EXHIBIT 10.103
[THE OMITTED PORTIONS INDICATED BY AN ASTERISK HAVE BEEN SEPARATELY FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.]
INTELLECTUAL PROPERTY LICENSE AGREEMENT
This INTELLECTUAL PROPERTY LICENSE AGREEMENT (this "AGREEMENT") is
dated this 15th day of July 2004, between Q-Med AB, a company organized under
the laws of the Kingdom of Sweden with corporate registration number 556258-6882
("Q-MED" or "LICENSOR"), and Medicis Aesthetics Holdings Inc., a corporation
organized under the laws of the State of Delaware ("MAHI" or "LICENSEE").
RECITALS
WHEREAS, Licensor desires to grant, and Licensee desires to accept,
the rights and licenses set forth herein with respect to the Licensed Rights,
Licensed Regulatory Data and certain Website Content (as each such term is
defined below); and
WHEREAS, Licensee desires to grant, and Licensor desires to accept,
the rights and licenses set forth herein with respect to certain portions of the
Territory Specific Materials, Licensee Regulatory Materials (as each such term
is defined below) and certain Website Content.
NOW, THEREFORE, in consideration of the premises and the
representations, warranties, covenants and agreements contained herein and for
other good and valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, intending to be legally bound hereby, the Parties hereto
hereby agree as follows:
ARTICLE I
DEFINITIONS
1.1 Definitions. As used in this Agreement, the following terms shall have
the meanings set forth or as referenced below:
"ACCOUNT" shall have the meaning set forth in Section 8.2.
"ACCOUNTING FIRM" shall have the meaning set forth in Section 8.5.
"ACTION" shall mean any action, claim, suit, litigation,
arbitration, investigation, notification, audit or other proceeding brought in
law or at equity by a Governmental Authority or other Person.
"ADVERTISING" shall have the meaning set forth in the Supply
Agreement.
"AESTHETIC ENHANCEMENT" shall mean the alteration of the visual
appearance, visual form, visual size, or visual shape of the naked human body or
any of its components; provided that Aesthetic Enhancement shall not be deemed
to include modification of the functions, restoration of the functions,
adjustment of the functions or correction of the functions of the human body or
any of its component parts.
"AFFILIATE" of a Person shall mean, with respect to any Person, any
other Person that directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with, such Person. As
used in this definition, the term "CONTROL" means the possession, directly or
indirectly, of the power to direct or cause the direction of the management and
policies of a Person, whether through ownership of voting securities, by
contract, or otherwise.
"AGERUP LETTER AGREEMENT" shall mean that certain letter from Bengt
Agerup to Medicis, dated as of the Closing Date.
"AGREEMENT" shall mean this Agreement, as the same may be amended or
supplemented from time to time in accordance with the terms hereof.
"BUSINESS DAY" shall mean any day other than a Saturday, a Sunday or
a day on which banks in Sweden or New York are authorized or obligated by Law or
executive order to remain closed.
"CANADIAN STUDY" shall have the meaning set forth in Section 2.1(c).
"CANADA'S FDA" shall mean Canada's Food and Drugs Act, R.S.C. 1985,
c. F-27, as amended.
"CAP" shall have the meaning set forth in Section 10.1(b).
"CHANGE IN CONTROL" shall mean (a) the disposition of all or
substantially all of the outstanding shares, assets or business of a Party or
Medicis on a consolidated basis; or (b) any transaction or event (or series of
transactions or events) as a result of which any Person (other than an Affiliate
of such Party or Medicis), acting singly or as a part of a "partnership, limited
partnership, syndicate or group" (within the meaning of Section 13(d)(3) of the
United States Securities Exchange Act of 1934, as amended): (i) acquires (by
purchase, merger, consolidation or otherwise) or for the first time controls or
is able to vote (directly or through nominees, beneficial ownership, proxy or
contract) fifty percent (50%) or more of the aggregate of all outstanding equity
securities of a Party or Medicis; or (ii) acquires (by purchase, merger,
consolidation or otherwise) equity securities of a Party or Medicis with the
right to, or for the first time is otherwise able to, nominate or designate
(directly or through nominees, beneficial ownership, proxy or contract) at least
fifty percent (50%) of the nominees to the board of directors of such Party or
Medicis, in each of (a) or (b), in the event that Licensor, Licensee or Medicis,
as the case may be, was not a party to the applicable transaction and/or such
transaction was not approved by the Board of Directors of Licensor, Licensee or
Medicis, as the case may be.
"CIPO" shall mean the Canadian Intellectual Property Office.
"CLAIMING PARTY" shall have the meaning set forth in Section 8.5.
"CLOSING" shall have the meaning set forth in Section 7.1.
"CLOSING DATE" shall have the meaning set forth in Section 7.1.
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"COMPETING PRODUCT" shall have the meaning set forth in Section
3.13.
"COMPLAINING PARTY" shall have the meaning set forth in Section
3.10(b).
"CONFIDENTIAL LICENSEE INFORMATION" shall have the meaning set forth
in Section 9.1.
"CONFIDENTIAL LICENSOR INFORMATION" shall have the meaning set forth
in Section 9.2.
"CONFIDENTIALITY AGREEMENT" shall have the meaning set forth in the
Supply Agreement.
"CONTRACT YEAR" shall have the meaning set forth in Section 8.2.
"DILIGENCE DEFAULT" shall have the meaning set forth in Section 3.1.
"DISPUTED LICENSE PAYMENT" shall have the meaning set forth in
Section 8.5.
"FDA" shall mean the United States Food and Drug Administration.
"FDCA" shall mean the United States Federal Food, Drug, and Cosmetic
Act of 1938, as amended (21 U.S.C. ss.ss. 301 et. seq.).
"FIELD" shall mean Aesthetic Enhancement.
"FOOD AND DRUGS ACT" shall mean the Canadian Food and Drugs Act of
1985, as amended (R.S., c. F-27).
"GOVERNMENTAL AUTHORITY" shall mean any supranational, national,
federal, state, provincial or local judicial, legislative, executive or
regulatory authority.
"GUARANTEE" shall mean the guarantee dated as of the Closing Date
from Medicis to Q-Med.
"HIGHEST MILESTONE" shall have the meaning set forth in Section 8.2.
"IMPROVEMENTS" shall mean any replacements, improvements or
modifications, including without limitation new indications or new uses, in each
case in the Field.
"INDEMNIFIED PARTY" shall have the meaning set forth in Section 10.3
herein.
"INDEMNIFYING PARTY" shall have the meaning set forth in Section
10.3 herein.
"JOINTLY OWNED IMPROVEMENTS" shall have the meaning set forth in
Section 2.3(c).
"LABELING" shall have the meaning set forth in the Supply Agreement.
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"LAUNCH" of a Licensed Product shall mean the first offer for sale
of the Licensed Product to the trade.
"LAWS" shall mean all applicable laws, statutes, rules, regulations,
ordinances and other pronouncements of law of any Governmental Authority.
"LIBOR RATE" shall have the meaning set forth in Section 8.2(b)
herein.
"LICENSED KNOW-HOW" shall mean, except to the extent published or
otherwise known, all of Licensor's and its Affiliates' proprietary know-how,
trade secrets, unpatented inventions, technical data, formulations, technical
information and business and marketing information which Licensor or any of its
Affiliates now own or have the right to license, or hereafter acquire or obtain
the right to license during the Term, but only to the extent necessary or
reasonably useful, in the ordinary course of Licensee's business, for marketing,
using, distributing, importing, offering for sale, selling, commercializing or
otherwise disposing of the Licensed Products in the Field in the Territory,
including sales and marketing materials, medical, clinical, toxicological
testing, scientific data and injection techniques relating to the Licensed
Products; provided, that the Licensed Know-How shall not include (a) information
that Licensor is under an obligation to unrelated Third Parties not to disclose,
such as patient data and (b) the Licensed Regulatory Data.
"LICENSED PATENTS" shall mean the U.S. Patent, U.S. Patent
Application and Canadian Patent Application set forth on Schedule A attached
hereto and any other patent or patent application or rights thereunder in the
Territory that covers the manufacture, use, import or sale of the Licensed
Products, together with any extensions, publications, reissues, continuations,
divisionals, continuations-in-part, reexamination certificates, substitutions or
renewals, supplemental protection certificates or certificates of inventions
thereof owned by Licensor or any of its Affiliates, or under which Licensor or
any of its Affiliates has the right to grant licenses in the Territory, as of
the date hereof or during the Term; provided, that the Licensed Patents shall
not include the Licensed Regulatory Data.
* * *
* * *
"LICENSED RIGHTS" shall mean the Licensed Patents and the Licensed
Know-How.
"LICENSEE INDEMNIFIED PERSONS" shall have the meaning set forth in
Section 10.1.
* * *
"LICENSEE MARKS" shall have the have the meaning set forth in
Section 3.2.
"LICENSEE REGULATORY MATERIALS" shall have the have the meaning set
forth in Section 2.3(b)(ii).
"LICENSEE TRADE DRESS" shall have the have the meaning set forth in
Section 3.2.
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"LICENSES" shall mean the licenses granted by Licensor to Licensee
herein.
"LICENSOR INDEMNIFIED PERSONS" shall have the meaning set forth in
Section 10.2.
"LICENSOR MARKS" shall have the have the meaning set forth in
Section 3.2.
"LICENSOR TRADE DRESS" shall have the have the meaning set forth in
Section 3.2.
"LOSS" or "LOSSES" shall mean any and all damages, fines, fees,
penalties, deficiencies, losses and expenses, including reasonable legal fees
and expenses, but excluding loss of profits or other special, punitive or
consequential damages.
"MACROLANE SIDE LETTER" shall mean that certain letter from Medicis
to Q-Med, dated as of the Closing Date.
"MANUFACTURE" shall have the meaning set forth in the Supply
Agreement.
"MEDICIS" shall mean Medicis Pharmaceutical Corporation, a Delaware
corporation.
"MASTER FILES" shall have the meaning set forth in the Supply
Agreement.
"MILESTONE" shall have the meaning set forth in Section 8.2.
"MILESTONE PAYMENT" shall have the meaning set forth in Section 8.2.
"NET REVENUES" shall mean, with respect to any Licensed Product, the
gross sales of such Licensed Product invoiced by Licensee and/or its Affiliates
to Licensee's and/or its Affiliates' customers who are not Affiliates, less, to
the extent actually paid or accrued net of payments by Licensee and/or its
Affiliates (as applicable), (a) normal and customary credits, allowances,
discounts and rebates to, and chargebacks from the account of, such customers
for spoiled, damaged, out-dated and returned Licensed Product; (b) normal and
customary freight and insurance costs incurred in transporting such Licensed
Product to and from such customers; (c) normal and customary cash, quantity and
trade discounts, rebates and other price reductions or special programs for such
Licensed Product; and (d) excise, sales, use, value-added and other direct taxes
(but not income taxes of any kind) imposed upon the sale of such Licensed
Product to such customers. For avoidance of doubt, Licensee shall calculate Net
Revenues for purposes of this Agreement according to U.S. generally accepted
accounting principles applied on a consistent basis and in a manner consistent
with Medicis' calculations of consolidated net revenues and consistent with the
numbers used to consolidate net revenues reported in Medicis' periodic reports
with the United States Securities and Exchange Commission.
"NON-COMPETE PERIOD" shall have the meaning set forth in Section
3.13(b).
"ONE TIME PAYMENT" shall have the meaning set forth in Section 8.1.
* * *
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"OTHER PARTY" shall have the meaning set forth in Section 8.5.
"OUT-OF-FIELD USE" shall have the meaning set forth in Section
3.10(b).
"PARTY" shall mean Licensor or Licensee and, when used in the
plural, means both Licensor and Licensee or their respective Permitted
Transferees or Third Party transferees, in each case upon the consummation of a
Transfer in accordance with the terms and conditions herein.
"PATENT REQUEST" shall have the meaning set forth in Section 3.7.
"PAYMENT DATE" shall have the meaning set forth in Section 8.5.
"PAYMENT TERM" shall commence on the Closing Date and, unless this
Agreement is earlier terminated pursuant to Section 6.2, last until * * *.
"PERMITTED TRANSFEREE" shall mean any Affiliate of the Licensor or
Medicis, as applicable, of whom the Licensor or Medicis, as applicable, directly
or indirectly, through one or more intermediaries, owns or controls more than
fifty percent (50%) of the voting securities or economic interest in such
Affiliate and such Affiliate is able to provide and at all times update a valid
Form W-8BEN in accordance with U.S. Treasury Regulation 1.1441-(e)(4)(ii), for
so long as such Affiliate continues to be a Permitted Transferee; provided, that
the Licensor or Licensee, as applicable, shall remain directly liable for the
performance by the Permitted Transferee of all obligations of the Licensor or
Licensee, as applicable, under this Agreement and no Transfer to a Permitted
Transferee hereunder shall relieve the Licensor or Licensee, as applicable, of
its obligations pursuant to this Agreement.
"* * * PAYMENT" shall have the meaning set forth in Section 8.1.
* * *
"PMA APPLICATION" shall have the meaning set forth in the Supply
Agreement.
"PMA APPROVALS" shall have the meaning set forth in the Supply
Agreement.
"PERSON" shall mean any individual, firm, corporation, partnership,
limited liability company, trust, joint venture or other entity or organization.
"PREVIOUS LICENSE AGREEMENT" shall mean the Amended and Restated
Intellectual Property License Agreement between Q-Med and HA North American
Sales AB, dated March 6, 2003 (as the same may be amended from time to time in
accordance with its terms).
"PREVIOUS LICENSE LETTER AGREEMENT" shall mean that certain letter
from Medicis to Q-Med, dated as of the Closing Date.
"PREVIOUS SUPPLY AGREEMENT" shall mean that certain Supply Agreement
dated as of March 7, 2003, between Medicis and Q-Med, as the same may be amended
from time to
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time in accordance with its terms.
"PROMOTIONAL LABELING" shall have the meaning set forth in the
Supply Agreement.
"REGULATORY APPROVALS" shall have the meaning set forth in the
Supply Agreement.
"RESPONSIBLE PARTY" shall have the meaning set forth in Section
3.10(b).
"RETURN PAYMENT" shall have the meaning set forth in Section 8.2.
"STEERING COMMITTEE" shall have the meaning set forth in the Supply
Agreement.
"SUPPLY AGREEMENT" shall mean the Supply Agreement, dated as of the
Closing, between Q-Med and MAHI (as the same may be amended from time to time in
accordance with its terms).
"TERM" shall have the meaning set forth in Section 6.1.
"TERRITORY" shall mean the United States, including its territories
and possessions, and Canada.
"TERRITORY SPECIFIC MATERIALS" shall have the meaning set forth in
Section 2.3(b)(i).
"THIRD ANNIVERSARY" shall have the meaning set forth in Section 10.1
herein.
"THIRD PARTY" shall mean any Person who or which is neither a Party
nor an Affiliate of a Party.
