CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
EXHIBIT 10.1
DEVELOPMENT & DISTRIBUTION AGREEMENT
BY AND BETWEEN
IPSEN LTD.
AND
AESTHETICA, LTD.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
DEVELOPMENT & DISTRIBUTION AGREEMENT
1. DEFINITIONS............................................................................................. 1
2. APPOINTMENT............................................................................................. 5
3. DEVELOPMENT AND REGULATORY PROGRAM...................................................................... 6
4. REVIEW COMMITTEE........................................................................................ 12
5. PRODUCT MANUFACTURE AND SUPPLY.......................................................................... 14
6. CONSIDERATION........................................................................................... 18
7. FUTURE PRODUCTS......................................................................................... 22
8. MARKETING AND PROMOTION OF THE PRODUCT.................................................................. 23
9. REPORTS................................................................................................. 25
10. Ipsen PROMOTION OF THE PRODUCTS IN THE TERRITORY........................................................ 26
11. PROCEDURES REGARDING TECHNICAL MATTERS.................................................................. 26
12. INTELLECTUAL PROPERTY................................................................................... 27
13. NON COMPETITION......................................................................................... 30
14. WARRANTIES.............................................................................................. 30
15. Ipsen DELIVERY COVENANT................................................................................. 32
16. LIABILITIES - INDEMNIFICATION........................................................................... 33
17. CONFIDENTIALITY......................................................................................... 36
18. PUBLICATION - ANNOUNCEMENT.............................................................................. 37
19. TERM - TERMINATION...................................................................................... 37
20. MISCELLANEOUS........................................................................................... 40
APPENDICES:
APPENDIX 1 - CURRENT PRODUCT SPECIFICATIONS (9 pages omitted)
APPENDIX 2 - U.S. PROGRAM (NON-U.S. PROGRAM to be attached in accordance with
Article 3.3.1) (4 pages omitted)
APPENDIX 3 - [INTENTIONALLY DELETED]
APPENDIX 4 - PRODUCT DATA FORWARDED TO MEDICIS
APPENDIX 5 - TRADEMARK(S)
APPENDIX 6 - MEDICIS DISTRIBUTION SYSTEM
APPENDIX 7 - LIST OF INITIAL MEMBERS OF REVIEW COMMITTEE
APPENDIX 8 - PRODUCT SUPPLY PRICE
APPENDIX 9 - TRADEMARK(S) LICENSE AGREEMENT [FILED AS EXHIBIT 10.2 TO FORM 10-Q]
APPENDIX 10 - [INTENTIONALLY DELETED]
APPENDIX 11 - TRADEMARK ASSIGNMENT AGREEMENT [FILED AS EXHIBIT 10.3 TO FORM 10-Q]
APPENDIX 12 - LIST OF AGREEMENTS TO BE TRANSFERRED (7 pages omitted)
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
DEVELOPMENT & DISTRIBUTION AGREEMENT
This Development & Distribution Agreement (Agreement) is entered into by and
between Ipsen Ltd., a company organized and existing under the laws of England,
with registered offices located at 190 Bath Road, Slough, Berkshire SL1 3XE,
United Kingdom ("Ipsen"), and Aesthetica Ltd., a company organized under the
laws of Bermuda, located at Dorchester House, 7 Church Street, Hamilton HM 11,
Bermuda ("Medicis"), a wholly owned subsidiary of Medicis Pharmaceutical
Corporation, a Delaware corporation
WHEREAS Ipsen has exclusive rights to certain Know-How related to formulation(s)
of botulinum toxin(s).
WHEREAS Ipsen is engaged, directly or through companies affiliated to the Ipsen
Group, in the development, registration, distribution and promotion world-wide
of said formulations in the form of pharmaceutical specialties for human use,
and has acquired valuable and proprietary Know-How in connection therewith.
WHEREAS Medicis is engaged in the development, registration, manufacture,
distribution and promotion of pharmaceuticals and medical devices and has
acquired experience and Know-How in the development, registration, distribution
and promotion of products for aesthetic uses.
WHEREAS Medicis wishes to develop, have registered with regulatory authorities,
distribute and promote in the U.S.A., Canada and Japan, Ipsen's current and any
future formulations of botulinum toxin(s) in the form of pharmaceutical
specialty for aesthetic use.
WHEREAS Medicis is well informed about the present stage of development,
distribution and promotion of formulations of botulinum toxin(s) competing with
Ipsen's formulations, and about the potential progress thereof as well as about
the overall situation as to competition among botulinum toxin based products,
and Medicis has taken such facts into consideration before signing this
Agreement.
WHEREAS Ipsen shall remain free to undertake research, development,
registration, distribution and promotion worldwide of Ipsen's formulations of
botulinum toxin(s) for all human uses except as expressly provided for in this
Agreement.
NOW THEREFORE, IN CONSIDERATION OF THE PREMISES SET FORTH ABOVE AND INTENDING TO
BE LEGALLY BOUND, THE PARTIES HAVE AGREED AS FOLLOWS:
1. DEFINITIONS
As used in this Agreement, the following terms have the meanings indicated
below:
Affiliate means, in relation to any party, any person, corporation or
entity which directly or indirectly controls, is controlled by
or under common control with such party. Control shall be
deemed to exist if a party beneficially owns more than 50% of
the share capital and/or of the voting rights of such a
person, corporation or entity. An Affiliate shall not be
considered a Third Party under this Agreement.
Bundled Product(s) means Product(s) sold or otherwise transferred or
delivered to a Third Party with one or more other products or
services in circumstances where the price of the Product(s) is
either not shown separately on the invoice, or is shown as nil
(free of charge) on a separate document in relation to the
Product(s) or to a portion of the quantities of Product(s)
vials.
1
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
cGMP means the current interpretation and implementation of Good
Manufacturing Practices.
Commercial Sale means the transfer, delivery, or sale, whether at retail,
wholesale or otherwise, of Product(s) or Bundled Product(s) to
(i) by Medicis or its Affiliates to McKesson or any other
approved equivalent full-service distributor or (ii) in the
event Commercial Sales of Products hereunder are not made
through McKesson (or any other approved equivalent
full-service distributor) by Medicis, or its Affiliates or an
appointed distributor to a Third Party.
Confidentiality mean the confidentiality agreement of September 19, 2005
Agreements between Ipsen Biopharm Ltd and Medicis and the mutual
confidentiality agreement of December 21, 2005 between Ipsen
Ltd and Medicis.
Cost of Goods means the invoice price paid by Medicis to Ipsen for the
Sold Product and/or any future Product, together with all royalties
paid by Medicis to Ipsen pursuant to this Agreement.
Current Product means, with respect to each country of the Territory the
Product which is the object of the Development and Regulatory
Program and which is then the object of a first Regulatory
Approval in such country. The Current Product could, for
example and without limitation, be vials containing either ***
units, *** units, or *** units of botulinum toxin type A
activity per vial. The specifications of the vials containing
*** of botulinum toxin type A activity per vial are set forth
in Appendix 1 hereto, and made a part hereof. The parties
acknowledge that, as regards the *** units, the actual content
of the vial may vary depending on the requirements of the
relevant regulatory authorities and may, for example, contain
***units or ***units of clostridium botulinum type A toxin
instead of ***units.
Development and means all development activities, including clinical trials
Regulatory with respect to any Product in order to obtain Regulatory
Program Approvals for such Product in one or more indications selected
in the Field by Ipsen after prior consultation with Medicis,
in any or all countries of the Territory, as agreed upon by
the parties as of the Effective Date and from time to time
after the Effective Date in accordance with Articles 3 and 4
hereof.
Effective Date means the Termination Date under that certain Termination
Agreement dated as of December 20, 2005, by and between Ipsen
and Inamed Corporation.
FDA means the United States Food and Drug Administration.
Field Customers means plastic surgeons, dermatologists, and any other
persons practicing aesthetic medicine and located in the
Territory, including, but not limited to, ear, nose and throat
specialists, ophthalmologists, obstetric and gynecology
specialists and general practitioners constituting the Medicis
Customer Base at any time.
Field ***
GAAP means United States of America generally accepted accounting
principles.
2
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Good means the requirements found in the legislations, regulations,
Manufacturing and administrative provisions for methods to be used in, and
Practice the facilities or controls to be used for, the manufacturing,
processing, packing, and/or holding of a drug to assure that
such drug meets the requirements as to safety, and has the
identity and strength, and meets the quality characteristics
that it purports or is represented to possess, all of which as
defined by the competent authorities of each country of the
Territory where and at the time Medicis sells the Product in
each such country.
Gross Profit means Net Sales minus Cost of Goods Sold, divided by Net
Margin Sales, expressed as a percentage, all calculated in accordance
with then-current GAAP applied in a consistent manner in
accordance with the accounting practices of Medicis.
Medicis Customer means those Field Customers identified by Medicis to Ipsen
Base prior to the Effective Date, together with such additional
Field Customers as are identified for inclusion by Medicis and
accepted by Ipsen, on or after the Effective Date, in
accordance with the quarterly update procedure set forth in
Article 8.6 of this Agreement.
Know-How means any information, whether patented, patentable or not,
developed or obtained by or on behalf of Ipsen, its
Affiliates, authorized licensees, sub-licensees, or Ipsen's or
any Ipsen Affiliate's Third Party partners or contractors,
which relates to the research, development, manufacture,
registration, distribution and promotion of the Current
Product and any future Products and which is reasonably
necessary for the purpose of this Agreement, including but not
limited to the data listed in Appendix 4 hereto, as well as
any data contained in the documentation disclosed to Medicis
under Confidentiality Agreements or under this Agreement.
