FIFTH AMENDMENT TO
CREDIT & SECURITY AGREEMENT
DATED NOVEMBER 22, 2002
NORWEST BANK ARIZONA, NATIONAL ASSOCIATION (as Successor
in interest to Norwest Business Credit, Inc. - "Lender")
MEDICIS PHARMACEUTICAL CORPORATION ("Borrower")
FIFTH AMENDMENT TO CREDIT AND SECURITY AGREEMENT
THIS FIFTH AMENDMENT TO CREDIT AND SECURITY AGREEMENT (the "Amendment") is
made as of the 22nd day of November, 2002 by and between MEDICIS PHARMACEUTICAL,
CORPORATION, a Delaware corporation ("Borrower"), and WELLS FARGO BANK ARIZONA,
NATIONAL ASSOCIATION, a national banking association, formerly known as NORWEST
BANK ARIZONA, NATIONAL ASSOCIATION, a national banking association ("Lender"),
as succcssor-in-interest to NORWEST BUSINESS CREDIT, INC., a Minnesota
corporation.
R E C I T A L S:
WHEREAS, Borrower and Lender are parties to that certain Credit and
Security Agreement dated as of August 3, 1995, as modified by letter agreements
dated March 6, 1996 and April 11, 1996, First Amendment to Credit and Security
Agreement dated as of May 29, 1996 among Borrower, Norwest Business Credit, Inc.
("NBCI") and Lender, Second Amendment to Credit and Security Agreement dated as
of November 22, 1996 between Borrower and Lender, Third Amendment to Credit and
Security Agreement dated as of November 22, 1998 between Borrower and Lender,
and Fourth Amendment to Credit and Security Agreement dated as of November 22,
2000 between Borrower and Lender (collectively, the "Credit Agreement"),
pursuant to which Lender agreed to make available to Borrower a $25,000,000
revolving credit facility (the "Acquisitions Credit Facility") to finance
acquisitions of complementary businesses, brand product lines, brand purchase
contracts, licensing agreements, and internal product research and development
costs, which Acquisitions Credit Facility is evidenced by that certain
Replacement Acquisitions Revolving Note from Borrower payable to the order of
Lender in the principal amount of $25,000,000;
WHEREAS, Borrower has requested that Lender extend the term of the Credit
Agreement and Acquisitions Credit Facility for an additional two (2) years and
Lender is willing to do so on the terms and conditions contained herein;
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, Borrower and Lender, intending to
be legally bound, agree as follows:
1. INTERPRETATION. Except as otherwise defined herein, all capitalized
terms used herein shall have the meanings ascribed thereto in the Credit
Agreement.
2. RECITALS. The recitals set forth above are true and accurate in every
respect.
3. OUTSTANDING INDEBTEDNESS. As of November 22, 2002: the outstanding
principal balance of the Revolving Loan is $0.00 and the accrued and unpaid
interest on the Revolving Loan is $0.00; the outstanding principal balance of
the Term Credit Facility is $0.00 and the accrued and unpaid interest on the
Term Credit Facility is $0.00; and the outstanding principal balance of the
Acquisitions Credit Facility is $0.00 and the accrued and unpaid interest on the
Acquisitions Credit Facility is $0.00.
4. NO OFFSETS. Borrower acknowledges with respect to the amounts owing to
Lender that, as of the date of execution of this Amendment (which may be after
the effective date of this Agreement), Borrower has no offset, defense or
counterclaim with respect thereto, no claim or defense in the abatement or
reduction thereof, or any other claim against Lender or with respect to any
document forming part of the transaction in respect of which the Acquisitions
Credit Facility was made or forming part of any other transaction under which
Borrower is indebted to Lender. Borrower acknowledges that all interest imposed
under the Acquisitions Credit Facility through the date of execution hereof, and
all fees and other charges that have been collected from or known by Borrower to
have been imposed upon Borrower with respect to the Acquisitions Credit Facility
evidenced by the Acquisitions Revolving Note were and are agreed to, and were
properly computed and collected, and that Lender has fully performed all
obligations that it may have had or now have to Borrower, and Lender has no
obligation to make any additional loan or extension of credit to or for the
benefit of Borrower, except as provided in the Credit Agreement, as amended by
this Amendment.
5. REPRESENTATIONS AND WARRANTIES OF BORROWER. To induce Lender to enter
into this Amendment and the arrangement contemplated by this Amendment, Borrower
represents and warrants to Lender as follows:
(a) This Amendment and all other instruments executed and delivered
to Lender concurrently herewith, were executed in accordance with the
requirements of law and in accordance with any requirements of Borrower's
certificate of incorporation and bylaws and any amendments thereto.
(b) The execution and delivery of this Amendment and any other
instruments executed and delivered to Lender concurrently herewith, and the full
and complete performance of the provisions hereof will not result in any breach
of, or constitute a default under, or result in the creation of any lien, charge
or encumbrance upon any property or assets of Borrower under any indenture,
mortgage, deed of trust, bank loan or credit agreement or other instrument to
which Borrower is a party or by which Borrower is bound.
(c) The Loan Documents executed by Borrower and this Amendment are
the legal, valid and binding obligations of Borrower enforceable against
Borrower in accordance with their terms.
(d) Except as previously disclosed to Lender in writing, there are
no actions, suits or proceedings pending or, to the knowledge of the Borrower,
threatened against or affecting Borrower or any of its Subsidiaries or the
properties of Borrower or any of its Subsidiaries before any court or
governmental department, commission, board, bureau, agency or instrumentality,
domestic or foreign, which, if determined adversely to the Borrower or any of
its Subsidiaries, would reasonably be expected to have a material adverse effect
on the financial condition, properties or operations of the Borrower or any
Subsidiaries and where such claim(s) exceed $200,000 individually, or
$500,000 in the aggregate.
(e) Except for the sale of TRIAZ under an Applicable License,
Borrower has not derived ten percent (10%) or more of Borrower's Net Sales in
any Fiscal Year from any Applicable License as described in Section 6.14 of the
Credit Agreement.
(f) Except as disclosed by Borrower to Lender in writing
contemporaneously with the execution and delivery of this Amendment, Borrower
does not have any patent applications pending before the PTO Office.
(g) There are no oral agreements, understandings or course of
conduct that would modify, amend, rearrange, vary, diminish or impair the Loan
Documents or the obligation of Borrower to pay the indebtedness evidenced
thereby or to perform fully the obligations of Borrower in strict accordance
with the Loan Documents, or which would permit Borrower to void or avoid its
obligations in whole or in part.
(h) All of the respective representations and warranties made by
Borrower in the Loan Documents remain true, complete and correct as of the date
hereof, including, without limitation, the representations and warranties in
Section 5 of the Credit Agreement, except to the extent of any changes to such
representations and warranties previously disclosed in writing to Lender.
No representation or warranty made by Borrower and contained herein or in the
other Loan Documents, and no certificate, information or report furnished or to
be furnished by Borrower in connection with any of the Loan Documents or any of
the transactions contemplated hereby or thereby, contains or will contain a
misstatement of material fact, or omits or will omit to state a material fact
required to be stated in order to make the statements contained herein or
therein not misleading in the light of the circumstances under which such
statements were made.
6. CONTINUED ENFORCEABILITY OF LOAN DOCUMENTS. Except as modified herein,
all of the terms and provisions of the Loan Documents remain in full force and
effect. In the event of any conflict between the terms and provisions of this
Amendment and the terms and provisions of the Loan Documents, the terms and
provisions of this Amendment shall govern and prevail. Borrower acknowledges,
confirms and ratifies the enforceability of the Credit Agreement, the
Acquisitions Revolving Note and the Loan Documents, as modified pursuant to this
Amendment, and the continuing validity, enforceability and priority of the liens
and security interests granted in the Loan Documents.
7. RELEASE OF CLAIMS.
(a) Borrower hereby releases Lender and its officers, employees and
agents from all claims and demands (known and unknown) it may have on the date
hereof arising out of or in any way relating to the extension or denial of
credit by Lender to Borrower or other matters relating to the indebtedness, any
collateral securing payment and performance of such indebtedness, or any matter
preliminary to the execution and delivery by Borrower and Lender of this
Amendment. The release set forth above shall not extend to any claim arising
after the date of execution hereof (which may be after the effective date of
this Agreement) to the extent based on acts or omissions of Lender occurring
after such date, except that such release is specifically intended by the
parties to include the transactions leading up to the execution of this
Amendment. This Amendment and the release provisions contained in this Section 7
are contractual, and not a mere recital.
(b) Borrower acknowledges and agrees that Lender is not, and shall
not be, obligated in any way to continue or undertake any loan, financing or
other credit arrangement with Borrower, including, without limitation, any
renewal of the indebtedness evidenced by the Loan Documents, except on the terms
and subject to the conditions set forth in the Loan Documents as hereby amended
and modified.
(c) Borrower understands and acknowledges that Lender and Account
Holder are separate and distinct corporate entities, as well as affiliate
corporations, and Borrower has knowingly and consciously made the determination
to proceed with the credit arrangements with Lender as provided in this Credit
Agreement and to maintain the investment advisor and custodian relationship with
Account Holder as provided in the Investment Agreement. Borrower (i) knowingly
waives and releases Lender for, from and against any claim, demand, cause of
action, liability, damages and expenses incurred by Borrower and (ii) covenants
and agrees that it will not claim, or attempt to claim, rights of setoff,
off-set, recoupment or the like against Lender, in the case of both clauses (i)
and (ii), arising out of, based upon, relating to, or otherwise occurring as a
result of, any acts or omissions of, or any breach of contract or tort or any
other theory of liability by, Account Holder. This provision is not intended to
affect any rights or remedies of Borrower against Lender pursuant to the Credit
Agreement.
8. CONDITIONS OF CLOSING. Lender's obligation to enter into this Amendment
and the other documents and instruments required hereunder shall be subject to
the satisfaction of all of the following conditions on or before February 14,
2003 (the "Closing" or the "Closing Date") in a manner, form and substance
satisfactory to Lender, which conditions may be waived by Lender in writing in
its sole and absolute discretion.
(a) On the Closing Date, the representations and warranties of
Borrower set forth in the Loan Documents shall be true and correct in all
material respects when made and at and as of the time of the Closing.
(b) The following shall have been delivered to Lender, each duly
authorized, executed and acknowledged, where applicable, and in form and
substance satisfactory to Lender:
(i) This Amendment;
(ii) First Amendment to Amended and Restated Patent Collateral
Assignment and Security Agreement;
(iii) First Amendment to Amended and Restated Trademark,
Tradename and Service Mark Collateral Assignment and Security Agreement;
(iv) A certificate of the Secretary or an Assistant Secretary
of the Borrower, certifying as to the resolutions of the directors and, if
required, the shareholders of the Borrower, authorizing the execution, delivery
and performance of the Fifth Amendment and all other documents and instruments
incident thereto and to the transactions contemplated by the Fifth Amendment,
reasonably satisfactory to Lender and its counsel.
(c) Borrower shall have performed and complied in all material
respects with all agreements and conditions contained in the Loan Documents to
be performed by or complied
with by Borrower prior to or at the Closing, and no Event of Default or Default
shall have occurred and be continuing or would occur by Borrower entering into
this Amendment and each condition precedent to the effectiveness of each of the
Loan Documents shall have been satisfied.
(d) Lender shall have received such documents as Lender shall
require to establish the proper organization and good standing of Borrower, the
authority of Borrower to execute this Amendment and any other documents or
instruments required hereunder, and evidence that all approvals and/or consents
of, or other action by, any shareholder, governmental agency or other Person
whose approval or consent is necessary or required to enable Borrower to (a)
enter into and perform its obligations under the Loan Documents and (b) grant to
Lender the Security Interests, have been obtained.
(e) All filings of Uniform Commercial Code financing statements and
other filings and actions necessary to perfect and maintain the Security
Interests as first, valid and perfected security interest in the Collateral
shall have been filed or taken (or such filings delivered for filing immediately
following the Closing, to Lender or a third party acceptable to Lender) and
confirmation thereof shall have been received by Lender.
(f) Lender shall have determined to its satisfaction that, as of the
Closing Date, there has been no material adverse change in the financial
condition of Borrower from the financial statements dated as of_______________,
2002 and other documents submitted by Borrower to Lender prior to the Closing
Date.
(g) Borrower shall have paid to Lender an extension fee of $32,500,
which shall be fully earned and non-refundable upon Lender's execution and
delivery of this Amendment, and, when invoiced, Lender's reasonable attorneys'
fees and costs incurred in connection with this Amendment.
(h) Lender shall be satisfied that (a) Borrower has good and
indefeasible title to all of the Collateral and (b) Borrower at all times shall
be entitled to the use and quiet enjoyment of all assets necessary and desirable
for the continued ownership and operation of Borrower's business, including,
without limitation, the use of equipment, licenses, fixtures and warehouses.
9. DEFINITIONS. (a) The definition of "Maturity Date" in Section 1.1 of
the Credit Agreement is hereby deleted in its entirety and the following
inserted therefor:
"Maturity Date" means November 22, 2004.
and (a) Section 1.1 of the Credit Agreement is hereby amended to add the
following definitions in proper alphabetical order:
"Fifth Amendment" means that certain Fifth Amendment to Credit
and Security Agreement dated as of November 22, 2002 between
Borrower and Lender.
"Fourth Amendment" means that certain Fourth Amendment to
Credit and Security Agreement dated as of November 22, 2000 between
Borrower and Lender.
10. FEES. Section 2.11 of the Credit Agreement is hereby amended to add
the following:
(g) Upon execution and delivery of the Fifth Amendment, Borrower
agrees to pay to Lender an extension fee of $32,500, which shall be fully
earned and non-refundable upon Lender's execution and delivery of the
Fifth Amendment, and, when invoiced, Lender's reasonable attorneys' fees
and costs incurred in connection with the Fifth Amendment.
11. SECURITY INTEREST. Article 3 of the Credit Agreement is hereby amended
to add the following:
3.6 Authorization to File Financing Statements. Borrower hereby
irrevocably authorizes Lender at any time and from time to time to file a
record in any filing office in any Uniform Commercial Code jurisdiction to
perfect the lien on, and security interest in, the Collateral and to
provide any information required by Article 9 of the Uniform Commercial
Code of any jurisdiction for the sufficiency or filing office acceptance
of any record. The Borrower agrees to furnish any such information to the
Lender promptly upon the Lender's request. Borrower also ratifies its
authorization for the Lender to have filed in any Uniform Commercial Code
jurisdiction any record perfecting the lien on, and security interest in,
the Collateral filed before the date of the Fifth Amendment.