"THIRD PARTY INDEMNIFIABLE CLAIM" shall have the meaning set forth
in Section 10.4 herein.
"TPD" shall mean Canada's Therapeutic Products Directorate.
"TRANSACTION AGREEMENTS" shall mean this Agreement, the Supply
Agreement, the Macrolane Side Letter, the Previous License Letter Agreement, the
Guarantee and the Confidentiality Agreement.
"TRANSFER" shall mean any Change in Control or Volitional Change in
Control of a Party or a transfer or assignment by a Party of its rights and
obligations under this Agreement; provided, however, that for purposes of this
Agreement the actions set forth in Section 2.1 hereof shall not be deemed to be
a Transfer.
"USPTO" shall mean the United States Patent and Trademark Office.
"VOLITIONAL CHANGE IN CONTROL" shall mean (a) the disposition of all
or substantially all of the outstanding shares, assets or business of a Party or
Medicis on a
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consolidated basis; or (b) any transaction or event (or series of transactions
or events) as a result of which any Person (other than an Affiliate of such
Party or Medicis), acting singly or as a part of a "partnership, limited
partnership, syndicate or group" (within the meaning of Section 13(d)(3) of the
United States Securities Exchange Act of 1934, as amended): (i) acquires (by
purchase, merger, consolidation or otherwise) or for the first time controls or
is able to vote (directly or through nominees, beneficial ownership, proxy or
contract) fifty percent (50%) or more of the aggregate of all outstanding equity
securities of a Party or Medicis; or (ii) acquires (by purchase, merger,
consolidation or otherwise) equity securities of a Party or Medicis with the
right to, or for the first time is otherwise able to, nominate or designate
(directly or through nominees, beneficial ownership, proxy or contract) at least
fifty percent (50%) of the nominees to the board of directors of such Party or
Medicis, in each of (a) or (b),in the event that Licensor, Licensee or Medicis,
as the case may be, was a party to the applicable transaction or of which the
Board of Directors of Licensor, Licensee or Medicis, as the case may be, shall
have approved.
"WEBSITE CONTENT" shall have the meaning set forth in Section 2.5.
1.2 Other Definitional Provisions.
(a) The words "HEREOF", "HEREIN", "HERETO" and "HEREUNDER" and words of
similar import, when used in this Agreement, shall refer to this Agreement as a
whole and not to any particular provision of this Agreement unless otherwise
indicated.
(b) The terms defined in the singular shall have a comparable meaning when
used in the plural, and vice versa.
(c) The term "INCLUDING" shall mean "INCLUDING, WITHOUT LIMITATION."
(d) When a reference is made in this Agreement to an Article, a Section or
Schedule, such reference shall be to an Article of, a Section of or a Schedule
to, this Agreement unless otherwise indicated.
ARTICLE II
LICENSE AND RESERVATION
2.1 Grant of Licenses to Licensee.
(a) Grant of License to Licensed Rights. Subject to the terms and
conditions of this Agreement, Licensor grants to Licensee, effective as of the
Closing Date, a payment bearing, exclusive (even as to Licensor and its
Affiliates), nonsublicensable (except as permitted in Section 12.1) and
nonassignable (except as permitted in Section 12.1) license to the Licensed
Rights in the Field in the Territory (i) to market, use, distribute, import,
offer for sale, sell, commercialize or otherwise dispose of, but not to make or
have made, Licensed Products in the Territory, itself or to have such done on
its behalf; (ii) to market, use, distribute, offer for sale, sell, commercialize
or otherwise dispose of Licensed Products in the Territory via the Internet,
itself or to have such done on its behalf, provided that any web site owned and
operated by or on behalf of Licensee is directed solely to users in the
Territory, and provided, further, that Licensee may only ship Licensed Products
or direct promotional materials related thereto to locations within the
Territory; and (iii) to conceive, but not develop, Improvements to the Licensed
Rights
8
except that Licensee may develop Improvements and conduct clinical development
(or have such development done on its behalf) only to the extent expressly
provided herein and in Article VI of the Supply Agreement, provided with respect
to (iii) herein that (x) Licensor remains the sole source of development work
for Licensee unless otherwise provided herein or in Article VI of the Supply
Agreement or Licensor is unable to provide Licensee with the research and
development reasonably required by Licensee, in which case the Steering
Committee shall select a contract laboratory to provide development work under
Licensor's supervision and (y) Licensor retains ownership of all Improvements,
as set forth in Section 2.3 herein, except as expressly provided herein and in
Article VI of the Supply Agreement. For avoidance of doubt, Licensee
acknowledges and agrees that the right to develop in accordance with Section
2.1(a)(iii) shall not include a right for Licensee to modify or develop changes
to the formulation, primary packaging, or manufacturing processes for Licensed
Products. Licensee shall not use the Licensed Rights outside the Territory for
any purpose or in the Territory for any purpose other than as specifically
authorized herein.
(b) Grant of License to Licensed Regulatory Data. Subject to the terms and
conditions of this Agreement, Licensor grants to Licensee, effective as of the
Closing Date, a payment bearing, exclusive (even as to Licensor and its
Affiliates), nonsublicensable (except as permitted in Section 12.1) and
nonassignable (except as permitted in Section 12.1) license in the Field in the
Territory to copy, reference and otherwise use the Licensed Regulatory Data, but
only to the extent recommended or suggested by the FDA or TPD or as necessary or
reasonably useful for the purpose of conducting clinical trials and obtaining
and maintaining Regulatory Approvals for the Licensed Products in the Field in
the Territory pursuant to this Agreement and the Supply Agreement.
(c) Limited Exception to Exclusivity. Notwithstanding the exclusive rights
granted in Section 2.1(b), the Parties agree that Licensor and its Affiliates
shall have the right to complete the clinical study in Canada titled * * * in
progress as of the date hereof (the "CANADIAN STUDY"). For the avoidance of
doubt, the data, materials and other results of the Canadian Study shall be
owned by Licensor and deemed to be "Licensed Regulatory Data" for purposes of
this Agreement without any additional consideration on the part of Licensee.
(d) Rights at End of Payment Term. As of the expiration of the Payment
Term, the Licenses shall be deemed fully paid up and irrevocable (except as
otherwise provided in Section 6.2) for the remainder of the Term.
2.2 Reservation of Rights. Other than as expressly stated herein or in the
Previous License Agreement, Licensee shall have no other right to use or
interest in the Licensed Rights or Licensed Regulatory Data. Specifically,
Licensee shall not have any interest in any other patents, trademarks or other
intellectual property owned, licensed, developed or controlled by Licensor,
other than as expressly provided in this Agreement, the Previous License
Agreement or other valid written agreements. Licensee undertakes not to make,
market, use, import, offer for sale, sell or in any other way take any action to
commercialize the Licensed Products, Licensed Regulatory Data or Licensed Rights
outside the Territory. Each Party shall use commercially reasonable efforts to
direct to the other Party customer requests for Licensed Products received
through each Party's customer service that relate, in case of the Licensee,
requests outside the Territory and, in the case of Licensor, requests in the
Territory, in each case only to the extent
9
that such referral does not violate or conflict with any confidentiality
obligations binding on the directing Party. The Parties intend that this
Agreement shall not restrict Licensor's freedom to make, use, import, offer for
sale, sell, practice or otherwise commercialize the Licensed Products, Licensed
Regulatory Data or Licensed Rights (a) within the Field outside the Territory or
(b) outside the Field whether or not in the Territory. Except as specifically
provided herein or in Article VI of the Supply Agreement, Licensee grants no
rights of ownership, use or otherwise in Licensee's patents, trademarks,
know-how or other intellectual property.
2.3 Ownership of Intellectual Property.
(a) Licensor's Ownership. Licensee acknowledges and agrees that, as
between Licensee and Licensor, Licensor is the sole owner of the Licensed Rights
and Licensed Regulatory Data and any Improvements to the Licensed Rights or
Licensed Regulatory Data, including without limitation products in whole or in
part based on, utilizing or otherwise incorporating the Licensed Rights or
Licensed Regulatory Data, whether conceived, created or developed by Licensor or
Licensee, except as expressly provided herein and in Article VI of the Supply
Agreement. Licensee shall not directly or indirectly question, attack, contest,
or in any other manner impugn the validity, enforceability, registration or
Licensor's ownership of, or right to use the Licensed Rights and Licensed
Regulatory Data and any Improvements thereupon (other than the Improvements
owned by Licensee as expressly provided herein and in Article VI of the Supply
Agreement), including without limitation products in whole or in part based on,
utilizing or otherwise incorporating the Licensed Rights and Licensed Regulatory
Data, nor shall Licensee willingly become an adverse party to Licensor in any
Action contesting the validity or enforceability of, or Licensor's ownership of
or rights in, the Licensed Rights and Licensed Regulatory Data, except that
Licensee shall be permitted to be an adverse party in connection with a
defensive counterclaim, and to assert any claim or defense in any Action based
on any dispute arising out of or in connection with this Agreement, or the
breach, termination, or invalidity hereof.
(b) Licensee's Ownership. Licensor acknowledges and agrees that, as
between Licensor and Licensee, Licensee shall have the right to create, develop
and acquire (itself or to have such done on its behalf) and own all right, title
and interest, and goodwill as applicable, in the following that are created,
developed or acquired by or on behalf of Licensee (and, to the extent that any
of the following constitute Improvements to the Licensed Rights or Licensed
Regulatory Data, such Improvements):
(i) "TERRITORY SPECIFIC MATERIALS" which shall mean: (A) trademarks
and trade dress for or utilized with the Licensed Products in the
Territory (including, for the avoidance of doubt, the mark "SUBQ" or any
mark containing the term "SUBQ"), but excluding the Licensor trademarks
used in accordance with Section 3.2(a) e.g., NASHA or Licensor corporate
identifier; (B) website content for the Licensed Products in the
Territory; and (C) marketing, sales and promotional materials for the
Licensed Products in the Territory, including Advertising and Promotional
Labeling;
(ii) * * *
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(iii) Improvements conceived by Licensee that are not in whole or in
part based on, do not utilize or do not otherwise incorporate, the
Licensed Rights or Licensed Regulatory Data.
For avoidance of doubt, Licensee acknowledges and agrees that Licensee's
ownership of the Improvements and materials included in the Territory Specific
Materials or Licensee Regulatory Materials does not imply ownership of the
Licensed Rights or Licensed Regulatory Data or any other Improvements or
materials. Licensor shall not directly or indirectly question, attack, contest,
or in any other manner impugn the validity, enforceability, registration or
Licensee's ownership of, or right to use the Territory Specific Materials or
Licensee Regulatory Materials nor shall Licensor willingly become an adverse
party to Licensee in any Action contesting the validity or enforceability of, or
Licensee's ownership of or rights in, the Territory Specific Materials or
Licensee Regulatory Materials, except that Licensor shall be permitted to be an
adverse party in connection with a defensive counterclaim, and to assert any
claim or defense in any Action based on any dispute arising out of or in
connection with this Agreement, or the breach, termination, or invalidity
hereof.
(c) Joint Ownership. The following Improvements shall be jointly owned by
the Parties: (i) Improvements to the Licensed Rights, Licensed Regulatory Data
or Licensee Regulatory Materials that the Parties' designees on the Steering
Committee mutually agree shall be jointly owned by the Parties for the purpose
of avoiding prior art status, under 35 U.S.C. ss. 102(e), and (ii) clinical data
developed by the Parties that the Parties' designees on the Steering Committee
mutually agree shall be jointly owned pursuant to Article VI of the Supply
Agreement (the "JOINTLY OWNED IMPROVEMENTS").
2.4 Improvements.
(a) Rights to Improvements. Notwithstanding the foregoing, any
Improvements to the Licensed Rights or Licensed Regulatory Data, including
Licensor's undivided interest in the Jointly Owned Improvements, made by or for
Licensor during the Term (other than the Improvements owned by Licensee as
expressly provided herein and in Article VI of the Supply Agreement) shall be
made available to Licensee and be deemed included within the scope of the
Licensed Rights or Licensed Regulatory Data, as applicable, without any
additional consideration on the part of Licensee. Without limiting the
generality of the foregoing and except for the Improvements owned by Licensee as
expressly provided herein and in Article VI of the Supply Agreement, Licensee
agrees not to, and not to assist any Third Party to, apply to register or
register title to any intellectual property rights in the Licensed Rights or
Licensed Regulatory Data or any Improvements thereupon, including Improvements
to Licensed Products that are, in whole or in part, based on, utilizing or
otherwise incorporating the Licensed Rights or Licensed Regulatory materials,
except for the Improvements owned by Licensee as expressly provided herein and
in Article VI of the Supply Agreement.
(b) Certain Improvements Relating to * * *. If, in order to obtain * * *
for the Licensed Products, Licensor develops an Improvement to the Licensed
Products for * * * use and such Improvement has an average particle size larger
than * * *, then such Improvement will be deemed a Licensed Product under this
Agreement and the Supply Agreement notwithstanding its average particle size or
any other provision of this Agreement or the Supply Agreement to the
11
contrary, and the definition of "Licensed Product" herein and in the Supply
Agreement and Section 2.1(a) hereof shall be automatically amended as necessary
to include such Improvement, provided, however that in the event * * * are
achieved with a Licensed Product having an average particle size equal to or
less than * * *, this Section 2.4(b) shall not apply and shall be of no force or
effect. For the avoidance of doubt, nothing in this Section 2.4(b) or this
Agreement is intended to require Licensor to develop an Improvement to the
Licensed Products having an average particle size larger than * * *.
(c) Grant Back License Outside the Territory. Subject to the terms and
conditions of this Agreement and to the extent that Licensee has the right to
grant license rights therein, Licensee grants to Licensor, effective as of
Closing Date, a fully paid-up, exclusive outside the Territory for all purposes,
nonsublicensable (except as permitted in Section 12.1) and nonassignable (except
as permitted in Section 12.1) license to make, market, use, distribute, import,
offer for sale, sell, commercialize or otherwise dispose of (i) all of the
Territory Specific Materials, except for the trademarks and trade dress for the
Licensed Products specified in Section 2.3(b)(i)(A) and the website content
specified in Section 2.3(b)(i)(B); (ii) all of the Licensee Regulatory Materials
except for the Regulatory Approvals and Opt Out Data; and (iii) Licensee's
undivided interest in the Jointly Owned Improvements. For the avoidance of
doubt, subject to the terms and conditions of this Agreement and to the extent
that Licensee has the right to grant license rights therein, Licensee grants to
Licensor, effective as of Closing Date, a fully paid-up, exclusive outside the
Territory for all purposes, nonsublicensable (except as permitted in Section
12.1) and nonassignable (except as permitted in Section 12.1) license to make,
market, use, distribute, import, offer for sale, sell, commercialize or
otherwise dispose of the Licensee Regulatory Materials (except for the
Regulatory Approvals and Opt Out Data), including, for the avoidance of doubt,
the regulatory and clinical data and materials generated in accordance with
Section 6.3(b)(iii) of the Supply Agreement.
