and covenants as
follows:
12.1. Wyeth 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 be en
taken to enable it to execute and deliver this Agreement and perform its
obligations hereunder.
12.2. This Agreement is Wyeth's valid and binding obligation enforceable in
accordance with its terms. Wyeth has the unencumbered right to enter into this
Agreement and to fulfill its obligations hereunder. It is not and will not
become a party to any agreement in conflict herewith. Accordingly, Wyeth has the
right to act as the exclusive licensee of the Products and Extended Products in
the Territory in accordance with the terms of this Agreement and the performance
of its obligations hereunder will not constitute a breach of any existing
contractual or other arrangements between Wyeth and any Affiliated or
non-Affiliated third party, nor shall it infringe the rights of any Affiliated
or non-Affiliated third party.
12.3. No approval, consent, order, authorization or license by, giving
notice to or taking any other action with respect to any governmental or
regulatory authority is required in connection with the execution and delivery
of this Agreement by Wyeth and
*Confidential portions have been omitted and filed separately with
the Commission.
-23-
the performance by Wyeth of its obligations hereunder, other than the Product
Approvals contemplated herein.
13. INSURANCE. (a) Biomatrix shall maintain comprehensive general liability
insurance coverage including products liability with a minimum limit of not less
than
*
(b) Wyeth warrants that it is self-insured for the first
*
of product liability exposure on an annual aggregate basis and purchases excess
insurance above such self-insurance amount.
14. INFRINGEMENT. Each of Wyeth and Biomatrix will promptly notify the
other party in writing of any infringement of a Patent or Trademark or the
know-how or unauthorized disclosure or use of any Confidential Information, of
which it becomes aware in the Territory. Biomatrix shall have the exclusive
right at its own cost to take all legal action in the Territory it deems
necessary or advisable to eliminate or minimize the consequences of such
infringement of a Patent or Trademark or the know-how in the Territory. For the
purpose of taking any such legal action, Biomatrix shall have the right, to use
the name of Wyeth and/or any Affiliate of Wyeth as plaintiff, either solely or
jointly in accordance with the applicable rules of procedure. Wyeth shall
promptly furnish Biomatrix with whatever written authority may be required in
order to enable Biomatrix to use Wyeth's name in connection with any such legal
action, and shall otherwise cooperate fully and promptly with Biomatrix in
connection with any such action. All proceeds realized upon any judgment or
settlement regarding such action shall belong exclusively to Biomatrix.
15. REGULATORY ACTIVITIES.
15.1. GENERAL.
(a) Approvals.
(i) Biomatrix shall, at its cost, be solely responsible for maintaining the
Initial Product Product Approvals in all countries in the Territory where the
Initial Product is approved as of the Effective Date.
(ii) Wyeth shall, at its cost, obtain and maintain Product Approvals in all
countries in the Territory except those approvals described in Section
15.1(a)(i). All such Product Approvals are subject to Biomatrix's rights under
section 15.1(b).
(iii) Wyeth shall, at its cost, obtain and maintain all Reimbursement
Approvals in each country in the Territory, subject to Biomatrix's rights under
Section 15.1(b).
*Confidential portions have been omitted and filed separately with
the Commission.
-24-
(b) Review by Biomatrix. Biomatrix shall be entitled to assist in
developing the strategy and content of all applications for Product Approvals
and Reimbursement Approvals and the content of all such applications shall be
subject to Biomatrix's prior written approval. All Product and Reimbursement
Approvals shall be held as the exclusive property of and in the name of
Biomatrix except to the extent that applicable law requires that such approvals
be held in the name of Wyeth, or unless otherwise agreed in writing by the
parties. Any filings for reimbursement or regulatory approval in the Territory
shall be subject to the prior written approval of each of the parties.
(c) Mutual support. Wyeth and Biomatrix shall provide reasonable advice and
assistance to each other as may be necessary to obtain and maintain Product
Approvals and, if applicable, satisfactory Reimbursement Approvals for Products
in the Territory.