12. FINANCIAL CONDITION; NO ADVERSE CHANGE. Section 5.5 of the Credit
Agreement is hereby deleted in its entirety and the following inserted therefor:
Section 5.5 Financial Condition; No Adverse Change. The Borrower has
heretofore furnished to the Lender audited financial statements of the
Borrower for its Fiscal Year ended June 30, 2002 and such statements
fairly present the financial condition of the Borrower on the dates
thereof and the results of its operations and cash flows for the period
then ended and were prepared in accordance with generally accepted
accounting principles applied in a consistent manner. Since the date of
such financial statements of the Borrower, there has been no material
adverse change in the business, properties or condition (financial or
otherwise) of the Borrower.
13. TOTAL LIABILITIES TO TANGIBLE NET WORTH. Section 6.16 of the Credit
Agreement is hereby deleted in its entirety and the following inserted therefor:
Section 6.16 Total Liabilities to Tangible Net Worth. Borrower shall
maintain on a consolidated basis, measured quarterly as of the last day of
March, June, September and December, a ratio of total liabilities under
GAAP to Tangible Net Worth of no more
than 3.0:1.0 from and including September 30, 2002 through the
remaining term of this Agreement.
14. MISCELLANEOUS.
(a) Arbitration Agreement; Waiver of Right to Jury Trial. The
Agreement contains an arbitration provision, governing law provision and waiver
of right to jury trial. In the event of any dispute arising out of or related to
this Amendment, the provisions of Section 9.12 of the Agreement shall apply.
(b) Voluntary Agreement. Borrower represents and warrants to Lender
that (i) it is, or has had the opportunity to be, represented by legal counsel
of its choice in regard to the transaction provided for by this Amendment and
that such counsel (if engaged) has explained the significance of the terms, and
the meaning and effect of this Amendment; (ii) it is fully aware and clearly
understands all of the terms and provisions contained in this Amendment; (iii)
it has voluntarily, with full knowledge and without coercion or duress of any
kind, entered into this Amendment and the documents executed in connection with
this Amendment; (iv) it is not relying on any representations, either written or
oral, express or implied, made to it by Lender other than as set forth in this
Amendment; and (v) the consideration received by Borrower to enter into this
Amendment and the arrangement contemplated by this Amendment has been actual and
adequate.
(c) Entire Agreement. This Amendment and the Loan Documents
constitute the entire agreement among the parties as to the agreements and
understandings contemplated by this Amendment. All parties to this Amendment
acknowledge that there are no agreements, understandings, warranties or
representations among the parties except as set forth in the Loan Documents and
this Amendment.
(d) Counterpart Execution. This Amendment may be executed in
counterparts, each of which shall be deemed an original document, and all of
which combined shall constitute a single document.
(e) Waiver. Neither this Amendment nor any of the provisions hereof
may be changed, waived, discharged or terminated, except by an instrument in
writing signed by the party against whom enforcement of the change, waiver,
discharge or termination is sought.
(f) Headings. Paragraph or other headings contained in this
Amendment are for reference purposes only and are not intended to affect in any
way the meaning or interpretation of this Amendment.
(g) Severability. If any clause or provision of this Amendment is
determined to be illegal, invalid, or unenforceable under any present or future
law by the final judgment of a court of competent jurisdiction, such clause or
provision shall be ineffective, but the remainder of this Amendment will not be
affected thereby.
(h) Binding Effect. All of the provisions of this Amendment shall be
binding upon and shall inure to the benefit of Borrower and Lender and their
permitted successors and
assigns, including, without limitation, any successor holder of any Note and any
successor mortgagee/beneficiary under any security document.
(i) Time of the Essence. Time is of the essence of each and every
provision under this Amendment.
(j) Amendment. Except as specifically set forth herein, the
Agreement and the other Loan Documents shall remain in full force and effect. In
the event of a conflict between the terms and provisions of this Amendment and
the terms and provisions of the Agreement, the terms and provisions of this
Amendment shall govern and control. Nothing contained in this Amendment is
intended to or shall be construed as relieving any person or entity, whether a
party to this Amendment or not, of any of such person's or entity's obligations
to Lender.
[THE REMAINDER OF THIS PAGE
IS LEFT INTENTIONALLY BLANK]
IN WITNESS WHEREOF, this Amendment is executed to be effective as of the
date first above written.
BORROWER:
MEDICIS PHARMACEUTICAL CORPORATION,
a Delaware corporation
By: /s/ Mark A. Prygocki, Sr.
-------------------------------------------
Name: Mark A. Prygocki, Sr.
Title: Executive Vice President and Chief
Financial Officer
Execution Date: MARCH 6, 2003
LENDER:
WELLS FARGO BANK ARIZONA, NATIONAL
ASSOCIATION, a national banking association
By: /s/ Tim Billings
-------------------------------------------
Name: Tim Billings
Title: Vice president
Execution Date: February, 2003
EXHIBIT 10.102
[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.]
SUPPLY AGREEMENT
This Supply Agreement (this "AGREEMENT") is entered into this 15th
day of July, 2004 between Medicis Aesthetics Holdings Inc., a corporation
organized under the laws of the State of Delaware ("MEDICIS"), and a
wholly-owned subsidiary of Medicis Pharmaceutical Corporation, a corporation
organized under the laws of the State of Delaware ("MEDICIS PHARMACEUTICAL"),
and Q-Med AB, a company organized under the laws of the Kingdom of Sweden with
corporate registration number 556258-6882 ("Q-MED").
RECITALS
WHEREAS, Medicis has been granted, pursuant to the License Agreement
(as defined herein), a license under the Licensed Rights (as defined herein)
without a right to manufacture or have manufactured, the Licensed Products in
the Territory (as defined herein);
WHEREAS, in connection with entering into such License Agreement,
Q-Med has agreed to supply Medicis and its Affiliates (as defined herein) with
the Licensed Products and Medicis has the right to sublicense immediately to
Medicis' Permitted Transferees (as defined in the License Agreement) its rights
under the Licensed Rights pursuant to the License Agreement; and
WHEREAS, Q-Med and Medicis desire to define their respective rights
and obligations with regard to the supply of the Licensed Products in this
Agreement.
NOW, THEREFORE, for good and valuable consideration, the sufficiency
and receipt of which are hereby acknowledged, the Parties 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:
"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.
"ACTUAL ASP" shall have the meaning given to such term in Section
4.1(b).
"ADVERTISING" shall mean printed or descriptive matter not
classified by the FDA as labeling (e.g., promotional material airing on
television and radio or appearing in journals, magazines and newspapers).
"ADVERTISING IN CANADA" shall mean printed or descriptive matter not
classified by the TPD as labeling (e.g., promotional material airing on
television and radio or appearing in journals, magazines and newspapers).
"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.
"AGREEMENT" shall mean this Agreement, as the same may be amended or
supplemented from time to time in accordance with the terms hereof.
"AMENDED MEDICAL DEVICE LICENSE" shall mean a license issued by the
TPD approving an Amended Medical Device License Application and allowing
Commercial Distribution of a Licensed Product in Canada.
"AMENDED MEDICAL DEVICE LICENSE APPLICATION" shall mean an
application amending an approved Medical Device License and requesting TPD's
approval to Commercially Distribute a Licensed Product reflecting any change or
supplement to the Medical Device License which is required or permitted to be
made pursuant to Canada's FDA and/or regulations made thereunder or other TPD
policies or guidelines, including all information submitted with or incorporated
by reference therein.
"AMENDED MEDICAL DEVICE LICENSE APPROVAL" shall mean TPD's approval
of an Amended Medical Device License.
"AVERAGE SELLING PRICE" shall mean in U.S. dollars the Net Revenues
for a given period divided by the number of units sold of a Licensed Product for
such given period.
"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.
"CANADA'S FDA" shall mean Canada's Food and Drugs Act, R.S.C. 1985,
c. F-27, as amended.
"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 Pharmaceutical 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 Pharmaceutical), acting singly or as
a
2
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 Pharmaceutical; or (ii) acquires (by purchase, merger, consolidation or
otherwise) equity securities of a Party or Medicis Pharmaceutical 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
Pharmaceutical, in each of (a) or (b), in the event that Q-Med, Medicis or
Medicis Pharmaceutical, 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 Q-Med, Medicis or Medicis Pharmaceutical, as the case may be.
"CLOSING" shall have the meaning set forth in the License Agreement.
"CLOSING DATE" shall mean the date of the Closing of the
transactions contemplated by the License Agreement.
"COMMERCIAL DISTRIBUTION" shall mean a distribution in accordance
with the terms and conditions of the Transaction Agreements for all purposes
other than Investigational Distribution.
"CONFIDENTIALITY AGREEMENT" shall mean the Confidentiality
Undertaking, dated as of March 29, 2004 between Q-Med and Medicis
Pharmaceutical, as the same may be amended from time to time in accordance with
its terms, which shall supercede and replace in its entirety any and all
confidentiality agreements or arrangements entered into prior to the date hereof
by the Parties or their respective officers, directors, employees, agents,
consultants or representatives with respect to the transactions contemplated by
the Transaction Agreements other than the Mutual Disclosure and Confidentiality
Agreement, dated September 15, 1999, between Medicis Pharmaceutical and Q-Med,
which shall continue in full force and effect in accordance with its terms.
"COST OF PRODUCTION" shall mean the production cost for producing
one unit, the calculation done once a year, calculations based on an Activity
Based Costing (ABC) model, using the information in the budget of Q-Med. Such
amount excludes the allocation of administrative costs not related to the
production. Related production variances will be determined by Q-Med subsequent
to the end of the calendar year and will be billed or credited to future orders
placed by Medicis.
"DIRECT COSTS" shall mean Cost of Production and Overhead plus any
additional direct costs applicable to providing Licensed Products for
Investigational Distribution.
"FCA" shall mean FCA as defined in the International Chamber of
Commerce Incoterms 2000.
"FDA" shall mean the United States Food and Drug Administration.
3
"FDCA" shall mean the United States Federal Food, Drug, and Cosmetic
Act of 1938, as amended (21 U.S.C. Sections 301 et. seq.).
"FIELD" shall mean Aesthetic Enhancement.
"FIRM ORDER" shall mean a written irrevocable firm purchase order
for the Licensed Products, which order shall set forth (i) the Licensed Product
requirement on a monthly basis for a three (3) month period and (ii) shall
include a delivery schedule specifying the monthly delivery date for each
Licensed Product ordered and the location to which shipment of such Licensed
Product is to be delivered by Q-Med.
"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 Pharmaceutical to Q-Med.
"IDE APPLICATION" shall mean an investigational device exemption
application requesting FDA or TPD approval to distribute an investigational
device for clinical study, pursuant to the requirements of 21 C.F.R. Part 812
and Part 3 of the Canadian Medical Device Regulations SOR/98-282 as amended.
"IDE APPROVAL" shall mean FDA's approval of an IDE Application or an
IDE deemed approved pursuant to the requirements set forth in 21 C.F.R. Part 812
permitting distribution of an investigational product.
"IDE CANADA APPROVAL" shall mean TPD permission to distribute an
investigational device for clinical study, pursuant to the provisions of Part 3
of the Canadian Medical Device Regulations SOR/98-282, as amended.
"IDE SUPPLEMENT" shall mean an IDE supplement application requesting
approval for changes in the investigational plan, clinical protocol, or
developmental or manufacturing changes pursuant to the requirements of 21 C.F.R.
Part 812.
"IDE SUPPLEMENT APPROVAL" shall mean FDA's approval of an IDE
Supplement.
"IMPROVEMENTS" shall mean any replacements, improvements or
modifications, including without limitation, new indications or new uses, in
each case in the Field.
"INVESTIGATIONAL DISTRIBUTION" shall mean distribution in accordance
with the terms and conditions of the Transaction Agreements pursuant to the
requirements of 21 C.F.R. Part 812 in the United States and Part 3 of the
Canadian Medical Device Regulations SOR/98-282 in Canada.
"LABELING" shall mean all labels and other written, printed or
graphic material upon any Licensed Product or any of its containers or wrappers
accompanying such Licensed Product (e.g., instructions sheets, package inserts).
4
"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.
"LICENSE AGREEMENT" shall mean the Intellectual Property License
Agreement, dated as of the date hereof, between Medicis and Q-Med.
"LICENSED KNOW-HOW" shall have the meaning given to such term in the
License Agreement.
* * *
"LICENSED REGULATORY DATA" shall have the meaning given to such term
in the License Agreement.
"LICENSED RIGHTS" shall have the meaning set forth in the License
Agreement.
"LICENSEE REGULATORY MATERIALS" shall have the meaning given to such
term in the License Agreement.
"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 (except as set forth in Sections 9.1(c) and 9.2(b)).
"MACROLANE SIDE LETTER" shall mean that certain letter from Medicis
to Q-Med, dated as of the Closing Date.
"MANUFACTURE", "MANUFACTURED" or "MANUFACTURING" shall mean
manufacture, process, test, assemble, fill, label and package and shall also
include the performance of any activity that would render an entity a
"manufacturer" under 21 C.F.R. Sections 803.3(o) and 820.3(o).
"MANUFACTURING DIRECT COSTS" shall mean Cost of Production, Overhead
and Profit.
"MEDICAL DEVICE DIRECTIVE" shall mean the European Council Directive
concerning Medical Devices, 93/42/EEC (OJ No L 169/1, July 12, 1993), as
amended.
"MEDICAL DEVICE LICENSE" shall mean a medical device license issued
by the TPD and approving the Commercial Distribution of a Licensed Product.
"MEDICAL DEVICE LICENSE APPLICATION" shall mean a medical device
license application requesting TPD's approval to commercially distribute a
Licensed Product, including all information submitted with or incorporated by
reference therein.
5
"MEDICAL DEVICE LICENSE APPROVAL" shall mean TPD's approval of a
Medical Device License Application.
"MILESTONE PAYMENTS" shall have the meaning given to such term in
the License Agreement.
"NET REVENUES" shall mean, with respect to any Licensed Product, the
gross sales of such Licensed Product invoiced by Medicis and/or its Affiliates
to Medicis' and/or its Affiliates' customers who are not Affiliates, less, to
the extent actually paid or accrued net of payments by Medicis 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, Medicis 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 Pharmaceutical's calculations of consolidated net revenues and
consistent with the numbers used to consolidate net revenues reported in Medicis
Pharmaceutical's periodic reports with the United States Securities and Exchange
Commission.
"NOTIFIED BODY" shall mean the certification organization designated
by the relevant national authority of any member of the European Union,
authorized to conduct conformity assessments in accordance with the procedures
listed in the Medical Device Directive.
"ONE TIME PAYMENTS" shall have the meaning given to such term in the
License Agreement.
"ORDERED PRODUCTS" shall mean the Licensed Products ordered pursuant
to a Firm Order.