(d) Grant Back License Inside the Territory Outside the Field. Subject to
the terms and conditions of this Agreement and to the extent that Licensee has
the right to grant license rights therein, Licensee grants to Licensor,
effective as of Closing Date, a fully paid-up, exclusive inside the Territory
outside the Field, nonsublicensable (except as permitted in Section 12.1) and
nonassignable (except as permitted in Section 12.1) license to make, market,
use, distribute, import, offer for sale, sell, commercialize or otherwise
dispose of (i) all of the Licensee Regulatory Materials except for the
Regulatory Approvals and Opt Out Data; and (ii) Licensee's undivided interest in
the Jointly Owned Improvements. For the avoidance of doubt, subject to the terms
and conditions of this Agreement and to the extent that Licensee has the right
to grant license rights therein, Licensee grants to Licensor, effective as of
Closing Date, a fully paid-up, exclusive inside the Territory outside the Field,
nonsublicensable (except as permitted in Section 12.1) and nonassignable (except
as permitted in Section 12.1) license to make, market, use, distribute, import,
offer for sale, sell, commercialize or otherwise dispose of the Licensee
Regulatory Materials (except for the Regulatory Approvals and Opt Out Data)
including, for the avoidance of doubt, the regulatory and clinical data and
materials generated in accordance with Section 6.3(b)(iii) of the Supply
Agreement.
(e) Grant Back License to the Opt Out Data. Subject to the terms and
conditions of this Agreement and to the extent that Licensee has the right to
grant license rights therein, Licensee grants to Licensor, effective as of
Closing Date, a fully paid-up, exclusive inside the
12
Territory outside the Field and outside the Territory, nonsublicensable (except
as permitted in Section 12.1) and nonassignable (except as permitted in Section
12.1) license to access and use the Opt Out Data solely for the purpose of
complying with the safety reporting requirements of the FDA, TPD, or an
equivalent regulatory body in a country outside the Territory; provided, that
the Opt Out Data shall not include data or information owned by Third Parties or
that Licensee is under an obligation at law or to Third Parties not to disclose
(e.g., protected patient identification information). For purposes of the
preceding sentence, "Third Party" shall not include contract laboratories or
other agents acting on behalf of Licensee or its Affiliates. Notwithstanding the
foregoing, with respect to data or information owned by Third Parties or that
Licensee is under an obligation to Third Parties not to disclose, Licensee shall
use commercially reasonable efforts to cause such Third Parties to provide
letters of authorization granting necessary rights of reference or permission to
disclose (e.g., to their confidential information).
2.5 Website Content and URLs.
(a) Cross License. To the extent a Party or an Affiliate of a Party has
the right to grant licenses to the content for its website that describes a
Licensed Product ("WEBSITE CONTENT"), such Party grants the other Party,
effective as of the Closing Date, a fully paid-up, non-exclusive,
nonsublicensable (except as permitted in Section 12.1) and nonassignable (except
as permitted in Section 12.1) license to use such Website Content in connection
with the marketing, offering for sale, and distribution of the Licensed
Products, which license shall include the right to copy, prepare derivative
works and publicly display such Website Content. The licensor of such Website
Content shall in all instances act reasonably to provide materials embodying the
Website Content to the licensee of such content and in allowing the licensee of
the Website Content to display such content as provided in all cases at the
licensee's reasonable request and sole expense. Prior to copying the Website
Content of the other Party or its Affiliates, the licensee of the Website
Content shall send the licensor an email describing the Website Content it wants
to copy, and the licensor shall, within five (5) Business Days, provide the
licensee with its commentary, updates and notes, if any, on the Website Content
identified in the licensee's email.
(b) Conditions to License. The license granted to Licensee in Section
2.5(a) is subject to the conditions that (i) any website owned or operated by or
on behalf of Licensee that displays Website Content (A) is directed solely to
users in the Territory, and (B) contains a prominent disclaimer to the effect
that any Website Content is directed solely to users in the United States or
Canada; (ii) any website owned or operated by or on behalf of Licensor that
displays Website Content (A) is directed solely to users outside the Territory,
and (B) contains a translation of Licensee's Website Content into a language
other than the English language or a prominent disclaimer to the effect that any
Website Content written in the English language is not directed to users in the
United States or Canada.
(c) Access to Websites. It is understood and agreed that it shall not be a
breach of this Section 2.5 if (i) users outside the Territory are able to gain
access to websites owned or operated by or on behalf of Licensee, provided that
Licensee does not take any affirmative measures to target such users and takes
commercially reasonable measures to respond only to users located within the
Territory, for example, by declining to provide additional information to users
who identify themselves as being located outside the Territory, or (ii) users in
the Territory
13
are able to gain access to websites owned or operated by or on behalf of
Licensor, provided that Licensor does not take any affirmative measures to
target such users and takes commercially reasonable measures to respond only to
users located outside the Territory, for example, by declining to provide
additional information to users who identify themselves as being located in the
Territory. Licensor and Licensee shall ensure that their respective websites
substantially comply with the applicable FDA and the applicable TPD
requirements. Licensor shall not, and shall cause its licensees not to, register
or use (i) any Licensee Mark in any URL or domain name, or (ii) any trademark
for a Licensed Product in any URL or domain name that contains the international
extension ".us" (for the United States) or ".ca" (for Canada).
ARTICLE III
OBLIGATIONS
3.1 Diligence Efforts.
(a) Diligence Obligations of the Parties. Licensee shall use commercially
reasonable efforts to obtain Regulatory Approvals for the Licensed Products in
the Territory, to bring Licensed Products to market, and to maximize sales of
Licensed Products in the Territory. At a minimum, it is Licensee's obligation
under this Section 3.1(a) to adopt and implement efforts to bring Licensed
Products to market and to maximize sales for each Licensed Product hereunder
that are reasonably equivalent to the sales and other efforts and sales
strategies adopted and implemented by Licensee's Affiliate pursuant to the
Previous License Agreement with regard to the launch and ongoing sales efforts
for Restylane;(TM) provided, however, that Licensee may adjust its efforts under
this Agreement to account for the differences in the products and the market
opportunities therefor. In the event the product currently marketed in Europe
under the trademark Restylane SubQ does not meet the requirements of * * *,
Licensor shall use commercially reasonable efforts to develop at least one
Licensed Product having * * *.
(b) Diligence Default. In the event that Licensor believes that Licensee
has committed a material breach of its obligations under Section 3.1(a) for a
particular Licensed Product and Licensor provides Licensee with written notice
of such alleged material breach, and Licensee thereafter fails to effect a cure
of such alleged material breach within thirty (30) days of receipt of the
written notice from Licensor, Licensor may invoke the dispute resolution
procedures set forth in Article XI. If, in a final arbitral decision, the
arbitral tribunal determines that Licensee has committed a material breach of
its obligations in Section 3.1(a) with respect to a particular Licensed Product
(a "DILIGENCE DEFAULT"), Licensor shall have the exclusive remedies specified in
Sections 3.1(c) and 3.1(d).
(c) Termination of Exclusive Rights. In the event a Diligence Default has
occurred, Licensor may (i) terminate the exclusive rights granted in Section 2.1
hereof for that particular Licensed Product by sending written notice of such
termination to Licensee, and (ii) obtain a duplicate PMA Approval with respect
to such Licensed Product in accordance with Section 3.1(d) only for purposes of
obtaining and maintaining approval to market and distribute such Licensed
Product in the Territory. If Licensor terminates the exclusive rights granted in
Section 2.1 hereof for a particular Licensed Product, such license with respect
to such Licensed Product shall continue in effect but shall become nonexclusive
with regard to such Licensed Product only.
14
(d) Duplicate PMA Approvals.
(i) For purposes of this Section 3.1(d), "Licensor" shall refer to
"Licensor or its licensee." The procedure for obtaining duplicate PMA
Approvals in the event of a Diligence Default shall be as follows:
(A) Pursuant to the FDA's existing procedure, Licensor shall prepare
and file a complete original PMA Application based upon a right of
reference to the information in Licensee's Regulatory Approvals for
the nonexclusive Licensed Product. Licensee shall cooperate fully to
ensure that such PMA Application is complete, accurate and
acceptable for filing under 21 C.F.R. ss. 814.12. Licensee shall
promptly provide all necessary letters of authorization granting
rights of reference, shall use commercially reasonable efforts to
cause Third Parties to provide letters of authorization granting
necessary rights of reference (e.g., to their Master Files) and
otherwise shall use commercially reasonable efforts to enable
Licensor to fully comply with and pursue the FDA requirements for
obtaining duplicates of the original PMA Approvals in accordance
with the terms of this Agreement. Licensee shall promptly cooperate
with Licensor's efforts and the FDA procedures as reasonably
requested by Licensor and as necessary to obtain such duplicate PMA
Approvals.
(B) The FDA generally refers to the foregoing procedure as licensing
of a PMA Approval, with the owner of the original Regulatory
Approval as the licensor and the owner of the newly issued PMA
Approval as the licensee. These terms are not used in this Section
3.1(d) in order to avoid confusion with this Agreement and terms
related hereto.
(ii) Upon the completion of the procedures referenced in Section
3.1(d)(i), above: (A) Licensor shall have irrevocable ownership of its
duplicate Regulatory Approvals for the sole purpose of marketing and
distributing the nonexclusive Licensed Product and (B) Licensor's
distribution (or distribution by its other licensees and/or agents) of
such nonexclusive Licensed Products in the United States shall be
conducted under the Regulatory Approvals that Licensor owns.
(iii) As applicable, both Parties shall provide all necessary
letters of authorization granting rights of reference, shall use
commercially reasonable efforts to cause Third Parties to provide letters
of authorization granting necessary rights of reference (e.g., to their
Master Files) and otherwise shall cooperate fully in complying with the
FDA requirements for obtaining duplicate PMA Approvals in accordance with
the terms of this Agreement.
(e) Exclusive Remedies. The remedies specified in Sections 3.1(b), 3.1(c)
and 3.1(d), shall be the exclusive remedy in the event of a Diligence Default
notwithstanding any other rights, powers, remedies and privileges that may be
available to Licensor under this Agreement (including, without limitation,
Article X hereof), the Transaction Agreements or Laws of any Governmental
Authority. If, following a Diligence Default, the exclusive license rights
granted in Section 2.1 hereof for a particular Licensed Product become
nonexclusive in accordance with
15
Section 3.1(c), Licensee shall have no further obligations under Section 3.1(a)
for that Licensed Product.
3.2 Markings and Trade Dress.
(a) Licensee shall use commercially reasonable efforts to substantially
comply with all patent marking and placement of corporate identifiers and
identifiers of NASHA technology on the packaging and package inserts of the
Licensed Products as required by applicable Law in the U.S. and Canada. Licensee
shall use and display on all packaging and package inserts of the Licensed
Products Licensor corporate identifiers and identifiers of NASHA technology that
are reasonably requested by Licensor and are of a size, format and location
appropriate for said packaging as reasonably determined by Licensee, provided
that such identifiers shall be displayed in a reasonably prominent manner.
Licensee shall not use or display Licensor's corporate identifiers or
identifiers of NASHA technology other than on promotional literature, packaging
and package inserts, without Licensor's express written consent, and in any
event shall not use or display Licensor's corporate identifiers or identifiers
of NASHA technology in a manner inconsistent with Licensor's use and display
thereof. It shall not be considered a breach by Licensee of this Section 3.2 if,
through inadvertence or Third Party error, such identifiers are not, or are
incorrectly, displayed on a small number of promotional literature, packages or
package inserts of the Licensed Products.
(b) Licensee shall have the right to adopt, own for registration and use
for Licensed Products, in each case solely in the Territory, (i) trademarks
owned or controlled by Licensor and used to brand the Licensed Products outside
the Territory or trademarks substantially similar thereto (the "LICENSOR MARKS)
and/or the trade dress owned or controlled by Licensor and used in connection
with the Licensed Products outside the Territory, or trade dress substantially
similar thereto (the "LICENSOR TRADE DRESS"); or (ii) trademarks distinctive to
Licensee, provided such trademarks are not confusingly similar to the Licensor
Marks existing and publicly known (the "LICENSEE MARKS) and/or trade dress
distinctive to Licensee, provided such trade dress is not confusingly similar to
the Licensor Trade Dress existing and publicly known (the "LICENSEE TRADE
DRESS") and provided further that Licensee (x) shall bear its own expenses with
regard to adoption or modification of Licensee Marks and Licensee Trade Dress,
and (y) shall not adopt a Licensee Trade Dress which is incompatible with or
unduly burdensome on Licensor's packaging or other equipment. For the avoidance
of doubt, Licensee may adopt any combination of the foregoing (e.g., the
Licensee Marks with the Licensor Trade Dress or the Licensor Marks with the
Licensee Trade Dress).
(c) In the event that Licensee adopts the Licensor Marks to brand and
market the Licensed Products in the Territory, the Parties agree that Licensor
shall, and shall cause its Third Party licensees to, refrain from adopting new
trademarks, or changing or modifying the existing trademarks, for any product of
Licensor that is distributed inside the Territory (either inside or outside the
Field) in a way as to make it confusingly similar to the marks adopted by
Licensee, provided that Licensor shall be free to change, modify or adapt its
trademarks used in connection with its products outside the Territory, even if
such changes, modifications or adaptations result in trademarks that are
confusingly similar to the trademarks used by Licensee in connection with
Licensed Products within the Territory.
16
(d) In the event that Licensee elects to adopt the Licensor Trade Dress
for use in connection with the Licensed Products in the Territory, the Parties
agree that each Party shall be free to change, modify or adapt its trade dress
used in connection with its products, even if such changes, modifications or
adaptations result in trade dress that is confusingly similar to the trade dress
used by the other Party in connection with its products; provided however
Licensor shall, and shall use commercially reasonable efforts to cause its Third
Party licensees to, refrain from modifying the Licensor Trade Dress in a way
identical to Licensee's modifications of Licensor Trade Dress adopted by the
Licensee.
(e) In the event that Licensee adopts the Licensee Marks or Licensee Trade
Dress to brand and market the Licensed Products in the Territory, the Parties
agree that Licensor shall, and shall cause its Third Party licensees to, refrain
from adopting new trademarks or trade dress or changing or modifying the
existing trademarks or trade dress, for any product of Licensor that is
distributed either in or outside the Territory in a way as to make it identical
or confusingly similar to the Licensee Marks or Licensee Trade Dress.
3.3 Protection of Intellectual Property. Licensee shall take such action
as Licensor reasonably requests in writing, at Licensor's expense except as
otherwise determined by the Steering Committee in accordance with the Supply
Agreement, to assist Licensor in obtaining, registering and perfecting the
Licensed Rights and disclosing pertinent information and executing documents in
connection therewith.
3.4 Compliance With Relevant Law. Licensor and Licensee shall each comply
in all material respects with all applicable Laws that pertain to the activities
for which Licensor and Licensee are each responsible under this Agreement.
