1
UNITED STATES 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 International 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. "Commercial Sales" means those sales by Wyeth or its Affiliates to
non-affiliated third-party purchasers that shall have commenced with defined
prices and are supported by normal sales promotion activities.
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1.4. "Competing Product" shall mean any
*
1.5. "Confidential Information" shall mean that term as defined in
Section 8.1.
1.6. "Contract Quarter" shall mean, with respect to the Territory, the
three (3) month period commencing on the first day of the first fiscal quarter
beginning immediately after the Launch Date in the Territory (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.
1.7. "Contract Year" shall mean, with respect to the Territory, the
twelve (12) month period commencing on the first day of the first fiscal quarter
beginning immediately after the Launch Date in the Territory (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.
1.8. "Designee" shall mean a designee contract field sales force.
1.9. "Development Program" shall mean the development program as set
forth in Section 6 hereof.
1.10. "Effective Date" shall have the meaning set forth in Section 25
hereof.
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
*
1.14. "Improvements" shall mean
*
*Confidential portions have been omitted and filed separately with the
Commission.
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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 the Territory, the date
of national introduction for commercial sale of the Product by Wyeth or an
Affiliate of Wyeth in the Territory.
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. "New Product" shall mean
*
1.20. "Non-competition Period" shall mean the period commencing on the
Effective Date and continuing until
*
thereafter.
1.21. "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 grant of patent term extensions therefor if and when such are
granted.
*Confidential portions have been omitted and filed separately with the
Commission.
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1.22. "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.
1.23. "Product Approvals" shall mean those regulatory approvals
required for promotion, pricing, marketing and sale of a Product or Extended
Product in the Territory.
1.24. "Product(s)" shall mean the Initial Product, together with any
Improvements (as defined in Section 1.14) to the Initial Product.
1.25. "Product Specialist" shall mean that terms as defined in Section
9.10.
1.26. "Reimbursement Approvals" shall mean any and all governmental and
other approvals necessary 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 the Territory.
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 the United States and its possessions.
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 (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
Trademark License Agreement by and between Biomatrix and Wyeth.
1.31. "Unit" shall mean, with respect to the Initial Product, a 2.0 ml
syringe of the Initial Product.
1.32. "International Agreement" shall mean the agreement of even date
herewith by and between Biomatrix (or one of its Affiliates) and Wyeth (or one
of its Affiliates)
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relating to the marketing of Products and Extended Products in the Regions as
defined therein, as the same may be amended, supplemented, modified or restated
and as in effect from time to time.
1.33. "United States Consumer Price Index" shall mean the Consumer
Price Index, All Items, United States, as published by the Bureau of Labor
Statistics.
1.34. "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 9.10) 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 except as provided
in the International Agreement, 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 except as
provided in the International Agreement.
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.
*Confidential portions have been omitted and filed separately with the
Commission.
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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 shall occur within
*
of the Effective Date or Product Approval date, whichever is later.
2.3. Conversion to Co-promotion or Co-exclusive License.
(a)
*
then Biomatrix may, at its option, elect to co-promote the Products and Extended
Products in the Territory either itself (or through an Affiliate) or with a
Designee selling for Wyeth's account.
*
If Biomatrix elects to convert this Agreement to a co-promotional arrangement
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 the
*Confidential portions have been omitted and filed separately with the
Commission.
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Territory under this Section 2.3(a), then Biomatrix (or an Affiliate) or its
Designee may co-promote under the Trademark in the Territory.
