Exhibit 10.100
The omitted portions indicated by asterisks have been separately filed with the
Securities and Exchange Commission pursuant to a request for confidential
treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
SUPPLY AGREEMENT
BETWEEN
MEDICIS PHARMACEUTICAL CORPORATION
AND
Q-MED AB
DATED AS OF MARCH 7, 2003
2
SUPPLY AGREEMENT
This Supply Agreement (this "AGREEMENT") is entered into this
7th day of March, 2003 between Medicis Pharmaceutical Corporation, a company
organized under the laws of the State of Delaware (the "PURCHASER"), 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, Startskottet 21914 AB (under proposed change of name
to Medicis Sweden Holdings AB), a Swedish limited liability company with
corporate registration number 556632-3548 ("MEDICIS SWEDEN") and Q-Med
International B.V., a company organized under the laws of the Netherlands with
its statutory seat at Amsterdam, the Netherlands and its principal offices at
Xxxxxxxxx 000, 0000 XX Xxxxxxxxx, xxx Xxxxxxxxxxx ("DUTCHCO"), have entered into
the Share Purchase Agreement, dated as of February 10, 2003, as amended by
Amendment No. 1 dated as of March 7, 2003 (as the same may be amended from time
to time in accordance with its terms, the "PURCHASE AGREEMENT"), pursuant to
which Dutchco has agreed to sell all of the outstanding shares (the "SHARES") of
HA North American Sales AB, a company organized under the laws of the Kingdom of
Sweden with corporate registration number 556636-3718 ("NEWCO"), to the
Purchaser;
WHEREAS, Medicis Sweden is a wholly-owned subsidiary of the
Purchaser;
WHEREAS, Dutchco is a wholly-owned subsidiary of Q-Med;
WHEREAS, Newco has been granted, pursuant to the Amended and
Restated License Agreement (as defined herein), a license under the Licensed
Rights (as defined herein) to use, import, offer for sale and sell, but not to
manufacture or have manufactured, the Licensed Products in the Territory (as
defined herein);
WHEREAS, in connection with the sale of the Shares to the
Purchaser, Q-Med has agreed to supply the Purchaser and its Affiliates (as
defined herein) with the Licensed Products and Newco has the right to sublicense
immediately to the Purchaser and the Purchaser's Permitted Transferees (as
defined in the Amended and Restated License Agreement, as defined herein) its
rights under the Licensed Rights pursuant to the Amended and Restated License
Agreement; and
WHEREAS, Q-Med and the Purchaser 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:
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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 by a
Governmental Authority or other Person.
"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 or visual shape of the naked human body or any of
its components; provided, that Aesthetic Enhancement shall not be deemed to
include modification, restoration, adjustment or correction of 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 AND RESTATED LICENSE AGREEMENT" shall mean the
Amended and Restated Intellectual Property License Agreement, dated as of March
6, 2003, and entered into prior to the Closing Date, between Newco and Q-Med,
amending and restating the License Agreement.
"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.
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"AMENDED MEDICAL DEVICE LICENSE APPROVAL" shall mean TPD's
approval of an Amended Medical Device License.
"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 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), 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 (ii) acquires (by purchase, merger, consolidation or otherwise) or for
the first time is 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, in each of (a) or (b), in the
event that Q-Med or the Purchaser, 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 or the Purchaser, as the case may be.
"CLOSING" shall have the meaning set forth in the Purchase
Agreement.
"CLOSING DATE" shall mean the date of the Closing of the
transactions contemplated by the Purchase Agreement.
"COMMERCIAL DISTRIBUTION" shall mean a distribution in
accordance with the terms and conditions of the Transaction Agreements for
purposes other than Investigational Distribution.
"CONFIDENTIALITY AGREEMENT" shall mean the Confidentiality
Agreement, dated as of December 5, 2002, between Credit Suisse First Boston
(Europe) Limited, solely as Q-Med's representative, and the Purchaser, 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 Corporation and Q MED
AB, which shall continue in full force and effect in accordance with its terms.
"FCA" shall mean FCA as defined in the International Chamber
of Commerce Incoterms 2000.
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"FDA" shall mean the United States Food and Drug
Administration.
"FDCA" shall mean the United States Federal Food, Drug, and
Cosmetic Act of 1938, as amended (21 U.S.C.Sections 301 et. seq.).
"FIELD" shall mean dermatologic aesthetic enhancement and the
aesthetic enhancement of the lips.
"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.
"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).
6
"LAWS" shall mean all applicable laws, statutes, rules,
regulations, ordinances and pronouncements of law of any Governmental Authority.
"LICENSE AGREEMENT" shall mean the Intellectual Property
License Agreement, dated as of December 20, 2002, between Q-Med and Q-Med
Holding Sweden AB, a company organized under the laws of the Kingdom of Sweden
and a wholly owned subsidiary of Q-Med ("HOLDCO"), which was assigned by Holdco
to Newco as of December 27, 2002.
"LICENSED PRODUCTS" ****
"LICENSED RIGHTS" shall have the meaning set forth in the
Amended and Restated 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)).
"MANUFACTURED" shall have the meaning set forth in Section
3.1.
"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.
"MEDICAL DEVICE LICENSE APPROVAL" shall mean TPD's approval of
a Medical Device License Application.
"NEW PRODUCTS" ****
"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.
"ORDERED PRODUCTS" shall mean the Licensed Products ordered
pursuant to a Firm Order.
"PARTY" shall mean Q-Med or the Purchaser and, when used in
the plural, means both Q-Med and the Purchaser 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.
7
"PERSON" shall mean any individual, firm, corporation,
partnership, limited liability company, trust, joint venture or other entity or
organization.
"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.
"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.
"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).
"PURCHASE AGREEMENT" shall have the meaning set forth in the
Recitals above.
"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.
"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.
8
"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.
"TERM" shall have the meaning set forth in Section 8.1.
"TERRITORY" shall mean the United States, including its
territories and possessions, and Canada.
"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
Purchase Agreement, the Amended and Restated License Agreement, the Escrow
Agreement and the Confidentiality Agreement.
"TRANSFER" shall mean any Change in Control or Volitional
Change in Control of a Party or a transfer or assignment by a Party of its
rights and obligations under this Agreement.
"VOLUME PRICING" shall mean, in respect of the period
commencing on the date hereof and ending on December 31, 2003, Q-Med's volume
pricing for calendar year 2003 as set forth on Schedule B and, in respect of
subsequent calendar years, shall mean the volume pricing in effect for each such
calendar year as determined pursuant to Sections 4.1 and 4.2.
"VOLITIONAL CHANGE IN CONTROL" shall mean (a) the disposition
of all or substantially all of the outstanding shares, assets or business of a
Party 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), 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 (ii) acquires (by purchase, merger, consolidation or
otherwise) or for the first time is 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, in each
of (a) or (b), in the event that Q-Med or the Purchaser, as the case may be, was
a party to the applicable transaction or of which the Board of Directors of
Q-Med or the Purchaser, as the case may be, shall have approved.
9
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.
(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. The Purchaser
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 the Purchaser and its
Affiliates, except as otherwise provided herein, all of the Purchaser's and its
Affiliates' requirements for the Licensed Products during the Term as provided
herein for marketing, use, import, offer for sale and sale for Commercial
Distribution and Investigational Distribution in the Territory in accordance
with the terms of the Transaction Agreements. The Purchaser 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 the Purchaser
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) (i) With respect to Licensed Products
supplied for Commercial Distribution and Investigational Distribution
in Canada, the Purchaser shall provide Q-Med with a forecast (attached
hereto as Schedule D1) of the Purchaser's and its Affiliate's estimated
monthly requirements of the Licensed Products for the period from the
date hereof through the end of the 2003 calendar year and an initial
firm order, which initial firm order shall set forth the Licensed
Product requirement on a monthly basis and 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 (an "INITIAL FIRM ORDER") (such Initial Firm Order
attached hereto as Schedule D2) for the period from the date hereof up
to and including April 30, 2003. Q-Med shall supply the quantities set
forth on Schedule D2 for each Licensed Product in accordance with the
monthly delivery schedule included in the Initial Firm Order to the
extent such Initial Firm Order is consistent with the forecasts
provided by Q-Med to the Purchaser prior to the date hereof, and to the
extent the Initial Firm Order exceeds such forecasts, Q-Med shall not
be obligated to supply more Licensed Products than it is able to supply
using commercially reasonable efforts. To the extent such Initial Firm
Order is
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not sufficient to meet the Purchaser's and its Affiliates' actual
requirements for any Licensed Product to be supplied for Commercial
Distribution and Investigational Distribution in Canada for such
period, Q-Med shall use its commercially reasonable efforts to supply
the Purchaser and its Affiliates with its requirements beyond the
amounts set forth on Schedule D2. For the periods after April 30, 2003,
Firm Orders with respect to Licensed Products to be supplied for
Commercial Distribution and Investigational Distribution in Canada
shall be filled by Q-Med in accordance with the forecasts and Firm
Orders placed by the Purchaser pursuant to Section 2.2(b).