3.5 Prosecution and Maintenance of Licensed Patents. Subject to the terms
and conditions of this Agreement, Licensor shall use reasonable best efforts to
prosecute and maintain all Licensed Patents in the Territory in Licensor's name
in accordance with the applicable terms set forth herein. Except as otherwise
set forth in Section 4.2 herein with respect to Actions for the infringement,
misappropriation or impairment of or damage to the Licensed Rights, Licensor
shall be responsible for all actions and costs associated with maintaining the
enforceability and validity of the Licensed Patents, and paying maintenance fees
and/or annuities, and all other costs required to maintain the Licensed Patents.
Licensor shall use reasonable best efforts to prosecute each of the Licensed
Patents either to issuance or until administrative appeals to the Board of
Patent Appeals and Interferences or its Canadian equivalent are exhausted.
Except as provided in Section 3.7 herein with regard to patent applications
requested by Licensee, the preparation and filing of any new patent applications
shall be entirely and solely at Licensor's discretion.
3.6 Correspondence Relating to Patent Prosecution. Licensor shall deliver
to Licensee, or counsel designated by Licensee, copies of all non-privileged
correspondence to and from the USPTO and CIPO relating to the Licensed Patents
in the Territory, as well as all non-privileged correspondence with the World
Intellectual Property Organization relating to any International Application
designating the United States or Canada, and all non-privileged correspondence
with any national or regional patent office containing any information that may
reasonably be material to the validity, scope or enforceability of the Licensed
Patents, relating to
17
applications corresponding to or claiming priority with or from the Licensed
Patents. Such correspondence shall be delivered promptly after the origination
or receipt of such correspondence. With respect to the Licensed Patents,
Licensee or counsel designated by Licensee shall have the right to submit
comments on such correspondence to Licensor within fifteen (15) Business Days
after Licensor sends such correspondence to Licensee or counsel designated by
Licensee. If Licensee or counsel designated by Licensee timely submits comments
to Licensor, and subject always to the best judgment of Licensor and its
counsel, Licensor shall use commercially reasonable efforts to incorporate all
reasonable comments in its further correspondence with the USPTO or CIPO,
provided incorporation of the comments would not unreasonably delay, burden or
increase the expense of the prosecution of pending patent applications.
3.7 Divisional, Continuation and New Patent Applications. From time to
time Licensee may desire that Licensor file a divisional, continuation or new
application for patent in the Territory embodying an invention conceived by
Licensee and in whole or in part based on, utilizing or otherwise incorporating
the Licensed Rights. In such circumstances, Licensee shall submit to the
Steering Committee, in accordance with the Supply Agreement, a request for
patent filing detailing the invention, the effect of the invention on the
commercialization of the Licensed Products in the Territory (if any) and any
information known to Licensee regarding the novelty, non-obviousness and general
patentability of the invention (a "PATENT REQUEST"). Licensee and Licensor shall
cause their respective designees on the Steering Committee, in accordance with
the Supply Agreement, to decide whether or not to approve the Patent Request,
taking into consideration both any effect on the commercialization of the
Licensed Products in the Territory and the patentability of the invention
proposed for patenting. If the Steering Committee in accordance with the Supply
Agreement approves a Patent Request, Licensor shall use commercially reasonable
efforts to timely file a patent application based on the invention detailed
therein and to diligently prosecute such application to issuance, provided that
Licensee shall pay all reasonable costs related to any patent application filed
pursuant to a Patent Request and any patent that issues therefrom to the extent
the application and patent relate exclusively to the Territory. To the extent
the application and any patent that issues therefrom are relevant to the
worldwide market, Licensee and Licensor shall cause their respective designees
on the Steering Committee to determine the appropriate allocation of cost as
between Licensee and Licensor. Notwithstanding Licensee's payment of prosecution
and maintenance fees, any patent application embodying an invention in whole or
in part based on, utilizing or otherwise incorporating the Licensed Rights,
filed pursuant to a Patent Request, or otherwise, and any patent that issues
therefrom shall be owned in its entirety by Licensor unless the Parties'
designees on the Steering Committee mutually agree that such application or
patent shall be jointly owned for the purpose of avoiding prior art status, such
as under 35 U.S.C. ss. 102(e). For the avoidance of doubt, the Parties intend
that Licensee has the right, on its own and at its sole expense, to prosecute
patents based on its own inventions to the extent, and only to the extent, such
inventions are not in whole or in part based on, do not utilize, and do not
otherwise incorporate the Licensed Rights.
3.8 March In Rights. If and only if Licensor is unwilling or unable due to
Licensor's bankruptcy, insolvency, appointment of receiver or similar proceeding
to maintain the Licensed Patents to the extent relevant to the Licensed Products
in the Territory, Licensee shall have the
18
right to prosecute and maintain such Licensed Patents in the Territory, provided
that in all events, ownership of all rights in and to such Licensed Patents
shall remain with Licensor.
3.9 Provision of Licensor Information and Access to Licensor Employees.
(a) Licensor shall, promptly after the Closing Date and at Licensee's sole
expense, use commercially reasonable efforts to deliver to Licensee
documentation of (1) the Licensed Know-How and Licensed Regulatory Data to the
extent such documentation (i) exists and (ii) is not subject to confidentiality
restrictions preventing its disclosure to Licensee and (2) any material
published by Licensor related to the Licensed Products, including but not
limited to marketing and sales materials, to the extent such documentation (i)
exists and (ii) is reasonably requested by Licensee for its use in the
marketing, use, distribution, importation, offering for sale, sale,
commercialization or other disposition of the Licensed Products in the
Territory. Licensor shall use commercially reasonable efforts to supplement such
documentation when new documentation reflecting the Licensed Know-How or
Licensed Regulatory Data becomes available to Licensor. For the avoidance of
doubt, Licensor shall have no obligation to author, create or produce initial or
supplemental documentation to the extent such documentation does not otherwise
exist, but Licensor agrees to share with Licensee such documentation related to
the marketing, use, distribution, importation, offering for sale, sale,
commercialization or other disposition of the Licensed Products in the Territory
as now exists or is hereafter created, other than documentation that Licensor is
under an obligation to unrelated Third Parties not to disclose, such as patient
data. All such documentation shall be provided by Licensor to the Licensee in
the form of one copy only in the English language or in another language if no
English copy exists.
(b) From time to time Licensor shall use commercially reasonable efforts
to provide Licensee reasonable access, at Licensee's sole expense, to relevant
employees designated by Licensor as having knowledge of Licensed Know-How or
Licensed Regulatory Data that are not reduced to writing and is reasonably
requested by Licensee for its use in the marketing, use, distribution,
importation, offering for sale, sale, commercialization or other disposition of
the Licensed Products in the Territory, to allow Licensee to meet and interview
such employees to enable Licensee to better practice the Licenses granted under
Section 2.1, provided that, if not otherwise agreed between the Parties, (i) the
total of such meetings shall be limited to no more than five (5) days per annum
or, in any year in which Licensee shall Launch a Licensed Product, no more than
ten (10) days per annum, of which no more than two (2) days at a time shall be
consecutive; (ii) such meetings shall occur upon not less than thirty (30) days'
prior notice to Licensor; (iii) such meeting shall only be conducted during
normal business hours; and (iv) such meetings shall not unreasonably disrupt or
interfere with Licensor's normal operations. For the avoidance of doubt, meeting
of the Steering Committee shall not be counted in the calculations set forth in
this Section 3.9(b).
3.10 Policing of Products.
(a) The Parties shall use commercially reasonable efforts to police the
Licensed Products and their channels of trade to ensure that (i) Licensor and
its Affiliates, licensees or designees do not sell, offer for sale, import,
market, distribute or have distributed, or otherwise dispose of Licensed
Products within the Territory; and (ii) Licensee and its Affiliates, licensees
19
or designees do not sell, offer for sale, import, market, distribute or have
distributed, or otherwise dispose of Licensed Products outside the Territory.
(b) The Parties shall use commercially reasonable efforts to police their
products to ensure that (i) products sold by Licensor and its Affiliates,
licensees or designees, other than Licensed Products sold by Licensee and its
Affiliates, licensees or designees, are not used in the Field in the Territory;
and (ii) Licensed Products sold by Licensee and its Affiliates, licensees or
designees are not used outside the Field in the Territory (in either case an
"OUT-OF-FIELD USE"). In the event that either Party (the "COMPLAINING PARTY")
believes that products sold by the other Party (the "RESPONSIBLE PARTY") or its
Affiliates, licensees or designees in the Territory have been or are being used
for an Out-of-Field Use, the Complaining Party shall present the Responsible
Party with the full, complete and most probative evidence of such Out-of-Field
Use available to the Complaining Party. If, after review of the proof presented
by the Complaining Party, the Responsible Party agrees that products sold by
itself or its Affiliates, licensees or designees in the Territory have been or
are being used for an Out-of-Field Use, such Responsible Party shall compensate
the Complaining Party for the lost profits suffered by the Complaining Party due
to the Out-of-Field Use of products sold directly by such Responsible Party or
its Affiliates, licensees or designees in the Territory. If, after review of the
proof presented by the Complaining Party, the Responsible Party refuses to
compensate the Complaining Party for its lost profits in accordance with this
Section 3.10(b), the Parties shall submit their claims to arbitration in
accordance with the dispute resolution provisions of Article XI herein.
3.11 Tax Certificate. Licensor shall provide Licensee with a properly
executed and valid Form W-8BEN and shall continue to update such Form W-8BEN
throughout the Term of this Agreement in accordance with U.S. Treasury
Regulation 1.1441-1(e)(4)(ii).
3.12 Other Agreements. Within thirty (30) days of the Closing Date,
Licensor shall deliver to Licensee a draft trademark license agreement pursuant
to which Licensee will receive a fully paid license to use the "NASHA" mark.
Following the Closing Date and prior to the date that the first Milestone
Payment is due in accordance with Article VIII hereof, the Parties shall execute
and deliver all documents, instruments and certificates required in connection
with establishing the Account contemplated by Section 8.2(a).
3.13 Non-Compete Undertaking of Licensee.
(a) During the Non-Compete Period (as defined below), Licensee agrees that
it will not sell, or enter into definitive agreements to sell, a Competing
Product. As used in this Section 3.13, the term "COMPETING PRODUCT" shall mean a
product for * * *.
(b) As used in this Section 3.13, the term "NON-COMPETE PERIOD" shall mean
* * *.
ARTICLE IV
INFRINGEMENT OF LICENSED RIGHTS
20
4.1 Obligations. Each Party shall promptly notify the other Party in
writing of any actual or potential infringement, misappropriation or impairment
of or damage to the Licensed Rights, or threatened Action against a Party that
the Party's acts under or related to the Licensed Rights infringe,
misappropriate, impair or otherwise damage the intellectual property rights of a
Third Party, of which the Party is or becomes aware.
4.2 Actions. Licensor shall have the exclusive right to bring an
Action for the infringement or misappropriation or impairment of or damage to
the Licensed Rights and shall use all reasonable, diligent efforts to pursue
parties who have infringed, misappropriated, impaired or otherwise damaged the
Licensed Rights known to Licensor or identified in writing to Licensor by
Licensee. Licensor shall bear all expenses, have complete control over, and
recover all proceeds, settlements and damages with respect to any such Action,
provided that, if such infringement, misappropriation, impairment or damage is
due in whole or in part to the actions or inactions of Licensee, Licensee shall
reimburse Licensor for such expenses, including reasonable attorney's fees and
expenses, in proportion to the degree to which Licensee's actions or inactions
contributed to such infringement, misappropriation, impairment or damage.
Licensee agrees to cooperate fully with Licensor at Licensor's expense in any
such Action, and to be joined as a party in such Action where required by Law.
If Licensor fails to provide Licensee with evidence reasonably sufficient to
Licensee that Licensor has undertaken demonstrable and reasonable efforts to
abate and investigate an infringement, misappropriation, impairment or damage
reported by Licensee in writing to Licensor within sixty (60) days after it
receives a written request from Licensee to do so, or if Licensor fails to bring
an Action in the Field in the Territory to abate an infringement,
misappropriation, impairment or damage within ninety (90) days after it receives
a written request from Licensee to do so, or if Licensor discontinues the
prosecution of any such Action after filing, Licensee may, in its discretion,
undertake such Action as it deems necessary to enforce the Licensed Rights. In
such case, Licensee shall bear all expenses and recover all proceeds,
settlements and damages with respect to any such Action, and Licensor shall
assist Licensee, upon Licensee's request, at Licensee's sole expense in taking
any action to enforce the Licensed Rights and shall consent to be joined as a
party in such Action where required by Law. In any Licensee-brought Action,
Licensee shall promptly send to Licensor a true copy of any and all notices or
communications between Licensee and the Third Party infringer as well as a true
copy of any and all pleadings, motions or other filings in or related to the
Action. To the extent that there are communications not in writing, Licensee
shall periodically, but at least monthly, provide to Licensor a report of all
material communications bearing upon the current status of the dispute as
between Licensee and the Third Party infringer, and any steps bearing upon
resolution of that dispute. In no event shall either Party settle any Action
referred to in this Section 4.2 with any Third Party, which settlement would
materially affect any of the rights of the other Party (as determined by that
Party in its reasonable discretion) under this Agreement, without the prior
approval of the other Party, which approval shall not be unreasonably withheld
or delayed.
ARTICLE V
REPRESENTATIONS, WARRANTIES AND COVENANTS
5.1 Representations and Warranties of Licensor. Licensor hereby represents
and warrants to Licensee that:
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(a) Corporate Organization and Authority. Licensor is a company duly
organized, validly existing and in good standing under the Laws of the Kingdom
of Sweden and has all requisite power and authority to execute and deliver this
Agreement and to perform its obligations hereunder. The execution and delivery
by Licensor of this Agreement, the performance by Licensor of its obligations
hereunder, and the consummation by Licensor of the transactions contemplated
hereby have been duly authorized by all requisite corporate action. This
Agreement has been duly executed and delivered by Licensor and, assuming the due
authorization, execution and delivery hereof by Licensee, constitutes a legal,
valid and binding obligation of Licensor, enforceable against Licensor in
accordance with its terms, except to the extent that such enforcement may be
subject to applicable bankruptcy, insolvency, reorganization, moratorium, or
other Laws of general application relating to or affecting enforcement of
creditors' rights and Laws concerning equitable remedies.
(b) No Conflict. The execution, delivery and performance by Licensor of
this Agreement and the consummation by Licensor of the transactions contemplated
hereby do not and will not, with or without the giving of notice or the passage
of time or both, violate, conflict with or cause a breach or termination of or
constitute a default under (i) the provisions of any Law applicable to Licensor
or its properties or assets; (ii) the provisions of the constituent
organizational documents or other governing instruments of Licensor; (iii) any
note, bond, mortgage, indenture, license, agreement or other instrument or
obligation to which Licensor is a party or by which Licensor, the Licensed
Products, the Licensed Regulatory Data or the Licensed Rights are bound or
subject; or (iv) any judgment, decree, order or award of any court or
Governmental Authority applicable to Licensor or its properties or assets.