(b)
*
shall fail to exceed,
*
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) or
through the use of a Designee in the Territory or (ii) to convert Wyeth's
license rights in the Territory to co-exclusive and co-market the Products and
Extended Products itself (or through an Affiliate) in the Territory, and/or
appoint a Designee in the Territory and sell Products and Extended Products
under a Trademark that is not similar to the Trademark. Biomatrix shall make any
such election within
*
If Biomatrix elects to co-promote the Products and Extended Products itself (or
through an Affiliate) or through a Designee pursuant to the provisions of this
Section 2.3(b), then Biomatrix and/or its Designee shall be compensated on one
of the following basis:
*
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 herein, Wyeth hereby agrees to
make the following additional non-refundable payments to Biomatrix:
(a)
*
payable within five (5) days after
*
(b)
*
payable within five (5) days after
*
(c)
*
payable within five (5) days after the last day of the month in which * of
Products and Extended Products for any * period in the Territory exceed * in the
aggregate during the period from the Launch Date to * after the Launch Date;
provided, however, that if such milestone is not achieved then Wyeth shall pay *
within * after the last day of the month in which Net Revenues from sales of
Products and Extended Products for any * period in the Territory exceed * in the
aggregate during the period from the Launch Date to * after the Launch Date.
*Confidential portions have been omitted and filed separately with the
Commission.
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(d)
*
payable within five (5) days after the last day of the month in which
(e)
*
payable within five (5) days after the last day of the month in which
*
For the avoidance of doubt, the performance milestones and payments set
forth in paragraphs (c), (d) and (e) of this Section 2.5 shall be
*
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.
(b) Exclusive Additional Period. During any Additional Period in which
*
Wyeth will pay Biomatrix for Products for sale in the Territory according to the
provisions of the Supply Agreement
*
*Confidential portions have been omitted and filed separately with the
Commission.
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*
2.7. Nature of Payments. Each of the payments referred to in Sections
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.
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 the later to
occur of (i) the fifteenth (15th) anniversary of the Launch Date or (ii) the
date of the expiration of the last to expire of the Patents in the Territory
(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
*Confidential portions have been omitted and filed separately with the
Commission.
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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
*
after written notice.
*
3.5. Wyeth Termination. Wyeth may terminate this Agreement with
respect 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) Wyeth's rights under the Trademark Agreement and Supply Agreement
shall terminate with respect to the Territory; and
(c) Wyeth shall not sell a Competing Product (as defined in Section
7.1) in the Territory for a period of * after the effectiveness of termination
of this Agreement.
*Confidential portions have been omitted and filed separately with the
Commission.
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3.6. Certain Rights Upon Termination. (a) Upon termination of this
Agreement for any reason whatsoever, other than pursuant to Section 3.1,
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, Reimbursement Approvals and price
approvals and other relevant documents relating to 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
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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 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. All payments hereunder shall be made in
U.S. Dollars. 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.
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 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. DEVELOPMENT PROGRAM
6.1. General. Commencing upon receipt of the necessary Product
Approvals for the sale of the Initial Product in the United States, during any
period in which Wyeth is the exclusive licensee of Products in the Territory,
the parties shall maintain a fund (the
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"Development Fund") for the purpose of funding research and clinical trials
relating to the marketing, sales and development of Improvements and Extended
Products and any post-marketing study required by the FDA as part of the Initial
Product approval (the "Development Program").
6.2. Funding. (a) The Development Program and Development Fund shall be
maintained and administered by the Committee.
(b) The Development Fund shall not, unless otherwise agreed by the
parties, exceed in the aggregate during its existence
*
At such time as the Development Fund has reached
*
the funding obligations of the parties for the Development Fund shall cease.
(c) The Development Program shall be funded as follows:
(i) Wyeth shall be obligated to contribute an amount
equal to
*
under this Agreement and the International License
Agreement annually, up to an aggregate of
*
per Contract Year, subject to subparagraph (iii)
below, commencing the first Contract Year after
receipt of the necessary Product Approvals for sale
of the Initial Product in the United States; and
(ii) Biomatrix shall be obligated to contribute an amount
equal to
*
under this Agreement and the International
License Agreement annually, up to an aggregate of
*
per Contract Year, commencing the first Contract Year
after receipt of the necessary Product Approvals for
sale of the Initial Product in the United States; and
(iii) In the event the amounts required to be contributed
by Wyeth and Biomatrix under subparagraphs (i) and
(ii) above are less than the amount needed to fund
the Development Program as determined by the
Committee,
*
Amounts advanced to the Development Fund
*
6.3. Development Program Projects.
*Confidential portions have been omitted and filed separately with the
Commission.