(d) Transfer of approvals. In the event that the Product Approvals and the
Reimbursement Approvals (if any) relating to any Product or Extended Product in
any country in the Territory is in the name of Wyeth or any of its Affiliates,
it shall be transferred to Biomatrix immediately upon termination of the
Agreement.
(e) Reporting on Agreement Product. 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 Products or Extended Products to comply with
any of the requirements therefor specified in any Product Approval.
(f) Ongoing information exchange. Each party shall keep the other advised
of regulatory interactions, activities and correspondence and the registration
status of Products on a quarterly basis, except that matters requiring more
immediate attention shall be communicated as soon as practicable.
15.2. CLINICAL TRIALS; PUBLICATION OF RESULTS.
(a) Wyeth shall be responsible, at its own cost, for
conducting and managing any clinical trials which may be required in order to
obtain or maintain Product Approvals and Reimbursement Approvals in the
Territory; provided that the protocols for all such clinical trials shall be
subject to Biomatrix's prior written approval and Biomatrix shall have the right
to audit the performance of any such clinical studies.
*
(b) Wyeth shall provide the completed data resulting from all clinical
trials conducted in accordance with this Section 15.2 to Biomatrix, and
Biomatrix shall be allowed to assist in analysis of the completed data and in
preparing the final reports relating to such clinical trial data. 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 Products and
Extended Products outside the Territory. The results of any such studies
*Confidential portions have been omitted and filed separately with
the Commission.
-25-
will not be published or publicized in any way without the prior written
approval of Biomatrix.
16. FURTHER ASSURANCES. The parties hereto agree to execute such further or
other documents and assurances as are necessary from time to time in order to
give effect to the provisions of this Agreement.
17. ASSIGNMENT. The rights and obligations of the parties hereto shall
inure to the benefit of and shall be binding upon the authorized successors and
permitted assigns of each party. Neither party may, without the prior written
consent of the other party, take any of the following actions (collectively
referred to hereby as an "Assignment"): (i) assign or transfer its rights or
obligations under this Agreement, (ii) license or sublicense any of its rights
or obligations under this Agreement, or (iii) designate another person to
perform all or part of its obligations under this Agreement or have all or part
of its rights and benefits under this Agreement; provided, however, that a party
may make Assignments to Affiliates of such party or to a successor, by merger or
acquisition; and provided, further that in the case of an Assignment to an
Affiliate the assigning party shall promptly notify the other party in writing
of such Assignment and shall remain liable (both directly and as guarantor) with
respect to all obligations so assigned and the other party will not be in a
direct contractual relationship with such Affiliate. In the event of any
permitted Assignment or in the event that an Affiliate of either party shall
exercise rights and/or perform obligations hereunder pursuant to the terms of
this Agreement, the assignee or Affiliate, as the case may be, shall
specifically assume and be bound by the provisions of the Agreement by executing
and agreeing to an assumption agreement satisfactory to the other party hereto.
18. GOVERNING LAW; INJUNCTIVE RELIEF.
(a) This Agreement and the respective rights and obligations of the parties
shall be governed by and construed in accordance with the internal and
substantive laws of the State of New Jersey, United States of America (without
regard to principles of conflicts of laws). The parties hereby agree that the
United Nations Convention on Contracts for the International Sale of Goods shall
not apply to this Agreement or any other document contemplated hereby. In the
event of any dispute touching or concerning this Agreement, the parties hereby
agree to submit such dispute to their respective chief executive officers or
their designees by notice delivered in accordance with the provisions of Section
23 hereof. Each of the parties agrees that any suit relating to this Agreement
may be brought in the courts of the State of New Jersey or any federal court
sitting therein and consents to the non-exclusive jurisdiction of such court and
service of process in any such suit being made by mail at the address specified
in Section 23. Each party hereby waives any objection that it may now or
hereafter have to the venue of any such suit or any such court or that such suit
is brought in an inconvenient court.