(c) Governmental and Third Party Consents. No consent, approval, exemption
or authorization is required to be obtained from, no notice is required to be
given to and no filing is required to be obtained from, any Third Party or
Governmental Authority by virtue of the execution and delivery of this
Agreement.
(d) Litigation. Except as set forth in Schedule 5.1(d), (i) there are no
Actions pending, or to Licensor's or its Affiliates' knowledge threatened, which
could reasonably be expected to have, individually or in the aggregate, a
material adverse effect on the prospects or condition of the Licensed Products,
Licensed Regulatory Data or the Licensed Rights nor (ii) to Licensor's or its
Affiliates' knowledge, do circumstances exist which are reasonably likely to
result in any Action of the kind described in clause (i) above.
(e) Licensor Know-How and Licensed Regulatory Data. The Licensed Know-How
and Licensed Regulatory Data, to the extent constituting or containing trade
secret information, are not, as of the date hereof, readily ascertainable by
proper means by those who can obtain economic value from its knowledge or use
and Licensor has taken steps reasonable under the circumstances to ensure that
the Licensed Know-How and Licensed Regulatory Data, to the extent constituting
or containing trade secret information, have been maintained in confidence.
(f) Licensed Rights and Licensed Regulatory Data. Licensor is the sole and
exclusive owner of, and has all rights, title and interest in and to, or has the
exclusive right to license the Licensed Rights and the Licensed Regulatory Data
in the Territory. No Actions are pending, or to Licensor's or its Affiliates'
knowledge threatened against Licensor alleging the
22
Licensed Rights or Licensed Regulatory Data in any respect are an infringement,
misappropriation or impairment or have otherwise caused damage to any Third
Party or any Third Party's intellectual property rights, or that challenge
Licensor's ownership of, or the enforceability or validity of the Licensed
Rights or Licensed Regulatory Data. To the best of Licensor's or its Affiliates'
knowledge after due inquiry, the Licensed Rights and Licensed Regulatory Data do
not and will not infringe, constitute a misappropriation or impairment of or
otherwise cause damage to or interfere with any patent, copyright, trademark,
design right or other intellectual property rights of any other Person in the
Territory. Licensor has complied and will, during the Term, comply in all
material respects with all provisions of the patent acts, regulations, and
statutes regarding the procurement and maintenance of, all Licensed Rights and
Licensed Regulatory Data in the Territory. Licensor is in compliance and will,
during the Term, remain in compliance with that certain settlement agreement
dated September 28, 1999, between Licensor and Biomatrix, Inc. in settlement of
Civil Case #99-CV-2021 in the U.S. District Court for the District of New Jersey
(Newark), Biomatrix, Inc. v. Bengt Agerup, et al., Filed May 3, 1999. Licensor
has not specifically admitted that any claim of an unexpired patent or pending
patent application included within the Licensed Patents is invalid or
unenforceable through reissue, disclaimer (other than that in U.S. Patent No.
5,827,937 and Canadian Patent Application No. 2,226,488, wherein a disclaimer
has been filed with respect to claim 4) or otherwise. Licensor has adopted and
will use measures reasonable under the circumstances to enforce non-disclosure
and confidentiality policies and has obtained agreements from employees,
consultants and others relating to such matters that are reasonable under the
circumstances to protect its rights in and to the Licensed Rights and Licensed
Regulatory Data.
(g) Third Party Rights. Neither Licensor nor its Affiliates have granted
to any Third Party or Affiliate any rights or licenses or have otherwise taken
any action that conflicts with or materially adversely affects the rights and
Licenses granted to Licensee under this Agreement and will not grant any such
rights or licenses to any Third Party during the Term.
(h) Schedules. All schedules in this Agreement are complete and correct.
Schedule A contains a complete and correct list of all U.S. and Canadian patents
and patent applications owned by Licensor or any of its Affiliates that cover
the marketing, manufacture, use, distribution, importation, offering for sale,
sale, commercialization or other disposition of the Licensed Products in the
Field in the Territory.
(i) Government Authority. Neither Licensor nor any of its Affiliates is
aware of any Action or pending or threatened Action by any Governmental
Authority, including, but not limited to, the TPD (as defined in the Supply
Agreement) or FDA, that would prohibit or disapprove of the sale of the Licensed
Products in the Territory. Licensor is not aware that any Governmental
Authority, including, but not limited to, the TPD and FDA, would have a basis
for prohibiting or not approving the sale of the Licensed Products in the
Territory.
(j) Trademarks. Neither Licensor nor any of its Affiliates has, directly
or indirectly, registered, or filed applications for the registration of, the
mark "SUBQ" or any mark containing the term "SUBQ" with any Governmental
Authority in the Territory.
5.2 Representations and Warranties of Licensee. Licensee represents and
warrants
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to Licensor that:
(a) Corporate Organization and Authority. Licensee is a company duly
organized, validly existing and in good standing under the laws of the
jurisdiction of its organization and has all requisite power and authority to
execute and deliver this Agreement and to perform its obligations hereunder. The
execution and delivery by Licensee of this Agreement, the performance by
Licensee of its obligations hereunder, and the consummation by Licensee of the
transactions contemplated hereby have been duly authorized by all requisite
corporate action. This Agreement has been duly executed and delivered by
Licensee and, assuming the due authorization, execution and delivery hereof by
Licensor, constitutes a legal, valid and binding obligation of Licensee,
enforceable against Licensee in accordance with its terms, except to the extent
that such enforcement may be subject to applicable bankruptcy, insolvency,
reorganization, moratorium, or other Laws of general application relating to or
affecting enforcement of creditors' rights and Laws concerning equitable
remedies.
(b) No Conflict. The execution, delivery and performance by Licensee of
this Agreement and the consummation by Licensee of the transactions contemplated
hereby do not and will not, with or without the giving of notice or the passage
of time or both, violate, conflict with or cause a breach or termination of or
constitute a default under (i) the provisions of any Law applicable to Licensee
or its properties or assets; (ii) the provisions of the constituent
organizational documents or other governing instruments of Licensee; (iii) any
note, bond, mortgage, indenture, license, agreement or other instrument or
obligation to which Licensee is a party or by which Licensee, the Licensed
Products or the Licensed Rights are bound or subject; or (iv) any judgment,
decree, order or award of any court or Governmental Authority applicable to
Licensee or its properties or assets.
(c) Governmental and Third Party Consents. No consent, approval, exemption
or authorization is required to be obtained from, no notice is required to be
given to and no filing is required to be obtained from, any Third Party or
Governmental Authority by Licensee by virtue of the execution and delivery of
this Agreement.
5.3 NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH
HEREIN AND IN THE OTHER TRANSACTION AGREEMENTS, (I) LICENSOR MAKES NO
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER AT LAW OR IN EQUITY,
RELATED TO THE LICENSED RIGHTS OR LICENSED PRODUCTS, INCLUDING WITHOUT
LIMITATION, ANY REPRESENTATION OR WARRANTY AS TO VALUE, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE OR FOR ORDINARY PURPOSES, OR ANY OTHER MATTER, (II)
LICENSOR MAKES NO, AND HEREBY DISCLAIMS, ANY REPRESENTATION OR WARRANTY,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY AND WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE REGARDING THE LICENSED RIGHTS AND LICENSED PRODUCTS, (III)
THE LICENSED RIGHTS ARE CONVEYED ON AN "AS IS, WHERE IS" BASIS EFFECTIVE AS OF
THE CLOSING DATE AND LICENSEE SHALL RELY UPON ITS OWN EXAMINATION THEREOF, (IV)
LICENSEE MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER AT LAW
OR IN EQUITY, RELATED TO THE LICENSEE LICENSED RIGHTS, INCLUDING WITHOUT
LIMITATION, ANY
24
REPRESENTATION OR WARRANTY AS TO VALUE, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR FOR ORDINARY PURPOSES, OR ANY OTHER MATTER, (V) LICENSEE
MAKES NO, AND HEREBY DISCLAIMS, ANY REPRESENTATION OR WARRANTY, INCLUDING ANY
IMPLIED WARRANTY OF MERCHANTABILITY AND WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE REGARDING THE LICENSEE LICENSED RIGHTS, AND (VI) THE LICENSEE LICENSED
RIGHTS ARE CONVEYED ON AN "AS IS, WHERE IS" BASIS EFFECTIVE AS OF THE DATE ANY
LICENSE TO THE LICENSEE LICENSED RIGHTS BECOMES EFFECTIVE AND LICENSOR SHALL
RELY UPON ITS OWN EXAMINATION THEREOF. Without limiting the foregoing, each
Party acknowledges that it has not and is not relying upon any implied warranty
of merchantability or fitness for a particular purpose, or upon any
representation or warranty whatsoever as to the prospects (financial, regulatory
or otherwise) or the reliability, suitability, ability to produce a particular
result, and validity, regarding the Licensed Rights or the Licensee Licensed
Rights, as the case may be, after the date of this Agreement, except that
Licensee may rely on the representations and warranties contained herein and in
the other Transaction Agreements. This provision shall not affect the rights or
obligations of either Party hereto with respect to any other Transaction
Agreement.
5.4 Disclaimer of Consequential, Incidental and Contingent Damages. Except
as otherwise expressly provided herein, to the extent permitted by Law, neither
Party shall be subject to, and each Party hereby disclaims, liability for all
consequential, incidental and contingent damages whatsoever of the other Party
or any of its Affiliates arising out of or relating to action or inaction under,
performance or non-performance of, or the breach of, this Agreement.
ARTICLE VI
TERM; TERMINATION
6.1 Term. The term of this Agreement ("TERM") commences on the date hereof
and, unless earlier terminated pursuant to Section 6.2, lasts until the last to
occur of (a) the last Licensed Patent in the Licensed Rights expires, is
abandoned or is finally adjudicated invalid and (b) the first to occur of (i)
all of the Licensed Know-How becomes publicly available, other than by a breach
by either Party of its obligations under Article IX herein, or (ii) one hundred
(100) years from the date hereof.
6.2 Termination.
(a) Licensor may terminate this Agreement effective upon written
notice to Licensee if Licensee breaches its obligation to pay to Licensor any
One Time Payment or Milestone Payment when due in accordance with this
Agreement, including Section 8.5 hereof, and has not cured such breach within
five (5) Business Days after receipt of written notice of such breach from
Licensor.
(b) Either Party may terminate this Agreement if there shall have
been a Transfer by the other Party pursuant to a Change in Control (other than a
Volitional Change in Control) in violation of Section 12.1.
25
6.3 Effect of Termination. Upon the termination of this Agreement in
accordance with Section 6.2(a) by Licensor, Licensee shall (a) cease all use of
the Licensed Rights, Licensed Regulatory Data, Licensor Marks and Licensor's
Website Content and promptly return all originals and copies of any Licensed
Know-How, Licensed Regulatory Data and Licensor Confidential Information in its
possession or control to Licensor, and (b) transfer to Licensor the then
existing Regulatory Approvals for the Licensed Products and Improvements thereof
in the Territory pursuant to the FDA and TPD procedures for such transfers;
provided, that if the TPD procedures prohibit the transfer of the Regulatory
Approval in Canada to Licensor, Licensee shall grant Licensor a right of
reference with respect to the Canadian Regulatory Approval and any Licensee
Regulatory Materials to the extent necessary to obtain a duplicate Canadian
Regulatory Approval, and, for avoidance of doubt, to at least the same extent
necessary to obtain a duplicate PMA Approval under the provisions of Section
3.1(d) herein, for purposes of obtaining and maintaining approval to market and
distribute such Licensed Product in Canada.
6.4 Survival. Article IX [Confidentiality], Article X [Indemnification]
and Article XI [Dispute Resolution], and Sections 12.8 [Expenses] and 12.15
[Publicity] shall survive the expiration or termination of this Agreement for
any reason; provided, however, that termination pursuant to Section 6.2 will not
relieve a defaulting or breaching Party from any liability to the other Party
hereto.
ARTICLE VII
CLOSING AND CONDITIONS TO CLOSING
7.1 Closing. The closing of the transactions contemplated hereby (the
"CLOSING") will take place at the offices of Akin Gump Strauss Hauer & Feld LLP,
at 590 Madison Avenue, New York, NY 10022, or at such other place as may be
mutually agreeable in writing by the Parties, on the date hereof (the "CLOSING
DATE"). At the Closing, the Parties will duly execute and deliver all documents
and instruments required to be delivered, and the Licensee will make all
payments required to be paid by the Licensee at the Closing under Section
8.1(a)(i), in each case as provided in this Agreement. The Closing of the
transactions contemplated hereby shall be deemed to have occurred as of 12:01
a.m. (New York City time) on the Closing Date.
7.2 Method of Payment. Except with respect to the payment due on the
Closing Date, all amounts payable by Licensee hereunder shall be paid in United
States Dollars by wire transfer in immediately available funds to such bank
account as designated from time to time in writing by Licensor to Licensee at
least three (3) Business Days prior to the date such payment is due.
7.3 Conditions of the Licensee's Obligations at Closing. The obligations
of Licensee under this Agreement are subject to the fulfillment at or before the
Closing of each of the following conditions, any of which may be waived in
writing by Licensee:
(a) Supply Agreement. Licensor shall have entered into the Supply
Agreement.
(b) Macrolane Side Letter. Licensor shall have entered into the Macrolane
Side Letter.
(c) Previous License Letter Agreement. Licensor shall have entered into
the Previous
26
License Letter Agreement.
(d) Agerup Letter Agreement. Bengt Agerup shall have entered into the
Agerup Letter Agreement.
(e) Tax Certificate. Licensor shall have provided Licensee with a properly
executed and valid Form W-8BEN.
(f) Injunctions. At the Closing there shall not be in effect any Law or
any order, writ, injunction, decree, stipulation, determination or award entered
by or with any Governmental Authority ("GOVERNMENTAL ORDER") directing that the
transactions provided for herein not be consummated as provided herein or which
has the effect of rendering it impossible to consummate the transactions
provided for herein.
(g) Certificate. Licensor shall deliver to Licensee a certificate of an
authorized board member of Licensor certifying and attaching: (i) Licensor's
organizational documents as in effect as of the date hereof, (ii) a copy of the
minutes of the meeting at which Licensor's board authorized the transactions
contemplated by this Agreement, and (iii) a copy of a power of attorney executed
on behalf of Licensor's board delegating the power to bind Licensor to
Licensor's officers signing this Agreement and any other documents, instruments
or certificates executed and delivered by Licensor at Closing.
(h) Opinion. Licensee shall have received an opinion from Simpson Thacher
& Bartlett LLP and Advokatfirman Vinge KB, each in a form reasonably acceptable
to Licensee.
7.4 Conditions of the Licensor's Obligations at Closing. The obligations
of Licensor under this Agreement are subject to the fulfillment at or before the
Closing of each of the following conditions, any of which may be waived in
writing by Licensor:
(a) Supply Agreement. Licensee shall have entered into the Supply
Agreement.