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(a) Both parties will, as the Committee shall determine, perform such
research and experimentation as the Committee shall determine toward the goal of
advancing the Development Program.
(b) The Committee shall meet periodically to review and discuss in
detail the progress of the Development Program. The parties shall use their best
efforts to have the appropriate personnel attend and participate in each of such
meetings.
(c) Each party acknowledges and agrees that, subject to the provisions
of Section 6 hereof, this Agreement is not an agreement for the development of
products other than Improvements and Extended Products; and, either party may
work, either independently or with one or more third parties, outside the scope
of this Agreement to develop other products, notwithstanding that such other
products may be directly competitive with and/or superior to any Products or
Extended Products developed hereunder.
6.4. Expenses. Unless otherwise directed by the Committee, expenses for
Development Projects shall be charged as follows:
(a) No senior management time of either Party shall be billed;
(b) Actual third-party expenses shall be billed as incurred;
(c) For services of Wyeth, including without limitation statistical and
monitoring services, for which there would be a clinical grant or which would
normally be performed by a third party, the parties agree that the amount
expensed by Wyeth shall be an amount equal to the clinical grant amount;
provided that such amount shall not exceed the amount that an independent third
party would charge to perform such services.
(d) For services of Biomatrix, including without limitation
pre-clinical or statistical/regulatory activities, the parties agree that the
amount expensed by Biomatrix shall not exceed the amount an independent third
party would charge to perform such services.
6.5. Ownership. (a) Biomatrix shall own all proprietary rights to all
Improvements and Extended Products (and any improvements thereto) that are
developed under the Development Program and/or using the Development Fund. To
the extent that employees of Wyeth may be inventors or joint inventors of any
Improvements or Extended Products or any other inventions under the Development
Program, Wyeth and its employees shall execute any and all necessary documents,
including without limitation, applications for letters patent and assignments,
to give effect to the intent of the parties that Biomatrix shall own all of the
foregoing properties. To the extent that Biomatrix employees are the only
inventors of any of these properties, then Biomatrix shall have the right to
apply for patent protection on these properties in its own name.
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(b) Extended Products shall be encompassed within the terms of this
Agreement and the International License Agreement, the Supply Agreement and the
Trademark Agreement as they relate to Products. The parties agree that there
shall be no additional milestone payments relating to any such Extended Products
and that the Minimum Prices and Transfer Prices applicable to any such Extended
Products would be substantially equivalent to the Minimum Price and Transfer
Price applicable to the Initial Product unless the cost of manufacture of any
such Extended Products is materially different than the cost to manufacture the
Initial Product. If the parties are unable to agree upon any terms relating to
Extended Products, the matter shall be submitted for resolution under the
provisions of Section 9.9.
(c) The parties agree that any Extended Products (to the extent that
the parties are able to negotiate terms for an Extended Product) shall have
their own Contract Years, Initial Term and Additional Periods separate and
distinct from the Contract Years, Initial Term and Additional Periods relating
to the Products on a country-by-country basis within the Territory.
7. COMPETING PRODUCTS.
7.1. 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
*
Wyeth acknowledges and agrees that, in the event of a breach or threatened
breach by Wyeth of its obligations under this Section 7.1, Biomatrix will have
no adequate remedy at law, and accordingly shall be entitled to injunctive or
other appropriate equitable remedies against such breach or threatened breach in
addition to any other remedies which Biomatrix may have.
7.2. New Products. Notwithstanding any provision in this Agreement or
in the International 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 7.2 within * of Wyeth's receipt of Biomatrix's first written
offer, then Biomatrix shall not be restricted by this Agreement or the
International 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 7.2 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.
*Confidential portions have been omitted and filed separately with the
Commission.
16
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*
8. CONFIDENTIAL INFORMATION; PUBLIC ANNOUNCEMENTS.
8.1. 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 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 3.6, 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
*Confidential portions have been omitted and filed separately with the
Commission.