-26-
(b) Each of the parties hereto acknowledges and agrees that damages will
not be an adequate remedy for any material breach or violation of this Agreement
if such material breach or violation would cause immediate and irreparable harm
(an "Irreparable Breach"). Accordingly, 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 Jersey, equitable relief of a kind appropriate
in light of the nature of the ongoing threatened Irreparable Breach, which
relief may include, without limitation, specific performance or injunctive
relief; provided, however, that if the party bringing such action is
unsuccessful in obtaining the relief sought, the moving party shall pay the
non-moving party's reasonable costs, including attorney's fees, incurred in
connection with defending such action. Such remedies shall not be the parties'
exclusive remedies, but shall be in addition to all other remedies provided in
this Agreement.
19. SEVERABILITY. In the event that any provision of this Agreement shall
be held by a court of competent jurisdiction or by any governmental body to be
invalid or unenforceable, such provision shall be deemed severable and the
remaining parts and provisions of this Agreement shall remain in full force and
effect.
20. FORCE MAJEURE. Each of the parties shall be excused from the
performance of its obligations hereunder in the event such performance is
prevented by force majeure, and such excuse shall continue as long as the
condition constituting such force majeure continues. For the purpose of this
Agreement, force majeure is defined as contingencies beyond the reasonable
control of either party, including, without limitation, acts of God, judicial or
regulatory action, war, civil commotion, destruction of production facilities or
materials by fire, earthquake or storm and labor disturbances (whether or not
any such labor disturbance is within the power of the affected party to settle)
or unavailability of supply materials. The party affected by force majeure shall
provide the other party with full particulars thereof as soon as it becomes
aware of the same (including its best estimate of the likely extent and duration
of the interference with its activities), and will use its reasonable endeavors
to overcome the difficulties created thereby and to resume performance of its
obligations as soon as practicable.
21. INTEREST. Any overdue amounts payable by either party hereunder shall
bear interest compounded monthly at the prime lending rate for U.S. Dollars
published from time to time in The Wall Street Journal plus
*
per annum, or, if lower, the highest rate permissible by applicable law, from
the due date until the date of payment.
22. NO PARTNERSHIP OR AGENCY. This Agreement and the relations hereby
established by and between Biomatrix and Wyeth do not constitute a partnership,
joint venture, agency or contract of employment between them.
23. NOTICES. All communications in connection with this Agreement shall be
in writing and sent by postage prepaid first class mail, courier, or telefax,
and if relating to
*Confidential portions have been omitted and filed separately with
the Commission.
-27-
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, with a copy to: ▇▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇, Esq., ▇▇▇▇▇▇▇, ▇▇▇▇ & ▇▇▇▇▇ LLP, ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, U.S.A., and in the case of Wyeth, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇. ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, Attn: Senior Vice President, Global
Business Development, with a copy to American Home Products Corporation, ▇
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, U.S.A., Attn: Senior Vice President
and General Counsel or to such other address as the addressee shall last have
designated by notice to the communicating party. The date of giving any notice
shall be the date of its actual receipt.
24. EU REGULATIONS. It is the intention of the parties hereto that this
Agreement shall at all times qualify for the exemption from the provisions of
Article 85(1) of the Treaty of Rome dated 25 March, 1957, as amended, which
either (a) is available under EEC Regulation Number 1983/83, or (b) may
otherwise be available under any other regulations or successor regulation
thereto. In the event that any provision of this Agreement is deemed to violate
the conditions for qualifying for the exemption, set out in whichever of those
regulations may be in effect at the relevant time, or if any such regulation is
amended after the date of this Agreement so as to cause this Agreement to fail
to qualify for the exemption, the parties hereto agree that they will, as soon
as it is practicable to do so, enter into good faith negotiations to amend this
Agreement as necessary in order to re-qualify for the exemption or notify the
Agreement.
25.
*
26. SURVIVAL. The provisions of Sections 3.2, 3.5, 3.6, 3.7, 7.1, 7.2, 8.2,
10.1, 10.2, 10.3, 10.4 and 15.1(d) 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.