(ii) With respect to all Licensed Products to be supplied
for Commercial Distribution and Investigational Distribution in the
United States and its territories and possessions, the Purchaser shall
provide Q-Med with a forecast of the Purchaser's and its Affiliate's
estimated monthly requirements of the applicable Licensed Products for
the twelve (12) month period commencing on the date hereof in
substantially the form attached hereto as Schedule D3. The Purchaser
shall update such forecast on a monthly basis until such time as the
Purchaser 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 the Purchaser is providing forecasts
and placing Firm Orders pursuant to Section 2.2(b), the Purchaser may
provide Q-Med with an initial Firm Order for Licensed Products at any
time; provided that Q-Med shall not be obligated to supply Licensed
Products under and in accordance with any such initial Firm Order prior
to the date that is ten (10) weeks after receipt of such Initial Firm
Order; provided further, that Q-Med will not be obligated to ship any
Licensed Product until the Purchaser makes the applicable Milestone
Payment or accepts the applicable Regulatory Approvals; provided,
further, that (i) with respect to Restylane(R), Q-Med shall not be
obligated to supply in excess of **** pursuant to any such initial Firm
Orders and (ii) with respect to all other Licensed Products, Q-Med
shall advise the Purchaser of the maximum number of syringes that it
may be obligated to deliver pursuant to the applicable initial Firm
Order. If the Purchaser, by placing an initial Firm Order prior to
receipt of the applicable Regulatory Approval, requests that Q-Med
commence the Manufacture of any Licensed Products prior to the receipt
of the applicable Regulatory Approval the Purchaser 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.
(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, the
Purchaser shall give to Q-Med a forecast of the Purchaser's and its Affiliates'
estimated monthly requirements of the Licensed Products for the twelve (12)
month period commencing with the next succeeding calendar month. The twelve (12)
month forecast delivered to Q-Med pursuant to the preceding sentence shall
represent the Purchaser's reasonable estimates of the quantity of the Licensed
Products that the Purchaser 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.
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(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 120% of the most recent forecast estimated
quantity for such Licensed Product for such one (1) month period provided by the
Purchaser to Q-Med in accordance with this Section 2.2 prior to the Firm Order
being placed by the Purchaser. In the event that the Purchaser shall submit a
Firm Order that is below 80% of the applicable forecast estimated quantity,
Q-Med shall deliver to the Purchaser and the Purchaser 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, the Purchaser shall give to Q-Med a
forecast of the Purchaser's 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
the Purchaser's reasonable estimates of the quantity of the Licensed Products
that the Purchaser 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 the
Purchaser 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 the Purchaser's 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 the Purchaser
(a "CAPACITY SHORTAGE"), whether due to insufficient manufacturing capacity or
otherwise, then Q-Med shall request written confirmation from the Purchaser's
Chief Executive Officer of the Purchaser's forecasted requirements for such
forty-eight (48) month period that give rise to such possible Capacity Shortage
(the "CERTIFIED PURCHASER REQUIREMENTS").
(b) (i) If Q-Med reasonably determines after further
consideration in light of such Certified Purchaser Requirements that
there will be a Capacity Shortage within the first twenty-four (24)
month period covered by such Certified Purchaser Requirements, Q-Med
shall provide the Purchaser with notice thereof within five (5)
Business Days of receipt of the Certified Purchaser Requirements. If
Q-Med has a plan of action with respect to such Capacity Shortage when
it delivers such notice, Q-Med shall provide the Purchaser 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
the Purchaser and Q-Med to discuss such plan. If Q-Med has not
developed a plan of action at the time of its notice to the Purchaser
of the Capacity Shortage, Q-Med shall promptly convene a meeting
between the Purchaser and Q-Med to develop in mutual consultation a
course of action
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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 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 the
Purchaser with capacity sufficient to fulfill that portion of the
Certified Purchaser Requirements that Q-Med is unable to fulfill or, if
the Certified Purchaser 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 the Purchaser, 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
Purchaser Requirements that Q-Med was unable to fulfill or if the
Certified Purchaser Requirements are no longer applicable, the then
current forecast provided under Section 2.2(b), the Purchaser shall
resume, as promptly as is commercially reasonable, the use of Q-Med as
the exclusive supplier of the Purchaser and its Affiliates.
(ii) If Q-Med determines after further consideration in
light of such Certified Purchaser 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 Purchaser
Requirements, Q-Med shall provide the Purchaser with notice thereof
within ten (10) Business Days of its receipt of the Certified Purchaser
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 Purchaser Requirement,
Q-Med believes that there is no Capacity Shortage, Q-Med shall so
inform the Purchaser in writing. If, within three (3) months after
delivery of such Certified Purchaser 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 the Purchaser in writing of
such plan of action. If, within three (3) months after delivery of such
Certified Purchaser Requirement, 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 the
Purchaser 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 the Purchaser 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, the Purchaser 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 the
Purchaser with capacity sufficient to fulfill that portion of the
Certified Purchaser
13
Requirements that Q-Med is unable to fulfill or, if the Certified
Purchaser 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 the Purchaser, 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 Purchaser
Requirements that Q-Med was unable to fulfill or, if the Certified
Purchaser Requirements are no longer applicable, the then current
forecast provided under Section 2.2(b), the Purchaser shall resume, as
promptly as is commercially reasonable, the use of Q-Med as the
exclusive supplier of the Purchaser and its Affiliates.
(iii) If Q-Med determines after further consideration in
light of such Certified Purchaser Requirements that there will be a
Capacity Shortage after the thirty-seventh (37th) month of the period
covered by such Certified Purchaser Requirements, Q-Med shall provide
the Purchaser with notice thereof within ten (10) Business Days of its
receipt of the Certified Purchaser 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 Purchaser Requirement, Q-Med believes that there is no
Capacity Shortage, Q-Med shall so inform the Purchaser in writing. If,
within six (6) months after delivery of such Certified Purchaser
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 the Purchaser in writing of such plan of
action. If, within six (6) months after delivery of such Certified
Purchaser Requirement, 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 the Purchaser 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 the Purchaser
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, the Purchaser 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 the Purchaser with
capacity sufficient to fulfill that portion of the Certified Purchaser
Requirements that Q-Med is unable to fulfill or, if the Certified
Purchaser 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 the Purchaser, 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 Purchaser
Requirements that Q-Med was unable to fulfill or, if the Certified
Purchaser Requirements are no longer
14
applicable, the then current forecast provided under Section 2.2(b),
the Purchaser shall resume, as promptly as is commercially reasonable,
the use of Q-Med as the exclusive supplier of the Purchaser and its
Affiliates.
(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
the Purchaser 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 Purchaser's 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 the Purchaser 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 the Purchaser of such shortage, then the Purchaser 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, xxxx 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 the Purchaser 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
the Purchaser 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, processed,
tested, filled, labeled and packaged ("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 clauses (b) and (c) below, Q-Med
shall deliver to the Purchaser Ordered Products with the Restylane trademark,
Restylane Fine Lines trademark and Perlane trademark
15
with a remaining shelf life of not less than **** from the date of delivery to
the Purchaser, provided, however, that in the event a Regulatory Approval for
the shelf life (a "REGULATORY SHELF LIFE") of any of Restylane(R), Restylane
Fine Lines(TM) or Perlane(TM) Licensed Products is obtained which is **** or
greater. Q-Med shall deliver to the Purchaser Restylane(R), Restylane Fine
Lines(TM) or Perlane(TM) Ordered Products, as the case may be, with a remaining
shelf life not less than the greater of ****; provided that notwithstanding the
foregoing, Q-Med shall not be obligated to deliver Ordered Products with a
remaining shelf life that is inconsistent with any Regulatory Approval or the
then-current shelf life in the Labeling applicable to such Licensed Product.
(b) Notwithstanding the foregoing, for the period
commencing on the date hereof and ending when an Amended Medical Device License
Approval for the improved Restylane Fine Lines(TM) with a Regulatory Shelf Life
of **** or greater has been received by Q-Med, Q-Med shall deliver and the
Purchaser shall accept Restylane Fine Lines(TM) Ordered Products with a
remaining shelf life of not less than ****; provided that Q-Med shall use its
commercially reasonable efforts to obtain such Amended Medical Device License
Approval.
(c) Other than with respect to Restylane(R), Restylane
Fine Lines(TM) and Perlane(TM) as set forth in clauses (a) and (b) above, unless
otherwise agreed in writing by the Parties, Q-Med shall deliver to the Purchaser
Licensed Products with a minimum remaining shelf life of the applicable ****
ARTICLE IV
CONSIDERATION
4.1 Pricing. (a) The Parties agree that the price for
each of the Licensed Products during the Term shall be the Volume Pricing of
such Licensed Product in effect at the time of delivery of the applicable
Initial Firm Order or Firm Order in accordance with Sections 2.2(a) and (b) to
Q-Med. Volume Pricing shall be expressed in SEK.
(b) The Volume Pricing applicable for the 2003 calendar
year shall be determined based on Schedule B and on the basis of the initial
forecasts for the period from the date hereof through the end of the 2003
calendar year provided pursuant to Section 2.2(a). Such Volume Pricing shall be
subject, retroactively to the date hereof, to adjustment (upward or downward) in
accordance with this clause. No later than January 15, 2004, Q-Med shall (i)
determine the actual amount of Licensed Product purchased by the Purchaser
during the 2003 calendar year, (ii) notify the Purchaser thereof in writing and
****
(c) The Parties further acknowledge that the Volume
Pricing applicable for the 2004 calendar year shall be determined in accordance
with Section 4.2 below. Such Volume Pricing shall be subject, retroactively to
January 1, 2004, to adjustment (upward or downward) in accordance with this
clause. No later than January 15, 2005, Q-Med shall (i) determine the actual
amount of Licensed Product purchased by the Purchaser during the 2004 calendar
year, (ii) notify the Purchaser thereof in writing and ****
16
(d) Commencing with the 2005 calendar year, the Volume
Pricing for each calendar year shall be determined in accordance with Section
4.2 below and shall be subject to adjustment (upward or downward) in accordance
with this clause (d). If, on June 30 of any such calendar year it is apparent to
Q-Med based on the Firm Orders placed by the Purchaser prior to June 30 of such
calendar year that ****
(e) For additional incremental units of **** for units
above ****, the Volume Pricing shall be determined based on the formula set
forth in Schedule B.