"OVERHEAD" shall mean as to the Licensed Product in the Territory
allocated, yearly sum, including the costs for maintenance of the quality
system, interest if any, related solely to loans on production facilities,
process development and production development, such yearly sum based on the
budget of Q-Med, and allocated to the number of units of Licensed Products.
"PARTY" shall mean Q-Med or Medicis and, when used in the plural,
means both Q-Med and Medicis 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.
"PERSON" shall mean any individual, firm, corporation, partnership,
limited liability company, trust, joint venture or other entity or organization.
6
"PMA APPLICATION" shall mean a premarket approval application under
section 515(c) of the FDCA requesting FDA's approval to commercially sell and
distribute a Licensed Product in the United States and its territories and
possessions, including all information submitted with or incorporated by
reference therein.
"PMA APPROVAL" shall mean approval from the FDA of a PMA
Application.
"PMA SUPPLEMENT" shall mean a supplemental application to an
approved PMA Application requesting FDA's approval of a Licensed Product or
relating to the Manufacture or Labeling thereof, including all information
submitted with or incorporated by reference therein.
"PMA SUPPLEMENT APPROVAL" shall mean FDA's approval of a PMA
Supplement allowing Commercial Distribution of a Licensed Product.
"PPI" shall mean the Producer Price Index as published by the
Statistical Central Bureau of Sweden.
"PREVIOUS LICENSE LETTER AGREEMENT" shall mean that certain letter
from Medicis Pharmaceutical to Q-Med, dated as of the Closing Date, relating to
the Previous License Agreement (as such term is defined in the License
Agreement).
"PRIOR SUPPLY AGREEMENT" shall mean that certain Supply Agreement
dated March 7, 2003, between Medicis Pharmaceutical and Q-Med, as the same may
be amended from time to time in accordance with its terms.
"PRODUCT CLAIM" shall mean an Action by a Third Party in respect of
potential or actual injury, harm or death whether based in strict tort
liability, strict products liability, negligence, misrepresentation, or breach
of express or implied warranty, allegedly due and owing as a result of the
manufacture, use, application or defective condition of any of the Licensed
Products or the Labeling of any of the Licensed Products.
"PROFIT" shall mean an amount per unit of a Licensed Product equal
to the amount of Cost of Production per unit.
"PROMOTIONAL LABELING" shall mean a subset of Labeling that is
intended as marketing material that is intended to promote Licensed Products
(e.g., customer presentations, detailing pieces, press kits, brochures, trade
show presentations, flyers, booklets, mailing pieces, and "Dear Doctor"
letters); provided, however, that excluded from this definition are written
materials or communications intended for a non-customer audience (e.g., United
States Securities Exchange Commission filings and press releases for the
financial community), price sheets and reminder labeling that sets forth the
product name but not the indications or other use information as defined in 21
C.F.R. Section 801.109(d).
"QUALITY SYSTEM REGULATION" or "QSR" shall mean the quality system
requirements applicable to manufacturers of finished medical devices
commercially distributed in the United States and its territories and
possessions, codified at 21 C.F.R. Part 820.
7
"QUALITY SYSTEM REGULATION CANADA" or "QSRC" shall mean the quality
system requirements applicable to manufacturers of medical devices commercially
distributed in Canada, as set forth in Canada's Medical Devices Regulations,
SOR/98-282, as amended.
"REGULATORY APPROVAL" shall mean a PMA Approval, PMA Supplement
Approval, IDE Approval, IDE Canada Approval, Medical Device License Approval
and/or Amended Medical Device License Approval.
"SEK" shall mean Swedish Krona, the currency currently used in
Sweden or the Euro if the Euro is adopted as the official currency used in
Sweden at the official exchange rate.
"SPECIFICATIONS" shall mean the specifications for each of the
Licensed Products as set forth on Schedule A; provided that all amendments
thereof shall be agreed to in a writing signed by both of the Parties.
"STEERING COMMITTEE" shall mean the Steering Committee already
established pursuant to the Prior Supply Agreement. It shall have all the same
membership, voting, delegation, and deadlock resolution procedures and
requirements, except that it shall not use the "most interested party" procedure
in connection with this Agreement. For convenience, a copy of these provisions
are attached in Schedule B to this Agreement. In the event of a conflict between
the provisions of Article VI hereof and Schedule B, Article VI shall control.
"SUBQ" shall mean the first Licensed Product.
"TERM" shall have the meaning set forth in Section 8.1.
"TERRITORY" shall mean the United States, including its territories
and possessions, and Canada.
"TERRITORY SPECIFIC MATERIALS" shall have the meaning given to such
term in the License Agreement.
"THIRD PARTY" shall mean any Person who or which is neither a Party
nor an Affiliate of a Party.
"TPD" shall mean Canada's Therapeutic Products Directorate.
"TRANSACTION AGREEMENTS" shall mean this Agreement, the License
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 Medicis Pharmaceutical or a transfer or assignment by a
Party of its rights and obligations under this Agreement.
"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 Pharmaceutical on a consolidated basis; or (b) any transaction or event
(or series of transactions
8
or events) as a result of which any Person (other than an Affiliate of such
Party or Medicis Pharmaceutical), 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 Pharmaceutical; or (ii) acquires (by purchase,
merger, consolidation or otherwise) equity securities of a Party or Medicis
Pharmaceutical 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 Pharmaceutical, in each of (a) or (b),in the
event that Q-Med, Medicis or Medicis Pharmaceutical, as the case may be, was a
party to the applicable transaction or of which the Board of Directors of Q-Med,
Medicis or Medicis Pharmaceutical, as the case may be, shall have approved.
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
SUPPLY OF LICENSED PRODUCTS; FORECASTS AND PURCHASE ORDERS
2.1 Licensed Products to be Supplied. Medicis shall, and shall cause
its Affiliates to, purchase from Q-Med or any manufacturer designated by Q-Med
as permitted by the terms of this Agreement, and Q-Med shall sell, and shall
cause to have sold, to Medicis and its Affiliates, except as otherwise provided
herein, all of Medicis' and its Affiliates' requirements for the Licensed
Products during the Term as provided herein for marketing, use, import, offer
for sale, commercializing or otherwise disposing of and sale for Commercial
Distribution and Investigational Distribution in the Territory in accordance
with the terms of the Transaction Agreements. Medicis shall, and agrees to cause
its Affiliates to, solely and exclusively purchase the Licensed Products from
Q-Med or any manufacturer designated by Q-Med, and neither Medicis nor any of
its Affiliates shall have the right to purchase any Licensed Product or any
generic version thereof from, directly or indirectly, any other Person.
2.2 Forecasts. (a) With respect to all Licensed Products to be
supplied for Commercial Distribution and Investigational Distribution in the
Territory, including any
9
portion thereof, Medicis shall provide Q-Med with a forecast of Medicis' and its
Affiliate's estimated monthly requirements of the applicable Licensed Products
(with Licensed Products required for Commercial Distribution and Licensed
Products required for Investigational Distribution being reported as separate
line items) for the twelve (12) month period commencing on the date hereof in
substantially the form attached hereto as Schedule C, which forecast shall be
delivered by Medicis to Q-Med within fourteen (14) calendar days of the date
hereof. Medicis shall update such forecast on a monthly basis until such time as
Medicis is providing forecasts and placing Firm Orders pursuant to Section
2.2(b). Such updates shall be delivered to Q-Med on the fifth (5th) Business Day
prior to the commencement of the subsequent month. In addition, until such time
as Medicis is providing forecasts and placing Firm Orders pursuant to Section
2.2(b), Medicis may provide Q-Med with three (3) separate initial Firm Orders
for Licensed Products (one for Investigational Distribution in the Territory,
one for Commercial Distribution in Canada and one for Commercial Distribution in
the United States) at any time; provided that (i) Q-Med shall not be obligated
to supply Licensed Products in accordance with each such initial Firm Order
prior to the later of ten (10) weeks after (A) the date on which Medicis
provides Q-Med with such initial Firm Order or (B) the date that Medicis
provides the approved Labeling with respect to such initial Firm Order,
provided, that Q-Med shall use commercially reasonable efforts to supply such
Licensed Products in less than ten (10) weeks; (ii) Q-Med shall not be obligated
to supply Licensed Products in accordance with each such initial Firm Order
unless Medicis has made all applicable One Time Payments and Milestone Payments
then due under the terms of the License Agreement, including Section 8.5
thereof; (iii) if Medicis, by placing an initial Firm Order prior to receipt of
the applicable Regulatory Approval for such Licensed Products, requests that
Q-Med commence the Manufacture of any Licensed Products prior to the receipt of
the applicable Regulatory Approval for such Licensed Products, Medicis shall
bear any risks, including without limitation additional direct (which shall be
deemed to include labor) costs and expenses, of any changes required, including,
without limitation, any changes in Labeling, to comply with such Regulatory
Approvals subsequently received and in such event, Q-Med shall then commence
such Manufacture as so requested; (iv) with respect to SubQ, Q-Med shall not be
obligated to supply, in excess of * * * pursuant to each such initial Firm
Order; and (v) with respect to all other Licensed Products, Q-Med shall advise
Medicis of the maximum number of syringes that it may be obligated to deliver
pursuant to the applicable initial Firm Order within five (5) Business Days of
the date of such Initial Firm Order.
(b) Except as provided in Section 2.2(a), on or before the fifth
(5th) Business Day prior to the first day of each calendar month, Medicis shall
give to Q-Med a forecast of Medicis' and its Affiliates' estimated monthly
requirements of the Licensed Products for the twelve (12) month period
commencing with the next succeeding calendar month (for example, a forecast
delivered on May 25 shall estimate the monthly requirements of Licensed Products
for the twelve (12) month period commencing July 1). The twelve (12) month
forecast delivered to Q-Med pursuant to the preceding sentence shall represent
Medicis' reasonable estimates of the quantity of the Licensed Products that
Medicis and its Affiliates will require during such twelve (12) month period to
which such forecast applies, and the forecast of its monthly requirements of the
Licensed Products during the first three (3) months of such twelve (12) month
period shall be reflected in a Firm Order accompanying such forecast.
(c) Notwithstanding the foregoing, any Firm Order for any Licensed
Product placed for a one (1) month period in accordance with Section 2.2(b)
shall be between 80% and
10
120% of the most recent forecast estimated quantity for such Licensed Product
for such one (1) month period provided by Medicis to Q-Med in accordance with
this Section 2.2 prior to the Firm Order being placed by Medicis. In the event
that Medicis shall submit a Firm Order that is below 80% of the applicable
forecast estimated quantity, Q-Med shall deliver to Medicis and Medicis shall be
required to purchase an amount equal to 80% of such applicable forecast
estimated quantity. To the extent that the Firm Order is for more than 120% of
the most recent forecast estimated quantity for a Licensed Product, Q-Med shall
not be obligated with respect to the excess over 120% to supply a greater
quantity than it is able to supply using its commercially reasonable efforts.
(d) In addition to the foregoing forecast requirements, commencing
on the date hereof, on or before the fifth (5th) Business Day prior to the first
day of each calendar quarter, Medicis shall give to Q-Med a forecast of Medicis'
and its Affiliate's estimated quarterly requirements of the Licensed Products
for an additional thirty-six (36) month period beyond the twelve (12) month
periods in Section 2.2(a) and (b). The thirty-six (36) month forecast delivered
to Q-Med pursuant to this clause (d) shall represent Medicis' reasonable
estimates of the quantity of the Licensed Products that Medicis and its
Affiliates will require during such period to which such forecast applies,
provided that such forecast shall be for planning purposes of Q-Med only and
shall not constitute a Firm Order.
(e) All forecasts to be provided or delivered by Medicis to Q-Med
pursuant to this Section 2.2 shall be in writing, which may be electronic.
2.3 Capacity. (a) Q-Med shall use its commercially reasonable
efforts to obtain and maintain capacity or inventory sufficient to meet Medicis'
requirements as indicated in the combined forty-eight (48) month forecast
provided to Q-Med in accordance with Section 2.2(b) and (d). If at any time
Q-Med reasonably believes that Q-Med may not have sufficient capacity or
inventory to fulfill the requirements so forecasted by Medicis (a "CAPACITY
SHORTAGE"), whether due to insufficient manufacturing capacity or otherwise,
then Q-Med shall request written confirmation from Medicis' Chief Executive
Officer of Medicis' forecasted requirements for such forty-eight (48) month
period that give rise to such possible Capacity Shortage (the "CERTIFIED MEDICIS
REQUIREMENTS").
(b) (i) If Q-Med reasonably determines after further consideration
in light of such Certified Medicis Requirements that there will be a
Capacity Shortage within the first twenty-four (24) month period covered
by such Certified Medicis Requirements, Q-Med shall provide Medicis with
notice thereof within five (5) Business Days of receipt of the Certified
Medicis Requirements. If Q-Med has a plan of action with respect to such
Capacity Shortage when it delivers such notice, Q-Med shall provide
Medicis with a written outline of such plan and its reasonably supported
conclusions relating thereto. Q-Med may take prompt action with respect to
such plan or, if Q-Med desires, Q-Med may promptly convene a meeting
between Medicis and Q-Med to discuss such plan. If Q-Med has not developed
a plan of action at the time of its notice to Medicis of the Capacity
Shortage, Q-Med shall promptly convene a meeting between Medicis and Q-Med
to develop in mutual consultation a course of action with respect to such
Capacity Shortage, such course of action to be reasonable. As soon as
practicable after such meeting, Q-Med shall take commercially reasonable
steps to carry out such mutually
11
determined plan of action. Q-Med shall be entitled to call a meeting at
any time to discuss the amendment or revision of such mutually agreed plan
of action. If Q-Med has not taken reasonably sufficient steps towards
implementing the plan within one (1) month of the meeting, then Q-Med
shall promptly furnish to an alternate manufacturer identified by Medicis
with capacity sufficient to fulfill that portion of the Certified Medicis
Requirements that Q-Med is unable to fulfill or, if the Certified Medicis
Requirements are no longer applicable, the then current forecast provided
under Section 2.2(b), all information and assistance necessary to qualify
and operate such alternate manufacturer so proposed by Medicis, the
selection of which shall be subject to Q-Med's prior consent, which
consent shall not be unreasonably withheld or delayed. Notwithstanding the
foregoing, promptly upon notice by Q-Med that such Capacity Shortage has
been remedied such that Q-Med has capacity sufficient to meet that portion
of the Certified Medicis Requirements that Q-Med was unable to fulfill or
if the Certified Medicis Requirements are no longer applicable, the then
current forecast provided under Section 2.2(b), Medicis shall resume, as
promptly as is commercially reasonable, the use of Q-Med as the exclusive
supplier of Medicis and its Affiliates.