Net Sales means the actual amount invoiced for Commercial Sale of
a Product under this Agreement (A) by Medicis or its
Affiliates to McKesson or any other equivalent full-service
distributor (with Ipsen's prior written approval as further
detailed in this paragraph) or (B) in the event Commercial
Sales of Products hereunder are not made through McKesson (or
any other approved equivalent full-service distributor) by
Medicis, or its Affiliates or an appointed distributor to a
Third Party, in each case of clause (A) or (B), after
deducting the following, to the extent actually incurred or
allowed with respect to such sale: (i) normal and customary
trade, cash and/or quantity discounts, credits or rebates,
including any volume, formulary or other positioning
discounts, credits or rebates paid or credited to the Third
Party; (ii) import, export, sales, use, excise and other
consumption taxes and custom duties or tariffs, to the extent
and up to the amount mentioned in that respect on the invoice,
and any other governmental charges imposed upon the
importation, use or sale of a Product; (iii) actual freight,
insurance and other transportation charges; (iv) compulsory
discounts, rebates, or payments (including retroactive price
reductions or statutorily required reimbursement) mandated by,
granted, credited, accrued, or paid for compliance with local,
state, provincial or federal law or regulation; (v) allowances
or credits to customers on account of recalls, rejection or
return of Product (including for spoiled, damaged and/or
outmoded goods) in the ordinary course of business; and (vi)
the bad debts actually incurred by Medicis in respect of the
resale of the Products, computed in accordance with
then-current GAAP applied in a consistent manner in accordance
with the
3
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
accounting practices of Medicis. Medicis will provide Ipsen
with a complete and accurate summary of its accounting
practices as in effect from time to time relating to the write
down and write off of bad debts, for Ipsen's reasonable
comments (if any) which Medicis shall use its commercial
reasonable efforts to take into account when determining Net
Sales. Net Sales will not include any Product supplied free of
charge as commercial samples or used free of charge for
testing, training or for clinical or marketing studies. Any
other Product sold or otherwise transferred other than in an
arm's-length transaction or in exchange for other property
(e.g., barter), and any Bundled Product, shall be deemed
invoiced at the Product market price established by the seller
in its general conditions of sales, in the relevant country of
sale, or failing such general conditions, at the arm's length
price that the seller would generally or in the average
invoice for such Product alone.
In the event discounts or rebates to the gross invoiced or
charged price are given in connection with the sale of goods
or services other than the Products, or for consideration or
purposes other than the sale, transfer or delivery of the
Products, the gross sales price invoiced for the concerned
Products shall be deemed to be increased to an amount equal to
the concerned Product's market price or arm's length price as
described above.
The parties agree, with respect to Products sold hereunder, in
the event Medicis enters into a distribution agreement with
McKesson similar to the one entered into in with McKesson on 1
April 2004, that the sale margin made by McKesson on the
Product shall be inferior or equal to ***%.
In case Medicis wishes to enter into a full-service agreement
with another distributor, with respect to Products sold
hereunder, Medicis shall obtain Ipsen's prior written approval
as to the identity of such distributor and the terms of the
proposed distribution agreement (such approval being not
unreasonably withheld or delayed).
Non-U.S. Program means the portion of the Development and Regulatory Program
applicable to the Current Product in Canada and Japan, as
initially agreed upon by the parties after the Effective Date
in accordance with Article 3.3.1 and set forth in Appendix 2
to this Agreement.
Product means any and all existing (as on the Effective Date) and/or
all future formulations of botulinum toxin(s), regardless of
type, in finished saleable form, developed, manufactured,
distributed or marketed by Ipsen or its Affiliates.
Product shall have the meaning ascribed to it in Article 7.1 of this
Extension Agreement.
Regulatory means all approvals and decisions from the relevant regulatory
Approval(s) authorities in the Territory (or such supra-national
authorities that may have jurisdiction in the Territory)
necessary to lawfully import, distribute, promote, and
administer to humans, the Product(s) for indications within
the Field in the Territory.
Review Committee means the committee established by the parties pursuant to
Article 4 below.
Specifications means the Product(s) specification(s) set out in any
Regulatory Approval.
4
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Territory means Canada, Japan, and the United States of America,
including Puerto Rico and including the territories,
possessions or commonwealths of Canada, Japan and the United
States as of the Effective Date.
Third Party means any entity or individual other than Medicis or Ipsen
or their respective Affiliates.
Trademark(s) shall mean the trademarks listed in Appendix 5. Trademark(s)
Trademark(s) shall have the meaning set forth in Article 12.3 herein.
Assignment
Agreement
Trademark(s) shall have the meaning set forth in Article 12.3 herein.
License
Agreement
U.S. Program means the portion of the Development and Regulatory Program
applicable to the Current Product in the United States for a
selected indication in the Field, as set forth in Appendix 2
of this Agreement as of the Effective Date.
2. APPOINTMENT
2.1 Ipsen hereby entrusts Medicis with the performance of the Development and
Regulatory Program so as to obtain, as soon as reasonably practicable from
the Effective Date, Regulatory Approvals in each country of the Territory
for use of the Current Product in the Field under one or more Trademarks.
Subject to Medicis obtaining one or more Regulatory Approvals for the
Current Product in the Field in each country of the Territory, in respect
of each country where such Regulatory Approval is obtained, Ipsen hereby
appoints Medicis as its sole and exclusive distributor and promoter of the
Current Product for use thereof in the Field in the concerned country(ies)
of the Territory and under the Trademarks. Such appointment includes the
right to use, import, offer for sale, sell, distribute and promote the
Current Product in the Field in the Territory and use the Know-How and the
Regulatory Approvals for the purpose of importing, offering for sale,
selling, distributing and promoting the Current Product in the Field in
the Territory and under the Trademark(s).
For so long as this Agreement shall remain in effect and except as
provided for under Article 6.1.8 herein, the appointments contained in
this Article 2.1 shall be exclusive to Medicis, even as to Ipsen, any of
its Affiliates and any Third Party.
Medicis shall distribute the Current Product solely to Field Customers
included in the Medicis Customer Base, to the exclusion of any
distribution aimed at customers not in the Medicis Customer Base, except
customers practicing in the Field which Medicis reasonably intends to
propose for inclusion in the Medicis Customer Base at the next quarterly
update of the Medicis Customer Base in accordance with the quarterly
update procedure set forth in Article 8.6 of this Agreement.
2.2 Medicis hereby accepts the appointments under Article 2.1 above, first and
second paragraph.
Medicis may appoint distributors and/or promoters for the Current Product
in the Field in the Territory, under Medicis's sole responsibility, within
the scope of Medicis's appointment under Article 2.1, provided that should
such distributors and/or promoters not belong to Medicis's current
distribution system for the Current Product as described in Appendix 6
attached hereto, Medicis shall promptly notify Ipsen in writing of the
identities of any new distributor or promoter in
5
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Medicis's distribution system for the Current Product for Ipsen's consent,
which consent shall not be unreasonably withheld.
2.3 The appointments under Article 2.1 by Ipsen of Medicis are strictly
restricted to those mentioned herein.
Medicis hereby acknowledges that Ipsen shall remain free to undertake
research, development, registration, distribution and promotion of the
Products under different and non-confusingly similar trademarks and trade
dress for all uses which do not pertain to the Field in the Territory, and
under any trademarks (including the Trademarks) and trade dress for all
uses without restriction outside the Territory.
Ipsen shall remain free to undertake research and development activities
in the Territory in connection with the Products for uses in the Field
provided that Medicis's exclusive distribution and promotion rights in the
Field are not affected thereby in the Territory. In the event Ipsen or any
Ipsen Affiliate conducts such development activities in the Field and in
the Territory, Ipsen shall inform Medicis fully as to the nature and scope
of the development and shall permit (or, in the case of an Ipsen
Affiliate, cause such Affiliate to permit) Medicis to participate in such
development to the extent reasonably practicable. Ipsen shall not, and
shall ensure that Ipsen's Affiliates do not, contact any Field Customers,
in connection with any such development, without Medicis's consent, which
consent shall not be unreasonably withheld.
2.4 Medicis acknowledges and agrees that Ipsen shall perform its obligations
under this Agreement directly or through some of Ipsen's Affiliates.
Unless and until advised otherwise in writing by Ipsen, Medicis may rely,
without inquiry, on all actions taken by Ipsen's Affiliates or their
employees in connection with this Agreement, which purport to be on behalf
of Ipsen. All rights vested in or created to the benefit of Ipsen or of
any of Ipsen's Affiliates under this Agreement, shall benefit to and may
be assigned to any other Ipsen's Affiliates or to Ipsen.
2.5 Ipsen acknowledges and agrees that Medicis shall perform its obligations
under this Agreement directly or through some of Medicis's Affiliates.
Unless and until advised otherwise in writing by Medicis, Ipsen may rely,
without inquiry, on all actions taken by Medicis's Affiliates or their
employees in connection with this Agreement, which purport to be on behalf
of Medicis. All rights vested in or created to the benefit of Medicis or
of any of Medicis's Affiliates under this Agreement, shall benefit to and
may be assigned to any other Medicis's Affiliates or to Medicis. If either
party delegates any of its obligations to an Affiliate (by assignment or
otherwise), it shall provide timely written notice of the delegation and
the identity of the Affiliate to the other party, but shall remain
responsible for the performance of the obligation delegated.
3. DEVELOPMENT AND REGULATORY PROGRAM
3.1 Medicis shall perform the Development and Regulatory Program in compliance
with all applicable regulatory requirements and guidelines of each country
of the Territory where the Development and Regulatory Program is
conducted, and shall set up a project team for this purpose.
Medicis and Ipsen shall agree upon a detailed procedure regarding how to
handle the reporting of adverse events from the clinical activities
conducted by Medicis under each of the U.S. Program and the Non-U.S.
Program. The parties shall agree upon such procedure as soon as practical
after the Effective Date as regards the U.S. Program, and as soon as
practical after the parties agreed upon the Non-U.S. Program applicable to
Canada and/or Japan, as applicable, as regards such Program. Medicis and
Ipsen shall in particular discuss and agree upon such procedure on the
basis of Ipsen's pharmacovigilance Standard Operating Procedures in force
as
6
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
on the Effective Date for the U.S. Program, or as on the date Medicis and
Ipsen agree upon the Non-U.S. Program for Canada or Japan, and subsequent
updates thereof, as applicable.
Ipsen shall use its commercially reasonable efforts to transfer to Medicis
the agreements listed in Appendix 12 relating to the development of the
Products (the "Current Agreements") promptly as from the Effective Date
and Medicis agrees to such transfer. For each Current Agreement, (a) until
its transfer to Medicis or (b) in the event the contractor of a Current
Agreement validly refuses such transfer and therefore until the expiry or
termination of such Current Agreement, Ipsen will act on behalf of Medicis
and under Medicis' instructions. Ipsen will be reimbursed by Medicis for
all costs and expense incurred while acting on behalf of Medicis.
3.2 U.S. Program:
3.2.1 Pursuant to the Confidentiality Agreements, Ipsen has disclosed to Medicis
information which pertains to the Know-How prior to the Effective Date.
Medicis has reviewed all such information thoroughly, has reviewed the US
Program taking into account such information and is satisfied that it can
as of the Effective Date assume responsibility for and complete the US
Program as required hereunder.