(b) Macrolane Side Letter. Licensee shall have entered into the Macrolane
Side Letter.
(c) Previous License Letter Agreement. Licensee shall have entered into
the Previous License Letter Agreement.
(d) Guarantee. Medicis shall have entered into the Guarantee.
(e) Injunctions. At the Closing there shall not be in effect any Law or
Governmental Order directing that the transactions provided for herein not be
consummated as provided herein or which has the effect of rendering it
impossible to consummate such transactions.
(f) Certificate. Licensee shall deliver to Licensor a certificate of an
authorized board member of Licensee certifying and attaching: (i) Licensee's
organizational documents as in effect as of the date hereof, (ii) the board
resolutions of Licensee authorizing the transactions contemplated by this
Agreement and (iii) the incumbency of Licensee's officers signing this Agreement
and any other documents, instruments or certificates executed and delivered by
27
Licensee at Closing.
(g) Opinion. Licensor shall have received an opinion from Akin Gump
Strauss Hauer & Feld LLP in a form reasonably acceptable to Licensor.
ARTICLE VIII
LICENSE FEES
8.1 One Time Payments.
(a) Subject to the terms and conditions of this Agreement, Licensee shall
pay to Licensor the following one time payments as set forth below (each, a "ONE
TIME PAYMENT"):
(i) Thirty Million United States Dollars (U.S.$30,000,000.00) shall
be paid to Licensor upon the Closing Date.
(ii) Ten Million United States Dollars (U.S.$10,000,000.00) shall be
paid to Licensor, promptly, and in any event within five (5) Business Days
of the date upon which * * *.
(iii) Twenty Million United States Dollars (U.S.$20,000,000.00)
shall be paid to Licensor, promptly, and in any event within five (5)
Business Days after the date of receipt by Licensee of written notice from
the FDA * * *.
(iv) Twenty Million United States Dollars (U.S.$20,000,000.00) shall
be paid to Licensor, promptly, and in any event within five (5) Business
Days of the Launch in the United States of the first Licensed Product.
(b) For the avoidance of doubt, the Parties acknowledge and agree that the
use of the term "first Licensed Product" hereinabove means that Licensor shall
not be entitled to any other One Time Payments in respect of any other Licensed
Products.
8.2 * * *
8.3 Certain Tax Matters.
(a) All payments under Sections 8.1 and 8.2 hereof shall be made net of
any amounts required to be withheld by Licensee or Licensor pursuant to the Laws
of any Governmental Authority.
(b) Licensee shall for all purposes be the owner of all amounts held in
the Account prior to distribution and shall be responsible to timely pay all
taxes required with respect to income thereon, provided that any distributions
from the Account made to either Party shall be made net of any amounts required
to be withheld pursuant to the Laws of any Governmental Authority.
8.4 Audit Rights.
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(a) Upon the written request of Licensor and not more than once in each
Contract Year, Licensee shall permit an independent certified public accounting
firm or, as applicable, regulatory consulting firm of nationally recognized
standing, selected by Licensor and reasonably acceptable to Licensee, at
Licensor's expense, to have access during normal business hours to such of the
books and records and regulatory files of Licensee as may be reasonably
necessary to (i) verify the accuracy of the Net Revenues achieved in any
Contract Year ending not more than thirty-six (36) months prior to the date of
such request, and (ii) verify receipt of the notice from the FDA specified in
Section 8.1(a)(iii) hereof and for no other purpose. The accounting firm or
regulatory consulting firm, as applicable shall disclose to Licensor only (x)
whether the Net Revenues achieved are equal to the Net Revenues reported by
Licensee to Licensor and the specific details concerning discrepancies, if any,
and (y) whether Licensee has received the notice specified in Section
8.1(a)(iii) hereof. No other information shall be shared.
(b) If such accounting firm concludes that the Net Revenues reported by
Licensee to Licensor during the audited period was incorrect or such regulatory
consulting firm concludes that the notice from the FDA specified in Section
8.1(a)(iii) hereof was actually received by Licensee, Licensee shall pay such
additional Milestone Payments as applicable to the audited Net Revenues (or, in
the case of receipt of the notice from the FDA specified in Section 8.1(a)(iii),
the applicable One Time Payment) within thirty (30) days of the date Licensor
delivers to Licensee such accounting firm's or, as applicable, such regulatory
consulting firm's written report so concluding. Notwithstanding the foregoing,
upon such accounting firm's conclusion that the Net Revenues reported by
Licensee to Licensor during the audited period was incorrect or such regulatory
consulting firm's conclusion that the notice from the FDA specified in Section
8.1(a)(iii) hereof was actually received by Licensee, Licensor may immediately
commence Dispute Resolution under Section 8.5 herein. The fees charged by such
accounting firm or, as applicable, such regulatory consulting firm shall be paid
by Licensor; provided, however, if the audit discloses that the Net Revenues
reported by Licensee for such audited period are less than ninety-five percent
(95%) of the Net Revenues actually achieved during such period or if the audit
discloses that the notice from the FDA specified in Section 8.1(a)(iii) was
actually received by Licensee, Licensee shall pay the reasonable fees and
expenses charged by such accounting firm or, as applicable, such regulatory
consulting firm.
(c) Licensor shall treat all financial or regulatory information subject
to review under this Section 8.4 as Licensee Confidential Information, and shall
cause its accounting firm to retain all such financial information in
confidence.
8.5 Dispute Resolution.
(a) In the event of a dispute between the Parties as to whether any One
Time Payment or Milestone Payment (a "DISPUTED LICENSE PAYMENT") is then due and
owing from either Licensee or Licensor (with respect to a Return Payment), as
the case may be, the Party claiming the Disputed License Payment is then due
(the "CLAIMING PARTY") shall, send a notice with respect thereto to the other
Party (the "OTHER PARTY").
(b) If the Parties have not resolved the matters in dispute within five
(5) Business Days of the Other Party's receipt of such notice, then on such
fifth (5th) Business Day the matter or matters in dispute shall be submitted to
an independent certified public accounting firm of
29
recognized international standing mutually agreeable to the Parties (or, if the
Parties cannot agree, then one selected mutually by the Parties' auditors) (the
"ACCOUNTING FIRM"). The Parties will cooperate with each other and each other's
authorized representatives and with the Accounting Firm during the term of its
engagement and each of the Parties may make a written submission. Each Party may
provide the Accounting Firm all relevant books and records, any work papers,
supporting documentation and any other documentation used in determining whether
a Disputed License Payment is due. The Accounting Firm shall make a final and
binding determination as to the matter or matters in dispute within 30 days of
its appointment and shall send written notice thereof to the Parties within such
30-day period (subject to the right of either Party to appeal the Accounting
Firm's determination pursuant to the arbitration procedures set forth in Article
XI hereof).
(c) In the event that the Accounting Firm determines that the Disputed
License Payment is then due to the Claiming Party, within three (3) Business
Days of receipt of written notice of such determination from the Accounting Firm
(the "PAYMENT DATE"), the Other Party shall pay to the Claiming Party the
Disputed License Payment (together with any interest accrued thereon at an
annual rate equal to the rate of interest per annum publicly announced from time
to time by JPMorgan Chase Bank as its prime rate in effect on the date such
payment is due at its principal office in New York City plus one percent (1%)
from the date such Disputed License Payment should have been paid pursuant to
Sections 8.1 or 8.2 up to the date such Disputed License Payment is actually
paid, but excluding the date such payment is made) and the Other Party shall
promptly pay the fees and expenses of the Accounting Firm. Notwithstanding any
other remedy available to Licensor under this Section, in the event that the
Accounting Firm determines that a Disputed License Payment is due to Licensor
and Licensee does not pay such Disputed License Payment to Licensor within three
(3) Business Days of receipt of written notice from the Accounting Firm of such
determination, Licensor, in its sole discretion may terminate this Agreement in
accordance with Section 6.2(a) herein without the need to give the notice
required by Section 6.2(a) or provide the opportunity to cure required by
Section 6.2(a). In the event that the Accounting Firm determines that the
Disputed License Payment is not then due and owing to the Claiming Party, the
Other Party shall be entitled to keep such Disputed License Payment and the
Claiming Party shall promptly pay the fees and expenses of the Accounting Firm.
ARTICLE IX
CONFIDENTIALITY
9.1 Licensor's Obligation. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement, Licensor
agrees that it shall keep confidential, and shall cause its officers, employees,
directors and counsel to keep confidential and shall not publish or otherwise
divulge to a Third Party, other than any agents or representatives of Licensor
(provided that such agents and representatives are informed of the confidential
and proprietary nature of such information and agree in writing to the
conditions set forth in this Article IX; and provided, further, that Licensor
shall be responsible for any breach of this Section by such representatives and
agents), or use for itself, unless Licensee shall have given its prior written
approval, any information (and all tangible and intangible embodiments thereof)
of a confidential and proprietary nature relating to Licensee's and its
Affiliates' business or operations, including non-public information concerning
Licensee's products, processes,
30
customers and suppliers and the products and processes of Licensee's customers
and suppliers furnished to Licensor by Licensee in connection with this
Agreement or the Supply Agreement but excluding Licensed Know-How, Licensed
Regulatory Data and Licensee Regulatory Materials which are addressed in Section
9.3 below (any of the foregoing, "CONFIDENTIAL LICENSEE INFORMATION"); provided,
however, that Licensor shall have the right to disclose any Confidential
Licensee Information provided hereunder if such disclosure is necessary (a) in
connection with the securing of any Regulatory Approvals or other governmental
approval necessary for the performance by Licensor of any of its obligations
hereunder or under any other agreement with Licensee, (b) for the purpose of
complying with applicable Laws and governmental regulations or (c) by Law or
legal process. Licensor shall promptly notify Licensee of Licensor's intent to
make any disclosure of Confidential Licensee Information prior to making such
disclosure so as to allow Licensee adequate time to take whatever action
Licensee may deem to be appropriate to protect the confidentiality of the
Confidential Licensee Information and Licensor will cooperate and provide any
assistance that the Licensee may reasonably request in connection with the
foregoing. For the avoidance of confusion, all information provided by Licensee
to Licensor in connection with this Agreement shall be deemed Confidential
Licensee Information unless Licensor can demonstrate that such information is
available to it from sources other than Licensee that are not under a duty of
confidentiality with respect thereto. Licensor shall use Confidential Licensee
Information only in connection with and for the purposes reflected in this
Agreement and the other Transaction Agreements and for no other purpose. The
confidentiality obligations set forth in this Section shall continue in effect
during the Term and for a period of ten (10) years after the end of the Term
except that the confidentiality obligations with respect to any Confidential
Licensee Information that constitutes a trade secret shall continue in effect
for so long as such information remains a trade secret.
9.2 Licensee's Obligation. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement, Licensee
agrees that it shall keep confidential, and shall cause its officers, employees,
directors and counsel to keep confidential and shall not publish or otherwise
divulge to a Third Party, other than any agents or representatives of Licensee
(provided that such agents and representatives are informed of the confidential
and proprietary nature of such information and agree in writing to the
conditions set forth in this Article IX; and provided, further, that Licensee
shall be responsible for any breach of this Section by such representatives and
agents), or use for itself, unless Licensor shall have given its prior written
approval, any information (and all tangible and intangible embodiments thereof)
of a confidential and proprietary nature relating to Licensor's and its
Affiliates' business or operations, including non-public information concerning
the Licensed Rights, Licensed Regulatory Data, Licensor's products, processes,
customers and suppliers and the products and processes of Licensor's customers
and suppliers, furnished to Licensee by Licensor in connection with this
Agreement or the Supply Agreement but excluding Licensed Know-How, Licensed
Regulatory Data and Licensee Regulatory Materials which are addressed in Section
9.3 below (any of the foregoing, "CONFIDENTIAL LICENSOR INFORMATION"); provided,
however, that Licensee shall have the right to disclose any Confidential
Licensor Information provided hereunder if such disclosure is necessary (a) in
connection with the securing of any Regulatory Approvals or other governmental
approval necessary for the performance by Licensee of any of its obligations
hereunder or under any other agreement with Licensor, (b) for the purpose of
complying with Applicable Laws and government regulations, or (c) by Law or
legal process.
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Licensee shall promptly notify Licensor of Licensee's intent to make any
disclosure of Confidential Licensor Information prior to making such disclosure
so as to allow Licensor adequate time to take whatever action Licensor may deem
to be appropriate to protect the confidentiality of Confidential Licensor
Information and Licensee will cooperate and provide any assistance that the
Licensor may reasonably request in connection with the foregoing. For the
avoidance of confusion, all information provided by Licensor to Licensee in
connection with this Agreement shall be deemed Confidential Licensor Information
unless Licensee can demonstrate that such information is available to it from
sources other than Licensor that are not under a duty of confidentiality with
respect thereto. Licensee shall use Confidential Licensor Information only in
connection with and for the purposes reflected in this Agreement and the other
Transaction Agreements and for no other purpose. The confidentiality obligations
set forth in this Section shall continue in effect during the Term and for a
period of ten (10) years after the end of the Term except that the
confidentiality obligations with respect to any Confidential Licensor
Information that constitutes a trade secret shall continue in effect for so long
as such information remains a trade secret.
9.3 Protection of Licensed Know-How, Licensed Regulatory Data and
Licensee Regulatory Materials. Each Party shall use protective measures that are
commercially reasonable and in no event less stringent than those used by such
Party within the Party's own business to protect its comparable know-how to
maintain the confidentiality of the Licensed Know-How, Licensed Regulatory Data
and Licensee Regulatory Materials and shall cause its officers, employees,
directors and counsel to keep confidential and shall not publish or otherwise
divulge to a Third Party, other than any licensees, Affiliates, agents or
representatives under appropriate confidentiality agreements during the Term and
after the end of the Term unless the Licensed Know-How, Licensed Regulatory Data
or Licensee Regulatory Materials: (a) is or has become known to the public other
than through a breach of this Agreement; or (b) lawfully was disclosed to the
disclosing Party on a non-confidential basis by a Third Party not prohibited
from disclosing such information by a legal, contractual or fiduciary
obligation, provided, however, such exception only applies to such portion of
the Licensed Know-How, Licensed Regulatory Data or Licensee Regulatory Materials
that falls within one or more of the above-cited exceptions. Licensee shall have
the right to disclose any Licensed Know-How or Licensed Regulatory Data if such
disclosure is necessary (i) in connection with the securing of any Regulatory
Approvals or other governmental approval necessary for the performance by
Licensee of any of its obligations hereunder, under the other Transaction
Agreements or under any other agreement with Licensor, (ii) for the purpose of
complying with applicable Laws and government regulations, or (iii) by Law or
legal process, provided however, that the foregoing shall not alter the Parties'
rights and obligations with respect to regulatory matters and compliance
therewith as more fully set out in the Supply Agreement. For the avoidance of
confusion, all Licensed Know-How, Licensed Regulatory Data and Licensee
Regulatory Materials shall be deemed confidential information subject to this
Section 9.3 unless the Party receiving the information can demonstrate that such
information falls within one or more of the above-cited exceptions. Licensee
shall use the Licensed Know-How and Licensed Regulatory Data only in connection
with and for the purposes reflected in this Agreement and the other Transaction
Agreements and for no other purpose. Licensor shall use the Licensee Licensed
Rights only in connection with and for the purposes reflected in this Agreement
and the other Transaction Agreements and for no other purpose.