(ii) If Q-Med determines after further consideration in light of
such Certified Medicis Requirements that there will be a Capacity Shortage
between the twenty-fifth (25th) and thirty-sixth (36th) months of the
period covered by such Certified Medicis Requirements, Q-Med shall provide
Medicis with notice thereof within ten (10) Business Days of its receipt
of the Certified Medicis Requirements and shall further consider such
Capacity Shortage and shall develop a plan of action with respect thereto.
If, within three (3) months after delivery of such Certified Medicis
Requirements, Q-Med believes that there is no Capacity Shortage, Q-Med
shall so inform Medicis in writing. If, within three (3) months after
delivery of such Certified Medicis Requirements, Q-Med believes that there
is a Capacity Shortage and Q-Med has developed a plan of action with
respect thereto, Q-Med shall inform Medicis in writing of such plan of
action. If, within three (3) months after delivery of such Certified
Medicis Requirements, Q-Med has not developed a plan of action and/or
taken action with respect to such Capacity Shortage, Q-Med shall convene a
meeting between representatives of Q-Med and Medicis to consider the
Capacity Shortage and to develop in mutual consultation an appropriate
plan of action with respect thereto, such course of action to be
reasonable. As soon as practicable after Q-Med and Medicis have developed
a plan of action with respect to the Capacity Shortage, Q-Med shall take
commercially reasonable steps to carry out such mutually determined plan
of action. Q-Med shall be entitled to call a meeting at any time to
discuss the amendment or revision of such mutually agreed plan of action.
If Q-Med has not taken reasonably sufficient steps in accordance with such
mutually determined plan of action, Medicis shall deliver a written notice
thereof. Within ten (10) Business Days of its receipt of such notice,
Q-Med shall provide reasonably sufficient evidence demonstrating its
reasonable compliance with such plan. If Q-Med does not provide reasonably
sufficient evidence within such period, then Q-Med shall promptly furnish
to an alternate manufacturer identified by Medicis with capacity
sufficient to fulfill that portion of the Certified Medicis Requirements
that Q-Med is unable to fulfill or, if the Certified Medicis Requirements
are no longer applicable, the then current forecast provided under Section
2.2(b), all information and assistance necessary to qualify and operate
such alternate manufacturer so proposed by Medicis, the selection of which
shall
12
be subject to Q-Med's prior consent, which consent shall not be
unreasonably withheld or delayed. Notwithstanding the foregoing, promptly
upon notice by Q-Med that such Capacity Shortage has been remedied such
that Q-Med has capacity sufficient to meet that portion of the Certified
Medicis Requirements that Q-Med was unable to fulfill or, if the Certified
Medicis Requirements are no longer applicable, the then current forecast
provided under Section 2.2(b), Medicis shall resume, as promptly as is
commercially reasonable, the use of Q-Med as the exclusive supplier of
Medicis and its Affiliates.
(iii) If Q-Med determines after further consideration in light of
such Certified Medicis Requirements that there will be a Capacity Shortage
after the thirty-seventh (37th) month of the period covered by such
Certified Medicis Requirements, Q-Med shall provide Medicis with notice
thereof within ten (10) Business Days of its receipt of the Certified
Medicis Requirements and shall further consider such Capacity Shortage and
shall develop a plan of action with respect thereto. If, within six (6)
months after delivery of such Certified Medicis Requirements, Q-Med
believes that there is no Capacity Shortage, Q-Med shall so inform Medicis
in writing. If, within six (6) months after delivery of such Certified
Medicis Requirements, Q-Med believes that there is a Capacity Shortage and
Q-Med has developed a plan of action with respect thereto during such
period, Q-Med shall inform Medicis in writing of such plan of action. If,
within six (6) months after delivery of such Certified Medicis
Requirements, Q-Med has not developed a plan of action and/or taken action
with respect to such Capacity Shortage, Q-Med shall convene a meeting
between representatives of Q-Med and Medicis to consider the Capacity
Shortage and to develop in mutual consultation an appropriate plan of
action with respect thereto, such course of action to be reasonable. As
soon as practicable after Q-Med and Medicis have developed a plan of
action with respect to the Capacity Shortage, Q-Med shall take
commercially reasonable steps to carry out such mutually determined plan
of action. Q-Med shall be entitled to call a meeting at any time to
discuss the amendment or revision of such mutually agreed plan of action.
If Q-Med has not taken reasonably sufficient steps in accordance with such
mutually determined plan of action, Medicis shall deliver a written notice
thereof. Within ten (10) Business Days of its receipt of such notice,
Q-Med shall provide reasonably sufficient evidence demonstrating its
reasonable compliance with such plan. If Q-Med does not provide reasonably
sufficient evidence within such period, then Q-Med shall promptly furnish
to an alternate manufacturer identified by Medicis with capacity
sufficient to fulfill that portion of the Certified Medicis Requirements
that Q-Med is unable to fulfill or, if the Certified Medicis Requirements
are no longer applicable, the then current forecast provided under Section
2.2(b), all information and assistance necessary to qualify and operate
such alternate manufacturer so proposed by Medicis, the selection of which
shall be subject to Q-Med's prior consent, which consent shall not be
unreasonably withheld or delayed. Notwithstanding the foregoing, promptly
upon notice by Q-Med that such Capacity Shortage has been remedied such
that Q-Med has capacity sufficient to meet that portion of the Certified
Medicis Requirements that Q-Med was unable to fulfill or, if the Certified
Medicis Requirements are no longer applicable, the then current forecast
provided under Section 2.2(b), Medicis shall resume, as promptly as is
commercially reasonable, the use of Q-Med as the exclusive supplier of
Medicis and its Affiliates.
13
(c) In addition to the requirements set forth in clauses (a) and (b)
above, in the event of a Capacity Shortage, Q-Med shall allocate to Medicis
capacity for each stock keeping unit ("SKU") of each Licensed Product based on
the forty-eight (48) month forecast referenced in the first sentence of clause
(a) above based on a fraction, the numerator of which shall be the Certified
Medicis Requirements for such SKU of Licensed Product for the period in question
and the denominator of which shall be the total forecasted requirements for
Q-Med's manufacturing facilities for all SKUs of such Licensed Product for the
period in question.
(d) If Medicis receives a shipment of Licensed Products that
contains less than 90% of the monthly requirement of Licensed Product to be
delivered pursuant to the applicable Firm Order and Q-Med does not deliver such
missing Licensed Product within one (1) month of Q-Med's receipt of a written
notice from Medicis of such shortage, then Medicis shall be entitled to deliver
written notice to Q-Med of a Capacity Shortage. Upon deliver of such notice of a
Capacity Shortage, Section 2.3(b)(i) shall govern.
2.4 Acceptance of Firm Order. Q-Med shall accept all Firm Orders
submitted in accordance with and on the terms set forth in this Agreement. No
terms and conditions contained in any Firm Order, acknowledgment, invoice, bill
of lading, acceptance or other preprinted form issued by either Party shall be
effective to the extent they are inconsistent with or modify the terms and
conditions contained herein.
2.5 Delivery. All Licensed Products sold pursuant to this Agreement
shall be delivered to not more than ten (10) distribution centers in the
Territory by the means designated by Medicis and shall be delivered FCA Q-Med's
place of manufacture or such other manufacturing facility as permitted under
this Agreement. For the avoidance of doubt, Q-Med shall be responsible for
coordinating the transportation with the carriers designated by Medicis for the
delivery of the Licensed Products and for providing all export and import
documentation with respect to such Licensed Products.
ARTICLE III
SUPPLY AND SERVICES CRITERIA
3.1 Certain Q-Med Obligations. All Licensed Products supplied
hereunder shall (i) be in finished form for Commercial Distribution or (ii) be
in an appropriate form for Investigational Distribution, and with respect to
each of sub-clauses (i) and (ii), shall be Manufactured by Q-Med in conformity
with the terms and conditions of this Agreement, the Specifications and the
applicable Regulatory Approval.
3.2 Shelf Life. (a) Unless otherwise agreed by the Parties in
writing and except as set forth in clause (b) below, Q-Med shall deliver to
Medicis Ordered Products with a remaining shelf life of not less than * * * from
the date of delivery to Medicis for Licensed Products having a Regulatory
Approval for shelf life (a "REGULATORY SHELF LIFE") equal to * * *; provided,
however, that in the event a Regulatory Shelf Life of any Licensed Product is
obtained which is greater than * * *, Q-Med shall deliver to Medicis Ordered
Products with a remaining shelf life not less than * * *. For example, if a
Licensed Product has a Regulatory Shelf Life of
14
* * *, then Q-Med shall deliver Ordered Products with a remaining shelf life of
not less than * * *.
(b) Unless otherwise agreed in writing by the Parties, for any
Licensed Product with a Regulatory Shelf Life that is less than * * *, Q-Med
shall deliver to Medicis Ordered Products with a minimum remaining shelf life
equal to the applicable * * *.
ARTICLE IV
CONSIDERATION
4.1 * * *. (a) * * *
(b) * * *
(c) The Parties agree that the SubQ Unit Price and each Other
Licensed Product Price for purposes of investigational supplies thereof during
the Term shall be the Direct Costs therefor.
4.2 Procedures for the Determination of A New SubQ Unit Price or New
Other Licensed Product Price. (a) * * * Fifteen (15) days following the date of
receipt of the Proposed Price Change Notice, the Party delivering the Proposed
Price Change Notice shall permit an independent certified public accounting firm
of nationally recognized standing, selected by the Party receiving the Proposed
Price Change Notice and reasonably acceptable to the other Party, at the expense
of the Party receiving the Proposed Price Change Notice, to have access during
normal business hours to such of the personnel and of the books and records of
Q-Med or Medicis, as the case may be, as may be reasonably necessary to verify
the accuracy of the information described in the Proposed Price Change Notice
and the compliance of the Proposed Price Change Notice to the requirements of
this Agreement including the definition of Manufacturing Direct Cost and the
other defined terms included therein. For the avoidance of doubt the accounting
firm shall have at least five (5) Business Days of such access. The accounting
firm shall disclose to Medicis or Q-Med, as the case may be, only whether the
information described in the Proposed Price Change Notice is accurate and the
specific details concerning discrepancies, if any. Each Party shall treat all
financial information subject to review under this Section 4.2 as Confidential
Supplier Information or Confidential Medicis Information, as the case may be,
and shall cause its accounting firm to retain all such financial information in
confidence. Thereafter, the Parties agree to negotiate a new SubQ Unit Price or
new Other Licensed Product Price, as the case may be, in accordance with Section
4.1 hereof, in good faith, such negotiations to commence within thirty (30) days
after the receipt of the Proposed Price Change Notice. If the Parties reach
agreement with respect to the applicable pricing within sixty (60) days after
receipt of the Proposed Price Change Notice, based on such agreement Medicis
shall receive a credit from or owe additional amounts to Q-Med retroactive to
the date of receipt of the Proposed Price Change Notice pursuant to this Section
4.2(a). * * *
(b) If the Parties are unable to reach agreement with respect to the
applicable pricing pursuant to Section 4.2(a) within sixty (60) days after
receipt of the Proposed Price Change Notice, an independent arbitrator mutually
appointed by the Parties and expert in
15
marketing and sales in the Territory shall be retained to determine the new SubQ
Unit Price or new Other Licensed Product Price, as the case may be, which shall
be determined on the basis of the Parties' Proposed Price Change Notice and
proposals submitted pursuant to this Section 4.2(b). The Parties shall each
submit one (1) proposal to the arbitrator who shall be required to select one
(1) of the submitted proposals, and the arbitrator shall not be entitled to
compromise between such proposals. The arbitrator's determination shall be made
within thirty (30) days of submission and shall be conclusive and binding upon
the Parties. With its proposal, each Party shall provide copies of those
portions of its books and records, any work papers, supporting documentation and
any other documentation supporting its proposal pursuant to this Section 4.2, as
it may determine; provided that such information and documentation shall be
provided to the other Party, except that the information and documentation
provided to the accounting firm pursuant to Section 4.2(a) hereof shall be
provided to the arbitrator, but shall not be provided to the other Party. The
arbitrator shall maintain the confidentiality of any information or
documentation it may receive pursuant to this Section 4.2(b) and shall not
disclose to the other Party the information and documentation provided to the
accounting firm pursuant to Section 4.2(a) hereof. All fees and expenses of the
arbitrator shall be paid by the Party whose proposal is not selected. Based on
the proposal which is selected, Medicis shall either receive a credit from or
owe additional amounts to Q-Med retroactive to the date of receipt of the
Proposed Price Change Notice.
(c) * * *
4.3 Payment Obligations. Invoices for Licensed Products accepted by
Medicis in accordance with Section 5.1(a) shall be submitted to Medicis upon
delivery by Q-Med of the Ordered Products and such invoices shall be payable in
SEK in full within thirty (30) days from the acceptance of the applicable
delivery in accordance with Section 5.1(a). Payment shall be made by Medicis by
wire transfer to an account designated in writing by Q-Med at least three (3)
Business Days prior to the date such payment is due or as specified in such
invoice; provided that Q-Med shall provide Medicis with a credit against the
next invoice for Licensed Products to be delivered to Medicis to the extent the
prior invoice includes a charge for Ordered Products not actually delivered. Any
required payment hereunder not made by Medicis on or before the date specified
in this Section 4.3 shall bear interest from the date such payment is due until
the date it is actually received by Q-Med 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%). Notwithstanding the foregoing, if
at any time Medicis has failed to make a payment in full when due in accordance
with the first and second sentence of this Section 4.3 (a "DELINQUENT PAYMENT")
and the aggregate amount of such Delinquent Payments exceeds 80% of the value of
the most recently placed Firm Order, Q-Med shall automatically be entitled to
pre-payment for all subsequent deliveries until such Delinquent Payment has been
paid in full with interest from and including the date such Delinquent Payment
was due (such interest to be determined in accordance with the immediately
preceding sentence) to but excluding the date of payment.
16
ARTICLE V
ACCEPTANCE OF Licensed PRODUCTS BY MEDICIS
5.1 Receipt of Licensed Product; Acceptance; Licensed Product
Returns.