Appendix 2 sets out the time periods and a schedule of estimated costs for
the completion of the U.S. Program. As set out in Appendix 2, the parties
contemplate that the clinical development component of the U.S. Program
will be completed within *** after the Effective Date. The parties
recognize, however, that despite their efforts to anticipate both the
likely scope of such clinical development activities and their likely
cost, there may be delays, cost overruns and/or increased costs due to
additional development activities not included in the U.S. Program. The
parties therefore have agreed to the following Articles 3.2.2 to 3.2.3
3.2.2 As of the Effective Date, Medicis shall fund, and shall use its
commercially reasonable efforts to perform, the U.S. Program as set out in
Appendix 2 in such manner as is reasonably required in order to obtain
Regulatory Approval for the Current Product in the United States. Medicis
shall pay all costs related to the performance of the U.S. Program as on
the Effective Date and obtaining and maintaining the Regulatory Approvals
in the U.S.A., including any cost overruns arising in connection with
completing those development activities included in the U.S. Program as of
the Effective Date, and including Medicis's share of all reproductive
toxicity studies requested by the FDA, it being understood that Ipsen and
Medicis shall equally share the costs of reproductive toxicity studies as
may be required specifically by the FDA to support Regulatory Approvals
for use of the Current Product in the Field in the U.S.A. Medicis will
have the primary responsibility for planning, conducting, and to the
extent provided in this Article 3.2 for funding all clinical trials
included in the U.S. Program that are necessary to file for and obtain the
Regulatory Approvals in the U.S.A. in the Field.
3.2.3 If it becomes necessary, as determined by the Review Committee, to revise
the U.S. Program, as a result of requests from the FDA or otherwise, to
include additional development activities not included in the U.S. Program
as of the Effective Date (Additional Activities), then Medicis shall be
responsible for the first USD *** (USD ***) of any Third Party costs (U.S.
Base Cost Amount) arising in connection with the performance of such
Additional Activities. If the Third Party costs expected to be incurred in
connection with the performance of such Additional Activities, as
reasonably estimated by Medicis at the time the U.S. Program is first or
thereafter revised by the Review Committee, would exceed the U.S. Base
Cost Amount, Medicis may, at its sole right and option, either (a) deliver
written notice to Ipsen that it intends nevertheless to perform such
Additional Activities, in which event Ipsen and Medicis shall each be
responsible for funding *** percent (***%) of all Third Party costs
incurred in connection with the performance of such
7
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Additional Activities which exceed the U.S. Base Cost Amount and are less
than an amount equal to *** times the U.S. Base Cost Amount(1), or (b)
terminate this Agreement in accordance with Article 19.2(iv). Medicis
shall notify Ipsen in writing of its decision under this Article 3.2.3,
within 30 days after the date of any meeting of the Review Committee at
which action is taken to revise the U.S. Program to include Additional
Activities of its election. If Medicis fails to so notify Ipsen, Medicis
shall be deemed to have elected not to terminate this Agreement pursuant
to Article 19.2(iv).
3.2.4 Ipsen, at its sole right and option, may terminate this Agreement
(notwithstanding any cost-sharing decision under Article 3.2.3(a))
pursuant to Article 19.2(v) at any time after the sixth anniversary of the
Effective Date if the clinical development component of the U.S. Program,
as contemplated as of the Effective Date, is not completed for any reason
whatsoever. If it becomes necessary, as determined by the Review
Committee, to revise the U.S. Program, as a result of requests from the
FDA or otherwise, to include Additional Activities (as defined in Section
7.1) which contain clinical development activities, the Review Committee
will revise the anticipated completion date for the whole clinical
development component of the U.S. Program taking into account such
clinical Additional Activities, which will be incorporated in a revised
Appendix 2 to this Agreement, and Ipsen will have the option
(notwithstanding any cost-sharing decision under Article 3.2.3(a)) to
terminate this Agreement pursuant to Article 19.2(v) if Medicis fails to
complete the whole clinical development component of the U.S. Program as
revised to include the Additional Activities, prior to the expiration of a
time period that is twice the time period anticipated to be required to
complete the whole clinical development component as set forth in such
revised Appendix 2.
3.3 Non-U.S. Program:
3.3.1 Within *** at the latest following the date Regulatory Approval for the
Current Product is obtained in the U.S.A., Medicis shall determine and
submit to Ipsen for discussion and approval the Non-U.S. Program, which
shall include a time table and a schedule of estimated costs necessary for
the completion of the Non-U.S. Program. The parties shall revise Appendix
2 to this Agreement to include the agreed details of the Non-U.S. Program
promptly following the date they reach such agreement.
However, if either (a) the Third Party costs required to complete the
clinical component of the Non-U.S. Program in Canada or Japan, as
reasonably estimated by Medicis on the date the details of the Non-U.S.
Program are agreed upon by the parties, would exceed the equivalent of USD
*** (USD ***) for Canada and USD *** (USD ***) for Japan, or (b) the time
required to complete the clinical development component of the Non-U.S.
Program in Canada or Japan, as reasonably estimated by Medicis on the date
the details of the Non-U.S. Program are agreed upon by the parties, would
be more than *** after such date, then Medicis may, at its sole right and
option, terminate this Agreement with respect to Canada or Japan, as
applicable, in accordance with Article 19.2(vi). Medicis shall notify
Ipsen in writing within 2 (two) months after the date the details of the
Non-U.S. Program are agreed upon by the parties as to whether it intends
to exercise is termination rights pursuant to this Article 3.3.1. If
Medicis fails to so notify Ipsen, Medicis shall be deemed to have elected
not to terminate this Agreement with respect to Canada or Japan, as
applicable, pursuant to this Article 3.3.1 and Article 19.2(vi).
- ----------
(1) Example: If the total costs for Additional Activities in the U.S. are ***
times the US Base Cost Amount (i.e., USD ***), Medicis would pay all of
the first USD *** (i.e., the US Base Cost Amount) and Medicis and Ipsen
would ***.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
3.3.2 Unless it has elected to exercise its termination rights in accordance
with Articles 3.3.1 and 19.2(vi), Medicis shall fund and shall use its
commercially reasonable efforts to perform, the Non-U.S. Program in such
manner as is reasonably required in order to obtain Regulatory Approval
for the Current Product in Canada and Japan as soon as reasonably
practicable following the Effective Date. Medicis shall pay all costs
related to the performance of the Non-U.S. Program as initially agreed
upon by the parties and obtaining and maintaining the Regulatory Approvals
in the Territory, including any cost overruns arising in connection with
completing those development activities included in the Non-U.S. Program
as of the date it is agreed upon by the parties. In particular, Medicis
will have the primary responsibility for planning and conducting at its
own expense all clinical trials included in the Non-U.S. Program that are
necessary to file for and obtain the Regulatory Approvals in each of
Canada and Japan for use of the Current Product in the Field.
3.3.3 If it becomes necessary, as determined by the Review Committee, to revise
the Non-U.S. Program, as a result of requests from the applicable
regulatory authorities in Canada or Japan or otherwise, to include
additional development activities not included in the Non-U.S. Program as
of the date it is agreed upon by the parties (Additional Non-U.S.
Activities), then Medicis shall be responsible for any Third Party costs
arising in connection with the performance of such Additional Non-U.S.
Activities in Canada or Japan, as applicable, to the extent such costs do
not exceed in an amount (for each country, the Non-U.S. Base Cost Amount)
equal to *** percent (***%) of the cost estimate for the Non-U.S. Program
applicable to each of Canada and Japan as originally agreed by the
parties. If the Third Party costs expected to be incurred in connection
with the performance of such Additional Non-U.S. Activities with respect
to Canada or Japan, as reasonably estimated by Medicis on the date the
Non-U.S. Program is first or thereafter revised by the Review Committee,
would exceed the Non-U.S. Base Cost Amount for such country, Medicis may,
at its sole right and option, either (a) deliver written notice to Ipsen
that it intends nevertheless to perform such Additional Non-U.S.
Activities, in which event Ipsen and Medicis shall each be responsible for
funding *** percent (***%) of all Third Party costs incurred in connection
with the performance of such Additional Non-U.S. Activities which exceed
the Non-U.S. Base Cost Amount for the applicable country and are less than
an amount equal to four times the Non-U.S. Base Cost Amount for the
applicable country, or (b) terminate this Agreement with respect to Canada
or Japan, as applicable, in accordance with Article 19.2(vii). Medicis
shall notify Ipsen in writing of its decision under this Article 3.3.3,
within 30 days after the date of any meeting of the Review Committee at
which action is taken to revise the Non-U.S. Program to include Additional
Non-U.S. Activities in excess of or which would exceed the applicable
Non-U.S. Base Cost Amount. If Medicis fails to so notify Ipsen, Medicis
shall be deemed to have elected not to terminate this Agreement with
respect to Canada or Japan, as applicable, pursuant to this Article 3.3.3
and Article 19.2(vii).
3.3.4 Ipsen, at its sole right and option, may terminate this Agreement with
respect to Canada or Japan, as applicable (notwithstanding any
cost-sharing decision under Article 3.3.3(a)), pursuant to Article
19.2(viii) at any time after the expiration of the time period that is
twice the estimated time period required to complete the clinical
development component of the Non-U.S. Program for such country as
originally agreed by the parties if such component is not completed by
such date for any reason whatsoever. If it becomes necessary, as
determined by the Review Committee, to revise the Non-U.S. Program, as a
result of requests from the applicable regulatory authorities in Canada or
Japan or otherwise, to include Additional Non-U.S. Activities which
contain clinical development activities, the Review Committee will revise
the anticipated completion date for the whole clinical development
component of the Non-U.S. Program for such country taking into account the
time period necessary to perform such clinical Additional Non-U.S.
Activities, which will be incorporated in a revised Appendix 2 to this
Agreement, and Ipsen will have the option (notwithstanding any
cost-sharing decision under Article 3.3.3(a)) to terminate
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
this Agreement with respect to Canada or Japan, as applicable, pursuant to
Article 19.2(viii) if Medicis fails to complete the whole clinical
development component of the Non-U.S. Program for the concerned country as
revised to include the Additional Non-U.S. Activities, prior to the
expiration of a time period that is twice the time period anticipated to
be required to complete the whole clinical development component for such
country as set forth in such revised Appendix 2.
