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.
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"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).
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"LAUNCH" of a Licensed Product shall mean the first offer for sale
of the Licensed Product to the trade.
"LAWS" shall mean all applicable laws, statutes, rules, regulations,
ordinances and other pronouncements of law of any Governmental Authority.
"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.
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"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.
If to Q-Med:
Q-Med AB
Seminariegatan 21
752 28 Uppsala, Sweden
Attention: Chief Executive Officer
Telephone No.: * * *
Facsimile No.: * * *
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
Attention: Jonah Shacknai
Telephone No.: * * *
Facsimile No.: * * *
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