(a) At least ten (10) Business Days prior to each shipment of
Licensed Products, Q-Med shall deliver either electronically (if possible), by
facsimile, provided that the receipt of such facsimile is promptly confirmed by
telephone, e-mail, or by overnight courier to Medicis (if requested by Medicis,
the expense of any such courier to be borne by Medicis), the following documents
and information with respect to each batch in such shipment (the "ORDER
INFORMATION"): (i) Certificate of Analysis (such Certificate of Analysis to
include, among other things, batch numbers, expiry date information and a
statement of conformance), (ii) such copies of all Labeling that will physically
accompany the Licensed Products (e.g., Package Insert), as are agreed upon by
the Parties from time to time, (iii) quantity of syringes to be delivered in
such shipment and (iv) reports of significant deviations and investigations into
such significant deviations. If Medicis determines to reject any batch, Medicis
shall notify Q-Med of Medicis' rejection of a batch within five (5) Business
Days following Medicis' receipt of the Order Information; provided that the
Order Information shall be the sole basis for such rejection. If no notice is
provided by Medicis within such time period, then Medicis shall be deemed to
have accepted the shipment. Any notice of rejection by Medicis shall be
accompanied by a reasonably detailed statement of its reasons for rejection.
(b) Medicis shall be entitled to reject all or any portion of a
shipment of Licensed Products within ten (10) Business Days of Medicis' receipt
in the Territory of such shipment of Licensed Products based solely on obvious
physical, packaging or Labeling damage or defect that is evident upon visual
inspection of the packaged Licensed Products as shipped by Q-Med (unless such
obvious physical, packaging or Labeling damage or defect was attributable to an
act or omission of Medicis or any of its Affiliates or the carrier once the
shipment was received by such carrier). Without in any way limiting Q-Med's
replacement obligation as set forth in clause (d) below, if no notice is
provided by Medicis within such time period, then Medicis shall be deemed to
have accepted the entire shipment. Medicis shall provide Q-Med with written
notice of any such rejection within the period set forth above together with a
reasonably detailed statement to support any such rejection. Q-Med shall notify
Medicis as promptly as reasonably possible, but in any event within ten (10)
Business Days after receipt of such written notice, whether it agrees with
Medicis' assertions with respect thereto. If Q-Med agrees with such assertions,
all such rejected Licensed Products shall be returned to Q-Med together with the
notice of rejection, a copy of the delivery receipt and the reasonably detailed
statement of Medicis' reasons for rejection and Q-Med shall replace such
Licensed Products in accordance with Section 5.1(c) and shall reimburse Medicis
for the cost of shipping (including insurance). If Q-Med does not agree with
Medicis' assertions and Medicis accepts Q-Med's determination, then Medicis
shall be responsible for the price of the Licensed Product (including the
shipping cost and insurance). If Q-Med does not agree with Medicis' assertions
and Medicis does not accept Q-Med's determination, then the Parties shall refer
the dispute to an arbitrator pursuant to and in accordance with the provisions
set forth in Section 12.6. If the final arbitral award is in favor of Q-Med,
then Medicis shall be responsible for the price of the Ordered Products that are
the subject of such award (including the shipping cost and insurance) and any
17
interest that has accrued from the date that is thirty (30) days after the
delivery by Q-Med of the Ordered Products FCA Q-Med's place of manufacture or
such other manufacturing facility as permitted under this Agreement (such
interest to be determined in accordance with Section 4.3). If the final arbitral
award is in favor of Medicis, then all Ordered Products that are the subject of
such award shall be returned to Q-Med and Q-Med shall replace such Ordered
Products in accordance with Section 5.1(c) below and shall reimburse Medicis for
the cost of shipping (including insurance). All replacement shipments provided
pursuant to this Section 5.1(b) shall also be subject to the procedures
contained in Section 5.1(a).
(c) As soon as practicable upon receipt of a notice of rejection,
unless otherwise specified by Medicis, Q-Med shall use commercially reasonable
efforts to provide replacement Licensed Products for those rejected by Medicis
in the proposed original shipment pursuant to Section 5.1(a) or in the original
shipment pursuant to Section 5.1(b). Q-Med shall bear all expenses for such
replacement Licensed Product to the extent Medicis previously paid for any
corresponding nonconforming Licensed Product. Replacement shipments shall also
be subject to the procedures contained in Sections 5.1(a) and (b).
(d) If it comes to Q-Med's attention that any Licensed Product
previously accepted by Medicis in accordance with Section 5.1(a) is
non-conforming with its Specifications, Q-Med shall provide prompt notice
thereof to Medicis and Medicis shall, at Q-Med's expense, return any such
non-conforming inventory to Q-Med. Q-Med shall use commercially reasonable
efforts to provide within thirty (30) days replacement Licensed Products for
such non-conforming Licensed Products and shall bear all expenses (including for
shipping and insurance) for such replacement Licensed Products. Such replacement
shipments shall also be subject to the procedures contained in Sections 5.1(a)
and (b).
(e) All Licensed Products provided in replacement shipments pursuant
to Sections 5.1(c) or (d) above shall have a minimum remaining shelf life equal
to the remaining shelf life of the Licensed Product replaced thereby; provided
that remaining shelf life of the replacement Licensed Product shall be measured
from the date of the receipt in the Territory by Medicis of such replacement
Licensed Product and shall be compared to the remaining shelf life of the
Licensed Product to be replaced, measured from the date of the notice of the
need to replace such Licensed Product, whether delivered by Medicis pursuant to
Section 5.1(b) above, or Q-Med pursuant to Section 5.1(d) above.
ARTICLE VI
PRODUCT DEVELOPMENT AND REGULATORY MATTERS
6.1 Compliance with Law.
(a) General. Q-Med and Medicis shall each comply in all material
respects with all applicable Laws that pertain to the activities for which Q-Med
and Medicis are each responsible under this Agreement. The termination or
expiration of this Agreement shall not relieve either Party of its
responsibility to comply in all material respects with any regulatory
requirements associated with Licensed Products.
18
(b) Manufacture of Licensed Products. Q-Med and Medicis shall each
operate in substantial compliance with QSR requirements and the QSRC
requirements applicable to its activities with respect to Licensed Products.
Each Party shall bear its own costs and expenses related to such QSR/QSRC
compliance. Q-Med shall inform Medicis of any material issues raised by the FDA,
the TPD, a Governmental Authority in Sweden or a Notified Body, in each case in
connection with Manufacturing compliance for the Licensed Product, and shall
provide Medicis with copies of any correspondence (including, but not limited
to, e-mails) related thereto.
(c) Supply of Licensed Products. Q-Med shall supply Licensed
Products for Commercial Distribution that conform to the conditions of the
applicable Regulatory Approvals. Q-Med shall maintain appropriate establishment
registration with the FDA and TPD when Manufacturing Licensed Products supplied
under this Agreement. Q-Med shall supply Licensed Products for Investigational
Distribution that conform to the conditions of the applicable Regulatory
Approval, including but not limited to, the quality controls described therein
(or appropriate quality controls for an IDE Application deemed approved pursuant
to the requirements set forth in 21 C.F.R. Part 812 or Part 3 of the Canadian
Medical Device Regulations, where appropriate).
(d) Maintenance of Regulatory Approvals. After obtaining Regulatory
Approvals for the Licensed Products, Medicis shall use commercially reasonable
efforts to maintain such Regulatory Approvals in good standing in order to
ensure the continued lawful Commercial Distribution of the Licensed Products and
in the event that the Regulatory Approvals may be transferred to Q-Med or that
Q-Med may obtain duplicate PMA Approvals in good standing as contemplated in
Section 3.1 or 6.3 of the License Agreement.
(e) Notification to Q-Med. Medicis shall inform Q-Med of any
material issues raised by the FDA, the TPD or Environmental Protection Agency in
the Territory, in each case in connection with non-financial regulatory
compliance and shall provide Q-Med with copies of any correspondence (including,
but not limited to, e-mails) related thereto.
6.2 Steering Committee. The Parties recognize that the development
and marketing of the Licensed Products in the Territory and regulatory
compliance with respect thereto will require significant good faith, mutual
cooperation and joint decision-making. The Parties shall use the existing
Steering Committee to serve as the primary vehicle for such mutual cooperation
and joint decision-making. By way of clarification, the Steering Committee is
intended to have maximum flexibility to delegate its activities in order to
enable the Parties to cooperate, make decisions and implement them in a manner
that is timely, efficient and expeditious.
6.3 Steering Committee Jurisdiction. Except as otherwise provided
for herein, all significant decisions with respect to the development of the
Licensed Products and Improvements thereof within the Territory shall be vested
in the Steering Committee as set forth below. The Steering Committee shall also
be responsible for supervising and coordinating cooperative regulatory
compliance activity; provided that, nothing in this Section 6.3 is intended to
relieve either Party of its obligation to ensure that its own activities comply
in all material
19
respects with the FDCA and FDA's regulations thereunder and/or Canada's FDA
and/or regulations thereunder (e.g. QSR/QSRC requirements).
(a) * * *(i) * * *
(ii) * * *
(iii) * * *
(iv) * * *
(v) At either Party's request, the Steering Committee may revisit
any decision in light of experience, market conditions or other
developments.
(b) * * * (i) * * *
(ii) * * *
(iii) * * *
(c) * * *
(i) * * *. * * *
(ii) * * *
(iii) * * *. * * *
(iv) * * *. * * *
(v) Corrections and Removals. (1) The Parties shall establish a
coordinated tracking system and appropriate distribution records for all
Licensed Products so as to permit successful tracking in the event of a
correction or removal (i.e., field action); (2) if either Party becomes
aware of any defect, problem or adverse condition in any Licensed Product,
whether inside or outside the Territory, that Party shall promptly notify
the other Party; (3) Medicis shall determine whether a correction or
removal involving a Licensed Product in the Territory is warranted and
shall supervise and coordinate any such action, appropriate record keeping
and the reporting thereof to the FDA or the TPD, if required; and (4) to
the extent a Party is responsible for the underlying cause of a correction
or removal such Party shall bear the cost and expenses of the same
(including out-of-pocket expenses incurred by the other Party in
cooperating with such correction or removal).
(vi) * * *. * * *
(vii) * * *
6.4 Audits and Inspections. (a) Q-Med shall provide Medicis or
Medicis's representatives reasonable access upon reasonable prior notice to
inspect, review and audit the premises where the Licensed Products are being
tested, handled, stored, designed, distributed
20
and/or Manufactured for the sole purpose of confirming that all Licensed
Products for the Territory tested, handled, stored, designed, distributed and/or
Manufactured at such facility are tested, handled, stored, designed, distributed
and/or Manufactured in accordance with the FDCA and FDA's regulations thereunder
and with Canada's FDA and/or regulations thereunder. To the extent that in
connection with such inspection any confidential Manufacturing information will
be inspected, reviewed or audited, a Third Party representative of Medicis bound
by the confidentiality obligations described in Section 11.2 hereof shall review
and inspect the applicable facility and records and to meet with Q-Med's
personnel solely for the purpose of confirming that Q-Med's Manufacturing and
record-keeping is compliant with the FDCA and FDA's regulations thereunder and
with Canada's FDA and/or regulations thereunder; provided that either Party has
the option to delete or redact information not relating to the Licensed
Products. Such inspections, reviews and audits shall occur upon not less than
thirty (30) days' prior written notice to Q-Med, shall only be conducted during
normal business hours and shall not unreasonably disrupt the normal operations
of Q-Med; provided that Q-Med shall be entitled to instruct Medicis to conduct
such inspection at an alternate date if Q-Med is currently undergoing an
inspection. Such inspections may be conducted only once every six (6) months,
except that Medicis may conduct follow-up inspections on less than thirty (30)
days' notice directed at significant or critical quality issues observed during
the initial inspection or brought to Medicis's attention through customer
complaints or FDA or TPD communications or enforcement actions or otherwise.
(b) Medicis will cause such Third Party representatives to enter
into agreements with Q-Med with respect to the proprietary and confidential
nature of such information, which agreements shall, among other things, prohibit
the disclosure of such information to Medicis. Such representatives will be
bound by such obligations and will follow such security and facility access
procedures as are designated by Q-Med. Q-Med may require that at all times
Medicis representatives be accompanied by a Q-Med representative and that
Medicis representatives not enter areas of the facility used in the production
of the Licensed Products at times other than when the production of the Licensed
Products are occurring.
(c) Medicis shall provide Q-Med or Q-Med's representatives
reasonable access upon reasonable prior notice to inspect, review and audit the
premises where the Licensed Products are being tested, handled, stored, or
distributed for the purpose of confirming that all Licensed Products tested,
handled, stored, or distributed at such facility are tested, handled, stored,
and/or distributed in accordance with the FDCA and FDA's regulations thereunder
and with Canada's FDA and/or regulations thereunder. In connection with such
inspection, review or audit, Medicis shall allow Q-Med or its representatives to
review and inspect the applicable facility and records and to meet with
Medicis's personnel solely for the purpose of confirming that Medicis's
procedures and record-keeping are compliant with the FDCA and FDA's regulations
thereunder and with Canada's FDA and/or regulations thereunder. Such
inspections, reviews and audits shall occur upon not less than thirty (30) days'
prior written notice to Medicis, shall only be conducted during normal business
hours and shall not unreasonably disrupt the normal operations of Medicis. Such
inspections may be conducted only once every six (6) months, except that Q-Med
may conduct follow-up inspections directed at significant or critical quality
issues observed during the initial inspection or brought to Q-Med's attention
through customer complaints or FDA or TPD communications or enforcement actions
or otherwise.
21
(d) Each Party shall promptly notify the other Party when an FDA or
a TPD inspection of its facilities (or an inspection by Third Parties in
accordance with the FDA regulations or Canada's FDA or regulations, as
applicable, where such inspection pertains to the Licensed Products, is expected
or underway, and will promptly provide such other Party with copies of all
regulatory correspondence, Establishment Inspection Reports, Form 483s, and
Warning Letters issued by FDA or the TPD (or the Third Party inspector) in
connection with any such inspection and pertaining to Licensed Products.
(e) Each Party shall bear its own costs and expenses in connection
with audits and FDA or TPD inspections of its facilities.
ARTICLE VII
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
7.1 Q-Med Representations. Q-Med hereby represents and warrants to
Medicis that:
(a) Corporate Organization and Authority. Q-Med 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 Q-Med of this Agreement, the performance by Q-Med of its obligations
hereunder, and the consummation by Q-Med of the transactions contemplated hereby
have been duly authorized by all requisite corporate action. This Agreement has
been duly executed and delivered by Q-Med and, assuming the due authorization,
execution and delivery thereof by Medicis, constitutes a legal, valid and
binding obligation of Q-Med, enforceable against Q-Med 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. As of the date of this Agreement, the execution,
delivery and performance by Q-Med of this Agreement and the performance by Q-Med
of the transactions contemplated hereby does 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 Q-Med or its properties or assets; (ii) the provisions of the
constituent organizational documents or other governing instruments of Q-Med;
(iii) any note, bond, mortgage, indenture, license, agreement or other
instrument or obligation to which Q-Med is a party or by which it is bound or
subject; or (iv) any judgment, decree, order or award of any court or
Governmental Authority applicable to Q-Med or its properties or assets.
