1
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
00 Xxxxxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000, X.X.X. ("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 (xxxxx X-X 20)
Synvisc currently approved as a device with a CE xxxx 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 xxxx, trademark or service xxxx 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 xxxxx Xxxxx 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; Commercially Reasonable Efforts
*
(a) Wyeth hereby accepts the license granted in section 2.1 above and
hereby agrees to use Commercially Reasonable Efforts (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. "Commercially
Reasonable Efforts" in this Agreement shall mean that Wyeth shall use generally
the * and shall be such as are commercially reasonable after taking into account
the establishment of the Product or Extended Product in the marketplace and the
* of the Product or Extended Product. * is not intended to be a substitute for
determining the Commercially Reasonable Efforts of Wyeth under this Section 2.2.
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)
*Confidential portions have been omitted and filed separately with the
Commission.
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Effective Date or (ii) Product Approval date.
*
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
*
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 fifteenth (15th) anniversary 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. Inventory. (a) Upon termination of this Agreement for any
reason, Wyeth and Wyeth Affiliates shall have the right to market and sell all
Products and Extended Products in inventory for a period *
(b) Subject to Wyeth's rights set forth in Section 3.2(a), upon
termination of this Agreement for any reason, Biomatrix shall have the right
but not the obligation to (i) repurchase all of the inventory of the Products
and Extended Products held by Wyeth or its Affiliates * (ii) assume title to
all such inventory, and (iii) become entitled to sell and distribute for the
benefit of Biomatrix such inventory *
*
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. Wyeth Termination. Wyeth may terminate this Agreement with
respect to any country in the Territory in its sole discretion at any time upon
one (1) year written notice to Biomatrix; provided, however, that in such event
(subject to Wyeth's rights set forth in Section 3.2(a)):
(a) Biomatrix may accelerate such termination to any date
after receipt of such termination notice;
(b) if such termination notice is with respect to less than
all countries in a Region then Biomatrix may, upon notice
to Wyeth immediately terminate this Agreement with respect
to any or all countries in the Region *
(c) Wyeth's rights under the Trademark Agreement and Supply
Agreement shall terminate with respect to any country with
respect to which this Agreement terminates; and
(d) Wyeth shall not sell a Competing Product (as defined in
Section 6.1) in any such country for a period of * after
the effectiveness of termination of this Agreement with
respect to such country.
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. New Products. Notwithstanding any provision in this Agreement or
in the U.S. License Agreement to the contrary, if Biomatrix develops a New
Product and Wyeth is an exclusive licensee of any Product or Extended Product
in a country, Biomatrix shall not commercialize any such New Product in any
country in which Wyeth is an exclusive licensee under this Agreement of any
Product or Extended Product until the following conditions have been satisfied:
(i) Biomatrix has made a commercially reasonable written
offer to Wyeth to participate with Biomatrix in the development
and marketing of such New Product;
(ii) Wyeth has failed to accept such written offer or make
its own commercially reasonable written offer within * of its
receipt of such offer; and
(iii) The parties shall have negotiated in good faith to
attempt to reach agreement based upon Biomatrix's and/or Wyeth's
offer for a period *
In the event that the parties fail to reach an agreement pursuant to
this Section 6.2 within * of Wyeth's receipt of Biomatrix's first written
offer, then Biomatrix shall not be restricted by this Agreement or the U.S.
License Agreement in the exercise of any rights that Biomatrix might otherwise
have to develop and/or commercialize any New Product to which such offer
relates; provided that *
Nothing in this Section 6.2 shall be construed, by implication or
otherwise, (i) to effect any sale or license of proprietary Biomatrix technology
(including any New Products), (ii) to grant any license relating to Biomatrix's
proprietary methods of formulating, fabricating and manufacturing Products,
Extended Products or New Products, or (iii) to xxxxx Xxxxx any rights in or to
any proprietary technology or Patents or Trademarks of Biomatrix.
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
16
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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.
17
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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, 00 Xxxxxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxxxx, 00000 X.X.X. 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
*Confidential portions have been omitted and filed separately
with the Commission.
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Biomatrix based upon current and new scientific, medical or marketing
information obtained.
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.
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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.
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8.13. Recalls of Products.