17
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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 8.1 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
8.1 shall be subject to Biomatrix's rights under Section 3.6.
8.2. Public Announcement. Except as shall be necessary for governmental
notification purposes or to comply with applicable laws and regulations, and
except as otherwise agreed to by the parties hereto in writing, the parties
agree to keep the existence of this Agreement, and the transactions contemplated
hereby, strictly confidential. 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.
9. INTELLECTUAL PROPERTY; AGREEMENT PRODUCT MARKING; PROMOTIONAL
INFORMATION; REGULATORY MATTERS.
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9.1. 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 patent term extensions, and for paying all maintenance,
fees on a large entity basis, on all patents, and all such applications and
patents shall constitute Patents under this Agreement.
(b) Upon Wyeth's request, Biomatrix shall provide Wyeth with a copy of
the prosecution file wrapper histories of each patent constituting Patents under
this Agreement.
9.2. 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.
9.3. 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.
9.4. 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.
9.5. 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 Product through other distribution arrangements in other
territories.
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9.6. 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.
9.7. 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.
9.8. 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 (the
"Marketing Plan") setting forth (i) its projections of Net Revenues for the
Territory for each of the
*Confidential portions have been omitted and filed separately with the
Commission.
20
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(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.
9.9. 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 either party under this Agreement. Decisions of the
Committee shall be made by consensus (a majority of the members designated by
each 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.
9.10. Co-Promotion. Promptly following the receipt of the Product
Approval for the Initial Product in the Territory, Biomatrix shall hire and
train as employees of Biomatrix (at Wyeth's expense)
*
sales representatives to assist Wyeth with the marketing and sale of the
Products (the "Product Specialists"). The Product Specialists shall co-promote
the 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
*
*Confidential portions have been omitted and filed separately with the
Commission.
21
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*
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. Biomatrix shall have the right to assign up to a
total of
*
of the Product Specialists under this Agreement and the International Agreement
toward the promotion of Products and Extended Products
*
9.11. Customer Lists. Wyeth shall maintain a master customer list
containing relevant information on sales of the Products and Extended Products
and shall deliver copies of such list to Biomatrix on a quarterly basis.
9.12 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 applicable 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.
9.13. Recalls of Products.
(a) If, in accordance with 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 *
(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.
*Confidential portions have been omitted and filed separately with the
Commission.
22
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*
9.14. Compliance. Wyeth shall, at its expense, 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 Biomatrix's reseller of products with any governmental authority,
and including all laws, regulations or orders that govern or affect the
ordering, 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 9.14 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.
9.15. 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.
9.16. 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.
10. SUPPLY OF PRODUCTS. The Supply Agreement sets forth the terms and
conditions for sale of Products by Biomatrix (or its Affiliates) to Wyeth.
11. INDEMNIFICATION; LIMITATION ON LIABILITY
11.1. Indemnification from Wyeth. Subject to the provisions of Section
11.3, 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:
*Confidential portions have been omitted and filed separately with the
Commission.
23
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(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) *
(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.
11.2. Indemnification from Biomatrix. Subject to the provisions of
Section 11.3, 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:
(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.
11.3. Limitation on Liability.
NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN SECTIONS 11.1 AND 11.2
ABOVE, OR ANY OTHER PROVISION OF THIS AGREEMENT, THE SUPPLY AGREEMENT, OR THE
TRADEMARK AGREEMENT, IN NO EVENT (INCLUDING THE FAULT, NEGLIGENCE OR STRICT
LIABILITY OF EITHER PARTY) SHALL EITHER PARTY BE LIABLE
*Confidential portions have been omitted and filed separately with the
Commission.
24
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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 11.1 OR SECTION 11.2,
AS THE CASE MAY BE.
11.4 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.
12. REPRESENTATIONS OF BIOMATRIX. Biomatrix represents, warrants and
covenants as follows:
12.1. 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.
12.2. 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.