(c) Q-Med possesses and has continuously maintained all permits,
authorizations and licenses issued by Governmental Authorities (other than the
FDA and the TPD) necessary for the conduct of Q-Med's business as currently
conducted, except where the failure to possess or maintain such permits,
authorizations and licenses would not, individually
22
or in the aggregate, have a material adverse effect on the ability of Q-Med to
perform its obligations hereunder.
7.2 Medicis Representations. Medicis hereby represents and warrants
to Q-Med that it is a corporation duly organized, validly existing and in good
standing under the laws of 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 Medicis of this
Agreement, the performance by Medicis of its obligations hereunder, and the
consummation by Medicis of the transactions contemplated hereby have been duly
authorized by all requisite corporate action. This Agreement has been duly
executed and delivered by Medicis and, assuming the due authorization, execution
and delivery thereof by Q-Med, constitutes a legal, valid and binding obligation
of Medicis, enforceable against Medicis 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.
7.3 NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY
PROVIDED HEREIN OR IN THE OTHER TRANSACTION AGREEMENTS, (I) Q-MED MAKES NO
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER AT LAW OR IN EQUITY,
RELATED TO THE 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) Q-MED
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 PRODUCTS AND (III) THE LICENSED PRODUCTS ARE
CONVEYED ON AN "AS IS" "WHERE IS" BASIS AND MEDICIS SHALL RELY UPON ITS OWN
EXAMINATION THEREOF. Without limiting the foregoing, Medicis 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, or the
likelihood of commercial success of the Licensed Products after the date of this
Agreement, except that Medicis 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.
7.4 Non-Compete. (a) Except as otherwise provided in this Section
7.4(a), commencing on the date hereof and ending upon the termination of this
Agreement pursuant to Section 8.2(d) or 8.2(e), Q-Med shall not, and shall cause
its subsidiaries and any of its Affiliates who have agreed to be bound by any
provision of this Agreement pursuant to Section 12.21 not to, directly or
indirectly, engage in business in direct competition in the Territory with the
Licensed Products for use in the Field; provided that any non-approved use (or
other use not in accordance with the Labeling) by any Third Party shall not be
deemed to be a violation of Q-Med's duty not to compete. Notwithstanding the
immediately preceding sentence, Q-Med, its subsidiaries and Affiliates may,
directly or indirectly, engage in business in direct competition in the
Territory and in the Field with only such Licensed Products as to which the
exclusive license
23
rights have been terminated pursuant to and in accordance with Section 3.1 of
the License Agreement from and after the date of such termination.
(b) Commencing on the Closing Date and ending upon the expiration of
the License Agreement, Medicis shall not, and shall cause its subsidiaries and
any of its Affiliates who have agreed to be bound by any provision of this
Agreement pursuant to Section 12.21 not to, directly or indirectly * * *.
Notwithstanding the foregoing, in the event of a Third Party Transfer effected
in accordance with the terms and conditions of Section 12.2, the business of
such Third Party transferee as conducted as of the date of such Third Party
Transfer shall not be deemed to constitute a violation of this Section 7.4(b).
7.5 Licensed Products. Q-Med shall convey good title to the Licensed
Products upon delivery of the Licensed Products to Medicis in accordance with
this Agreement and such Licensed Products shall be free and clear of any
security interest, claim, lien or encumbrance.
ARTICLE VIII
TERM AND TERMINATION
8.1 Term. Except as provided in Section 8.4, and unless earlier
terminated in accordance with Sections 8.2 or Section 8.3, this Agreement shall
have a term ("TERM") beginning on the date hereof and ending on the later to
occur of (a) the ten (10) year anniversary of the date of Launch in the United
States of the first Licensed Product and (b) expiration, abandonment or final
adjudication of invalidity of the last Licensed Patent in the Licensed Rights;
provided, however, that Medicis may, upon at least twelve (12) months' written
notice prior to the expiration of the Term to Q-Med, extend the Term for an
additional four (4) year period following the otherwise applicable expiration
date.
8.2 Termination by Q-Med. This Agreement may be terminated by Q-Med,
at its option:
(a) if Medicis breaches its obligations to pay any material amounts
owing to Q-Med under this Agreement, including, without limitation, its
obligation to make any Delinquent Payments with interest as provided in Section
4.3, and such breach continues for ten (10) Business Days after written notice
of such breach was provided to Medicis by Q-Med;
(b) if Medicis commits a material breach of any of its other
obligations under this Agreement, and fails to (i) cure such breach within
thirty (30) days of receipt of written notice of such breach; or (ii) commence
cure of such breach and make substantial progress towards cure within thirty
(30) days of receipt of such notice, and cure such breach within thirty (30)
additional days thereafter, such thirty (30) day period to apply only to the
extent such breach in either of (i) or (ii) is curable;
(c) upon the insolvency of Medicis; an assignment by Medicis for the
benefit of its creditors; the commencement against Medicis of a voluntary or
involuntary proceeding under any bankruptcy, insolvency, liquidation or similar
Law, upon the appointment with respect
24
to Medicis of a successor, trustee, custodian, sequestrator or similar official
or upon the dissolution of Medicis;
(d) if the License Agreement is terminated pursuant to Section
6.2(a) thereof (the termination right set forth in this clause (d), the "SPECIAL
TERMINATION PROVISION"); provided, that this Special Termination Provision is
the sole remedy under this Agreement in the event of such a termination; or
(e) if there shall have been a Transfer by Medicis pursuant to a
Change in Control (other than a Volitional Change in Control) in violation of
Section 12.2.
8.3 Termination by Medicis. This Agreement may be terminated by
Medicis, at its option:
(a) if Q-Med commits a material breach of its obligations under this
Agreement, and fails to (i) cure such breach within thirty (30) days of receipt
of written notice of such breach; or (ii) commence cure of such breach and make
substantial progress towards cure within thirty (30) days of receipt of such
notice, and cure such breach within thirty (30) additional days thereafter, such
thirty (30) day period to apply only to the extent such breach in either of (i)
or (ii) is curable;
(b) upon the insolvency of Q-Med; an assignment by Q-Med for the
benefit of its creditors; the commencement against the Q-Med of a voluntary or
involuntary proceeding under any bankruptcy, insolvency, liquidation or similar
Law, upon the appointment with respect to Q-Med of a successor, trustee,
custodian, sequestrator or similar official or upon the dissolution of Q-Med; or
(c) if there shall have been a Transfer by Q-Med pursuant to a
Change in Control (other than a Volitional Change in Control) in violation of
Section 12.2.
8.4 Effect of Termination or Expiration. (a) Upon termination of
this Agreement pursuant to Section 8.2(b) or (c) or 8.3(a), (b) or (c), Q-Med
will furnish to Medicis a complete inventory of all work-in-progress for the
Manufacture of the Licensed Product and an inventory of all finished Licensed
Product. Unless otherwise agreed to between the Parties, all stock on hand as of
the termination of this Agreement will be dealt with promptly as follows:
(i) Licensed Products Manufactured pursuant to Firm Orders accepted
by Q-Med will be delivered by Q-Med to Medicis, whereupon Medicis will pay
Q-Med therefor in accordance with the terms of this Agreement; and
(ii) Work-in-progress commenced by Q-Med against accepted Firm
Orders accepted by Q-Med or work-in-progress or finished Licensed Product
commenced or finished in reliance on the quantity of Licensed Product
forecasted for the current calendar month and the immediately succeeding
three (3) calendar months in the forecast delivered to Q-Med on or before
the first day of the current calendar month will be completed by Q-Med and
delivered to Medicis, whereupon Medicis will pay Q-Med therefor in
accordance with the terms of this Agreement.
25
(b) Upon termination of this Agreement by Q-Med pursuant to Section
8.2(a) or (d), Medicis shall immediately return to Q-Med all finished Licensed
Product then held by Medicis. Medicis shall bear all expenses for transportation
of such Licensed Products and Medicis shall pay to Q-Med an amount equal to
Q-Med's cost for all Licensed Products Manufactured pursuant to Firm Orders from
Medicis, work-in-progress commenced by Q-Med against accepted Firm Orders from
Medicis and work-in-progress or finished Licensed Product commenced or finished
in reliance on the quantity of Licensed Product forecasted for the current
calendar month and the immediately succeeding three (3) calendar months in the
forecast delivered to Q-Med on or before the first day of the current calendar
month.
(c) Upon termination of this Agreement pursuant to Section 8.2 or
8.3, each of Medicis and Q-Med will immediately at its expense return to the
other Party all proprietary and confidential documents, work papers and other
material of the other Party and its Affiliates relating to the transactions
contemplated hereby obtained from that other Party or its Affiliates pursuant to
this Agreement, whether so obtained before or after the execution hereof, and
all copies, extracts or other reproductions, in whole or in part thereof which
may have been made by or on behalf of Medicis or Q-Med or their respective
representatives, as the case may be, and shall deliver to the other Party or
destroy all notes or memorandum or other stored information of any kind
containing, reflecting or derived from such documents, work papers and other
material, except that one archival copy may be retained by each Party's outside
counsel or in-house counsel. The return or destruction, as applicable, of such
documents, work papers and other material (and all copies, extracts or other
reproductions in whole or in part thereof) pursuant to this Section 8.4(c) shall
be certified in writing by an authorized officer supervising the same. This
Section 8.4(c) shall not apply to information obtained pursuant to any other
Transaction Agreement. Notwithstanding such return or destruction, each Party
will continue to be bound by its obligations of confidentiality under Article XI
herein. Each Party shall not use or disclose to any Person any information
derived from such confidential and proprietary documents, work papers and other
material of the other Party and shall be responsible for preventing the
disclosure of any such information as provided in Article XI.
(d) (i) Upon termination of this Agreement by reason of Section 8.2
or 8.3, all obligations of the Parties hereunder shall terminate, except
for Article XI [Confidentiality], Sections 7.4 [Non-Compete], 8.4 [Effect
of Termination or Expiration], 12.6 [Arbitration], 12.12 [Expenses] and
12.20 [Publicity], and the continuing regulatory compliance obligations of
the Parties set forth in Section 6.1(a) and the indemnity obligations of
the Parties set forth in Article IX; provided, however, that termination
pursuant to Section 8.2 or 8.3 will not relieve a defaulting or breaching
Party from any liability to the other Party hereto, including the
obligation to pay invoiced amounts when due; provided, further, that upon
termination of this Agreement by reason of Section 8.2(d) or (e), all
obligations pursuant to Section 7.4(a) [Non-Compete] shall immediately
terminate and six (6) months after the termination of this Agreement, all
obligations pursuant to Section 7.4(b) [Non-Compete] shall terminate.
(ii) Upon termination of this Agreement by reason of Section 8.1,
all obligations of the Parties hereunder shall terminate, except for
Article XI [Confidentiality], Sections 7.4(a) [Non-Compete], 8.4 [Effect
of Termination or Expiration], 12.6 [Arbitration], 12.12 [Expenses] and
12.20 [Publicity], and the
26
continuing regulatory compliance obligations of the Parties set forth in
Section 6.1(a) and the indemnity obligations of the Parties set forth in
Article IX; provided, however, that termination pursuant to Section 8.1
will not relieve a defaulting or breaching Party from any liability to the
other Party hereto, including the obligation to pay invoiced amounts when
due.
ARTICLE IX
INDEMNIFICATION
9.1 Indemnification by Q-Med. (a) Q-Med shall indemnify, defend and
hold harmless Medicis, its Affiliates and their respective directors, officers,
stockholders, employees, agents and representatives (the "MEDICIS INDEMNIFIED
PARTIES"), 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
Q-Med or any of its Affiliates to the extent such Affiliate is bound hereunder
(other than the breach of Sections 3.1, 3.2 and 6.1(b) and (c) for which the
sole remedy shall be the remedy set forth in Section 5.1(c)) (provided, that for
purposes of this Section 9.1(a), Section 7.1(c) shall be read without regard to
qualification with respect to material adverse effect), (ii) any Product Claim
by a patient to the extent such injury or harm was solely and directly caused by
the use of any Licensed Product; provided that such Licensed Product shall have
at all times been handled, stored, used and otherwise managed in accordance with
the Labeling or clinical protocols, as applicable; and (iii) the marketing,
import, sale, offer for sale, use, storage or possession of Licensed Products
outside of the Territory by Q-Med or its Affiliates, or their respective
licensees, successors and assigns or their respective customers or end-users.
(b) In addition to the remedies set forth in clause (a) hereof, in
the event of a final arbitral award pursuant to Section 12.6 that a material
breach (other than a willful material breach which is addressed by Section
10.1(b)) by Q-Med of its obligations to supply the Licensed Products to Medicis
in accordance with Article II of this Agreement for a six (6) month period has
occurred, Q-Med shall obtain and qualify an alternate manufacturer able to
fulfill Medicis' requirements as forecasted by Medicis in accordance with
Sections 2.2(b) and (d). If Q-Med has not taken reasonably sufficient action to
qualify such an alternate manufacturer within one (1) month of such final
arbitral award, then Q-Med shall promptly furnish to an alternate manufacturer
as identified by Medicis all information and assistance necessary to qualify and
operate such alternate manufacturer. Notwithstanding the foregoing, promptly
upon notice by Q-Med that such material breach has been cured, Medicis shall use
its commercially reasonable efforts to resume the use of Q-Med as exclusive
supplier.
(c) Notwithstanding anything to the contrary contained herein, (i)
Losses shall not include loss of profits or consequential damages unless a final
arbitral award is issued pursuant to Section 12.6 determining that the breach by
Q-Med giving rise to such Losses was an intentional and willful breach of a
material obligation under this Agreement and (ii) after the consummation of a
Transfer to a Third Party, with respect to any final arbitral award pursuant to
Section 12.6 that determines that such Third Party has intentionally and
willfully breached any of its material obligations under this Agreement, Losses
arising out of or due to such intentional and willful breach of a material
obligation under this Agreement shall be deemed to include loss of
27
profits, consequential damages and such other damages, fees, penalties,
deficiencies, losses and expenses as the arbitral tribunal making such award may
determine.
(d) Q-Med and its Affiliates shall have no liability under this
Section 9.1 to the extent that a Medicis Indemnified Party has been paid
pursuant to the License Agreement for an indemnifiable claim involving the
identical substantive issue.
9.2 Indemnification by Medicis. (a) Medicis shall indemnify, defend
and hold harmless Q-Med, its Affiliates and their respective directors,
officers, stockholders, employees, agents and representatives (the "Q-MED
INDEMNIFIED PARTIES"), 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
Medicis or any of its Affiliates to the extent such Affiliate is bound under
this Agreement or (ii) with respect to obtaining Regulatory Approvals for the
first of the Licensed Products in accordance with Section 6.3(b)(iii) hereof,
clinical trials conducted by or on behalf of Medicis or other services performed
by or on behalf of Q-Med in accordance with Section 6.3(b)(iii) hereof, except
(x) as otherwise provided in Section 9.1(a) hereof, and (y) to the extent
arising from Q-Med's own negligence or willful misconduct.