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9.4 Permitted Disclosure or Use of Information. Nothing in this
Article IX shall prevent the disclosure or use of Confidential Licensee
Information or Confidential Licensor Information, as the case may be, that (a)
is or has become known to the public other than through a breach of this
Agreement or (b) lawfully was disclosed to the disclosing Party on a
non-confidential basis by a Third Party not prohibited from disclosing such
information by a legal, contractual or fiduciary obligation.
9.5 Use of Information to Perform Obligations under this Agreement.
Within the limits set forth in this Article IX, each Party shall be entitled at
all times to use all Confidential Licensee Information or Confidential Licensor
Information, as the case may be, provided by the other Party to the extent
necessary to perform its obligations under this Agreement or any other
Transaction Agreement.
ARTICLE X
INDEMNIFICATION
10.1 Licensor
(a) Licensor shall indemnify, defend and hold harmless Licensee, its
Affiliates and their respective officers, directors, stockholders, employees,
agents and representatives (the "LICENSEE INDEMNIFIED PERSONS") from and against
any Losses that they may incur resulting from any Action to the extent arising
out of or due to (i) any breach of any representation, warranty, covenant or
other agreement under this Agreement by Licensor or any of its Affiliates to the
extent such Affiliate is bound under this Agreement (provided, that for purposes
of this Section 10.1(a)(i), Section 5.1(d)(ii) shall be read without regard to
qualification with respect to knowledge); or (ii) the infringement,
misappropriation or impairment of or damage to any Third Party's intellectual
property rights arising out of the Licensee's exercise of the Licensed Rights,
use of the Licensed Regulatory Data or the Licensee's marketing, use,
distribution, importation, offer for sale, sale, commercialization, or
disposition of Licensed Products, or the Licensee's use of the Confidential
Licensor Information.
(b) Licensor shall not have any liability under Section 10.1(a) unless the
aggregate of all Losses relating thereto for which Licensor would, but for
Section 10.1(b), be liable exceeds on a cumulative basis an amount equal to
U.S.$159,000, and then only to the extent of any such excess, after which the
entire amount of such Losses which is payable pursuant to the provisions of
Section 10.1 shall be paid by Licensor subject to the Cap (as such term is
defined below); provided that Licensor shall not have any liability under
Section 10.1(a) for any individual item where the Loss relating to such item is
less than U.S.$10,000; provided, further, however, that Licensor's aggregate
liability under Section 10.1(a) shall in no event exceed the greater of (i)
U.S.$ 100 million, or (ii) as of the date which is the third anniversary of the
date of receipt of Regulatory Approval in the United States for the first
Licensed Product (the "THIRD ANNIVERSARY"), the amount actually paid out to
Licensor under Article VIII of this Agreement, plus the amounts described in the
next sentence (the "CAP"). In the event that amounts which were deposited as of
the Third Anniversary into the Account in accordance with Article VIII are
actually paid out to Licensor under Article VIII of this Agreement from the
Account after the Third Anniversary (a "SUBSEQUENT ACCOUNT DISTRIBUTION"), the
Cap shall include the amount of such Subsequent Account Distribution, if
applicable under the terms of the definition of Cap. If
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prior to any such Subsequent Account Distribution, if applicable, Licensee
suffered Losses for indemnifiable claims which in the aggregate exceeded the Cap
as calculated on the Third Anniversary, Licensor shall pay to Licensee from such
Subsequent Account Distribution, within five (5) Business Days of its receipt
thereof, an amount equal to such excess.
For purposes of illustration only, if (A) Licensee's Losses in respect of
an indemnifiable claim prior to the Third Anniversary are * * * and (B) as of
the Third Anniversary, (1) Licensee has paid to Licensor under this Agreement *
* * and (2) an additional * * * is held in the Account, then Licensor would bear
* * * of such Losses and Licensee would bear * * * of such Losses. If,
subsequent to the Third Anniversary, the * * * previously deposited into the
Account is actually paid out by Licensee to Licensor under Article VIII of this
Agreement, then (I) the Cap would include the * * * and would be * * *, (II)
Licensor would be entitled to keep * * * of such amount and would be required to
pay to Licensee with respect to Licensee's prior indemnifiable claim * * *
thereby meeting the Cap.
(c) All amounts paid by Licensor to Licensee Indemnified Persons pursuant
to Section 10.1 of this Agreement shall be aggregated for purposes of
determining the satisfaction of the Cap. The limitations of Section 10.1(b)
shall not apply to any claim for indemnification made under Section 3.10(b)
herein. Licensor and its Affiliates shall have no liability under Section
10.1(a) to the extent a Licensee Indemnified Person has been paid pursuant to
the Supply Agreement for an indemnifiable claim involving the identical
substantive issue.
10.2 Licensee
(a) Licensee shall indemnify, defend and hold harmless Licensor, its
Affiliates and their respective officers, directors, stockholders, employees,
agents and representative (the "LICENSOR INDEMNIFIED PERSONS") from and against
any Losses that they may incur resulting from any Action to the extent arising
out of or due to (i) any breach, from and after the Closing, of any
representation, warranty, covenant or other agreement under this Agreement by
the Licensee or any of its Affiliates to the extent such Affiliate is bound
under this Agreement or (ii) any FDA or TPD action related to Licensee's Website
Content arising out of an act or omission by the Licensee.
(b) Licensee shall not have any liability under Section 10.2(a) unless the
aggregate of all Losses relating thereto for which Licensee would, but for this
Section 10.2(b), be liable exceeds on a cumulative basis an amount equal to
U.S.$159,000, and then only to the extent of any such excess; provided that
Licensee shall not have any liability under Section 10.2(a) for any individual
item where the Loss relating to such item is less than U.S.$10,000; provided,
further, however, that the Licensee's aggregate liability under Section 10.2(a)
shall in no event exceed the Cap. All amounts paid by Licensee to Licensor
Indemnified Persons pursuant to Section 10.2 of this Agreement shall be
aggregated for purposes of determining the satisfaction of the Cap. The
limitations of this Section 10.2(b) shall not apply to any claim for
indemnification made under Section 3.10(b) herein. Licensee and its Affiliates
shall have no liability under Section 10.2(a) to the extent a Licensor
Indemnified Person has been paid pursuant to the Supply Agreement for an
indemnifiable claim involving the identical substantive issue.
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10.3 Notice of Claims. If there occurs an event which any of the
Persons to be indemnified under this Article X asserts is indemnifiable pursuant
to Section 10.1 or 10.2 (the "INDEMNIFIED PARTY"), the Party or Parties seeking
indemnification shall so notify the Party from whom indemnification is sought
(the "INDEMNIFYING PARTY") promptly in writing describing such Loss, the amount
or estimated amount thereof, if known or reasonably capable of estimation, and
the method of computation of such Loss, all with reasonable particularity and
containing a reference to the provisions of this Agreement in respect of which
such Loss shall have occurred. If any Action is instituted by or against a Third
Party with respect to which the Indemnified Party intends to claim any liability
as a Loss under this Article X, the Indemnified Party shall promptly notify the
Indemnifying Party of such Action and tender to the Indemnifying Party the
defense of such Action. A failure by the Indemnified Party to give notice and to
tender the defense of the Action in a timely manner pursuant to this Section
10.3 shall not limit the obligation of the Indemnifying Party under this Article
X, except to the extent such Indemnifying Party is materially prejudiced
thereby.
10.4 Control of Claims.
The Indemnifying Party under this Article X shall have the right,
but not the obligation, to conduct and control, through counsel of its choosing,
any Action for which indemnification is sought pursuant to this Article X with
respect to a Third Party claim (a "THIRD PARTY INDEMNIFIABLE CLAIM"), and if the
Indemnifying Party elects to assume the defense thereof, the Indemnifying Party
shall not be liable to the Party or Parties seeking indemnification hereunder
for any legal expenses of other counsel or any other expenses subsequently
incurred by such Party or Parties in connection with the defense thereof;
provided that if the Indemnified Party has been advised in writing by outside
counsel that there is a potential conflict between the interests of the
Indemnifying Party and the Indemnified Party, the reasonable out-of-pocket fees
and expenses of one separate counsel for the Indemnified Party shall be paid by
the Indemnifying Party and such separate counsel shall be selected by the
Indemnified Party in its sole discretion. Notwithstanding the foregoing, the
reasonable legal fees and expenses of counsel selected by the Indemnified Party
in its sole discretion in connection with a Third Party Indemnifiable Claim as
to which the Indemnifying Party does not assume the defense or is not entitled
to assume the defense shall be considered Losses for purposes of this Article X.
The Indemnifying Party may compromise or settle such Action, provided that the
Indemnifying Party shall give the Indemnified Party advance notice of any
proposed compromise or settlement, provided, further, that the Indemnifying
Party shall not compromise or settle any Third Party Indemnifiable Claim without
the prior written approval of the Indemnified Party, such approval not to be
unreasonably withheld or delayed, unless all relief provided is paid or
satisfied in full by the Indemnifying Party. No Indemnified Party may compromise
or settle any Third Party Indemnifiable Claim without the prior written approval
of the Indemnifying Party. If the Indemnifying Party elects not to control or
conduct the defense or prosecution of a Third Party Indemnifiable Claim, the
Indemnifying Party nevertheless shall have the right to participate in the
defense or prosecution of any Third Party Indemnifiable Claim and, at its own
expense, to employ counsel of its own choosing for such purpose. The Parties
hereto shall cooperate with each other and their respective counsel in the
defense, negotiation, settlement or prosecution of any Third Party Indemnifiable
Claim.
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10.5 Survival. The representations and warranties of the Parties
contained in this Agreement shall survive until the eighteen (18) month
anniversary of the termination or expiration of this Agreement pursuant to
Section 6.1 and the covenants to be performed following the date hereof shall
survive until the date that is six (6) months after the end of the applicable
period for performance thereof.
10.6 Indemnification Calculations. The amount of any Losses for
which indemnification is provided under this Article X shall be computed net of
any insurance proceeds received by the Indemnified Party in connection with such
Losses. If an Indemnified Party receives insurance proceeds in connection with
Losses for which it has received indemnification, such Party shall refund to the
Indemnifying Party the amount of such insurance proceeds when received, up to
the amount of indemnification received. An Indemnified Party shall use its
commercially reasonable efforts to pursue insurance claims with respect to any
Losses.
10.7 Exclusive Remedies
Except as otherwise set forth herein and for any available equitable
remedies, the remedies set forth in this Article X will be the exclusive
remedies available to the Parties hereto with respect to any Losses or any other
damages, costs or expenses of any kind or nature or any other claim or remedy
directly or indirectly resulting from, arising out of or relating to any of this
Agreement (including alleged breaches of representation, warranty, covenant or
any other term or provision or for any alleged misrepresentation), the Licensed
Rights, Licensed Regulatory Data, Licensee Licensed Rights and the transactions
contemplated hereby; provided that nothing herein shall limit in any way either
Party's remedies in respect of fraud by the other Party in connection herewith
or in connection with the transactions contemplated hereby. Notwithstanding
anything to the contrary in this Agreement, the Parties hereby agree that any
and all Actions resulting from, arising out of or based upon the provisions of
this Agreement may be asserted or brought solely under and in accordance with
the terms of this Agreement.
ARTICLE XI
DISPUTE RESOLUTION
11.1 Purpose. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to litigation.
To accomplish this objective, the Parties agree to follow the procedures set
forth in this Article XI if and when a dispute arises under this Agreement.
11.2 Arbitration. The Parties agree that any dispute arising out of
or in connection with this Agreement, or the breach, termination, or invalidity
hereof, shall be resolved as follows. In the event of a dispute between the
Parties, either Party may initiate the dispute resolution procedures of this
Section 11.2 by providing written notice (the "NOTICE OF CLAIM") to the other
Party identifying the dispute and stating the desire to resolve the dispute.
After receiving the Notice of Claim, respondent will respond in writing by
stating its position and setting forth a proposed resolution of the dispute. If
claimant and respondent are not able to
36
resolve the dispute within twenty (20) days thereafter, the matter in dispute
shall be settled by arbitration in accordance with the Rules of Arbitration of
the International Chamber of Commerce (the "ICC"). The arbitral tribunal shall
be comprised of three arbitrators; the Party-nominated arbitrators shall be
appointed in accordance with the Rules of the ICC. The Party-nominated
arbitrators will have thirty (30) days to appoint a chair who shall have
relevant expertise in the subject matter of the dispute and the applicable laws
of the Territory. If they are unable to make such appointment within that time,
then the chair shall be appointed in accordance with the Rules of the ICC,
provided that the chair appointed by the ICC shall have relevant expertise in
the subject matter of the dispute and the applicable laws of the Territory. The
place of arbitration shall be Stockholm, Sweden. The language to be used in the
arbitral proceedings shall be English. The Parties agree that the losing Party
shall bear the cost of the arbitration filing and hearing fees, the cost of the
arbitrators and the ICC administrative expenses and the attorney's fees and
reasonable associated costs and expenses of each Party. The Parties agree to
reasonable document discovery provided the requesting Party makes a showing of
relevance and need to the tribunal. Notwithstanding the foregoing, either Party
may seek an immediate injunction from a court of competent jurisdiction (i) to
prevent the disclosure of Confidential Licensor Information or Confidential
Licensee Information, as applicable, in violation of Article IX herein or (ii)
to prevent an assignment of this Agreement in violation of Section 12.1 herein.
ARTICLE XII
MISCELLANEOUS
12.1 Assignment and Sublicense. The Parties may only sublicense or
Transfer their respective rights and obligations hereunder in accordance with
this Section 12.1.
(a) Commencing on the date hereof each of Licensor and Licensee shall be
entitled to sublicense its rights or obligations under this Agreement without
the written consent of the other Party hereto to a Permitted Transferee for so
long as such Affiliate continues to be a Permitted Transferee. A sublicensing
Party shall remain directly liable for the performance by its Permitted
Transferee of all obligations of such sublicensing Party under this Agreement
and no sublicense to a Permitted Transferee hereunder shall relieve Licensor or
Licensee of its obligations pursuant to this Agreement.