3.4 For purposes of paying any costs Ipsen may become obligated to fund
pursuant to Article 3.2.3(a) or 3.3.3(a), in lieu of paying cash, Ipsen
may issue credits, on a dollar-for-dollar basis, against future royalties
owed by Medicis to Ipsen under Article 6 of this Agreement. Despite
Ipsen's issuance of credits under the previous sentence, however, in no
event, for any Royalty Year for any country in the Territory, shall
Medicis remit in cash less than *** percent (***%) of the royalties due
for that Royalty Year for such country. In no event shall Ipsen be
responsible for funding, whether in cash or by issuance of royalty
credits, more than the maximum amounts set forth in Articles 3.2.3(a) and
3.3.3(a).
Any of Ipsen's obligation to reimburse Medicis a share of Third Party
costs under Articles 3.2.3(a) or 3.3.3(a), whether in cash or by issuance
of royalty credits, shall be subject to Medicis forwarding evidence of
existence and payment thereof.
3.5 In case of the termination of this Agreement in its entirety or as to one
or more countries in the Territory by either party pursuant to this
Article 3, Medicis will promptly transfer to Ipsen, for Ipsen's
unrestricted usage and exploitation, exclusive ownership and possession of
all of the data including but not limited to clinical data, in whatever
form or medium, generated in connection with the performance of the
Development and Regulatory Program in the applicable country or countries
through the date of termination. In case Ipsen terminates this Agreement
under Article 3.2.4 or Article 3.3.4 Ipsen shall pay to Medicis, in
consideration for such data, an amount in U.S. Dollars equal to (a) ***%
(***percent) of any Third Party costs for the country concerned, actually
paid or incurred by Medicis with respect to activities contained in the
U.S. Program or Non-U.S. Program for the country concerned, as applicable,
below and inclusive of the U.S. Base Cost Amount or Non-U.S. Base Cost
Amount for the country concerned, as applicable, and (b) ***% of any Third
Party costs for the country concerned, actually paid or incurred by
Medicis with respect to Additional Activities in excess of the U.S. Base
Cost Amount and Non-U.S. Base Cost Amounts, as applicable. Medicis will
give Ipsen notice of the amount and computation of the foregoing payment,
with a computer-generated summary of the date, amount and payee supporting
the computation, in writing, within ten (10) days of the date after its
receipt of Ipsen's termination notice.
3.6 Medicis undertakes to enable and assist Ipsen to file for Regulatory
Approval of the Current Product in the Field first in the U.S. and to use
commercially reasonable efforts to obtain said Regulatory Approval first
in the U.S. and simultaneously or thereafter in the other countries of the
Territory.
Ipsen shall file the Regulatory Approvals submissions for the Development
and Regulatory Program. For this purpose, Medicis shall forward to Ipsen
all necessary documents and data so as to enable Ipsen to file for the
Regulatory Approvals submissions in each country of the Territory. In
particular without limitation, Medicis will provide necessary reports of
clinical trials contained in the Development and Regulatory Program and
bear the external costs of the filings or reimburse Ipsen in respect of
any customary and reasonable Third Party expenses borne by Ipsen as a
result of such filings.
Medicis shall pay all customary and reasonable costs related to
maintaining the Regulatory Approvals in the Territory.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Ipsen shall not reach final agreement with the FDA or the competent
authorities of Canada and Japan on the Product labeling, as long as
Medicis has reasonable objections to the proposed labeling and provided
Medicis objects in writing and within reasonable time to any proposed
labeling.
3.7 Ipsen and Medicis will mutually cooperate to obtain the Regulatory
Approvals. Without limiting the foregoing sentence, Ipsen shall (a)
consult with Medicis regarding the regulatory strategy in each country of
the Territory and consider in good faith Medicis's comments regarding the
same, (b) promptly provide Medicis with copies of all correspondence from
regulatory authorities copies of any draft response, and consider in good
faith Medicis's comments thereon prior to filing any such response, and
(c) allow Medicis to have a reasonable number of representatives attend
and participate in all meetings with regulatory authorities that affect
Medicis' rights or obligations under this Agreement as discussed and
agreed by the Review Committee. Upon Regulatory Approval, Ipsen shall
promptly appoint Medicis as Ipsen's regulatory agent for the approved
glabellar line BLA and for other approved aesthetic indications as and
when approved. When Medicis is appointed agent, Medicis shall (a) consult
with Ipsen regarding the regulatory strategy in each country of the
Territory and consider in good faith Ipsen comments regarding the same,
(b) promptly provide Ipsen with copies of all correspondence from
regulatory authorities copies of any draft response, and consider in good
faith Ipsen's comments thereon prior to filing any such response, and (c)
allow Ipsen to have a reasonable number of representatives attend and
participate in all meetings with regulatory authorities that affect
Ipsen's rights or obligations under this Agreement as discussed and agreed
by the Review Committee.
Ipsen will cross reference any Ipsen FDA Master File for the Current
Product promptly after such file is established and any open U.S.
Investigational New Drug Applications (INDs) or equivalent in Canada and
Japan, that upon or after the Effective Date of this Agreement may exist
for the Current Product in the Territory. Ipsen shall make available any
other existing non-clinical, clinical or safety data required to support
the Current Product Regulatory Approvals filing, to the extent necessary
to achieve the Development and Regulatory Program.
Medicis shall provide Ipsen with reasonable details of the results of the
performance of the Development and Regulatory Program after the accrual
thereof in a format to be agreed between the parties, and shall upon prior
request from Ipsen deliver all such documentation as may be necessary to
enable Ipsen to use the same in accordance with the terms of Article 2
above, which in particular includes Ipsen's right to use such results
together with the Regulatory Approval files provided that Medicis's rights
under this Agreement are not affected thereby in the Territory.
3.8 It is both parties' intention that the performance of the Development and
Regulatory Program, as it may be revised by the Review Committee, or as
may be drafted in connection with future Products, be coordinated and
consistent with Ipsen's regulatory programs for the Products. On this
basis, Medicis shall at all times take into account Ipsen's reasonable
requests to achieve this goal.
3.9 Medicis shall not conduct or sponsor any clinical trial with the Products
other than: (i) through an agreed Development and Regulatory Program, (ii)
Phase III(b) or Phase IV studies or trials in the Field, (iii) studies or
trials within the labeling of the approved Product, in the Field and
Territory, or (iv) with Ipsen's prior written consent.
3.10 Applications for Regulatory Approvals in all countries of the Territory
shall be made in the name of Ipsen or any of its Affiliates or its
nominee, or if not possible, filed in the name of Medicis and transferred
to Ipsen or its nominee at the earliest date possible after filing. Ipsen
shall solely own all Regulatory Approvals submissions and issued
certificates in the Territory, together with all
11
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
data, information, files developed, gathered and drafted by Medicis or any
Third Party partner or contractor, in the course of the Development and
Regulatory Program. All licenses and authorizations whatsoever in
connection with the performance by Medicis of the Development and
Regulatory Program shall be submitted and owned by Ipsen.
4. REVIEW COMMITTEE
4.1 The parties shall establish a Review Committee which shall be comprised of
six (6) members, three (3) of whom shall be appointed by Medicis and three
(3) of whom shall be appointed by Ipsen. The initial members of the Review
Committee are listed in Appendix 7. At any time during this Agreement,
each party may appoint one or more new members on the Review Committee in
replacement of one or more of such party's appointed members on the Review
Committee, with immediate effect upon written notice to the other party of
such replacement.
The Review Committee shall act in good faith at all times and shall be
responsible for the following:
(a) Provide guidance to and monitor the progress of the Development and
Regulatory Program, debate and decide any adjustments or changes to the
Development and Regulatory Program.
(b) Establish and implement the strategy for Regulatory Approvals and
monitor the status of all such Regulatory Approvals. The Review Committee
shall place its priority on ensuring that Medicis sets up and delivers to
Ipsen the clinical study reports and associated summaries for submission
by Ipsen to the FDA and granting of the first Regulatory Approval for the
Current Product in the U.S.A. as soon as possible following the Effective
Date.
(c) Evaluate and put forward as appropriate to Ipsen and Medicis
management, product development plans for any new formulations or other
line extensions, improvements, new indications and/or new delivery systems
so as to stay competitive in the marketplace.
4.2 The Review Committee shall meet for the first time within one (1) month
after the Effective Date; thereafter, it shall meet at least once every
four (4) months, or more often if reasonably deemed necessary by either
party, until the Development and Regulatory Program has been completed.
Meetings of the Review Committee shall alternately be hosted by each
party, either in Phoenix, Arizona (U.S.A.) or Slough, Berkshire (United
Kingdom) as the hosting party shall select, and may be held in other
locations agreed by the Review Committee. Meetings of the Review Committee
may be held in person, by videoconference, or by teleconference.
4.3 The Review Committee shall be chaired by one of its members nominated by
Medicis; the initial Chairperson is set forth on Appendix 7. The
Chairperson shall be responsible for compiling all meeting agendas,
conducting all meetings, and keeping minutes of the meetings of the Review
Committee; the Chairperson shall also be responsible for providing a copy
of the minutes of such meetings to the members of the Review Committee.
The Chairperson shall call regular meetings of the Review Committee once
every four (4) months, by sending a written notice by email and facsimile
with receipt confirmed to the parties at least two (2) weeks prior to the
proposed meeting date. In addition, the Chairperson shall, without delay
by email and facsimile with receipt confirmed, call a special meeting of
the Review Committee upon written request for the same by any member of
the Review Committee, which meeting shall in no event be held later than
thirty (30) days from such written request. In the event that the
Chairperson shall fail to call a regular or special meeting in accordance
with the obligations imposed upon him or her under the two previous
sentences within ten (10) calendar
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
days after the required date for performance, any member of the Review
Committee may call the meeting in accordance with the procedures
prescribed in the two previous sentences. No later than one (1) week prior
to any Review Committee meeting, the Chairperson shall send to the parties
the agenda of the meeting, reasonable details relating to all matters and
decisions to be discussed and/or voted during the meeting, together with a
written report, in a mutually-agreed format, showing the progress and
results of the Development and Regulatory Program and the status of the
proceedings before the relevant regulatory authorities with respect to the
Regulatory Approvals.
If, following receipt of the written notice of meeting set forth in this
Article 4.3, a meeting cannot be attended by at least one (1)
representative of each party hereunder, a second meeting shall be
organized for a date no later than one (1) month from the initial proposed
meeting date.
If the second planned meeting cannot be attended by at least one (1)
representative of each party, a third meeting shall be organized for a
date no later than ten (10) business days after the second proposed
meeting date. Except if due to a force majeure event affecting the
non-attending party, if a third planned meeting cannot be attended by at
least one (1) representative of a party, the attending party may hold the
meeting so long as such meeting is conducted in accordance with the
written notice of such meeting, and the business of such meeting is
limited to the items in the agenda accompanying such notice.