(b) Notwithstanding anything to the contrary contained herein, (i)
Losses shall not include loss of profits or consequential damages unless a final
arbitral award is issued pursuant to Section 12.6 determining that the breach by
Medicis giving rise to such Losses was an intentional and willful breach of a
material obligation under this Agreement and (ii) after the consummation of a
Transfer to a Third Party in accordance with Section 12.2, with respect to any
final arbitral award pursuant to Section 12.6 that determines that such Third
Party has intentionally and willfully breached any of its material obligations
under this Agreement, Losses arising out of or due to such intentional and
willful breach of a material obligation under this Agreement shall be deemed to
include loss of profits, consequential damages and such other damages, fees,
penalties, deficiencies, losses and expenses as the arbitral tribunal making
such award may determine.
(c) Medicis and its Affiliates shall have no liability under this
Section 9.2 to the extent that a Q-Med Indemnified Party has been paid pursuant
to the License Agreement for an indemnifiable claim involving the identical
substantive issue.
9.3 Notice of Claims. If there occurs an event which any of the
Persons to be indemnified under this Article IX asserts is indemnifiable
pursuant to Section 9.1 or 9.2 (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 or
any other agreement or instrument delivered pursuant hereto 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 IX, 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
28
in a timely manner pursuant to this Section 9.3 shall not limit the obligation
of the Indemnifying Party under this Article IX, except to the extent such
Indemnifying Party is materially prejudiced thereby.
9.4 Control of Claims. The Indemnifying Party under this Article IX
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 IX 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 IX. 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 consent 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, settlement,
negotiation or prosecution of a Third Party Indemnifiable Claim.
9.5 Indemnification Calculations. The amount of any Losses for which
indemnification is provided under this Article IX 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.
9.6 Exclusive Remedies. Except as otherwise set forth herein and for
any available equitable remedies, the remedies set forth in this Article IX 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,
29
warranty, covenant or any other term or provision or for any alleged
misrepresentation), and the transactions contemplated hereby; provided that
nothing herein shall limit in any way any 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.
9.7 Survival. The representations and warranties of the Parties
contained in this Agreement shall survive until the eighteen (18) month
anniversary of termination or expiration of this Agreement pursuant to Section
8.1, 8.2 or 8.3 and the covenants to be performed hereunder shall survive until
the date that is six (6) months after the end of the applicable period for
performance thereof.
ARTICLE X
CERTAIN COVENANTS
10.1 Manufacturing Option.
(a) Q-Med hereby grants to Medicis an option (the "OPTION") to
obtain a license commencing on the date that is * * * from the expiration date
of the Term without giving effect to any extensions thereof, to make and have
made, develop and improve by itself or on its behalf in the Territory, the
Licensed Products. Such license (the "MANUFACTURING LICENSE") shall be granted
by Q-Med within * * * of the date of Q-Med's receipt from Medicis of an exercise
notice (the "EXERCISE NOTICE"), and shall include the terms set forth on
Schedule D hereto and any other terms and conditions negotiated in good faith
and agreed to by the Parties during such * * * period. The Parties hereby agree
that this Section 10.1 imposes an enforceable obligation to grant the
Manufacturing License based on the terms set forth in Schedule D and to
negotiate in good faith such additional terms as may be agreed to by the
Parties. Medicis shall deliver the Exercise Notice no less than * * * prior to
the date on which Medicis intends to commence to make or to have made, develop
and improve the Licensed Products pursuant to the Option; provided that Medicis
shall not deliver the Exercise Notice earlier than the later to occur of * * *.
Medicis may deliver the Exercise Notice at any time from and after the date
referred to in the immediately preceding sentence and before the expiration of
the Term without giving effect to any extensions thereof. Medicis and Q-Med will
fully cooperate in obtaining all required Regulatory Approvals in connection
with Medicis' lawful manufacture of the Licensed Products for Commercial
Distribution and Investigational Distribution; provided that Medicis will pay
the cost and expenses of obtaining such approvals.
(b) Notwithstanding the foregoing, Medicis shall have * * * the
Exercise Notice and Q-Med shall grant the Manufacturing License on the terms set
forth in Schedule D within ninety (90) days of receipt of such notice in the
event of (i) a final arbitral award pursuant to Section 12.6 determining that
Q-Med has intentionally and willfully breached a material obligation related to
the Manufacture or supply of Licensed Products under this Agreement; provided
that Medicis shall bear the burden of proof with respect to the determination
that any such breach was intentional, willful and material or (ii) upon Q-Med
entering into a liquidation
30
process due to bankruptcy. In the event that Medicis has the right to
immediately deliver the Exercise Notice in accordance with clause (i) of this
Section 10.1(b), Medicis shall also concurrently have the right to deliver a
notice to Q-Med and/or its Affiliates which shall immediately terminate any and
all licenses granted by Medicis to Q-Med and/or its Affiliates pursuant to the
terms hereof or of the License Agreement.
10.2 Back-up Facility. The Parties acknowledge and agree that
Q-Med's efforts to date to construct a back-up facility to Manufacture Licensed
Products (the "NEW FACILITY") and to obtain the necessary Regulatory Approvals
from the FDA and the TPD for such New Facility are satisfactory for purposes of
this Agreement as of the date hereof. * * *
10.3 Third Party Contractors. Q-Med shall have the right in
connection with its obligations hereunder to contract with its Affiliates and/or
one or more Third Parties for the Manufacture and supply of the Licensed
Products in finished form to Medicis; provided, however, that: (i) Q-Med shall
cause such contractor to comply fully with the terms and conditions set forth in
this Agreement with respect to the Manufacture and supply of such Licensed
Products; (ii) Q-Med shall remain fully responsible for the Manufacture and
supply of such Licensed Products to Medicis; and (iii) the use of such
contractor shall not increase the cost of the Licensed Products to Medicis in
excess of a cost increase otherwise permitted by this Agreement. Q-Med shall
bear the costs and expense of any required Regulatory Approvals due to the
contracting with any Affiliate and/or Third Party for the Manufacture and supply
of the Licensed Products. Prior to supplying Medicis with Licensed Products
Manufactured by a non-Affiliate Third Party, Q-Med must submit the contractor's
name to Medicis for reasonable approval, such approval not to be unreasonably
withheld or delayed. If Medicis reasonably objects to Q-Med's use of any
non-Affiliate Third Party for the Manufacture and supply of Licensed Products,
Medicis shall have no obligation to accept any Licensed Products Manufactured by
such non-Affiliated Third Party. The foregoing shall not affect, apply to,
prevent or otherwise limit Q-Med's right to select and employ Third Party
suppliers and subcontractors to provide ingredients, components, parts, and
processing activities to aid Q-Med's manufacturing process.
ARTICLE XI
CONFIDENTIALITY
11.1 Q-Med's Obligation. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement, Q-Med
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 Q-Med
(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 XI; and provided, further, that Q-Med shall
be responsible for any breach of this Section 11.1 by such representatives and
agents), or use for itself, unless Medicis shall have given its prior written
approval, any information (and all tangible and intangible embodiments thereof)
of a confidential and proprietary nature relating to Medicis' and its
Affiliates' business
31
or operations, including non-public information concerning Medicis' products,
processes, customers and suppliers and the products and processes of Medicis'
customers and suppliers furnished to Q-Med by Medicis in connection with this
Agreement (any of the foregoing, "CONFIDENTIAL MEDICIS INFORMATION"); provided,
however, that Q-Med shall have the right to disclose any Confidential Medicis
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 Q-Med of any of its obligations hereunder or
under any other agreement with Medicis, (b) for the purpose of complying with
applicable Laws and governmental regulations or (c) by Law or legal process.
Q-Med shall promptly notify Medicis of Q-Med's intent to make any disclosure of
Confidential Medicis Information prior to making such disclosure so as to allow
Medicis adequate time to take whatever action Medicis may deem to be appropriate
to protect the confidentiality of the Confidential Medicis Information and Q-Med
will cooperate and provide any assistance that Medicis may reasonably request in
connection with the foregoing. For the avoidance of confusion, all information
provided by Medicis to Q-Med in connection with this Agreement shall be deemed
Confidential Medicis Information unless Q-Med can demonstrate that such
information is available to it from sources other than Medicis that are not
under a duty of confidentiality with respect thereto. Q-Med shall use
Confidential Medicis 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 11.1
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 Medicis Information that constitutes a trade secret
shall continue in effect for so long as such information remains a trade secret.
11.2 Medicis' Obligation. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement and except
for the information referenced in Section 11.3 which shall be subject to Section
11.3, Medicis 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 Medicis (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 XI; and provided,
further, that Medicis shall be responsible for any breach of this Section by
such representatives and agents), or use for itself, unless Q-Med shall have
given its prior written approval, any information (and all tangible and
intangible embodiments thereof) of a confidential and proprietary nature
relating to Q-Med's and its Affiliates' business or operations, including
non-public information concerning the Licensed Rights, the Licensed Products or
other products of Q-Med and its Affiliates, processes of Q-Med and its
Affiliates, customers and suppliers and the products and processes of Q-Med's
customers and suppliers, furnished to Medicis by Q-Med in connection with this
Agreement (any of the foregoing, "CONFIDENTIAL SUPPLIER INFORMATION"); provided,
however, that Medicis shall have the right to disclose any Confidential Supplier
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 Medicis of any of its obligations hereunder or
under any other agreement with Q-Med, (b) for the purpose of complying with
applicable Laws and governmental regulations or (c) by Law or legal process.
Medicis shall promptly notify Q-Med of Medicis' intent to make any disclosure of
Confidential Supplier
32
Information prior to making such disclosure so as to allow Q-Med adequate time
to take whatever action Q-Med may deem to be appropriate to protect the
confidentiality of Confidential Supplier Information and Medicis will cooperate
and provide any assistance that Q-Med may reasonably request in connection with
the foregoing. For the avoidance of confusion, all information provided by Q-Med
to Medicis in connection with this Agreement (included information subject to
Section 11.3) shall be deemed Confidential Supplier Information unless Medicis
can demonstrate that such information is available to it from sources other than
Q-Med that are not under a duty of confidentiality with respect thereto. Medicis
shall use Confidential Supplier 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
11.2 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 Supplier Information that constitutes a trade secret
shall continue in effect for so long as such information remains a trade secret.
11.3 Manufacturing Data and other Information. In addition to any of
the foregoing confidentiality obligations, Medicis agrees that it shall keep
confidential and shall not use or disclose, and shall cause its officers,
employees, directors and counsel to keep confidential and to not use or
disclose, any information or data (and all tangible and intangible embodiments
thereof) of a confidential and proprietary nature relating to the Manufacture of
the Licensed Products, or any other information or data related to the
manufacture of any other products by Q-Med and/or its Affiliates of a
confidential and proprietary nature, including any such information to which
Medicis has access by virtue of the Regulatory Approvals for the Licensed
Products. Notwithstanding the foregoing, Medicis shall have the right to use,
and, to the extent required to have Licensed Products made in accordance with
the Manufacturing License, disclose (provided that the Person to whom such
disclosure is made is informed of the confidential and proprietary nature of
such information and agrees in writing to be bound by the conditions set forth
in this Section 11.3; provided, further, that Medicis agrees in writing to be
responsible for any breach of these provisions by such Person) such information
or data related to the Manufacture of Licensed Products that it may have access
to by virtue of the Regulatory Approvals related to the Licensed Products (i) in
the event that Q-Med has failed to comply with its obligation to provide an
alternate manufacturer with the information required pursuant to Section 9.1(b)
within the time period set forth in Section 9.1(b) or (ii) Medicis has exercised
the Option in accordance with Section 10.1(b) herein. Notwithstanding the
foregoing, Medicis shall have the right to disclose any such information or data
provided hereunder if such disclosure is necessary (a) in connection with the
securing of any Regulatory Approval or other governmental approval necessary for
the performance by Medicis of any of its obligations hereunder or under any
other agreement with Q-Med or its Affiliates, (b) for the purpose of complying
with applicable Laws and governmental regulations or (c) by Law or legal
process. Medicis shall promptly notify Q-Med of Medicis' intent to make such
disclosure prior to making such disclosure so as to allow Q-Med adequate time to
take whatever action Q-Med may deem to be appropriate to protect the
confidentiality of such information and Medicis will cooperate and provide any
assistance that Q-Med may reasonably request in connection with the foregoing.
Medicis shall not be prohibited from using or disclosing any such information
that (a) is or has become known to the public other than through a breach of
this Agreement or (b) lawfully was disclosed to Medicis on a non-confidential
basis by a Third Party not prohibited from disclosing such information by a
legal, contractual or fiduciary obligation. Within the limits set forth in this
Section 11.3, Medicis
33
shall be entitled to use such information to the extent necessary to perform its
obligations under this Agreement and the other Transaction Agreements.
11.4 Permitted Disclosure Or Use Of Information. Nothing in this
Article XI shall prevent the disclosure or use of Confidential Medicis
Information or Confidential Supplier 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.
11.5 Use Of Information to Perform Obligations under this Agreement.
Within the limits set forth in this Article XI, each Party shall be entitled at
all times to use all Confidential Medicis Information or Confidential Supplier
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 XII
MISCELLANEOUS
12.1 Force Majeure. No Party shall be liable to another for its
failure to perform any of its obligations hereunder if such failure is caused by
contingencies beyond such Party's control, including, but not limited to, acts
of God, fire, flood, wars, acts of terrorism, sabotage, strike and government
actions. Any Party asserting its inability to perform any obligation hereunder
as a result of any such contingency shall promptly notify the other Party of the
existence of any such contingency that prevents performance and the extent of
such Party's inability to perform. The non-performing Party shall use its
reasonable best efforts to avoid or remove such causes of non-performance
obligation as soon as commercially practicable.
12.2 Assignment. Except as expressly otherwise provided herein, the
Parties may only Transfer their respective rights and obligations hereunder in
accordance with this Section 12.2.