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 Biomatrix and the performance by Biomatrix of its
obligations hereunder, other than the Product Approvals contemplated herein and
any required approvals under Section 25.
25
-25-
13. REPRESENTATIONS OF WYETH. Wyeth represents, warrants and covenants
as follows:
13.1. 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.
13.2. 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.
13.3. 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 the performance by Wyeth of its obligations
hereunder, other than the Product Approvals contemplated herein and any required
approvals under Section 25.
14. 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.
15. 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
*Confidential portions have been omitted and filed separately with the
Commission.
26
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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.
16. REGULATORY ACTIVITIES.
16.1. GENERAL.
(a) Approvals. (i) Biomatrix shall, at its cost, be solely responsible
for obtaining and maintaining Product Approvals for the Initial Product in the
Territory. (ii) Wyeth shall, at its cost, obtain and maintain all Reimbursement
Approvals in the Territory.
(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 or
the Reimbursement Approvals (if any) relating to any Product or Extended Product
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.
16.2. CLINICAL TRIALS; PUBLICATION OF RESULTS.
27
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(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 16.2 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 will
not be published or publicized in any way without the prior written approval of
Biomatrix.
17. 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.
18. 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.
19. 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
*Confidential portions have been omitted and filed separately with the
Commission.
28
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the State of New Jersey, United States of America (without regard to principles
of conflicts of laws). 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 24 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 24. 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.
(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.
20. 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.
21. 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.
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22. 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.
23. NO PARTNERSHIP; AGENCY OR FRANCHISE. This Agreement and the
relations hereby established by and between Biomatrix and Wyeth do not
constitute a partnership, joint venture, agency, franchise or contract of
employment between them.
24. NOTICES. All communications in connection with this Agreement shall
be in writing and sent by postage prepaid first class mail, courier, or telefax,
and if relating to default, late payment or termination, by certified mail,
return receipt requested, telefax or courier, addressed to each party at the
address above, in the case of Biomatrix, Attn: Chief Executive Officer, 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.
25. XXXX-XXXXX-XXXXXX. If required by law, the parties will, at their
own expense (other than any required filing fees which shall be paid by Wyeth),
prepare and make appropriate filings under Title II of the Xxxx-Xxxxx-Xxxxxx
Antitrust Improvements Act of 1976, as amended, and the rules and regulations
promulgated thereunder (16 C.F.R. 801.1 et. seq.) (the "Act") as soon as
reasonably practicable. The parties shall cooperate in the antitrust clearance
process and agree to furnish promptly to the FTC and the Antitrust Division of
the Department of Justice any additional information reasonably requested by
them in connection with such filings. This provision shall bind Biomatrix and
Wyeth upon execution but the other provisions of the Agreement shall not become
effective until the waiting period provided by the Act shall have terminated or
shall have expired without any action by any government agency or challenge to
the transaction (the "Effective Date"). In the event the expiration of the
waiting period does not occur within three (3) months after the date of
signature of this Agreement by both parties, the parties shall revert to their
status prior to signing this Agreement.
26. SURVIVAL. The provisions of Sections 3.2, 3.5, 3.6, 3.7, 3.8, 8.1,
8.2, 9.2, 11.1, 11.2, 11.3, 11.4 and 16.1(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
*Confidential portions have been omitted and filed separately with the
Commission.
30
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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
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]
31
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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
32
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EXHIBITS
Exhibit A - Initial Product Specifications
Exhibit B - Patents and Trademarks
33
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EXHIBIT A
Initial Product Specifications
U.S. AGREEMENT PRODUCT SPECIFICATIONS
SPECIFICATION OF SYNVISC(R)
(XXXXX X-X 20)
Test Specifications
*
*Confidential portions have been omitted and filed separately with the
Commission.
34
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EXHIBIT B
Patents and Trademarks
I. SYNVISC RELATED UNITED STATES PATENTS
*
II. SYNVISC(R)
Country Registration No. Term Expiration Date
------- ---------------- ---- ---------------
*
*Confidential portions have been omitted and filed separately with the
Commission.