(f) The Parties acknowledge that the costs of any
manufacturing or process development conducted subsequent to the receipt of the
Regulatory Approvals for the Licensed Products in the Territory shall be a
component of, and reflected in, the Volume Pricing; provided that (i) such
development is required by a Governmental Authority in the Territory or Sweden
or by the Notified Body with jurisdiction over Q-Med or by a Governmental
Authority with jurisdiction over regulatory matters relating to this Agreement
or is mutually agreed to in writing by the Parties and (ii) the Parties shall
have the right to determine, pursuant to the applicable good faith annual price
negotiations pursuant to Section 4.2, how such costs will be allocated. The
costs associated with obtaining any requisite Regulatory Approvals and
conducting any requisite clinical trials prior to the receipt of or as a
condition to such PMA Approvals or PMA Supplement Approvals shall not be a
component of, or otherwise included in, the Volume Pricing and such costs shall
be allocated in accordance with the methodology set forth in Section 6.5(a)(iv).
(g) Except with respect to the costs for obtaining the
original Regulatory Approvals for Restylane(R), Restylane Fine Lines(TM) and
Perlane(TM), which costs the Purchaser will not be required to bear, the Parties
acknowledge that any incremental costs per unit, including Labeling and
Manufacturing costs, related to Investigational Distribution of the Licensed
Products in the Territory shall be borne by the Purchaser. Such incremental
costs shall be determined by Q-Med on a case-by-case basis and shall be
allocated in accordance with the methodology set forth in Section 6.5(a)(iv).
4.2 Procedures for the Determination of Volume Pricing.
(a) The Purchaser shall submit a forecast of the Purchaser's and its Affiliate's
estimated monthly requirements for the Licensed Products for the next succeeding
calendar year on or before the fifth (5th) Business Day prior to October 1st of
each year, beginning with the submission of such a forecast on the fifth (5th)
Business Day prior to October 1st, 2003 for the 2004 calendar year. Q-Med shall
on November 7th of each year (or, if November 7th is not a Business Day, the
next Business Day) send a proposed pricing schedule to the Purchaser based on
its best estimates of actual cost of production and overhead and allocation in
accordance with the parameters set forth on Schedule B, including reasonably
detailed supporting documentation therefor to justify any pricing increase or
decrease; provided, that Q-Med shall be under no obligation to disclose
sensitive information related to any product other than Licensed Products. Based
on such proposal, the Parties agree to negotiate the pricing schedule for each
calendar year in good faith, such negotiations to commence promptly after the
Purchaser's receipt of Q-Med's proposal. ****
17
(b) If the Parties are unable to reach agreement with
respect to the Volume Pricing for a given calendar year before December 1st of
the preceding year, an independent arbitrator mutually appointed by the Parties
and expert in accounting shall be retained to determine the Volume Pricing for
the applicable calendar year which shall be determined on the basis of estimated
actual costs of production and overhead and allocation in accordance with the
parameters set forth on Schedule B and Section 4.2(a) hereof. 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
conclusive and binding upon the Parties. Each Party shall provide the arbitrator
all relevant books and records, any work papers, supporting documentation and
any other documentation used in determining its proposal pursuant to this
Section 4.2; provided that such documentation shall be the same documentation
provided to the other Party pursuant to Section 4.2(a). All fees and expenses of
the arbitrator shall be paid by the Party whose proposal is not selected.
4.3 Payment Obligations. Invoices for Licensed Products
accepted by the Purchaser in accordance with Section 5.1(a) shall be submitted
to the Purchaser 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 the Purchaser 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 the
Purchaser with a credit against the next invoice for Licensed Products to be
delivered to the Purchaser to the extent the prior invoice includes a charge for
Ordered Products not actually delivered. Any required payment hereunder not made
by the Purchaser 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 at its principal office in New York City plus one percent (1%).
Notwithstanding the foregoing, if at any time the Purchaser 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.
ARTICLE V
ACCEPTANCE OF LICENSED PRODUCTS BY THE PURCHASER
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 the Purchaser (if
requested by the Purchaser, the expense of any such courier to be borne by the
18
Purchaser), 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) copies of all Labeling
that will physically accompany the Licensed Products (e.g., Package Insert) and
(iii) quantity of syringes to be delivered in such shipment. If the Purchaser
determines to reject any batch, the Purchaser shall notify Q-Med of the
Purchaser's rejection of a batch within five (5) Business Days following the
Purchaser's receipt of the Order Information; provided that the Order
Information shall be the sole basis for such rejection. If no notice is provided
by the Purchaser within such time period, then the Purchaser shall be deemed to
have accepted the shipment. Any notice of rejection by the Purchaser shall be
accompanied by a reasonably detailed statement of its reasons for rejection.
(b) The Purchaser shall be entitled to reject all or any
portion of a shipment of Licensed Products within ten (10) Business Days of the
Purchaser's 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 the Purchaser 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 the Purchaser within such time period, then the Purchaser
shall be deemed to have accepted the entire shipment. The Purchaser 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 the Purchaser as promptly as reasonably possible,
but in any event within ten (10) Business Days after receipt of such written
notice, whether it agrees with the Purchaser's 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 the Purchaser's
reasons for rejection and Q-Med shall replace such Licensed Products in
accordance with Section 5.1(c) and shall reimburse the Purchaser for the cost of
shipping (including insurance). If Q-Med does not agree with the Purchaser's
assertions and the Purchaser accepts Q-Med's determination, then the Purchaser
shall be responsible for the price of the Licensed Product (including the
shipping cost and insurance). If Q-Med does not agree with the Purchaser's
assertions and the Purchaser 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 the Purchaser 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 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 the Purchaser, 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 the Purchaser 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).
19
(c) As soon as practicable upon receipt of a notice of
rejection, unless otherwise specified by the Purchaser, Q-Med shall use
commercially reasonable efforts to provide replacement Licensed Products for
those rejected by the Purchaser 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 the
Purchaser 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 the Purchaser in accordance with Section 5.1(a)
is non-conforming with its Specifications, Q-Med shall provide prompt notice
thereof to the Purchaser and the Purchaser 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 the
Purchaser 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 the Purchaser 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 the Purchaser shall each comply in
all material respects with all applicable Laws that pertain to the activities
for which Q-Med and the Purchaser 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.
(b) Manufacture of Licensed Products. Q-Med and the
Purchaser 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 QSR/QSRC
compliance. Q-Med shall inform the Purchaser 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, and shall provide the
Purchaser with copies of any correspondence related thereto.
20
(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 Restylane(R), Perlane(TM), and Restylane Fine
Lines(TM), Q-Med shall maintain such Regulatory Approvals in good standing as
necessary in order to ensure that the Purchaser receives its own Regulatory
Approvals in good standing for Restylane(R), Perlane(TM) and Restylane Fine
Lines(TM), as contemplated in Sections 6.2 and 6.3 below.
(e) Purchaser Notification. The Purchaser 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 related thereto.
6.2 Transfer of Canadian Regulatory Approvals. (a)
Promptly upon receipt by the Seller (as defined in the Purchase Agreement) of
the Restylane(R) Milestone Payment (as defined in the Purchase Agreement), Q-Med
shall transfer the then existing Medical Device License Approvals and Amended
Medical Device License Approvals, where applicable, for the Licensed Products
and Improvements thereof in Canada pursuant to the TPD's existing procedure for
such transfers (a true and correct copy of which is attached hereto on Schedule
C). Q-Med shall provide all necessary letters of authorization granting rights
of reference, shall use commercially reasonable efforts to cause Third Parties
to provide letters of authorization granting necessary rights of reference
(e.g., to their Master Files) and otherwise shall cooperate fully in complying
with the TPD requirements for transferring Medical Device Licenses. All
subsequent Regulatory Approvals for Licensed Products and Improvements thereof
in Canada shall be obtained, owned and paid for by the Purchaser. Thereafter,
the Purchaser's distribution of Licensed Products in Canada shall be conducted
under the Regulatory Approvals that the Purchaser owns.
(b) In the event that the procedure for the transfer of
the Medical Device License Approvals and Amended Medical Device License
Approvals described in Section 6.2(a) cannot be finalized, whether due to a
change in Law or otherwise, Q-Med shall investigate and use its reasonable best
efforts to promptly implement a structure to provide the Purchaser with the same
substantive rights and obligations as the Purchaser would have enjoyed with
respect to the Medical Device License Approvals described in Section 6.2(a) if
transfer had been finalized; provided that Q-Med shall have no obligation under
the foregoing if the failure to complete the procedure described in Section
6.2(a) is due to the action, inaction, fault or omission of the Purchaser. For
the avoidance of doubt, the Parties agree that the Purchaser would not be
considered to have received the same substantive rights and obligations if Q-Med
were to grant
21
the Purchaser a distributorship with respect to the Regulatory Approvals to have
been transferred pursuant to Section 6.2(a).