27. MISCELLANEOUS. This Agreement, the International License Agreement, the
Supply Agreement and the Trademark Agreement together set forth the entire
agreement between the parties with respect to the transactions and arrangements
contemplated hereby and supersede all prior oral or written arrangements between
the parties. 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
*Confidential portions have been omitted and filed separately with
the Commission.
-28-
constitute one instrument, and in making proof of this Agreement it shall not be
necessary to produce or account for more than one such counterpart. The English
language version of this Agreement shall govern and control any translations of
the Agreement into any other language. References herein to Sections and
Exhibits are to Sections of and Exhibits to this Agreement. The title of this
Agreement and the section headings contained herein are for convenience of
reference only and shall not define or limit the provisions hereof.
[signature page to follow]
-29-
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the date and year first above written.
AMERICAN HOME PRODUCTS CORPORATION
BY: /s/ ▇▇▇▇ ▇▇▇▇▇▇
---------------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇
Title: Executive Vice President
BIOMATRIX, INC.
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
----------------------------------
▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Chief Executive Officer
-30-
EXHIBITS
Exhibit A - Initial Product Specifications
Exhibit B - Patents and Trademarks
Exhibit C - Minimum
*
Net Revenues
*Confidential portions have been omitted and filed separately with
the Commission.
EXHIBIT A
Initial Product Specifications
EUROPEAN AGREEMENT PRODUCT SPECIFICATIONS
SPECIFICATION OF SYNVISC(R)
(▇▇▇▇▇ ▇-▇ 20)
*
*Confidential portions have been omitted and filed separately with
the Commission.
EXHIBIT B
Patents and Trademarks
*
*Confidential portions have been omitted and filed separately with
the Commission.
*
*Confidential portions have been omitted and filed separately with
the Commission.
*
*Confidential portions have been omitted and filed separately with
the Commission.
EXHIBIT C
Minimum
*
Net Revenues
*
*Confidential portions have been omitted and filed separately with
the Commission.
FIRST AMENDMENT TO
INTERNATIONAL LICENSE AGREEMENT
This FIRST AMENDMENT (this "Amendment Agreement"), is made as of June 13,
2000 (the "Amendment Effective Date"), by and between Biomatrix, Inc.
("Biomatrix") and American Home Products Corporation, acting through its
unincorporated Wyeth-Ayerst Laboratories division (together "Wyeth") to amend
that certain
International License Agreement, dated as of February 7, 1997, by
and between Biomatrix and Wyeth (the "
International License Agreement")
WHEREAS, Biomatrix and Wyeth entered into the
International License
Agreement by which Biomatrix granted to Wyeth a license to sell Biomatrix'
proprietary product Synvisc in various countries outside the United States and
now the parties wish to amend certain provisions of the
International License
Agreement;
NOW, THEREFORE, in consideration of the mutual promised contained in this
Agreement, and intending to be legally bound thereby, the parties hereto agree
as follows:
1. Capitalized terms used in this Amendment Agreement and not otherwise
defined shall have the meanings ascribed to such terms in the
Internationa1 License Agreement.
2. Section 1.26 of the
International License Agreement is hereby deleted
in its entirety.
Section 1.28 of the International License is hereby deleted in its
entirety and replaced with the following:
1.28 "Territory" shall mean the following countries: Germany, Greece,
Portugal, Turkey, Poland and Czech Republic.
3. Section 2.1(d) of the
International License Agreement is hereby
deleted in its entirety.
4. Section 2.2(b) of the
International License Agreement is
hereby amended by deleting the words "(other than Spain)" and by
deleting the following sentence in its entirety:
"The Launch Date with respect to Spain, if Spain remains as a country
in this Agreement pursuant to Section 2.1(d), shall occur within six
months after the parties mutually approve the business plan for Spain
as set forth in Section 2.1(d)."
Sections 2.3(a) and 2.3(b) of the International License Agreement are
hereby amended by deleting the word, "Region" throughout and replacing
therefor the word "country" in each instance.
5. Section 2.5(c) of the International License Agreement is hereby
deleted in its entirety.