(a) Each of Q-Med and Medicis shall be entitled to Transfer its
rights or obligations under this Agreement without the written consent of
Medicis or Q-Med, as the case may be, to an Affiliate of Medicis Pharmaceutical
or Q-Med, as the case may be, provided that Q-Med or Medicis Pharmaceutical, as
the case may be, directly or indirectly, through one or more intermediaries,
owns or controls greater 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
1.1441-1(e)(4)(ii) (a "PERMITTED TRANSFEREE") for so long as such Affiliate
continues to be a Permitted Transferee; provided, further, that such Transfer
shall be null and void ab initio and of no further force and effect unless (i)
such Transfer was affected in accordance with the terms and conditions of this
Agreement, (ii) in connection with such Transfer, Q-Med executes and delivers to
Medicis a guarantee substantially in the form attached hereto as Exhibit A, and
(iii) the Permitted Transferee, if not already a Party hereto, shall have
executed and delivered to Medicis or Q-Med, as the case may be, as a condition
precedent to such Transfer, an instrument or instruments
34
reasonably satisfactory to Q-Med or Medicis, as the case may be, 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 Q-Med or Medicis, as the case may be, shall cause such Permitted Transferee
to, assign or transfer back to (or to another Permitted Transferee of the
transferred Party) its rights and obligations hereunder prior to such Permitted
Transferee ceasing to be a Permitted Transferee of Q-Med or Medicis, as the case
may be. 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 Q-Med or Medicis of its
obligations pursuant to this Agreement.
(b) Commencing on the date on which all of the One Time Payments
(other than the * * * Payment (as such term is defined in the License
Agreement), 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 the License Agreement) and the First
Milestone Payment to be paid pursuant to the License Agreement have been paid to
and received by Q-Med or its Affiliates (provided that all such payments may be
prepaid at any time, regardless of whether such payments are then due under such
agreements), Medicis or its Permitted Transferees shall be entitled, in
accordance with this clause (b) to Transfer its rights and obligations under
this Agreement to a Third Party, subject to the prior written consent of Q-Med;
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 Q-Med as a condition precedent to such Transfer, an instrument or
instruments reasonably satisfactory to Q-Med confirming that the Third Party
shall be bound by the terms of this Agreement to the same extent applicable to
Medicis 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 License 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 8.2(d) herein
unless such Transfer was effected in accordance with the terms and conditions of
this Agreement. The Parties agree that Q-Med may only withhold its consent in
the event that Q-Med 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
* * *, (iv) does not have financial condition at least comparable to that of
Medicis as of the Closing Date or (v) has been or is currently debarred under
the authority of the FDCA or Canada's FDA and/or regulations thereunder.
(c) Q-Med or its Permitted Transferee shall be entitled to Transfer
its rights and obligations under this Agreement to a Third Party, subject to the
prior written consent of Medicis; 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 Medicis as a condition precedent to such
Transfer, an instrument or
35
instruments reasonably satisfactory to Medicis confirming that the Third Party
shall be bound by the terms of this Agreement to the same extent applicable to
Q-Med or its Permitted Transferee as if such Third Party was originally a Party
hereto and that such Third Party has, or as of the date of the proposed Transfer
will have, the know-how and patents necessary to fulfill its obligations under
and in accordance with this 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 8.3(c) herein unless such
Transfer was effected in accordance with the terms and conditions of this
Agreement. The Parties agree that Medicis may only withhold its consent in the
event that Medicis 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 does
not have the financial condition to perform Q-Med's obligations under this
Agreement, (ii) if Q-Med 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 a manufacturing capacity at least comparable to
Q-Med's and its Affiliates' manufacturing capacity immediately prior to such
proposed Transfer, (iii) such Transfer has not received all required Regulatory
Approvals, or, if Q-Med and/or one of its Affiliates 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 has been or is currently debarred under the
authority of the FDCA or under Canada's FDA and/or regulations thereunder.
(d) Subject to the provisions of this Section 12.2, this Agreement
shall be binding upon and inure to the benefit of the successors and assigns of
each of the Parties.
(e) Notwithstanding anything to the contrary contained elsewhere
herein, Q-Med shall be entitled to engage a Third Party as provided in Sections
2.3, 9.1(b) and 10.3 herein to supply Medicis with Licensed Products for use in
accordance with the terms and conditions of this Agreement and such action shall
not be deemed a violation of this Section 12.2; provided that in such event
Q-Med not be released from its obligations hereunder.
(f) Other than as set forth in clause (e) above, Q-Med and Medicis,
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.
12.3 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
withholding and other employment related statutes applicable to that Party.
Except as is expressly set forth herein, neither Party will have any right by
virtue of this Agreement to bind the other Party in any manner whatsoever.
36
12.4 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.
with a copy to (which shall not constitute notice):
Simpson Thacher & Bartlett LLP
425 Lexington Avenue
New York, New York 10017
Attention: Richard A. Miller
Telephone No.: (212) 455-7150
Facsimile No.: (212) 455-2502
If to Medicis:
Medicis Aesthetics Holdings Inc.
8125 N. Hayden Road
Scottsdale, Arizona 85258-2463
with a copy to (which shall not constitute notice):
Akin Gump Strauss Hauer & Feld LLP
590 Madison Avenue
New York, New York 10022
Attention: Susan Cohen
Telephone No.: (212) 872-1000
Facsimile No.: (212) 872-1002
12.5 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 and the
37
application of the 1980 United Nations Convention on Contracts for the
International Sale of Goods.
12.6 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 12.6 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 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 Medicis Information or Confidential Supplier Information, as
applicable, in violation of Article XI herein or (ii) to prevent an assignment
of this Agreement in violation of Section 12.2 herein.
12.7 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.
12.8 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.
12.9 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 Parties with respect to the subject
matter hereof and supersede all prior agreements or understandings of the
Parties relating thereto.
12.10 Sales and Use Taxes. Medicis shall be responsible for the
payment of any sales and use taxes on the Licensed Products delivered by Q-Med
to Medicis.
38
12.11 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.
12.12 Expenses. Except as set forth in this Agreement, Q-Med and
Medicis will each bear their own expenses and the expenses of their respective
Affiliates incurred in connection with the negotiation and preparation of this
Agreement.
12.13 Further Actions. Q-Med and Medicis each 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 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.
12.14 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 Q-Med or Medicis in
exercising any right, power or privilege hereunder will operate as a waiver
thereof, nor will any waiver on the part of either Q-Med or Medicis 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.
12.15 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.
12.16 No Third Party Rights. Other than as set forth in Article IX
and Section 12.21, 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.
12.17 Construction. This Agreement will be deemed to have been
drafted by both Q-Med and Medicis 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.
12.18 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.
39
12.19 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.
12.20 Publicity. Neither Party shall issue or release any media
release or public announcement (including, without limitation, 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 the Agreement or term or condition of the 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 the other Party, including by
e-mail, no later than simultaneously with such issuance of such issuance and
shall use commercially reasonable efforts to provide a copy of the relevant
wording relating to the Agreement, or any term or condition thereof or the other
Party prior to the disclosure thereof. Q-Med shall contact Medicis' Investor
Relations Group for approval. Medicis shall contact * * * for approval.
12.21 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; provided, that
Sections 7.4(a) or (b), as applicable, and Article XI shall be deemed in all
cases to be relevant.
12.22 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) and (b) are collectively, the "INADMISSIBLE MATTERS"), shall be
admissible in any action, suit or proceeding relating to only the Prior Supply
Agreement or the agreements entered into in connection therewith, unless the
Parties otherwise agree in a writing referring to this Section 12.22; provided,
however, that if an action, suit or proceeding relates in part to the Prior
Supply 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 Supply 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
40
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 Supply 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 Supply 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 Supply Agreement (or the agreements entered into in
connection therewith), except as may be required by Law pursuant to a Third
Party subpoena.
41
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
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.
2
"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.
3
"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.
4
"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.
* * *
5
"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
6
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
7
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) * * *
10
(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:
21
(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
23
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.
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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
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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
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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.
35
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
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.
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.
41
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.
43
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
Exhibit 12
COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
(in thousands)
Fiscal Year Ended June 30,
2000
2001
2002
2003
2004
EARNINGS:
Income before income tax
expense
$
67,382
$
59,325
$
78,984
$
77,660
$
46,157
Add: Fixed charges
3,378
2,801
2,967
14,375
13,161
Earnings as defined
$
70,760
$
62,126
$
81,951
$
92,035
$
59,318
FIXED CHARGES:
Interest expense
$
2,246
$
1,263
$
1,376
$
10,038
$
8,663
Amortization of deferred
financing fees
2,542
2,145
Interest expense as reported
2,246
1,263
1,376
12,580
10,808
Portion of rent expense as interest
1,132
1,538
1,591
1,795
2,353
Fixed charges as defined
$
3,378
$
2,801
$
2,967
$
14,375
$
13,161
Ratio of earnings to fixed charges
21.0
x
22.2
x
27.6
x
6.4
x
4.5
x
For purposes of computing the ratios of earnings to fixed charges,
earnings represent pretax income from continuing operations plus fixed charges.
Fixed charges represent interest expense and the portion of rents
representative of interest related to continuing operations.
EXHIBIT 21.1
SUBSIDIARIES
Percentage
Subsidiary
Incorporated In
Owned
Medicis, The Dermatology Company®
Delaware
100
%
Dermavest, Inc.
Nevada
100
%
Medicis Manufacturing Corporation
Delaware
100
%
GenDerm Corporation
Delaware
100
%
Medicis Canada, Ltd
Canada
100
%
Ucyclyd Pharma, Inc.
Maryland
100
%
Medicis Pediatrics, Inc.
Delaware
100
%
Medicis Aesthetics Holdings Inc.
Delaware
100
%
Medicis Aesthetics Inc.
Delaware
100
%
Dermavest Swedish Holdings AB
Sweden
100
%
HA North American Sales AB
Sweden
100
%
Medicis Aesthetics Canada Ltd.
Canada
100
%
Exhibit 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statement
(Form S-8 No. 33-45573) pertaining to the 1988 and 1990 Stock Option Plans, in
the Registration Statement (Form S-8 No. 33-88590) pertaining to the 1992 Stock
Option Plan, in the Registration Statement (Form S-8 No. 33-311419) pertaining
to the 1995 Stock Option Plan, in the Registration Statement (Form S-8 No.
33-333647) pertaining to the 1996 Stock Option Plan, in the Registration
Statement (Form S-8 No. 333-81647) pertaining to the 1998 Stock Option Plan, in
the Registration Statement (Form S-8 No. 333-101467) pertaining to the 2002
Stock Option Plan, and in the Registration Statements (Form S-3 No. 333-97207
and Form S-4 No. 333-107089) of Medicis Pharmaceutical Corporation of our
report dated August 13, 2004, with respect to the consolidated financial
statements and schedule of Medicis Pharmaceutical Corporation included in this
Annual Report (Form 10-K) for the year ended June 30, 2004.
/s/ ERNST & YOUNG LLP
Phoenix, Arizona
September 10, 2004
Exhibit 31.1
CERTIFICATION
I, Jonah Shacknai, certify that:
1.
I have reviewed this annual report on Form 10-K of Medicis
Pharmaceutical Corporation;
2.
Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect
to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other
financial information included in this annual report, fairly present
in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the
periods presented in this report;
4.
The registrants other certifying officer(s) and I are
responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) for the registrant and have:
(a)
Designed such controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report
is being prepared;
(c)
Evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting; and
5.
The registrants other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons
performing the equivalent functions):
(a)
All significant deficiencies and material
weaknesses in the design or operation of internal control
over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process,
summarize and report financial information; and
(b)
Any fraud, whether or not material, that
involves management or other employees who have a significant
role in the registrants internal control over financial
reporting.
Date: September 10, 2004
JONAH SHACKNAI
/s/ JONAH SHACKNAI
(Jonah Shacknai)
Chairman of the Board and
Chief Executive Officer
Exhibit 31.2
CERTIFICATION
I, Mark A. Prygocki, Sr., certify that:
1.
I have reviewed this annual report on Form 10-K of Medicis
Pharmaceutical Corporation;
2.
Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect
to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other
financial information included in this annual report, fairly present
in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the
periods presented in this report;
4.
The registrants other certifying officer(s) and I are
responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) for the registrant and have:
(a)
Designed such controls and procedures, or caused
such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(c)
Evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal control
over financial reporting; and
5.
The registrants other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons
performing the equivalent functions):
(a)
All significant deficiencies and material
weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely
affect the registrants ability to record, process, summarize
and report financial information; and
(b)
Any fraud, whether or not material, that involves
management or other employees who have a significant role in
the registrants internal control over financial reporting.
Date: September 10, 2004
MARK A. PRYGOCKI, SR.
/s/ MARK A. PRYGOCKI, SR.
(Mark A. Prygocki, Sr.)
Executive Vice President, Chief Financial Officer,
Corporate Secretary and Treasurer
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of Medicis Pharmaceutical Corporation
(the Company) on Form 10-K for the fiscal year ended June 30, 2004, as filed
with the Securities and Exchange Commission on the date hereof (the Report),
I, Jonah Shacknai, Chief Executive Officer of the Company, to the best of my
knowledge, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in
all material respects, the financial conditions and results of
operations of the Company for the periods presented.
A signed original of this written statement required by Section 906, or other
document authenticating, acknowledging, or otherwise adopting the signature
that appears in typed form within the electronic version of this written
statement required by Section 906, has been provided to Medicis Pharmaceutical
Corporation and will be retained by Medicis Pharmaceutical Corporation and
furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies this Report on Form 10-K pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required
by such Act, be deemed filed by the Company for purpose of Section 18 of the
Securities Exchange Act of 1934, as amended (the Exchange Act). Such
certification will not be deemed to be incorporated by reference into any
filing under the Securities Act of 1933, as amended, or the Exchange Act,
except to the extent that the Company specifically incorporates it by
reference.
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of Medicis Pharmaceutical Corporation
(the Company) on Form 10-K for the fiscal year ended June 30, 2004, as filed
with the Securities and Exchange Commission on the date hereof (the Report),
I, Mark A. Prygocki, Sr., Chief Financial Officer of the Company, to the best
of my knowledge, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section
13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in
all material respects, the financial conditions and results of
operations of the Company for the periods presented.
/s/ MARK A. PRYGOCKI, SR.
Mark A. Prygocki, Sr.
Chief Financial Officer
September 10, 2004
A signed original of this written statement required by Section 906, or other
document authenticating, acknowledging, or otherwise adopting the signature
that appears in typed form within the electronic version of this written
statement required by Section 906, has been provided to Medicis Pharmaceutical
Corporation and will be retained by Medicis Pharmaceutical Corporation and
furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies this Report on Form 10-K pursuant to Section 906
of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required
by such Act, be deemed filed by the Company for purpose of Section 18 of the
Securities Exchange Act of 1934, as amended (the Exchange Act). Such
certification will not be deemed to be incorporated by reference into any
filing under the Securities Act of 1933, as amended, or the Exchange Act,
except to the extent that the Company specifically incorporates it by
reference.