Except to the extent set forth above in connection with a third planned
meeting, in order to validly hold meetings and vote on decisions, a quorum
consisting of at least one (1) member from each party must be present at
each meeting. Any party nominating such member shall have the right to
appoint a replacement or substitute member. In addition, each party shall
have the right to have one (1) secretary participate in all meetings of
the Review Committee; each party may also invite any of its respective
employees or consultants to such meetings as a guest, provided that such
participation is consistent with the matters to be discussed by the Review
Committee and prior notice of each such attendee is provided to the other
party. Secretaries or guests invited in accordance with the foregoing
shall have no vote but may express opinions on any matters addressed by
the Review Committee.
Notwithstanding the fact that each party shall have three (3) members on
the Review Committee, each party shall have one (1) collective vote on all
matters presented for vote to the Review Committee, regardless of the
number of persons from each party attending the meeting.
All decisions to be taken by the Review Committee shall be taken
unanimously. In the event that the parties do not reach a unanimous
decision and are in a "deadlock", either party may refer the matter to be
voted upon to a senior executive of each party with relevant knowledge and
authority with respect to the subject matter of the deadlock immediately
upon "deadlock", who shall render a conclusive decision within fifteen
(15) days from the date of the referral of the matter thereto. Each party
shall disclose to the other party within three (3) business days following
request therefor by either party, the identity and business address of the
senior executive appointed by each such party for the purpose of this
deadlock resolution procedure. A copy of any referral to said senior
executives by either party shall be forwarded to the other party. In the
absence of agreement between said senior executives of the parties,
Ipsen's appointed senior executive for the purpose of the deadlock
resolution procedure may take the decision he or she reasonably believes
will best comply with the terms of this Agreement (the Casting vote) and
such decisions shall have the same effect as if agreed by the Review
Committee. Decisions by the Review Committee whether agreed unanimously or
through the Casting vote are subject to Medicis's right and option under
and in accordance with Articles 3.2.3 (a) and (b), and 3.3.3 (a) and (b).
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
4.4 Adequate minutes of each meeting of the Review Committee shall be prepared
by the Chairperson of the Review Committee and sent within seven (7)
business days from the date of each meeting to all of its members for
comment or approval in writing within ten (10) business days from the date
of receipt thereof. Minutes of meetings shall contain, at a minimum, a
list of all actions agreed upon and of issues in deadlock, and the
positions expressed by the members of the Review Committee on all matters
covered by the Review Committee during the meeting.
4.5 The Review Committee may, in the discretion of the Chairperson, cease to
hold meetings on the schedule set forth in this Article 4 after Medicis
has launched the Current Product in all countries of the Territory;
however, in such event the Committee shall meet at least annually. The
Review Committee shall resume meetings and activities in accordance with
the provisions of this Article 4 as soon as the parties elect to apply for
a Regulatory Approval in the Territory in connection with a future Product
in the Field.
5. PRODUCT MANUFACTURE AND SUPPLY
5.1 During the term of this Agreement, Medicis shall purchase or otherwise
obtain exclusively from Ipsen or from any Affiliate or Third Party
appointed by Ipsen, all of the Product requirements for the Products
Medicis, its Affiliates, or appointed distributors distribute under this
Agreement.
5.2 Ipsen shall use commercially reasonable efforts to manufacture or have
manufactured and deliver to Medicis clinical batches of Current Product
and agreed future Products which are the subject of a Development and
Regulatory Program, in those quantities indicated by Medicis to Ipsen
prior to the Effective Date and further agreed by the Review Committee as
reasonably sufficient to enable Medicis to perform the Development and
Regulatory Program, according to instructions received with reasonable
notice from the Review Committee. The agreed quantities of clinical trial
supplies of Current Product will be provided by Ipsen without cost to
Medicis.
5.3 Ipsen shall use commercially reasonable efforts to ensure that each
clinical batch and marketing batch of the Current Product shall be
manufactured in conformity with the specifications attached in Appendix 1
as existing at the Effective Date or as modified pursuant to a change
required under applicable regulations or by the Review Committee. Such
changes shall be notified to Medicis prior to implementation. Ipsen shall
use commercially reasonable efforts not to delay the delivery of clinical
or marketing batches of Current Product so that any such changes do not
affect the delivery thereof to Medicis. Ipsen shall use commercially
reasonable efforts to ensure that each clinical batch or marketing batch
of any future agreed Products be manufactured in conformity with agreed
specifications.
5.4 Ipsen shall use commercially reasonable efforts to supply Medicis or its
designees with all such ordered quantities of marketing batches of
Products in a timely manner as follows:
- Products shall be delivered in a finished, packed and labeled form as
agreed between the parties taking into account applicable regulatory
constraints in the United Kingdom and in the Territory;
- Conditions of sales shall be CIP (Carriage and Insurance Paid -
Incoterms 2000 of International Chamber of Commerce), at one of Medicis's
principal distribution points within each of the three countries of the
Territory, which distribution points shall be reasonably agreed upon by
the parties.
- Ipsen will use commercially reasonable efforts to deliver Products to
Medicis as promptly as possible with as much shelf life remaining as
possible.
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(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Ipsen shall provide Medicis with the regulatory content which shall appear
on packaging materials for the Products, and with the packaging materials
format and specifications, in order (by way of example) for Medicis to
conceive the artwork for the packaging materials for the Products,
including but not limited to outer and inner packaging, leaflets and
labels. Medicis shall start working on said artwork for the Products
forthwith as from receipt of the regulatory content provided by Ipsen,
without prejudice to final changes to the artwork which Medicis shall
implement on the basis of the final regulatory content as shall be
determined by the corresponding Regulatory Approvals in the Territory.
The artwork conceived by Medicis shall be consistent with the
Specifications set forth in Appendix 1 hereof with respect to the Current
Product, and with the packaging materials format and specifications
provided by Ipsen. In particular, Medicis shall make commercially
reasonable efforts to use artwork tools and software compatible with
Ipsen's technical standards concerning pre-printed packaging components.
Ipsen shall inform Medicis of such standards. Medicis shall provide Ipsen
with all the artwork, including the layouts and films (if possible on
disc), relating to the Products packaging materials for Ipsen to pack the
Product into final saleable form. The packaging materials for the Products
conceived by Medicis shall include all the applicable regulatory contents
provided by Ipsen, subject to changes required by the Regulatory Approvals
issued in the Territory.
Medicis and Ipsen shall each provide the other with appropriate and
updated information related to the legal and regulatory requirements in
the Territory with regards to the Products (including but not limited to
quality, therapeutic use, packaging, labeling and storage). Such
information shall be forwarded by one party to the other forthwith upon
its becoming aware of the same. Final decision on whether to proceed to
the regulatory modification of the content of any of the Products
packaging materials, including all Product labels, shall be vested
exclusively in Ipsen subject to Medicis's reasonable objection in writing
to the proposed modification, within reasonable time.
All Products sales boxes and leaflets shall bear the mentions referred to
in Article 8.8(iii).
Medicis shall provide Ipsen with reasonable relevant technical assistance
if so requested by Ipsen for the operations contemplated under this
Article 5.4.
5.5 Medicis shall provide warehouse facilities in the Territory adequate to
store the Products in accordance with the relevant prescriptions of the
Specifications and with standard requirements related to pharmaceutical
products storage and handling.
5.6 For Ipsen manufacturing operations planning purposes only of clinical
batches and marketing batches of the Current Product and agreed future
Products, Medicis will use commercially reasonable efforts to provide
Ipsen with
5.6.1 a thirty six month rolling order forecast updated and complemented
by an additional six month forecast simultaneously with the placing
of each semester binding offer,
5.6.2 a rolling twelve-month order forecasts updated and complemented each
month by an additional monthly forecast, and
5.6.3 a firm order for clinical batches and marketing batches of the
Current Product and agreed future Products that shall cover a period
of six months and which shall provide for delivery dates.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Ipsen shall use commercially reasonable efforts so as to meet the
requested delivery dates; provided however that should any of Medicis's
firm purchase orders for the Product differ by more than ten percent (10%)
from the quantities appearing in the applicable rolling forecast, Ipsen
will not be responsible in case of delays in the delivery of excess
quantities.
Detailed procedure as to such forecast and ordering processes is set forth in
the technical agreement referred to in Article 5.14 hereof.
5.7 In consideration for the supply of the Current Products by Ipsen to
Medicis, Medicis shall pay to Ipsen the price set forth in Appendix 8
hereto or as later determined as a result of the following Article 5.7 and
as a result of Article 6.4.
Such prices are based on *** units of toxin activity per vial, being
functionally equivalent to approximately ***units of the competing product
of the Current Product (Botox(R) by Allergan) as such competing product
exists at the Effective Date.
Without prejudice to either party's right to seek price adjustment under
and in accordance with Article 6.4, in the event that, through the dose
ranging studies which Medicis shall perform under the Development and
Regulatory Program, and to the extent further analysis reveals that the
functional equivalent of the Current Product and of its competing
formulation as at the Effective Date is not 3:1, the prices set forth in
Appendix 8 hereto will be adjusted proportionately, either up or down.
Agreed quantities of promotional marketing samples will be provided by
Ipsen to Medicis at a fixed price set forth in Appendix 8 (and without
royalty nor inclusion in Net Sales) for Medicis's use for promotional
purposes.
5.8 In case of Product shortage resulting in Product supplies insufficient to
fill both Ipsen's world-wide sales requirements and Medicis's requirements
for Products for the Territory, whether as a consequence of force majeure
or any other cause, Ipsen and Medicis will each receive a pro rata share,
based on the relative proportion of the last six (6) months of Ipsen's
world-wide sales to Medicis's Product sales in the Territory, each
expressed in number of vials, of available quantities of Product for as
long as the shortage lasts.
Ipsen will use its commercially reasonable efforts at all times to supply
Medicis with enough Product for Medicis to maintain a safety stock
corresponding to Medicis's Product sales in the Territory during the three
(3) months preceding any Product delivery. Medicis undertakes to
permanently hold such three-month safety stock unless such safety stock
cannot be constituted owing to Ipsen's failure to supply Products in
sufficient quantities. In the event of complete stock-out in a country of
the Territory, except in case of force majeure and provided Medicis
previously complied with its obligation to maintain a three-month safety
stock, for each five (5) business days of stock out, Medicis shall receive
a credit towards future royalties in an amount equal to *** percent (***%)
of the royalties accrued over the last four (4) weeks Medicis was able to
fully supply the market in the concerned country of the Territory.