(b) Commencing on the date hereof, each of Licensor and Licensee shall be
entitled to Transfer its rights or obligations under this Agreement without the
written consent of the other Party hereto, to a Permitted Transferee of Licensor
or Licensee, as applicable; provided, that such Transfer shall be null and void
ab initio and of no further force and effect unless (i) such Transfer was
effected in accordance with the terms and conditions of this Agreement, (ii) in
connection with such Transfer, Licensor executes and delivers to Licensee a
guarantee substantially in the form attached hereto as Exhibit A, and (ii) the
Permitted Transferee, if not already a Party hereto, shall have executed and
delivered to the other Party hereto, as a condition precedent to such Transfer,
an instrument or instruments reasonably satisfactory to the other Party hereto,
confirming that the Permitted Transferee shall be bound by the terms of this
Agreement to the same extent applicable to the transferring Party, as if such
Permitted Transferee was originally a Party hereto. Any such Permitted
Transferee shall and the transferring Party shall cause such Permitted
Transferee to Transfer back to the transferring Party
37
(or to another Permitted Transferee of the transferring Party), its rights and
obligations hereunder prior to such Permitted Transferee ceasing to be a
Permitted Transferee of the transferring Party. Upon such Permitted Transferee
ceasing to be a Permitted Transferee hereunder, any Transfer of rights and
obligations hereunder shall be null and void from inception and of no further
force or effect. A transferring Party shall remain directly liable for the
performance by its Permitted Transferee of all obligations of such transferring
Party under this Agreement. No Transfer to a Permitted Transferee hereunder
shall relieve Licensor or Licensee of its obligations pursuant to this
Agreement.
(c) Except as otherwise provided in Section 2.1 hereof, commencing on the
date on which all of the One Time Payments (other than the * * * Payment, which
payment shall only be required to be paid and received as a condition to
Transfer if as of the date of Transfer, such payment is then due and payable
under the terms of this Agreement) and the First Milestone Payment to be paid
pursuant to Section 8.1 hereof have been paid to and received by the Licensor or
its Affiliates (provided that all such One Time Payments and Milestone Payments
may be pre-paid at any time, regardless of whether such One Time Payments and
Milestone Payments are then due under Section 8.1 or 8.2 hereof), Licensee or
its Permitted Transferees shall be entitled in accordance with this clause (c)
to Transfer or sublicense its rights and obligations under this Agreement to a
Third Party, subject to the prior written consent of Licensor; provided,
further, that (i) in the event of a Volitional Change in Control such Transfer
shall be null and void ab initio and of no further force and effect unless (A)
such Transfer was effected in accordance with the terms and conditions of this
Agreement and (B) the Third Party shall have executed and delivered to Licensor
as a condition precedent to such Transfer, an instrument or instruments
reasonably satisfactory to Licensor confirming that the Third Party shall be
bound by the terms of this Agreement to the same extent applicable to the
Licensee or its Permitted Transferee as if such Third Party was originally a
Party hereto and that such Third Party is, or as of the date of the proposed
Transfer will be, a party to the Supply Agreement and (ii) in the event of a
Change in Control (other than a Volitional Change in Control) such Transfer
shall give rise to a right of termination pursuant to Section 6.2(b) herein
unless such Transfer was effected in accordance with the terms and conditions of
this Agreement. The Parties agree that Licensor may only withhold its consent in
the event that Licensor reasonably determines (such determination to be made
without unreasonable delay, and such consent, or the withholding thereof, to be
promptly communicated once determined) that the proposed Third Party transferee
or sublicensee * * *, (iv) does not have financial condition at least comparable
to that of Licensee as of the Closing Date hereunder or (v) has been or is
currently debarred under the authority of the FDCA or the Food and Drugs Act
and/or regulations thereunder.
(d) Licensor or its Permitted Transferee shall be entitled to Transfer or
sublicense its rights and obligations under this Agreement to a Third Party,
subject to the prior written consent of Licensee; provided that (i) in the event
of a Volitional Change in Control such Transfer shall be null and void ab initio
and of no further force and effect, unless (A) such Transfer was effected in
accordance with the terms and conditions of this Agreement and (B) the Third
Party shall have executed and delivered to Licensee as a condition precedent to
such Transfer, an instrument or instruments reasonably satisfactory to Licensee
confirming that the Third Party shall be bound by the terms of this Agreement to
the same extent applicable to Licensor or its Permitted Transferee as if such
Third Party was originally a Party hereto and (ii) in the event of a Change in
Control (other than a Volitional Change in Control) such Transfer shall give
rise to a
38
right of termination pursuant to Section 6.2(b) herein unless such Transfer was
effected in accordance with the terms and conditions of this Agreement. The
Parties agree that Licensee may only withhold its consent in the event that
Licensee reasonably determines (such determination to be made without
unreasonable delay, and such consent, or the withholding thereof, to be promptly
communicated once determined) that (i) the proposed Third Party transferee or
sublicensee does not have the financial condition to perform Licensor's
obligations under this Agreement, (ii) if Licensor is not to be the surviving
entity upon the consummation of such proposed Transfer, upon the consummation of
such proposed Transfer the successor entity will not have manufacturing capacity
at least comparable to Licensor's manufacturing capacity immediately prior to
such proposed Transfer, (iii) such Transfer has not received all required
Regulatory Approvals, or if Licensor is not to be the surviving entity upon the
consummation of such proposed Transfer, upon the consummation of such proposed
Transfer, the proposed Third Party transferee will not have all Regulatory
Approvals required for its performance of this Agreement or (iv) such proposed
Third Party transferee or sublicensee has been or is currently debarred under
the authority of the FDCA or the Food and Drugs Act and/or regulations
thereunder.
(e) Licensor and Licensee, as the case may be, and each of their
respective present and former officers, directors, employees and Affiliates
shall be released and discharged of its respective rights and obligations
pursuant to this Agreement and from any and all claims, rights, causes of
actions or suits and recoveries related thereto upon the consummation of a
Transfer to a Third Party in accordance with the terms and conditions set forth
herein.
(f) Subject to the foregoing provisions of this Section 12.1, this
Agreement shall be binding upon and inure to the benefit of the successors and
assigns of each of the Parties.
12.2 Notices. All notices or other communications hereunder shall be
deemed to have been duly given and made if in writing and if served by personal
delivery upon the Party for whom it is intended, if delivered by registered or
certified mail, return receipt requested, or by a national courier service, or
if sent by facsimile, provided that the facsimile is promptly confirmed by
telephone confirmation thereof, to the Person at the address set forth below, or
such other address as may be designated in writing hereafter, in the same
manner, by such Person.
If to Licensor:
Q-Med AB
Seminariegatan 21
752 28 Uppsala, Sweden
Attention: Carina Bolin
Telephone No.: * * *
Facsimile No.: * * *
with a copy to (which shall not constitute notice):
Simpson Thacher & Bartlett LLP
Attention: Richard Miller
425 Lexington Avenue
39
New York, New York 10017
Telephone No.: (212) 455-2000
Facsimile No.: (212) 455-2502
If to Licensee:
Medicis Aesthetics Holdings Inc.
c/o Medicis Pharmaceutical Corporation
8125 N. Hayden Road
Scottsdale Arizona, 85258-2463
Attention: Jonah Shacknai
Telephone No.: * * *
Facsimile No.: * * *
with a copy to (which shall not constitute notice):
Akin Gump Strauss Hauer & Feld LLP
Attention: Susan Cohen
590 Madison Avenue
New York, NY 10022
Telephone No.: (212) 872-1066
Facsimile No.: (212) 407-3266
with a copy to (which shall not constitute notice):
Covington & Burling
Attention: Andrea Reister
1201 Pennsylvania Ave., N.W.
Washington, D.C. 20004
Telephone No.: (202) 662-5141
Facsimile No.: (202) 778-5141
12.3 Governing Law. This Agreement shall in all respects be governed
by and construed in accordance with the Laws of the State of New York, excluding
any Law that would result in the application of the Laws of any jurisdiction
other than the State of New York.
12.4 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, and all of which shall
constitute one and the same agreement.
12.5 Headings. The heading references herein are for convenience
purposes only, do not constitute a part of this Agreement and shall not be
deemed to limit or affect any of the provisions hereof.
12.6 Entire Agreement. The Transaction Agreements, each of their
appendices, exhibits, schedules and certificates, and all documents and
certificates delivered or contemplated in connection herewith and therewith
constitute the entire agreement between the
40
Parties with respect to the subject matter hereof and supersede all prior
agreements or understandings of the Parties relating thereto.
12.7 Severability. In the event that any one or more of the
provisions contained herein, or the application thereof in any circumstances, is
held invalid, illegal or unenforceable in any respect for any reason, the
Parties shall negotiate in good faith with a view to the substitution therefor
of a suitable and equitable solution in order to carry out, so far as may be
valid and enforceable, the intent and purpose of such invalid provision;
provided, however, that the validity, legality and enforceability of any such
provision in every other respect and of the remaining provisions contained
herein shall not be in any way impaired thereby, it being intended that all of
the rights and privileges of the Parties shall be enforceable to the fullest
extent permitted by Law.
12.8 Expenses. Each Party will bear its own expenses incurred in
connection with the negotiation and preparation of this Agreement and, except as
set forth in this Agreement, the performance of the obligations contemplated
hereby.
12.9 Further Actions. Each Party hereby agrees to use all reasonable
efforts to take, or cause to be taken, all actions and to do, or cause to be
done, all things reasonably necessary or proper and execute and deliver such
documents and other papers as may be required to make effective the transactions
contemplated by this Agreement.
12.10 Waiver. Any term or provision of this Agreement may be waived
at any time by the Party entitled to the benefit thereof only by a written
instrument executed by such Party. No delay on the part of either Party in
exercising any right, power or privilege hereunder will operate as a waiver
thereof, nor will any waiver on the part of such Party of any right, power or
privilege hereunder operate as a waiver of any other right, power or privilege
hereunder nor will any single or partial exercise of any right, power or
privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder.
12.11 Amendment. This Agreement may be modified or amended only by
written agreement of the Parties hereto signed by authorized representatives of
the Parties hereto and specifically referencing this Agreement.
12.12 No Third Party Rights. Other than as set forth in Article X
and Section 12.17 herein, no provision of this Agreement will be deemed or
construed in any way to result in the creation of any rights or obligations in
any Person not a Party to this Agreement.
12.13 Construction. This Agreement will be deemed to have been
drafted by each Party and will not be construed against either Party as the
draftsperson hereof. Whenever this Agreement refers to a number of days, such
number shall refer to calendar days unless Business Days are specified.
12.14 Appendices, Exhibits, Schedules and Certificates. Each
appendix, exhibit, schedule and certificate attached hereto is incorporated
herein by reference and made a part of this Agreement.
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12.15 Publicity. Neither Party shall issue or release any media
release or public announcement (including any announcements made via any posting
on the World Wide Web or Internet), or other similar publicity announcing the
existence of this Agreement or relating to any term or condition of this
Agreement or the relationships created by this Agreement without three (3)
Business Days' prior written notice, including by e-mail, to the other Party and
the prior agreement of the other Party on the relevant wording relating to this
Agreement or term or condition of this Agreement. Notwithstanding the foregoing,
each Party shall have the right to issue media releases, immediately and without
the prior consent of the other Party that disclose any information required by
the rules and regulations of the Securities and Exchange Commission, the
Stockholm Stock Exchange or applicable Law; provided that the disclosing Party
shall notify, including by e-mail, the other Party no later than simultaneously
with such issuance of such disclosure and shall use commercially reasonable
efforts to provide a copy of the relevant wording relating to this Agreement, or
any term or condition hereof to the other Party prior to the disclosure thereof.
As of the Closing, Licensor shall contact Licensee's Investor Relations Group
for approval and Licensee shall contact * * * for approval.
12.16 Enforcement. The Parties agree that irreparable damage would
occur in the event that any of the provisions of this Agreement were not
performed in accordance with their specific terms. It is accordingly agreed that
the Parties shall be entitled to specific performance of the terms of this
Agreement, this being in addition to any other remedy to which they are entitled
at law or in equity.
12.17 Certain Affiliate Transfers. Neither Party shall (1) invest,
directly or indirectly, in an Affiliate which has operations or conducts
activities in the field of Aesthetic Enhancement, or (2) transfer or make
available any of its activities, operations or assets in the field of Aesthetic
Enhancement (including research and development, marketing, know-how or other
intellectual property, management of regulatory relations and protection of
intellectual property) to an Affiliate, without causing such Affiliate to enter
into an agreement for the benefit of the other Party by which such Affiliate
agrees to be bound by the provisions hereof in all relevant respects to the same
effect as if such Affiliate had originally been a Party hereto.
12.18 Independent Contractor. The Parties shall each be an
independent contractor in the performance of their respective obligations
hereunder and the provisions hereof are not intended to create any partnership,
joint venture, agency or employment relationship between the Parties. Each Party
shall be responsible for and shall comply with all state, local, federal and
foreign laws pertaining to employment taxes, income withholdings and other
employment related statutes applicable to that Party. Except as expressly set
forth herein, neither Party shall have the right by virtue of this Agreement to
bind the other Party in any manner whatsoever.
12.19 Prior Transactions. Each Party acknowledges and agrees, on
behalf of itself and each of its respective subsidiaries, that (a) nothing in
any of the Transaction Agreements or in any other agreement, instrument or other
document delivered in connection herewith or therewith (the "OTHER PAPERS"), and
(b) nothing discussed or delivered in connection with the negotiation of the
Transaction Agreements or the Other Papers, including any correspondence,
spreadsheets, notes, reports, memoranda or any full or partial drafts or prior
versions of the Transaction Agreements or the Other Papers (the matters referred
to in clause (a)
42
and (b) are collectively, the "INADMISSIBLE MATTERS"), shall be admissible in
any action, suit or proceeding relating to only the Prior License Agreement or
the agreements entered into in connection therewith, unless the Parties
otherwise agree in a writing referring to this Section 12.19; provided, however,
that if an action, suit or proceeding relates in part to the Prior License
Agreement (or the agreements entered into in connection therewith) and in part
to any other matter, none of the Inadmissible Matters shall be admissible with
respect to claims or defenses relating to the Prior License Agreement (or the
agreements entered into in connection therewith). Each Party covenants and
agrees, on behalf of itself and each of its respective subsidiaries, that it and
they will not, directly or indirectly, do or cause to be done or omit to do
anything, the doing, causing or omitting of which would provide in discovery or
introduce into evidence any of the Inadmissible Matters in any action, suit or
proceeding relating to only the Prior License Agreement (or the agreements
entered into in connection therewith), except as may be required by Law pursuant
to a Third Party subpoena; provided, however, that if an action, suit or
proceeding relates in part to the Prior License Agreement (or the agreements
entered into in connection therewith) and in part to any other matter, none of
the Inadmissible Matters shall be admissible with respect to claims or defenses
relating to the Prior License Agreement (or the agreements entered into in
connection therewith), except as may be required by Law pursuant to a Third
Party subpoena.
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IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of
the day and year first above written.
Q-MED AB
By: /s/ Bengt Agerup
--------------------------------------
Name: Bengt Agerup
Title: CEO
MEDICIS AESTHETICS HOLDINGS INC.
By: /s/ Mark A. Prygocki, Sr.
--------------------------------------
Name: Mark A. Prygocki, Sr.
Title: Vice President