(c) Promptly upon the breach by the Purchaser (as defined
in the Purchase Agreement) of its obligation to make any Milestone Payments (as
defined in the Purchase Agreement) when due pursuant to Section 2.2 therein, the
Purchaser shall transfer to Q-Med the then existing Medical Device License
Approvals and Amended Medical Device License Approvals, where applicable, for
the Licensed Products and Improvements thereof in Canada pursuant to the TPD's
existing procedure for such transfers (a true and correct copy of which is
attached hereto on Schedule C).
(d) In the event that the procedure for the transfer of
the Medical Device License Approvals and Amended Medical Device License
Approvals described in Section 6.2(c) cannot be finalized, whether due to a
change in Law or otherwise, Purchaser shall use its reasonable best efforts to
(i) file appropriate Medical Device License Amendments amending all Medical
Device Licenses and Amended Medical Device Licenses for the Licensed Products
and Improvements thereof in Canada, amending the tradenames of all Licensed
Products and Improvements thereof in Canada to tradenames that would not be
confused by the public with "Restylane", "Perlane" or "Restylane Fine Lines";
and (ii) shall provide all necessary letters of authorization granting rights of
reference and cross-reference, and shall use commercially reasonable efforts to
cause Third Parties to provide letters of authorization granting necessary
rights of reference and cross-reference (e.g., to their Master Files) and
otherwise shall cooperate fully in complying with the applicable TPD
requirements for enabling Q-Med to file new Medical Device License Applications,
using the names "Restylane", "Restylane Fine Lines", and/or "Perlane", or any
other names chosen by Q-Med, and cross-referencing all Purchaser's Medical
Device Licenses and Amended Medical Device Licenses for the Licensed Products
and Improvements thereof in Canada; provided that the Purchaser shall have no
obligation under the foregoing if the failure to complete the procedure
described in Section 6.2(d) is due to the action, inaction, fault or omission of
Q-Med.
(e) In the event that the procedure for the
cross-referencing of Medical Device Licenses and Amended Medical Device Licenses
described in Section 6.2 (d) cannot be finalized, whether due to a change in Law
or otherwise, Purchaser shall investigate and use its reasonable best efforts to
promptly implement a structure to provide Q-Med with the same substantive rights
and obligations as Q-Med would have enjoyed with respect to the Medical Device
Licenses and Amended Medical Device Licenses described in Section 6.2(c) if such
transfer of licenses back to Q-Med had been finalized, provided that the
Purchaser shall have no obligation under the foregoing if the failure to
complete the procedure described in Section 6.2(d) is due to the action,
inaction, fault or omission of Q-Med.
(f) Uses. Upon the completion of the procedures
referenced in Section 6.2(a), above: (i) the recipient of the transferred
Regulatory Approval shall have irrevocable (except as contemplated by Section
6.2(c), (d) or (e)) ownership thereof and (ii) the Purchaser's distribution of
Licensed Products in Canada shall be conducted under the Regulatory Approvals
that the Purchaser owns.
22
(g) Timing. Q-Med shall own and hold all original
Regulatory Approvals pertaining to Restylane(R), Perlane(TM), and Restylane Fine
Lines(TM); provided that promptly upon the Seller's (as defined in the Purchase
Agreement) receipt of the Restylane(R) Milestone Payment (as defined in the
Purchase Agreement), Q-Med shall prepare and within forty-five (45) Business
Days submit on behalf of the Purchaser an Amended Medical Device License
Application for the transfer of the then existing Medical Device Licenses and
Amended Medical Device Licenses for the Licensed Products (based on the
procedures described in Section 6.2(a) or (b), as applicable, above). The
Purchaser shall cooperate with Q-Med's efforts and TPD procedures as reasonably
requested by Q-Med and as necessary to finalize such transfer.
6.3 Duplicate PMA Approvals. (i) Pursuant to the FDA's
existing procedure (a true and correct copy of which is attached hereto on
Schedule C), Q-Med shall prepare and submit on behalf of the Purchaser a
complete original PMA Application based upon a right of reference to the
information in Q-Med's Regulatory Approvals for Restylane(R), Perlane(TM), and
Restylane Fine Lines(TM), as applicable and Q-Med shall use commercially
reasonable efforts to ensure that such PMA Application shall be complete,
accurate and acceptable for filing (provided, that Q-Med shall not be
responsible as to the accuracy, completeness or timeliness of the information
provided by the Purchaser) under 21 C.F.R. 814.12. Q-Med shall use commercially
reasonable efforts to ensure that any such PMA Application is accepted for
filing. Q-Med shall provide all necessary letters of authorization granting
rights of reference, shall use commercially reasonable efforts to cause Third
Parties to provide letters of authorization granting necessary rights of
reference (e.g., to their Master Files) and otherwise shall use commercially
reasonable efforts to fully comply with and pursue the FDA requirements for
obtaining duplicates of the original PMA Approvals. The Purchaser shall
cooperate with Q-Med's efforts and FDA procedures as reasonably requested by
Q-Med and as necessary to obtain such duplicate PMA Approvals. Q-Med shall pay
the filing fees of both Parties related to the FDA procedures for obtaining
duplicates of the original PMA Approvals or PMA Supplements.
(ii) The Parties may avail themselves of the FDA procedure
to create duplicate PMA Approvals for Licensed Products and
Improvements pursued through the Steering Committee as provided for
herein. As applicable, both Parties shall provide all necessary letters
of authorization granting rights of reference, shall use commercially
reasonable efforts to cause Third Parties to provide letters of
authorization granting necessary rights of reference (e.g., to their
Master Files) and otherwise shall cooperate fully in complying with the
FDA requirements for obtaining duplicate PMA Approvals.
(iii) The FDA generally refers to the foregoing procedure
as licensing of a PMA Approval, with the owner of the original
Regulatory Approval as the licensor and the owner of the newly issued
PMA Approval as the licensee. These terms are not used herein in order
to avoid confusion with the Amended and Restated License Agreement and
terms related thereto.
(b) In the event that the procedure for obtaining
duplicate PMA Approvals described in Section 6.3(a) cannot be finalized, whether
due to a change in Law or otherwise Q-Med shall investigate and use its
reasonable best efforts to promptly implement a structure to provide the
Purchaser with the same substantive rights and obligations as the Purchaser
would
23
have enjoyed with respect to the PMA Approvals described in Section 6.3(a) if
such duplicate approval had been issued; provided that Q-Med shall have no
obligation under the foregoing if the failure to complete the procedure
described in Section 6.3(a) is due to the action, inaction, fault or omission of
the Purchaser. If Q-Med, in its determination, is ultimately unable to conceive
of a structure with the same substantive rights and obligations as the Purchaser
would have enjoyed if such duplicate approval had been issued, then Q-Med will,
promptly transfer ownership of the original Regulatory Approvals for
Restylane(R), Perlane(TM) and Restylane Fine Lines(TM) to the Purchaser pursuant
to the FDA's procedure for such transfers, and Q-Med will have the right to
obtain duplicates of the Regulatory Approvals so transferred. For the avoidance
of doubt, the Parties agree that the Purchaser would not be considered to have
received the same substantive rights and obligations if Q-Med were to grant the
Purchaser a distributorship with respect to the Regulatory Approvals to have
been duplicated.
(c) Uses. Upon the completion of the procedures
referenced in Section 6.3, above: (i) the recipient of the newly issued
Regulatory Approval shall have irrevocable ownership thereof; (ii) the
Purchaser's distribution of Licensed Products in the United States shall be
conducted under the Regulatory Approvals that the Purchaser owns; and (iii)
Q-Med shall solely use its Regulatory Approvals, if desired, to obtain
additional Regulatory Approval for indications that are both within the United
States and outside the Field and, if desired, to manufacture Licensed Products
in the United States for export outside the Territory (and, if desired by the
Purchaser, to manufacture Licensed Products in the United States for use in the
Territory solely by the Purchaser). If the FDA is unwilling to grant Regulatory
Approvals for more than one product in the United States with the same trade
name, Q-Med shall modify the trade name pertaining to its Regulatory Approvals
to resolve the problem, shall immediately discontinue use of the trade names in
the United States, and shall promptly submit all required regulatory filings.
Q-Med shall use commercially reasonable efforts to ensure that such PMA
Supplements are accepted for filing and that they receive FDA approval thereof.
For the avoidance of doubt, Q-Med shall not use and shall not assist any Person
in using the retained or original Regulatory Approvals or any later acquired
Regulatory Approvals in the United States: (a) to make Licensed Products in the
United States, except for the Purchaser or its Affiliates; or (b) to use, sell,
import or otherwise commercialize the Licensed Products in the Field in the
Territory; until such time as the Purchaser's exclusive rights in the Licensed
Products in the Field and in the Territory have terminated or expired.