5.9 Ipsen covenants with Medicis that:
- Ipsen shall use commercially reasonable efforts to manufacture the
Products in accordance with cGMP regulations, if applicable, or in
accordance with applicable law and
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CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
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AND EXCHANGE COMMISSION.
regulations in the case of samples of Product supplied for use in the
Development and Regulatory Program;
- the Products shall be manufactured to meet the specifications therefor
submitted to any regulatory authority having jurisdiction over such
Products in the Territory and to be of satisfactory quality as specified
in the applicable Regulatory Approval.
5.10 Ipsen shall, with each delivery of Product to Medicis, supply a
certificate of analysis related to each batch delivered and a signed
statement that each such batch conforms with the Specifications and
accords in all other respects with the relevant Regulatory Approvals in
the Territory, that the Product meets all stability requirements and that
the manufacturing procedures have been checked in conformity with cGMP or,
in the case of samples of the Products supplied for use in the Development
and Regulatory Program, in conformity with applicable law.
5.11 Medicis shall notify Ipsen of any defective material or workmanship of the
Product in writing as follows:
- claims in respect of visible nonconformity shall be made within fifteen
(15) days after arrival of the concerned Products at Medicis's principal
distribution points,
- claims in respect of any hidden nonconformity shall be made within
thirty (30) days after Medicis became aware of the same,
- defects which could involve product liability for Ipsen, Medicis, or any
of their Affiliates or distributors, shall be notified promptly upon
becoming aware of the same,
- Third Party claims relating to product liability matters shall be
notified promptly upon becoming aware of the same.
5.12 In the event of any claim with respect to the quality of the Product or
its conformity to the Specifications which is not due to events that
occurred after delivery of the Product by Ipsen to the first carrier,
Ipsen will use commercially reasonable efforts to make available to
Medicis the necessary quantity of samples of the defective/non-conforming
Product together with Ipsen's own certificate of analysis and, if
requested by either party, the unsold quantities of the concerned batch of
defective Product and said samples, shall be retained intact for
inspection by the other party or any agent appointed by such party to
which the other party has made no reasonable objection.
In case of non-conformity to the Specifications of any quantity of the
Product delivered to Medicis which is not due to events that occurred
after delivery of the Product by Ipsen to the first carrier, Ipsen shall
take back, at its own expense, the quantities concerned and shall replace
them as soon as commercially practicable so as to avoid any disruption of
supply in the Territory. If Ipsen does not replace any non-conforming
quantities of Product promptly, Ipsen shall promptly refund the price paid
by Medicis in respect of such quantities.
Any dispute between the parties regarding the conformity to the
Specifications of any quantity of the Product delivered hereunder shall be
resolved in accordance with the dispute resolution procedures set forth in
the technical agreement referred to in Articles 5.14 of this Agreement.
5.13 In the event either party has reason to believe that one or more batch(es)
of Product supplied hereunder should be recalled from distribution in the
Territory, or that any Product supplied
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CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
hereunder should be withdrawn from the Territory, such party shall
promptly inform the other in writing.
Upon Ipsen's reasonable request, Medicis shall implement any Product batch
recall or Product withdrawal from the Territory in accordance with the
applicable procedure as shall be agreed under Article 11.
5.14 A technical agreement covering all technical, quality and logistical
aspects of manufacturing for the supply by Ipsen to Medicis of the
necessary quantities of Current Product and any other agreed Products,
shall be agreed as soon as practical and no later than one hundred and
twenty (120) days after the Effective Date. With regards to clinical trial
supplies of Current Product, the technical agreement shall be agreed upon
between the parties as soon as possible after the Effective Date. All such
technical agreements will detail a change control policy with the
obligation to communicate prior to implementation any planned changes in
the manufacturing of the Product. On reasonable notice to Ipsen and
subject to any obligations owed or limitations on access agreed to with
any Third Parties, Ipsen shall grant Medicis and its authorized
representatives reasonable access to Ipsen's present and future
manufacturing facilities in order to inspect and evaluate Ipsen's
facilities for Current Product and any other agreed Products in order to
satisfy any regulatory requirements or requests.
6. CONSIDERATION
6.1 The appointment of Medicis under Article 2 hereof is made in consideration
of (i) the performance by Medicis of all its obligations herein, in
particular Medicis's undertaking under Article 5.1, and (ii) Medicis
making the following payments to Ipsen:
6.1.1 Non Refundable One Time Milestone Payments:
- - Ninety million and one hundred thousand USD (90,100,000 USD) on ***
- - Twenty five million USD (25,000,000 USD) on ***.
- - One million and five hundred thousand USD (1,500,000 USD) on ***.
- - Seventy five million USD (75,000,000 USD) on Regulatory Approval of the
Current Product in the U.S.A. for use of such Current Product in the Field.
- - Two million USD (2,000,000 USD) on Regulatory Approval of the Current
Product in Japan for use of such Current Product in the Field.
For the purpose of this Article 6.1.1, a milestone shall be deemed to be
achieved by the party concerned if achieved by any of its Affiliates or Third
Party contractor.
Each milestone payment shall be due and payable as indicated in this Agreement
and no later than thirty (30) calendar days following the achievement of the
milestone event to which it relates. For the avoidance of doubt, Medicis will
not be obligated to make any milestone payment more than once.
Ipsen's wire instructions are as follows:
Account name: Ipsen Limited
Account number: ***
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AND EXCHANGE COMMISSION.
BIC: ***
Sort code: ***
IBAN: ***
Bank name: HSBC
Bank address: Poultry & Princes Street, London EC2P 2BX
6.1.2 Running Royalties:
Medicis shall pay to Ipsen a royalty of ***% (***percent) on Net Sales of
the Product achieved in each and every country in the Territory as from
the date of first Commercial Sale hereunder of a Product in the Territory
(each, a Running Royalty). No more than one Running Royalty shall be
levied on an individual Product.
Each Running Royalty shall be payable at the expiry of each calendar
quarter, on the basis of the Net Sales achieved during the preceding
quarter in such country in the Territory. Royalties shall be due and
payable within forty-five (45) calendar days after the end of each
calendar quarter, simultaneously with remittance of the quarterly market
sales report described in Article 9 below.
All royalty payments pursuant to this Agreement shall be made in U. S.
Dollars (USD), by wire transfer (net of bank charges which shall be borne
by the paying party) to an account designated by Ipsen.
Conversion from currencies other than USD shall be made using the
arithmetic average of the spot rates on the last business day of each
month of the fiscal quarter in which the Net Sales were made. The middle
market exchange rates of National Westminster Bank PLC or any other
exchange rate reference agreed to by the parties, shall be used as the
source of spot rates to calculate the average as defined in the preceding
sentence.
6.1.3 Minimum Royalties. In addition to the Running Royalties described in
Article 6.1.2 of this Agreement, for each country in the Territory in and
for which Medicis obtains a Regulatory Approval to sell the Product in the
Field, and for each Royalty Year as defined below, Medicis shall pay Ipsen
a Minimum Royalty to be determined in accordance with Articles 6.1.3,
6.1.4 and 6.1.5. For each country and for each Royalty Year for which
Medicis has an obligation to pay a Minimum Royalty under this Article
6.1.3, it shall receive a credit equal to all Running Royalties timely
paid by Medicis on Net Sales in and for such country for such Royalty
Year. Medicis shall pay each Minimum Royalty owed under this Article
annually as provided for in Article 6.1.6. For purposes of the United
States, a Royalty Year shall begin on January 1st of the calendar year
immediately following the calendar year (the Year of Initial Approval) in
which Medicis obtains a Regulatory Approval to sell the Product in the
Field, if such Regulatory Approval was obtained in the first six months of
the Year of Initial Approval, or on January 1st of the second calendar
year following the Year of Initial Approval, if such Regulatory Approval
was obtained in the last six months of the Year of Initial Approval. For
purposes of Japan and Canada, a Royalty Year shall begin on January 1st of
the calendar year immediately following the calendar year in which a
Regulatory Approval is received in and for that country.
6.1.4 With respect to the United States, the Minimum Royalty shall be USD ***
for the ***, USD *** for the ***, and USD *** (***) for the ***. The
Minimum Royalty for each of Japan and Canada, and for each Royalty Year
applicable to the United States after the first ***Royalty Years specified
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
above, shall subject to the following sentence, be determined in
accordance with the provisions of Article 6.1.5. If and when a new
competitor enters the market with a botulinum toxin-based product in the
Territory in the Field, the parties shall consider reasonably expected
changes to the market and appropriate changes to the Medicis' projections
and, following any such changes, the parties' shall negotiate in good
faith equitable adjustments to the Minimum Royalties to reflect the
modifications to the projections.
6.1.5 Minimum Royalties shall be determined for a *** period. In order to ensure
the timely determination and payment of Minimum Royalties under this
Article 6.1.5, the parties agree that they shall start their negotiation,
in respect of the U.S., not later than July 1st of the ***Royalty Year
(and of each subsequent, *** anniversary year), and as respects Japan and
Canada not later than July 1st of the calendar year in which a Regulatory
Approval was received or is expected to be received and subsequently, not
later than July 1st of the *** Royalty Year (and of each subsequent,
***anniversary year) applicable to such country.
For the purpose of negotiating Minimum Royalties, the parties shall
consider, among other things, published analysts' reports regarding
projected total sales of botulinum toxin of all kinds for use in the Field
in such country over the *** Royalty Year period under consideration. In
addition, for the period of the first *** Royalty Years applicable to
Canada and Japan, the parties shall determine the Minimum Royalty
applicable to such country on the assumption that Medicis will capture a
minimum of ***%, ***% and then ***% of total sales of botulinum
toxin-based products for use in the Field in such country in each of the
*** Royalty Years of such *** Royalty Year period. For each subsequent
three Royalty Year period applicable in the United States, Canada or
Japan, the parties shall determine the Minimum Royalty applicable to such
country on the assumption that Medicis will capture a minimum of ***% of
total sales of botulinum toxin based products in such country in each
Royalty Year of such *** -year period.