6. Pursuant to Section 3.2 of the International License Agreement,
Biomatrix agrees to repurchase inventory of the Product specifically
designated for sale in the Relinquished Countries (as defined below)
at a price equal to the price actually paid by Wyeth; provided that no
such inventory with an expiration date of less than one year from the
date hereof shall be repurchased by Biomatrix. Wyeth agrees to
promptly transfer such inventory to such location as designated by
Biomatrix at Biomatrix' cost and Wyeth agrees to allow Biomatrix or
its designee to distribute all such Product in its current packaging
for a period of up to one year.
7. Section 3.5(b) of the International License Agreement is hereby
deleted in its entirety and replaced with the following:
(b) if such termination notice is with respect to one or more
countries selected from Germany, Greece, Portugal and Turkey,
then Biomatrix may, upon notice to Wyeth, immediately terminate
this Agreement with respect to any or all of such countries
(provided that this shall not apply with respect to Germany upon
a termination in any other such country); and if such termination
notice is made with respect to either Poland or Czech Republic
then Biomatrix may, upon notice to Wyeth, immediately terminate
this Agreement with respect to the other such country.
8. Section 8.8 of the International License Agreement is hereby amended
by deleting the words "on a Region by Region basis".
9. Section 8.10 of the International License Agreement is hereby amended
by deleting the last sentence in its entirety.
10. Section 8.11 of the International License Agreement is hereby amended
by deleting the words "Spain" and "Austria" therefrom.
11. Section 15.1(a)(ii) of the International License Agreement is amended
by adding the following sentence: "Wyeth may register Product(s) in
Poland as a drug."
12. EXHIBIT B to the International License Agreement is hereby deleted in
its entirety and replaced with EXHIBIT B attached hereto.
13. EXHIBIT C to the International License Agreement is hereby amended to
remove all references to the Relinquished Countries (as defined below)
and to the Total ECE Region.
14. As of the date of this Amendment Agreement, Wyeth shall discontinue
using the Trademarks or making any representations regarding its
status as a licensee of Biomatrix and shall cease conducting any
activities with respect to the marketing, promotion, sale or
distribution of the Products in Austria, Spain, Hungary, Slovakia,
Bulgaria, Croatia, Yugoslavia, Slovenia, Romania, Egypt, Bahrain,
Kuwait, Oman, Qatar, United Arab Emirates, Yemen, Iran, Iraq, Jordan,
Lebanon, Syria and Saudi Arabia (the "RELINQUISHED COUNTRIES") and
shall take such action as is necessary to terminate Wyeth's
registration as Biomatrix's licensee with any governmental authority
in the Relinquished Countries. Wyeth agrees that it shall not,
directly or indirectly (alone or with others), and it shall ensure
that its Affiliates shal1 not, directly or indirectly (alone or with
others), for a period of twenty-four (24) months after the date of
this Amendment Agreement, manufacture, sell, market, distribute or
promote a Competing Product in any Relinquished Country. For the
avoidance of doubt, as OF the date of this Amendment Agreement, Wyeth
shall cease all sales of Products in the Relinquished Countries.
15. With respect to each of the Relinquished Countries, Wyeth shall
promptly transfer or cause to be transferred to Biomatrix the
following items relating to any product or Extended Product in any
Relinquished Country and in the name of Wyeth or any of its
Affiliates: all Product Approvals, Reimbursement Approvals, import
licenses, instructions, specifications, records of medical device
vigilance systems and clinical trials, records of any regulatory
interactions, activities, correspondence or other communications, and
marketing, labeling, packaging and promotional material, customer
lists and history of orders of Products in each such Relinquished
Country. To the extent that any clinical trials or other activities
are ongoing within any Relinquished County as of the date of this
Amendment Agreement, Wyeth will use its reasonable efforts s to
transition such activity to Biomatrix or its designee in a manner
which would allow the activity to be continued without material
interruption Wyeth shall remit to Biomatrix all labeling masters,
-2-
instructions, specifications, and copies of all marketing, labeling
and promotional materials used or intended for use in relation to
Products in the Relinquished Countries.