(d) Timing. Q-Med shall own and hold all original
Regulatory Approvals pertaining to Restylane(R), Perlane(TM), and Restylane Fine
Lines(TM); provided that:
(i) promptly upon the Seller's (as defined in the
Purchase Agreement) receipt of the Restylane(R) Milestone Payment (as
defined in the Purchase Agreement), Q-Med shall prepare and within
forty-five (45) Business Days submit on behalf of the Purchaser a PMA
Application for the issuance of a duplicate PMA Approval (based on the
procedures described in Section 6.3 above) with respect to
Restylane(R). The Purchaser shall cooperate with Q-Med's efforts and
FDA procedures as reasonably requested by Q-Med and as necessary to
obtain such duplicate PMA Approvals;
(ii) promptly upon the Seller's (as defined in the
Purchase Agreement) receipt of the final Milestone Payment (as defined
in the Purchase Agreement), Q-Med shall
24
prepare and within forty-five (45) Business Days submit on behalf of
the Purchaser a PMA Application for obtaining issuance of a duplicate
PMA Approval or PMA Supplement (based on the procedures described in
Section 6.3 above) with respect to Perlane(TM). Q-Med shall prepare and
submit on behalf of the Purchaser a PMA Application for obtaining
issuance of a duplicate PMA Approval (based on the procedures described
in Section 6.3 above) with respect to Restylane Fine Lines(TM) promptly
upon receipt of the final Milestone Payment or the original PMA
Approval or PMA Supplement Approval for Restylane Fine Lines(TM),
whichever is later. The Purchaser shall cooperate with Q-Med's efforts
and FDA procedures as reasonably requested by Q-Med and as necessary to
obtain such duplicate PMA Approvals.
6.4 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 establish a
Steering Committee to serve as the primary vehicle for such mutual cooperation
and joint decision-making (the "STEERING COMMITTEE"). Each Party shall bear its
own costs and expenses of participation in the Steering Committee.
(a) Membership. The Steering Committee shall consist of
four (4) representatives of each Party with appropriate expertise, including,
but not limited to, each of the Parties' respective head of Regulatory Affairs.
At the request of the members of the Steering Committee, additional persons may
attend the meetings of the Steering Committee; provided, that such additional
attendees shall not have the right to vote on matters before the Steering
Committee; provided, further, that the bylaws of the Steering Committee shall
include a limitation on the number of persons who may attend meetings of the
Steering Committee. The Steering Committee shall adopt appropriate bylaws for
its governance at its first meeting, which may be amended from time to time as
provided for therein.
(b) Voting. All decisions by the Steering Committee shall
be made by unanimous vote of at least a quorum (to be set forth in the bylaws);
provided that in all cases an equal number of representatives from each Party
must participate in a vote.
(c) Delegation. The Steering Committee may vote to
delegate (on a time-limited, project limited, or standing/permanent basis)
fact-finding, advising, operational, implementation and decision-making
functions as it unanimously deems useful or appropriate, or as expressly
provided for herein. Such delegates may include representatives solely from one
Party, from both Parties or outside experts, as the Steering Committee shall
deem appropriate or as expressly provided for herein.
(d) Resolving Deadlocks. Except as set forth in Section
6.4(e) below, if the Steering Committee does not reach a unanimous decision on a
matter subject to its vote after reasonably thorough deliberation, the
President/Chief Executive Officer of both Parties shall jointly make a final
decision with respect to such matter. If the President/Chief Executive Officers
do not reach a unanimous decision after reasonably thorough deliberation, the
deadlock shall be resolved by accelerated arbitration before a panel of three
(3) arbitrators ("ARBITRATION PROCEDURE"), unless a different procedure is
expressly specified herein. Each Party's President/Chief Executive Officer will
choose an industry expert to serve as arbitrator under the
25
Arbitration Procedure, and the two (2) chosen arbitrators will retain a third
arbitrator. The date of the third arbitrator's agreement to serve on the panel
will constitute the date of empanelment. The Arbitration Procedure must be
completed within seven (7) Business Days following the date of empanelment and
the Arbitration Procedure shall include a briefing by the Parties and a decision
by the panel (such decision to be effective when rendered; provided that the
panel may have an additional three (3) Business Days to reduce its decision to
writing if requested by either Party). All decisions under the Arbitration
Procedure shall be made by majority vote of the arbitration panel (i.e., 3-0 or
2-1). The arbitration panel's jurisdiction for decision-making shall be limited
to matters that may be decided by the Steering Committee. In particular, the
arbitration panel established in this Section 6.4(d) shall not have jurisdiction
to resolve disputes between the Parties relating to the interpretation,
compliance or alleged non-compliance or breach of the terms of this Agreement
(including, without limitation, with respect to the determination of the costs
to be allocated pursuant to this Agreement).
(e) Most Interested Party. To the extent specifically set
forth herein, to enable or maximize regulatory compliance and/or for other
practical reasons, this Agreement shall designate one or the other Party as the
final decision maker to resolve deadlocks with respect to certain matters under
the consideration of the Steering Committee ("MOST INTERESTED PARTY PROCEDURE"
or "MIP PROCEDURE"). In such cases, the Arbitration Procedure shall not be used
and instead the MIP Procedure shall be used.
6.5 Steering Committee Jurisdiction. All significant
decisions with respect to the development of the Licensed Products within the
Territory and Improvements thereof and FDA and TPD regulatory strategy and
compliance for the periods prior to and after the receipt of the relevant
Regulatory Approvals (the "PREMARKET" and "POSTMARKET" periods, respectively)
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 6.5 is
intended to relieve either Party of its obligation to ensure that its own
activities comply in all material respects with the FDCA and FDA's regulations
thereunder and/or Canada's FDA and/or regulations thereunder (e.g. QSR/QSRC
requirements).
(a) ****
(vi) At either Party's request, the Steering Committee may
revisit any decision in light of experience, market conditions or other
developments.
(b) Premarket Regulatory Matters. (i) Q-Med shall take
full responsibility for and control of pursuing, and shall use commercially
reasonable efforts to obtain, the original Regulatory Approvals for
Restylane(R), Perlane(TM) and Restylane Fine Lines(TM) **** but shall consult
the Steering Committee for advice on all significant decisions with respect
thereto and shall report to the Steering Committee at least monthly with respect
thereto, including, but not limited to, consulting the Steering Committee to
obtain input from the Purchaser regarding the content, appearance and trade
dress to be used in the Labeling submitted to the FDA and/or TPD for Regulatory
Approval.
(ii) ****
26
(iii) ****
(iv) ****
(c) ****
(d) Corrections and Removals. (i) (1) The Steering
Committee shall ensure that the Parties 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) The Steering Committee shall establish a system to ensure that all
corrections and removals are properly reported to the FDA and/or the TPD and
proper records kept pursuant to FDA and TPD requirements; (3) if either Party
becomes aware of any defect, problem or adverse condition in any Licensed
Product, that Party shall promptly concurrently notify the Steering Committee
(or its delegate) and the head of Regulatory Affairs for the other Party; (4)
the Steering Committee may determine whether a correction or removal involving a
Licensed Product 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; (5) notwithstanding Section 6.5(d)(4), if either Party
reasonably believes a correction or removal is necessary, it may initiate such
correction or removal and the Steering Committee shall accept that determination
as final and the Parties through the Steering Committee shall fully cooperate
and coordinate to implement such correction or removal; (6) notwithstanding
Section 6.5(d)(5), if both Parties agree through the Steering Committee that a
proposed correction or removal would be considered a Class III recall by FDA (in
which exposure to violative product is not likely to cause adverse health
consequences), then the President/Chief Executive Officers of both Parties shall
jointly make a final decision with respect to a Steering Committee deadlock as
to whether a correction or removal decision should be taken; if the
Presidents/Chief Executive Officers are unable to decide, the matter shall be
resolved by Q-Med pursuant to the MIP procedure prior to completion of the
procedure set forth in Section 6.2(a) or (b) or 6.3, as applicable, and by the
Purchaser under the MIP procedure after the completion of the procedure set
forth in Section 6.2 (a) or (b) or 6.3, as applicable; and (7) 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).
(e) ****
(f) QSR/QSRC Compliance. Except as necessary to carry out
the functions set forth above, the Steering Committee shall not have any other
role in the Parties' respective QSR/QSRC compliance.
6.6 Promotional Labeling and Advertising. The Purchaser
shall solely develop, draft and modify and shall have sole responsibility for
disseminating all Promotional Labeling and Advertising for Licensed Products for
use in the Field in the Territory and shall make all determinations about the
likely effectiveness, utility, aesthetic merit or desirability of such
Promotional Labeling and Advertising. Prior to completion of the procedures set
forth in Section 6.2(a) or (b) or 6.3, as applicable, Q-Med's head of Regulatory
Affairs shall be entitled to review all Promotional Labeling and Advertising for
Licensed Products to determine whether
27
such material would adulterate or misbrand Licensed Products or violate Canada's
FDA and/or regulations thereunder. To facilitate such review, the Purchaser
shall provide Q-Med's head of Regulatory Affairs with all proposed Promotional
Labeling and Advertising (or any portion thereof or any significant modification
thereto) and Q-Med's head of Regulatory Affairs shall review such Promotional
Labeling and Advertising during a period of (7) Business Days, such period to
commence upon receipt of such Promotional Labeling and Advertising. Q-Med's head
of Regulatory Affairs may withhold approval of such Promotional Labeling and
Advertising (or any portion thereof) only if he or she reasonably believes that
the same would adulterate or misbrand the Licensed Products or violate Canada's
FDA and/or regulations thereunder; provided that, prior to Q-Med's head of
Regulatory Affairs making a final decision to reject such Promotional Labeling
and Advertising, the Promotional Labeling and Advertising, upon the Purchaser's
request, shall be submitted to a Third Party legal expert in FDA and/or TPD
regulation (as appropriate) of Promotional Labeling and Advertising for an
opinion as to whether such Promotional Labeling and Advertising would adulterate
or misbrand Licensed Products or violate Canada's FDA and/or regulations
thereunder; (which opinion either Party may request in writing; provided that
such written opinion shall be addressed to both Parties as clients (unless
addressing the opinion to both parties would destroy the claim of privilege),
each Party shall treat such opinion, whether or not in writing, as privileged
information, neither Party shall waive privilege with respect to such opinion,
neither Party shall disclose such opinion to any Person outside the zone of
privilege and each Party shall use protective measures that are in no event less
stringent than those used by such Party within the Party's own business to
protect its comparable privileged information); provided, further, that Q-Med's
head of Regulatory Affairs shall take such legal experts' opinion into
consideration in making a final decision, such decision to be reasonable in
light of such expert opinion. The Parties shall share equally the cost of such
Third Party review. The Purchaser shall bear the cost and expense of developing,
drafting, disseminating, and modifying all Promotional Labeling and Advertising
for use in the Territory.