If the negotiation is not successful by August 31st of such year, then
either party may request the resolution of such matter by a Third Party
expert pursuant to Article 20.12. By November 1st of such year, each of
the parties shall submit a single letter brief, of not more than ten (10)
pages, stating its position as to the applicable Minimum Royalty for the
*** Royalty Year period for the country in question (which must be a sum
certain, expressed in U.S. Dollars, per annum). The expert shall issue his
or her report by December 31st of such year, and shall select either
Medicis's or Ipsen's Minimum Royalty figure for each Royalty Year
comprising the *** Royalty Year period in question, i.e., the Third Party
expert shall not select any compromise figures or any figures not proposed
by one of the parties.
6.1.6 Medicis shall make any and all payments required to be made in respect of
Minimum Royalties for any and all countries net of credits for or, if
applicable, together with (and on the date when due) payment of Running
Royalties corresponding to the last calendar quarter of the concerned
Royalty Year.
6.1.7 In the event that Running Royalties arising from the Net Sales in any
country in any Royalty Year shall exceed the Minimum Royalty applicable to
such country, and Medicis shall have properly computed and timely paid
such amounts under Article 6.1.2, Medicis shall not owe Ipsen any Minimum
Royalty for such country for such Royalty Year.
6.1.8 In the event that, for any Royalty Year, Medicis owes and fails to pay the
applicable Minimum Royalty when due, upon Ipsen's written notice of such
failure or deficiency to Medicis delivered within thirty (30) days after
the date on which such payment is due, and upon Medicis's failure within
thirty (30) days to cure such deficiency, Ipsen may elect to convert
Medicis's exclusive distribution rights under Article 2 (solely with
respect to the concerned country for which Medicis
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(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
failed to pay the applicable Minimum Royalty), into non-exclusive rights,
whereupon Medicis shall be relieved from its obligations to pay Minimum
Royalties to Ipsen with respect to that country of the Territory, and in
which case this Agreement will automatically terminate with respect to
that same country at the expiry of a *** period as from the date of
Ipsen's notice to Medicis that the rights for the country concerned were,
under this Article, turned into non exclusive rights. If Ipsen elects to
convert the rights under Article 2 into non-exclusive rights for a
concerned country of the Territory, such conversion shall be Ipsen's sole
and exclusive remedy for any failure by Medicis to pay Minimum Royalties
for the country concerned. Medicis shall not be considered to be in
default of its Minimum Royalty obligations at any time, and for so long
as, any force majeure event, any failure by Ipsen to deliver required
quantities of conforming Product in a timely fashion, or any other
material breach of this Agreement by Ipsen, either of which was a
substantial factor in Medicis's failure to satisfy its Minimum Royalty
obligations as of such time.
6.1.9 In the event that, for any period of *** consecutive Royalty Years
applicable to a country in the Territory for which a Minimum Royalty is
due, Medicis fails to pay such Minimum Royalty, upon Ipsen's written
notice of such failure or deficiency to Medicis delivered within thirty
(30) days after the date on which such payment is due for the *** such
Royalty Year, and upon Medicis's failure within thirty (30) days to cure
such deficiency for the entire *** period, Ipsen may elect to terminate
Medicis's appointment pursuant to Article 19.2(ix) with respect to such
country, and such termination of appointment shall, in effect, be treated
as a termination of this Agreement by Ipsen for cause, albeit with respect
to such country only.
6.2 Medicis shall pay all taxes that by law (including existing treaties for
bilateral taxation) it is required to pay on payments accruing under this
Agreement and shall withhold from the sums payable to Ipsen all such taxes
or levies and Medicis shall forward to Ipsen withholding tax certificates
whenever possible.
6.3 Late payments of all monies provided for in this Agreement shall bear
interest, on a daily basis, from the due date to the date of actual
payment, at a rate equal to 1.5% above EURIBOR. The accrual and payment of
such late payment interest shall not prejudice the suffering party's other
rights and remedies that may arise from breach of this Agreement by the
defaulting party.
6.4 The parties acknowledge that it is their intent that Medicis will realize
a Gross Profit Margin of approximately *** percent (***%) on its Net Sales
of the Product in each country of the Territory, and the parties therefore
agree as follows:
6.4.1 In the event that it appears, after the commencement of Commercial Sales
in a country in the Territory, that, because of a significant change in
market conditions or other factors, Medicis has failed, for a period of
four (4) consecutive fiscal quarters, to realize a Gross Profit Margin in
respect of Commercial Sales in such country of at least *** percent (***%)
cumulatively over such period, or Medicis has, for a period of four (4)
consecutive quarters, realized a Gross Profit Margin of more than ***
percent (***%) cumulatively in respect of Commercial Sales in such country
over such period, Ipsen and Medicis will negotiate in good faith a revised
supply price for the Product which will restore Medicis to a Gross Profit
Margin of ***percent (***%).
6.4.2 During such negotiation period and only in case Medicis made use of this
Article 6.4, if a Gross Profit Margin of less than ***percent (***%)
results over any period of four (4) consecutive fiscal quarters, then ***
percent (***%) of all payments due by Medicis under this Agreement shall
be made to an escrow account in a bank mutually agreed to by the parties;
the balance, *** percent (***%), being paid to Ipsen. Allocation between
or to either of Medicis or Ipsen of the amounts paid to the escrow account
shall be decided on the basis of the outcome of revisions to the supply
price for the Product, it being understood that the revisions shall be
retroactive to the date
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AND EXCHANGE COMMISSION.
Medicis effectively ceased achieving a Gross Profit Margin of at least ***
percent (***%) or effectively began to achieve a Gross Profit Margin in
excess of *** percent (***%).
6.4.3 In case the parties do not agree upon a mutually acceptable revised
Product supply price within four (4) months from the date on which a party
gave notice pursuant to this Article 6.4, either party may refer the
matter for resolution by a Third Party expert pursuant to Article 20.12.
If the matter is referred to a Third Party expert, pending the expert
decision and only in case Medicis made use of this Article 6.4 for
achieving a Gross Profit Margin of less than *** percent (***%), Medicis
shall continue to pay *** percent (***%) of amounts otherwise due to Ipsen
into escrow. Escrowed amounts shall be distributed to the parties hereto,
in accordance with a final determination under Article 20.12 of this
Agreement, and within thirty (30) days after the issuance of the final
determination. In determining the revised Product supply price, the Third
Party expert may consider any and all factors which he/she deems
appropriate including, without limitation, competition in the relevant
markets within the Territory, and sales levels and trends for the
Products. If none of the parties referred the matter for resolution by a
Third Party expert, escrowed amounts shall be distributed to Ipsen.
6.4.4 Neither party shall seek an adjustment of the Gross Profit Margin more
frequently than once in any period of four (4) consecutive fiscal
quarters. In no event shall any expert determine a revised Product supply
price of less than USD *** (USD ***) per vial for the Current Product (or
its equivalent) and, even if he or she does, in no event shall Medicis pay
Ipsen less than USD *** (USD***) per vial (or its equivalent).
6.4.5 Upon request from time to time, Medicis agrees to provide Ipsen with
adequate data for Ipsen to calculate the Gross Profit Margin if such
calculation is not feasible based on the reports to be delivered to Ipsen
pursuant to Article 9.
7. FUTURE PRODUCTS
7.1 Ipsen hereby declares that it is currently working to develop ***. Ipsen
will use commercially reasonable efforts to make available Product
Extensions available to Medicis within the time schedule of any
modification of the Development and Regulatory Program adopted by the
Review Committee. However, Ipsen explicitly makes no assurance or warranty
regarding the outcome of any such developments.
***
In the event that Ipsen or any Ipsen Affiliate shall develop or consider
licensing-out to a Third Party (or setting-up a joint-venture with a Third
Party for) ***, in each instance Ipsen shall, and shall cause such Ipsen
Affiliate to, before approaching any Third Party, first offer Medicis the
opportunity to assume responsibility for a development and regulatory plan
for the New Product, and to take appointment as sole and exclusive
distributor and promoter of the New Product, within the Field and in the
Territory. If Medicis elects to negotiate for such rights, then Ipsen
agrees to negotiate, and Ipsen shall cause such Ipsen Affiliate to
negotiate, in good faith, exclusively with Medicis, for a period of ***
after Ipsen's or such Ipsen Affiliate's above mentioned opportunity offer
to Medicis, the commercially reasonable terms of an exclusive Development
and Distribution Agreement for the New Product. All material terms of
Ipsen's or such Ipsen Affiliate's best offer shall be memorialized in a
written outline prepared by Ipsen. If Medicis does not elect to negotiate
for such rights within *** after Ipsen's or such Ipsen Affiliate's above
mentioned offer to Medicis, or if Medicis and Ipsen or such Ipsen
Affiliate are unable to reach agreement with respect to a new Development
and Distribution Agreement within the above mentioned *** period, then
Ipsen or such Ipsen Affiliate shall be free to negotiate with any Third
Party with respect to
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AND EXCHANGE COMMISSION.
the development and distribution of any New Product, provided that neither
Ipsen nor such Ipsen Affiliate may enter into any agreement with a Third
Party for such New Product which would provide for terms which are more
favorable in the aggregate to the Third Party than Ipsen's or such Ipsen
Affiliate's best offer to Medicis.
8. MARKETING AND PROMOTION OF THE PRODUCT
8.1 Medicis shall have sole responsibility to determine first Commercial Sales
timing and dates in the Territory, provided however that Medicis shall
perform or have performed the first Commercial Sale of the Current Product
and any agreed future formulations of the Product, in each country of the
Territory in which the first corresponding Regulatory Approval is granted
without delay after the grant of such Regulatory Approval, but no later
than three (3) months after such Regulatory Approval has been obtained;
provided that Ipsen shall have made available sufficient supplies of such
Product for Commercial Sales to commence.
8.2 Medicis will have sole responsibility for establishing the Product pricing
for use in the Field, subject to applicable government regulations.
8.3 Medicis shall promote, distribute and sell the Product in the Territory
through its established distribution systems as appearing in Appendix 6
hereto and/or through other Affiliates and/or Third Parties in accordance
with the provisions of Article 2.2 above.
8.4 Medicis shall use its best endeavors comparable to the manner Medicis
applies to its own leading aesthetic products in the Field in the
Territory, or if not applicable, in other therapeutic or commercial areas,
to promote, distribute and sell the Product in the Territory.
8.5 Medicis shall commit to a high level of quality and scientific excellence
in its marketing, promotion and distribution of the Product in the
Territory consistent with Medicis's highest standard of quality and
scientific excellence. To that end, Medicis shall make sure that the sales
representatives used by Medicis or any of Medicis's Affiliates,
distributors or Third Party contractors are well trained in order to
maintain a high level of quality and scientific excellence in all
marketing activities.