(a) * the * either party in good faith determines that a * such
party shall immediately notify the other party in writing and shall advise such
other party of the * The parties shall consult with each other as to any action
to be taken in *
(b) Except as otherwise provided in (c) below, in the event of
a recall of a Product or Extended Product, Biomatrix shall correct any
deficiency relating to its manufacturing, packaging, testing, labelling,
storing or handling of the Product or Extended Product for which it is
responsible, if applicable, and shall at its cost replace such defective
Product or Extended Product recalled.
(c) Biomatrix shall reimburse Wyeth for all direct costs and
expenses (including without limitation shipping, quality control testing and
notification costs) incurred by Wyeth and its Affiliates as a result of any
recall, except where such recall (i) is the result of the failure of Wyeth or
its Affiliates to comply with their obligations under this Agreement and/or
(ii) was opposed by Biomatrix and proved to be unwarranted, in either case
Wyeth shall reimburse Biomatrix for all direct costs and expenses (including
without limitation shipping, quality control testing and notification costs)
incurred by Biomatrix and its Affiliates as a result of such recall.
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.
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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:
(a) any failure * by Wyeth to act in accordance with the terms
of this Agreement, the Supply Agreement, the Trademark Agreement and/or
any applicable laws and regulations in the Territory in connection with
the Products, including without limitation any unauthorized
representations, warranties or guarantees given by Wyeth;
(b) any breach by Wyeth or any of its Affiliates of a
representation, warranty or covenant made by it or on its behalf in
this Agreement, the Trademark Agreement or in the Supply Agreement;
(c) any activities of Wyeth relating to the promotion,
marketing, sale and distribution of Products and Extended Products;
and/or
(d) any * on the part of Wyeth or its Affiliates in connection
with Products and Extended Products.
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.
22
-22-
(a) any failure * by Biomatrix to act in accordance with the
terms of this Agreement and/or to act in accordance with applicable
laws and regulations in the Territory in connection with the Products
and Extended Products;
(b) *
(c) any breach by Biomatrix or any of its Affiliates of a
representation, warranty or covenant made by or on its behalf in this
Agreement; and/or
(d) any * on the part of Biomatrix or its Affiliates in
connection with Products and Extended Products.
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.
23
-23-
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 xxxxx Xxxxx 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 been
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.
24
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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.
25
-25-
(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.
26
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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.
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(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.
28
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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: Xxxxxx X.
Xxxxxxxx, Esq., Xxxxxxx, Xxxx & Xxxxx LLP, 000 Xxxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxxxxx 00000, U.S.A., and in the case of Wyeth, 000 Xxxx Xxxxxxxxx
Xxxxxx, Xx. Xxxxxx, Xxxxxxxxxxxx 00000, Attn: Senior Vice President, Global
Business Development, with a copy to American Home Products Corporation, 0
Xxxxxxx Xxxxx, Xxxxxxx, Xxx Xxxxxx 00000, 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. * Biomatrix agrees that it will * with any * prior to * without
the *
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.
29
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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]
30
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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/ Xxxx Xxxxxx
------------------------
Name: Xxxx Xxxxxx
Title: Executive Vice President
BIOMATRIX, INC.
/s/ Xxxxx X. Xxxxxx
-----------------------
Xxxxx X. Xxxxxx
Chief Executive Officer
31
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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.
32
EXHIBIT A
Initial Product Specifications
EUROPEAN AGREEMENT PRODUCT SPECIFICATIONS
SPECIFICATION OF SYNVISC(R)
(XXXXX X-X 20)
Test Specifications
*
*Confidential portions have been omitted and filed separately with the
Commission.
33
EXHIBIT B
Patents and Trademarks
*
*Confidential portions have been omitted and filed separately with the
Commission.
34
II. SYNVISC(R)
Country Registration No. Term Expiration Date
------- ---------------- ---- ---------------
*
*Confidential portions have been omitted and filed separately with the
Commission.
35
Country Registration No. Term Expiration Date
------- ---------------- ---- ---------------
*
*Confidential portions have been omitted and filed separately with the
Commission.
36
EXHIBIT C
Minimum
*
Net Revenues
*
*Confidential portions have been omitted and filed separately with the
Commission.