6.7 Certain Regulatory Costs and Expenses. Q-Med shall
bear the costs and expenses in connection with obtaining the original Regulatory
Approvals for Restylane(R), Perlane(TM) and Restylane Fine Lines(TM) (including
carrying out any postmarketing studies or similar requirements imposed as
conditions of approval ****). Except as otherwise provided in Section
6.5(e)(ii), the Purchaser shall bear all such regulatory costs and expenses,
including, without limitation, payments to Third Party consultants and experts
in obtaining Regulatory Approvals to the extent such payments relate to
obtaining such Regulatory Approval, preparation of IDE Applications, PMA
Applications, Medical Device License Applications, PMA Supplements, Amended
Medical Device License Applications and FDA and TPD filing fees for future
approvals of Licensed Products in the Field in the Territory.
6.8 Regulatory Emergencies. In the event of a regulatory
emergency involving an immediate threat to patient health or imminent FDA import
alert, import detention, administrative detention, TPD enforcement action (other
than a warning letter) or court action against either Party with respect to a
Licensed Product, Q-Med, prior to the completion of the procedures set forth in
Section 6.2(a) or (b) or 6.3 with respect to such Licensed Product, as
applicable, and the Purchaser after the completion of such procedures with
respect to such Licensed Product may take regulatory action or communicate with
the FDA and/or the TPD without consulting the Steering Committee; provided such
Party shall use its reasonable best efforts to (i) immediately notify and
consult the President/Chief Executive Officer of the other
28
Party and (ii) consult with the Steering Committee as soon as practicable with
respect to such regulatory emergency; provided, further, that the Steering
Committee shall assume general oversight with respect to the regulatory
emergency as soon as practicable. The Party taking emergency action shall bear
its own costs and expenses with respect thereto.
6.9 Audits and Inspections. (a) Q-Med shall provide the
Purchaser or the Purchaser'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 and/or
Manufactured for the sole purpose of confirming that all Licensed Products
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 the Purchaser bound by the
confidentiality obligations described in Section 6.9(b) 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 the Purchaser 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
the Purchaser 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 the Purchaser's attention through customer
complaints or FDA or TPD communications or enforcement actions or otherwise.
(b) The Purchaser 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 the
Purchaser. 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 the Purchaser representatives be accompanied
by a Q-Med representative and that the Purchaser 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) The Purchaser 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, the Purchaser shall allow
Q-Med or its representatives to review and inspect the applicable facility and
records and to meet with the Purchaser's personnel solely for
29
the purpose of confirming that the Purchaser'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 the Purchaser,
shall only be conducted during normal business hours and shall not unreasonably
disrupt the normal operations of the Purchaser. 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.
(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, FDA and TPD inspections of its facilities. In
particular, Q-Med shall bear the cost of preapproval inspections for
Restylane(R), Perlane(TM) and Restylane Fine Lines(TM), preapproval
manufacturing inspections for all other Licensed Products and manufacturing
changes as provided in Section 6.5(e)(ii). The Purchaser shall bear the cost of
all other PMA preapproval inspections.
ARTICLE VII
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
7.1 Q-Med Representations. Q-Med hereby represents and
warrants to the Purchaser 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 the Purchaser, 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
30
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 or in the
aggregate, have a material adverse effect on the ability of Q-Med to perform its
obligations hereunder.
7.2 Purchaser Representations. The Purchaser hereby
represents and warrants to Q-Med that it is a company 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 the
Purchaser of this Agreement, the performance by the Purchaser of its obligations
hereunder, and the consummation by the Purchaser of the transactions
contemplated hereby have been duly authorized by all requisite corporation
action. This Agreement has been duly executed and delivered by the Purchaser
and, assuming the due authorization, execution and delivery thereof by Q-Med,
constitutes a legal, valid and binding obligation of the Purchaser, enforceable
against the Purchaser 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 THE PURCHASER SHALL RELY UPON ITS
OWN EXAMINATION THEREOF. Without limiting the foregoing, the Purchaser
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 the Purchaser may rely on the representations and
warranties contained herein and in the other Transaction
31
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) Commencing on the Closing Date and
ending upon the termination of this Agreement pursuant to Section 8.2(d), 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.
(b) Commencing on the Closing Date and ending upon the
expiration of the Amended and Restated License Agreement, the Purchaser 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 the Purchaser in
accordance with this Agreement and such Licensed Products shall be free and
clear of any security interest, claim, lien or encumbrance.
7.6 Pledges of Regulatory Approvals. Q-Med shall not, and
shall cause its Affiliates not to, directly or indirectly, transfer, sell,
assign, pledge, hypothecate, encumber or otherwise dispose of any Regulatory
Approval of the Licensed Products, or any economic interest therein, whether now
owned or hereafter received or obtained, to any Person.
ARTICLE VIII
TERM AND TERMINATION
8.1 Term. Except as provided in Section 8.4, this
Agreement shall have a term ("TERM") beginning on the date hereof and ending on
the commencement of the Purchaser making or having made the Licensed Products
pursuant to the exercise of the Option (as defined in Section 10.1) in
accordance with its terms.
8.2 Termination by Q-Med. This Agreement may be
terminated by Q-Med, at its option:
(a) if the Purchaser 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) days after
written notice of such breach was provided to the Purchaser by Q-Med;
32
(b) if the Purchaser 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 the Purchaser; an assignment
by the Purchaser for the benefit of its creditors; the commencement against the
Purchaser of a voluntary or involuntary proceeding under any bankruptcy,
insolvency, liquidation or similar Law, upon the appointment with respect to the
Purchaser of a successor, trustee, custodian, sequestrator or similar official
or upon the dissolution of the Purchaser;
(d) if the Purchaser (as defined in the Purchase
Agreement) breaches its obligation to make the Milestone Payments (as defined in
the Purchase Agreement) when due pursuant to Section 2.2 therein (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 for the breach by the Purchaser of its obligation to
make the Milestone Payments when due; or
(e) if there shall have been a Transfer by the Purchaser
pursuant to a Change in Control (other than a Volitional Change in Control) in
violation of Section 12.2.
8.3 Termination by the Purchaser. This Agreement may be
terminated by the Purchaser, 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 the Purchaser 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:
33
(i) Licensed Products Manufactured pursuant to Firm
Orders accepted by Q-Med will be delivered by Q-Med to the Purchaser,
whereupon the Purchaser will pay Q-Med therefore 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 the Purchaser, whereupon the
Purchaser will pay Q-Med therefore in accordance with the terms of this
Agreement.
(b) Upon termination of this Agreement by Q-Med pursuant
to Section 8.2(a), (d) or (e), the Purchaser shall immediately return to Q-Med
all finished Licensed Product then held by the Purchaser. The Purchaser shall
bear all expenses for transportation of such Licensed Products and the Purchaser
shall pay to Q-Med an amount equal to Q-Med's cost for all Licensed Products
Manufactured pursuant to Firm Orders from the Purchaser, work-in-progress
commenced by Q-Med against accepted Firm Orders from the Purchaser 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 the Purchaser 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 the Purchaser 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], 10.4 [Duty of
First Offer], 12.6 [Arbitration], 12.12 [Expenses] and 12.20
[Publicity], and
34
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 (x) 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 and (y) Section 8.2(a), (b), (d) or (e), all
obligations pursuant to Section 10.4 [Duty of First Offer] 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], 10.4 [Duty of First Offer],
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 8.1 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 the Purchaser, its Affiliates and their respective
directors, officers, stockholders, employees, agents and representatives (the
"PURCHASER 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 by Q-Med or
any of its Affiliates to the extent such Affiliate is bound under this Agreement
(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; 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
the Purchaser 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 the Purchaser's requirements as forecasted by the
Purchaser in accordance with
35
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 the Purchaser 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, the
Purchaser 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
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 Purchaser Indemnified Party has been
paid pursuant to the Amended and Restated License Agreement or the Purchase
Agreement for an indemnifiable claim involving the identical substantive issue.
9.2 Indemnification by the Purchaser. (a) The Purchaser
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 any breach of any representation, warranty, covenant or other agreement
by the Purchaser or any of its Affiliates to the extent such Affiliate is bound
under this Agreement.
(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 the Purchaser 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) The Purchaser 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 Amended and Restated License Agreement or the
Purchase Agreement for an indemnifiable claim involving the identical
substantive issue.