16. Wyeth represents, warrants and covenants with respect to the
Relinquished Countries that (a) no recall of a Product in any country
in the Territory is warranted for medical or safety purposes, (b)
Wyeth has complied in all material respects with all governmental
laws, regulations, and orders, including all laws, regulations or
orders that govern or affect the ordering, export, shipment, import,
sale (including government procurement), delivery, or redelivery of
Products and Extended Products, (c) Wyeth has not, directly or
indirectly, in the name of, on behalf of, or for the benefit of
Biomatrix offered, promised or authorized to pay, or paid any
compensation or given anything of value to, any official, agent or
employee of any government or governmental agency, or to any political
party or officer, employee or agent thereof in connection with the
promotion or sale of Products and Extended Products, and (d) to the
best of Wyeth's knowledge, there has been no failure of the Products
or Extended Products to comply with any of the requirements therefor
specified in any Product Approval
17. To the extent that there are any returns of any Product sold by Wyeth
in any Relinquished Country after the date of this Amendment
Agreement, Biomatrix shall have no obligation to take back or make any
reimbursement for any such returns and Wyeth shall be solely
responsible for any returns of Product sold by Wyeth or its
sub-licensees or delegees in any Relinquished Country.
18. For a period of three months after the date of this Amendment
Agreement, Wyeth shall maintain a customer service office and staff
that will receive telephone and other inquiries relating to Products
and refer all such inquiries to Biomatrix or its designee. Thereafter,
Wyeth will cooperate with Biomatrix to complete an orderly transition
of customer service for the Products in the Relinquished Countries.
19. This Amendment Agreement and the respective rights and obligations of
the parties shall be governed and construed in accordance with the
internal and substantive laws of the State of
New Jersey, United
States of America (without regard to principles of conflicts of laws).
This Amendment 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.
20. Except as specifically modified hereby, the International License
Agreement shall remain unmodified and in full force and effect. Any
liabilities and obligations of either party arising prior to the date
of this Amendment Agreement shall remain in full force and effect.
-3-
IN WITNESS WHEREOF, the parties hereto have executed this Amendment
Agreement as an instrument under seal as of the date first above stated.
BIOMATRIX, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
-----------------------
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Chief Executive Officer
AMERICAN HOME PRODUCTS CORPORATION
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇
-----------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇
Title: Vice President
-4-
EXHIBIT B
PATENTS AND TRADEMARKS
I. SYNVISC RELATED GERMAN PATENTS
A. Biocompatible Viscoelastic Gel Slurries, Their Preparation and Use
EP 0466 300 (De 691 29 391), will expire 4/22/2011
B. Chemically Modified Hyaluronic Acid and Method of Recovery. Thereof
from Animal Tissues
Patent No. 36 07 897; expires 3/10/2006
Patent No. 35 45 191; expires 3/10/2006
Patent No. 36 45 226; expires 3/10/2006; and
European Patent No. P 38 52 992 (Germany); expires 11/29/2008
C. Cross-Linked Gels of Hyaluronic Acid and Products Containing Such Gels
Patent No. 35 20 008; expires 6/4/2005
Patent No. 85 46 811; expires 6/4/2005
D. Water Insoluble Preparation of Hyaluronic Acid
Patent No. P 34 34 082; expires 9/17/2004
Patent No. P 34 34 104; expires 9/17/2004
-5-
II. Synvisc(R)
COUNTRY REGISTRATION NO. TERM EXPIRATION DATE
------- ---------------- ---- ---------------
Germany 1,110,922 10 Yrs. December 20, 1996
(Renewal) 10 Yrs. December 20, ▇▇▇▇
▇▇▇▇▇▇ 127,446 10 Yrs. March 17, 2008
[CTM Ser. No. 000338731 PENDING]
Turkey 180724 10 Yrs. January 30,2007
Portugal 314081 10 Yrs. September 4, 2006
Poland Being Filed / Pending
Czech Republic Being Filed / Pending 10 Yrs. February 24, 2007
-6-