36
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 at law or in equity 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 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 ("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 an 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 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 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 an
Indemnifiable Claim, the Indemnifying Party nevertheless shall have the right to
participate in the defense or prosecution of any 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 any 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
37
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 provided
herein, 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, 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 the Purchaser an option (the
"OPTION") to obtain a license to make and have made, develop and improve by
itself or on its behalf in the Territory, commencing on the date that is ****
after the receipt by Q-Med of the exercise notice (the "EXERCISE NOTICE"), the
Licensed Products. Such license (the "MANUFACTURING LICENSE") shall be granted
by Q-Med within **** of the date of the Exercise Notice and shall include the
terms set forth on Schedule E hereto and any other terms and conditions
negotiated in good faith and agreed to by the Parties during such ****. 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 E and
to negotiate in good faith such additional terms as may be agreed to by the
Parties. The Purchaser shall deliver the Exercise Notice no less than **** prior
to the date on which the Purchaser intends to commence to make or to have made,
develop and improve the Licensed Products pursuant to the Option; provided that
the Purchaser shall not deliver the Exercise Notice prior to the **** of the
date hereof. The Purchaser and Q-Med will fully cooperate in obtaining all
required Regulatory Approvals in connection with the Purchaser's lawful
manufacture of the Licensed Products for Commercial Distribution and
Investigational
38
Distribution; provided that the Purchaser will pay the cost and expenses of
obtaining such approvals.
(b) Notwithstanding the foregoing, the Purchaser shall
have **** the Exercise Notice and Q-Med shall grant the Manufacturing License on
the terms set forth in Schedule E within **** 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 Licensed Products under this Agreement or a material
obligation pursuant to Section 6.2(a), (b), (f) or (g) or 6.3 herein; provided
that the Purchaser 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 process due to bankruptcy.
10.2 Back-up Facility. Q-Med shall, within **** after the
Closing Date, submit the necessary PMA Supplement and Amended Medical Device
License Application seeking necessary Regulatory Approvals with the FDA and the
TPD to lawfully employ a back-up facility (a "BACK-UP FACILITY") to Manufacture
Licensed Products, such Back-up Facility to be located in a building other than
the building housing Q-Med's existing manufacturing facility in Uppsala (the
"EXISTING FACILITY") so as to avoid a material risk of destruction of both the
Back-up Facility and the Existing Facility in a single catastrophic event, and
shall use commercially reasonable efforts to pursue such submissions and obtain
such Regulatory Approvals. The appropriate establishment registration with FDA
and the TPD and all requisite Regulatory Approvals of the FDA and the TPD
allowing the lawful Manufacture of the Licensed Products with respect to the
Back-up Facility shall be valid and in full force and effect at all times that
such Back-up Facility is supplying Licensed Product to the Purchaser.
Notwithstanding the foregoing, Q-Med shall not be deemed to be in breach of its
obligation pursuant to this Section 10.2 if Q-Med has not made such submissions
within the **** after the Closing Date if Q-Med is working in good faith and in
mutual consultation and cooperation with the Purchaser or in accordance with a
plan mutually developed and agreed by Q-Med and the Purchaser to obtain and
qualify the Back-Up Facility or another back-up facility. ****
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 the Purchaser; 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 the Purchaser; and (iii) the use of such
contractor shall not increase the cost of the Licensed Products to the Purchaser
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 the Purchaser with Licensed
Products Manufactured by a non-Affiliate Third Party, Q-Med must submit the
contractor's name to the Purchaser for reasonable approval, such approval not to
be unreasonably withheld or delayed. If the Purchaser reasonably objects to
Q-Med's use of any non-Affiliate Third Party for the Manufacture and supply of
Licensed Products, the Purchaser shall have no obligation to accept any Licensed
Products Manufactured by such non-Affiliated Third Party.
39
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.
10.4 ****
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 the Purchaser shall have given its prior
written approval, during the Term and for a period of ten (10) years after the
end of the Term, any information (and all tangible and intangible embodiments
thereof) of a confidential and proprietary nature relating to the Purchaser's
and its Affiliates' business or operations, including non-public information
concerning the Purchaser's products, processes, customers and suppliers and the
products and processes of the Purchaser's customers and suppliers furnished to
Q-Med by the Purchaser in connection with this Agreement (any of the foregoing,
"CONFIDENTIAL PURCHASER INFORMATION"); provided, however, that Q-Med shall have
the right to disclose any Confidential Purchaser Information provided hereunder
if such disclosure is necessary (a) in connection with the securing of any
governmental approval necessary for the performance by Q-Med of any of its
obligations hereunder or under any other agreement with the Purchaser, (b) for
the purpose of complying with governmental regulations or (c) by Law or legal
process. Q-Med shall promptly notify the Purchaser of Q-Med's intent to make any
disclosure of Confidential Purchaser Information prior to making such disclosure
so as to allow the Purchaser adequate time to take whatever action the Purchaser
may deem to be appropriate to protect the confidentiality of Confidential
Purchaser Information and Q-Med will cooperate and provide any assistance that
the Purchaser may reasonably request in connection with the foregoing. For the
avoidance of confusion, all information provided by the Purchaser to Q-Med in
connection with this Agreement shall be deemed Confidential Purchaser
Information unless Q-Med can demonstrate that such information is available to
it from sources other than the Purchaser that are not under a duty of
confidentiality with respect thereto. Q-Med shall use Confidential Purchaser
Information only in connection with and for the purposes reflected in this
Agreement and the other Transaction Agreements and for no other purpose.
11.2 Purchaser's 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, the Purchaser 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 the Purchaser (provided that such
agents and representatives are informed of
40
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 the
Purchaser 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, during the Term and for a period of ten (10) years
after the end of the Term, any information (and all tangible and intangible
embodiments thereof) of a confidential and proprietary nature relating to Q-Med
and its Affiliates' business or operations, including non-public information
concerning the Licensed Rights, the Licensed Products or New Products, 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 the Purchaser by Q-Med in connection with this Agreement
(any of the foregoing, "CONFIDENTIAL SUPPLIER INFORMATION"); provided, however,
that the Purchaser 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 governmental approval necessary for the performance by
the Purchaser of any of its obligations hereunder or under any other agreement
with Q-Med, (b) for the purpose of complying with government regulations or (c)
by Law or legal process. The Purchaser shall promptly notify Q-Med of the
Purchaser's intent to make any disclosure of Confidential Supplier 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 the Purchaser 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
the Purchaser in connection with this Agreement (included information subject to
Section 11.3) shall be deemed Confidential Supplier Information unless the
Purchaser 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. The Purchaser 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.
11.3 Manufacturing Data and other Information. In addition
to any of the foregoing confidentiality obligations, the Purchaser 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 the
Purchaser has access by virtue of the Regulatory Approvals for the Licensed
Products. Notwithstanding the foregoing, the Purchaser 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 the Purchaser 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) the
Purchaser has exercised the Option in accordance with Section 10.1(b) herein.
Notwithstanding the
41
foregoing, the Purchaser 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 governmental approval necessary for the performance by
the Purchaser of any of its obligations hereunder or under any other agreement
with Q-Med or its Affiliates, (b) for the purpose of complying with governmental
regulations or (c) by Law or legal process. The Purchaser shall promptly notify
Q-Med of the Purchaser's 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
the Purchaser will cooperate and provide any assistance that Q-Med may
reasonably request in connection with the foregoing. The Purchaser 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 the Purchaser 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, the
Purchaser shall be entitled to use such information to the extent necessary to
perform its obligations under this Agreement.
11.4 Permitted Disclosure Or Use Of Information. Nothing
in this Article XI shall prevent the disclosure or use of Confidential Purchaser
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 Purchaser 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.
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.
42
(a) Each of Q-Med and the Purchaser shall be entitled to
Transfer its rights or obligations under this Agreement without the written
consent of the Purchaser or Q-Med, as the case may be, to an Affiliate of the
Purchaser or Q-Med, as the case may be, provided that Q-Med or Medicis, as the
case may be, owns or controls greater than fifty percent (50%) of the voting
securities or economic interest in such Affiliate (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 and (ii) the Permitted Transferee, if not
already a Party hereto, shall have executed and delivered to the Purchaser or
Q-Med, as the case may be, as a condition precedent to such Transfer, an
instrument or instruments reasonably satisfactory to Q-Med or the Purchaser, 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 the Purchaser, 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 the Purchaser, 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 the Purchaser of its
obligations pursuant to this Agreement.
(b) Commencing on the date on which all of the Milestone
Payments to be paid pursuant to Section 2.2(b) of the Purchase Agreement have
been paid to and received by Q-Med (provided that all such Milestone Payments
may be prepaid at any time, regardless of whether such Milestone Payments are
then due under Section 2.2 of the Purchase Agreement), the Purchaser 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 the Purchaser 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 Amended and Restated 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(e) 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 the Purchaser
as of the Closing Date or (v) has been or is
43
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 the Purchaser; 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 the Purchaser as a condition
precedent to such Transfer, an instrument or instruments reasonably satisfactory
to the Purchaser 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 the Purchaser may only withhold its consent in the event that
the Purchaser reasonably (such determination to be made without unreasonable
delay, and such consent, or the withholding thereof, to be promptly communicated
once determined) determines 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 the Purchaser 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 the Purchaser, 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.
44
12.3 Independent Contractor. The Parties shall each be an
independent contractor in the performance of their respective obligations
hereunder, and, 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.
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
Xxxxxxxxxxxxxx 00
000 00 Xxxxxxx, Xxxxxx
Attention:
Telephone No.: x00 00 000 00 00
Facsimile No.: x00 00 000 00 00
with a copy to (which shall not constitute notice):
Xxxxxxx Xxxxxxx & Xxxxxxxx
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxx X. Xxxxxx
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
If to the Purchaser:
Medicis Pharmaceutical Corporation
0000 X. Xxxxxx Xxxx
Xxxxxxxxxx, Xxxxxxx 00000-0000
Attention: Xxxxx Xxxxxxxx
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
with a copy to (which shall not constitute notice):
Akin Gump Xxxxxxx Xxxxx & Xxxx LLP
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxx X. Older and Xxxxx Xxxxx
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
45
12.5 Governing Law. This Agreement shall be governed by
and construed in accordance with the Laws of the State of New York, regardless
of Laws that might otherwise govern pursuant to applicable principles of
conflicts of Laws thereof.
12.6 Arbitration. The Parties agree that any dispute
arising out of or in connection with this Agreement, or the breach, termination,
or invalidity thereof, 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 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. 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. 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 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.
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. The Purchaser shall be
responsible for the payment of any sales and use taxes on the Licensed Products
delivered by Q-Med to the Purchaser.
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
46
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 the Purchaser 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 the Purchaser 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 the
Purchaser 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 the
Purchaser 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 the Purchaser 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.
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
47
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 the Purchaser's Investor Relations Group for approval. The
Purchaser 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, Section 10.4 and Article XI shall be
deemed in all cases to be relevant.
IN WITNESS WHEREOF, the Parties have duly executed this
Agreement as of the day and year first above written.
Q-MED AB
By: /s/ Xxxxx Xxxxxx
-------------------------------------------
Name: Xxxxx Xxxxxx
Title: Director
MEDICIS PHARMACEUTICAL CORPORATION
By: /s/ Xxxx X. Xxxxxxxx, Xx.
-------------------------------------------
Name: Xxxx X. Xxxxxxxx, Xx.
Title: Chief Financial Officer
SCHEDULE A
SPECIFICATIONS
(omitted pursuant to the Company's request for confidential treatment.)
SCHEDULE B
VOLUME PRICING
(omitted pursuant to the Company's request for confidential treatment.)
SCHEDULE C
REGULATORY PROCEDURES
SCHEDULE D1
CANADIAN FORECAST
(omitted pursuant to the Company's request for confidential treatment.)
SCHEDULE D2
INITIAL FIRM ORDER
(omitted pursuant to the Company's request for confidential treatment.)
SCHEDULE D3
U.S. FORECAST
(omitted pursuant to the Company's request for confidential treatment.)
SCHEDULE E
TERMS OF THE MANUFACTURING LICENSE
Capitalized terms used herein and not otherwise defined herein shall have the
meaning ascribed to such term in the Supply Agreement.
Term: Perpetual.
Exercise Price: No additional financial consideration.
Scope: (1) Manufacturing License to include, among other
terms and conditions, (a) the exclusive right, except
as to Q-Med, its Affiliates and any manufacturing
licensees or designees, to make and have made,
develop and improve the Licensed Products in the
Territory to market, use, distribute, import, offer
for sale and sell for Commercial Distribution or
Investigational Distribution in the Territory and (b)
a license to use all of Q-Med's manufacturing
know-how and the Licensed Patents (the "MANUFACTURING
LICENSED RIGHTS"), in each case to the extent
necessary or reasonably useful in connection with the
Manufacturing License.
(2) Manufacturing License in no way restricts the
ability of Q-Med and its Affiliates to Manufacture
the Licensed Products in the Territory or outside of
the Territory, provided that Q-Med shall at all times
act in accordance with the terms and conditions of
the Amended and Restated License Agreement.
(3) Q-Med shall be the sole owner of any improvements
to the Manufacturing Licensed Rights, whether
conceived of, created or developed by Q-Med and/or
the Purchaser, but excluding improvements to the
Manufacturing Licensed Rights that the Parties
mutually agree shall be jointly owned for the purpose
of avoiding prior art status, such as under 35 U.S.C.
Section 102(e). To the extent any improvements to the
Manufacturing Licensed Rights, now or in the future,
are owned solely or jointly by the Purchaser
notwithstanding the foregoing, the Purchaser shall
grant to Q-Med a fully paid-up, non-exclusive license
to make, use, market, distribute for Commercial
Distribution or Investigational Distribution, import,
offer for sale, sell, commercialize or otherwise
dispose of such improvements to the Manufacturing
Licensed Rights and any products based on
improvements to the Manufacturing Licensed Rights.
Non-Compete: ****
Confidentiality: The Purchaser 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 the Purchaser (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 the Manufacturing License; and provided,
further, that the Purchaser shall be responsible for
any breach 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
and its Affiliates' business or operations, including
non-public information concerning the Manufactured
Licensed Rights, the Licensed Products or New
Products, 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 the Purchaser
by Q-Med in connection with the Manufacturing License
(any of the foregoing, "CONFIDENTIAL Q-MED
INFORMATION"); provided, however, that the Purchaser
shall have the right to disclose any Confidential
Q-Med Information provided under the Manufacturing
License if such disclosure is necessary (a) in
connection with the securing of any governmental
approval necessary for the performance by the
Purchaser of any of its obligations under the
Manufacturing License or under any other agreement
with Q-Med, (b) for the purpose of complying with
government regulations or (c) by Law or legal
process. The Purchaser shall promptly notify Q-Med of
the Purchaser's intent to make any disclosure of
Confidential Q-Med 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 Q-Med
Information and the Purchaser 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 the Purchaser in connection with the
Manufacturing License shall be deemed Confidential
Q-Med Information unless the Purchaser can
demonstrate that such information is available to it
from sources other than the Q-Med that are not under
a duty of confidentiality with respect thereto. The
Purchaser shall use Confidential Q-Med Information
only in connection with and for the purposes
reflected in the Manufacturing License.
Assignment: Except as expressly provided in the assignment
provision of the Manufacturing License, Q-Med and the
Purchaser may only Transfer their respective rights
and obligations under the Manufacturing License in
accordance with the following:
(a) Each of Q-Med and the Purchaser shall be
entitled to Transfer its rights or obligations under
the Manufacturing License without the written consent
of the Purchaser or Q-Med, as the case may be, to an
Affiliate of the Purchaser or Q-Med, as the case may
be, provided that Q-Med or the Purchaser, as the case
may be, owns or controls greater than fifty percent
(50%) of the voting securities or economic interest
in such
Affiliate (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 and (ii) the Permitted Transferee,
if not already a party to the Manufacturing License,
shall have executed and delivered to the Purchaser or
Q-Med, as the case may be, as a condition precedent
to such Transfer, an instrument or instruments
reasonably satisfactory to Q-Med or the Purchaser, as
the case may be, confirming that the Permitted
Transferee shall be bound by the terms of the
Manufacturing License to the same extent applicable
to the transferring Party, as if such Permitted
Transferee was originally a party to the
Manufacturing License. Any such Permitted Transferee
shall, and Q-Med or the Purchaser, 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 under the Manufacturing License prior to
such Permitted Transferee ceasing to be a Permitted
Transferee of Q-Med or the Purchaser, as the case may
be. Upon such Permitted Transferee ceasing to be a
Permitted Transferee under the Manufacturing License,
any Transfer of rights and obligations under the
Manufacturing License 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 the
Manufacturing License. No Transfer to a Permitted
Transferee under the Manufacturing License shall
relieve Q-Med or the Purchaser of its obligations
pursuant to the Manufacturing License.
(b) The Purchaser or its Permitted Transferees
shall be entitled, in accordance with this clause (b)
to Transfer its rights and obligations under the
Manufacturing License to a Third Party, subject to
the prior written consent of Q-Med; 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 the Manufacturing License 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 the Manufacturing License to the same
extent applicable to the Purchaser or its Permitted
Transferee as if such Third Party was originally a
party to the Manufacturing License 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 of the Manufacturing License
unless such Transfer was effected in accordance with
the terms and conditions of the Manufacturing
License. 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 the
Purchaser as of the date of the Manufacturing License
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
the Manufacturing License to a Third Party, subject
to the prior written consent of the Purchaser;
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 the Manufacturing License and
(B) the Third Party shall have executed and delivered
to the Purchaser as a condition precedent to such
Transfer, an instrument or instruments reasonably
satisfactory to the Purchaser confirming that the
Third Party shall be bound by the terms of the
Manufacturing License to the same extent applicable
to Q-Med or its Permitted Transferee as if such Third
Party was originally a party to the Manufacturing
License 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 the Manufacturing
License 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
under the Manufacturing License unless such Transfer
was effected in accordance with the terms and
conditions of the Manufacturing License. The parties
agree that the Purchaser may only withhold its
consent in the event that the Purchaser reasonably
(such determination to be made without unreasonable
delay, and such consent, or the withholding thereof,
to be promptly communicated once determined)
determines that (i) the proposed Third Party
transferee does not have the financial condition to
perform Q-Med's obligations under the Manufacturing
License, (ii) 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 the Manufacturing License or (iii)
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) The Manufacturing License shall be binding
upon and inure to the benefit of the successors and
assigns of each of the Parties.
(e) Q-Med and the Purchaser, 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 the Manufacturing License 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 in the Manufacturing
License.
Cooperation: Q-Med will cooperate with the Purchaser in any
filings required for the Purchaser to obtain any
necessary Regulatory Approvals; provided that the
foregoing shall be at the Purchaser's sole cost and
expense (including Q-Med's reasonable costs and
out-of-pocket expenses in connection therewith.