Medicis will use commercially reasonable efforts to provide Field
Customers included in the Medicis Customer Base with technical support,
training with the Product and instructions for use of the Product, in a
manner consistent with Medicis's current practices in the provision of
such support to its present customer base for its hyaluronic acid-based
products.
8.6 Medicis shall promote the Products only within the Field and solely to
Field Customers located in the Territory, to the exclusion of any contacts
with or promotional visits to health professionals who do not pertain to
the Field Customers; however, Medicis's marketing and promotion over the
internet, radio, television or other broad-based media that spills over
into countries outside the Territory shall not be a breach of this
provision.
Medicis shall promote, distribute and sell the Products solely under one
or more of the Trademarks.
Medicis shall supply the Product in response to orders received only from
Field Customers within the Medicis Customer Base. For purposes of this
Agreement, the Medicis Customer Base shall include any and all
practitioners, groups, clinics and institutions located in the Territory,
identified as such on a list of customers prepared and maintained by
electronic means on the Effective Date and thereafter, who have practiced
or may reasonably be expected to practice in the Field
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CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
and become customers for the Product. Such list shall disclose the name of
the practitioner, group, clinic or other institution, its primary address
any affiliation, and any practice specialties. Promptly after the end of
each fiscal quarter, Medicis shall transmit the complete, revised list in
electronic form to Ipsen, which list shall be marked to clearly indicate
the identities of any Field Customers who have been added or removed from
the list in the prior quarter. Ipsen shall have the right to approve the
list as it exists on the Effective Date, and to approve all additions and
subtractions to the list thereafter, which approval shall not be
unreasonably withheld. Ipsen may reasonably retract its consent as to a
particular Field Customer if it receives information about such Field
Customer's use of any Current Products or agreed future Product that
requires such removal. Medicis may deliver Product for use in the Field to
a Field Customers whose names do not appear on the list so long as Medicis
includes such customer's identifying information in the next quarterly
update of the list. Medicis shall refer to Ipsen all enquiry's and orders
received other than from the Medicis Customer Base. Ipsen shall refer to
Medicis all inquiries and orders received from the Medicis Customer Base
or from Field Customers whom Ipsen has reason to believe desire to use the
Products in the Field. Ipsen acknowledges and agrees that the Medicis
Customer Base is a trade secret of Medicis and is subject to the
confidentiality provisions of Section 17. Accordingly, the Parties shall
cause the Review Committee or their designees to develop promptly a
written plan to limit access to and safeguard the Medicis Customer
Database.
8.7 Medicis shall pay for all costs related to and shall bear all
responsibility for all marketing, promotion, sale and distribution
activities of Medicis and Medicis's Affiliates under this Agreement in the
Territory.
8.8 Medicis shall decide on the strategy to adopt regarding its Product
promotion activities in the Field in the Territory, provided however that
(i) Medicis shall meet with Ipsen at least once a year by September 30th,
to review a written report documenting Medicis's actual and proposed
strategies and promotional activities, together with the results thereof,
(ii) Medicis shall implement any reasonable modifications to its actual or
proposed strategies which Ipsen may reasonably request so as to safeguard
consistency with Ipsen's Product promotional or marketing strategies;
provided that such modifications do not impose unreasonable costs,
burdens, or other limitations on Medicis, or otherwise conflict with
Medicis's overall marketing strategies, and (iii) if required by Ipsen,
the packaging of the Product in the Territory shall indicate that such
Product is manufactured by Ipsen and/or such other company or group name
as may be reasonably requested by Ipsen; the parties shall agree on the
way such mention shall appear on the packaging.
Promptly following the Effective Date, each of the parties shall use
commercially reasonable efforts to jointly develop and implement a plan to
detect and seek prevention, of unauthorized parallel imports of Products
and counterfeit Products into the Territory throughout the term of this
Agreement to the extent permitted by applicable law, including permitting
Medicis to enforce its exclusivity rights as to unauthorized third party
parallel importers.
8.9 Each party undertakes that it will use commercially reasonable efforts to
substantially comply with all applicable laws and regulations when
developing, testing, manufacturing, marketing, promoting, storing,
packaging, shipping, selling and/or distributing the Products.
Each party further undertakes to use commercially reasonable efforts to
substantially comply with all applicable proceedings or documentation
required by regulations in force in the United Kingdom, in the European
Union or in the Territory applicable to the developing, testing,
manufacturing, storing, packaging, shipping, distribution, promotion, sale
and administration of botulinum toxin-based products in accordance with
this Agreement.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
9. REPORTS
9.1 Within forty-five (45) calendar days after the end of each calendar
quarter, simultaneously with payment of royalties mentioned in Article 6
above, Medicis shall provide Ipsen with a written report indicating the
Commercial Sales of the Product achieved during the preceding calendar
quarter including all details setting forth all Net Sales by Medicis and
its Affiliates and the calculation of Net Sales, the percentage of
royalties applicable for such quarter, and the amount of royalties due
under Article 6.
Such quarterly report shall include without limitation the following
items:
- Products Commercial Sales records expressed in value and volume (in
number of Product vials), in aggregate and broken down by groups and
agreed types of Field Customers, as well as in each country of the
Territory, and agreed areas or sub-zones;
- Products stock movements reports;
- Products returns from customers by Territory.
Medicis agrees that it shall keep, during the whole duration of this
Agreement and thereafter for a period of at least (i) six (6) calendar
years, or (ii) the duration corresponding to commercial prescription under
U.S. laws, whichever of (i) and (ii) is shorter, after each Commercial
Sale, accurate records of each Commercial Sale in sufficient detail,
including but not limited to details of the price at which the Product was
sold by Medicis, and of any and all deductions applicable in determining
the Net Sales, in order to enable assessment and control of the amounts
due to the other party under Article 6.
Upon Ipsen's request, which request shall not be made more frequently than
once per any twelve-month period, Ipsen may have an inspection performed
by an independent auditor selected by Ipsen and to which Medicis has no
reasonable objection during ordinary business hours, of such Medicis's
records, books and accounts as may be necessary to verify the accuracy of
information submitted under this Article 9 to Ipsen in respect of all
royalty payments from Medicis to Ipsen under this Agreement. All expenses
related to such verification shall be borne by Ipsen except where it is
determined by the auditor that Medicis has made an annual underpayment of
five percent (5%) or more, in which event such expenses shall be borne by
Medicis only. If Medicis disagrees with any determination made by the
auditor pursuant to this Article 9.1, it may refer such disagreement for
resolution pursuant to the dispute resolution procedures set forth in
Articles 20.11 and 20.12. Any under or overpayment shall be balanced
within fifteen (15) days after the later of (i) the date of the auditor's
examination or (ii) resolution of any disputes with respect to the
auditor's examination pursuant to the processes set forth in Article 20.11
and 20.12, together with accrued late payment interest calculated in
accordance with Article 6.3.
9.2 Within ninety (90) calendar days before the end of each calendar year,
Medicis shall provide Ipsen with a written report indicating annual
Commercial Sales forecasts for the following calendar year, and reports on
the impact of competitive products, acceptance of the Product by the Field
Customers in the Territory, results and analysis thereof, of implemented
promotional strategies during the current calendar year, and detail of
planned promotion strategy for the following calendar year, and other
information Medicis deems relevant.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
9.3 Medicis shall advise Ipsen in writing of any known complaints from
competitors or regulatory authorities regarding promotional activities,
within ten (10) days or sooner if the regulatory agency rules specify a
shorter period.
10. IPSEN PROMOTION OF THE PRODUCTS IN THE TERRITORY
10.1 Ipsen shall not, and Ipsen shall ensure that its Affiliates do not,
promote the Products in the Territory with respect to indications
pertaining to the Field or using the same or confusingly similar brand
names, packaging, or trade dress as used by Medicis or its Affiliates or
distributors. Furthermore, Ipsen shall not, and Ipsen shall ensure that
its Affiliates do not, promote the Products in the Territory to the
Medicis Customer Base except in connection with new use(s) for the
Products outside the Field which Ipsen registered in the Territory after
the Effective Date and which might be prescribed or used by customers
within the Medicis Customer Base. Ipsen and its Affiliates may promote or
have the Products promoted in the Territory outside the Field and to
ophtalmologists who practice medical treatment outside the Field.
10.2 The parties recognize that a Field Customer may wish to use the Product
for at least one use within the Field and at least one use outside the
Field. With respect to each such Field Customer, Medicis and Ipsen shall
use their commercially reasonable efforts to come to an individual
agreement appropriately allocating the sales revenues pertaining to such
Field Customer's use to each of Medicis and Ipsen, in proportion to such
Field Customer's actual use.
10.3 Either party may require that the other provide reasonable access during
ordinary business hours to the other party's records, books of account,
other documents, employees, consultants, Affiliates, Third Party
contractors and facilities in order to verify the other party's compliance
with this Article 10. Any dispute regarding either party's compliance with
this Article 10 shall be subject to the dispute resolution procedures set
forth in Articles 20.11 and 20.12.
10.4 In the event that either party to this Agreement violates its obligation
to remit agreed funds to the other under this Article 10, such party shall
promptly pay the non-breaching party the amount owed, plus interest, as
agreed to by the parties through negotiation or as conclusively determined
by the Third Party expert.
11. PROCEDURES REGARDING TECHNICAL MATTERS
Ipsen and Medicis shall agree in writing as soon as possible and no later
than within one hundred and twenty (120) days after the Effective Date,
upon a Safety Data Exchange Agreement which will describe the process for
adverse event and reporting.
Discussions between Ipsen and Medicis regarding such Safety Data Exchange
Agreement, shall be initiated on the basis of the Standard Operating
Procedures in force at the time of the signing of this Agreement and
subsequent updates, which are in effect on the Effective Date within
Ipsen's organization and of which Ipsen will send a copy to Medicis for
the purpose of these discussions.
The Safety Data Exchange Agreement which Ipsen and Medicis shall
agree-upon shall be consistent with the provisions of this Agreement.
During the 120 days during which the Safety Data Exchange Agreement is
being finalised, Ipsen and Medicis agree to exchange all serious adverse
event reports received from clinical trials and serious spontaneous
reports received by either party. CIOMS I or MedWATCH forms will be
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
used to exchange such reports within five (5) calendar days of receipt
(life-threatening or fatal reports) or ten (10) calendar days for all
other serious reports.
12. INTELLECTUAL PROPERTY
12.1 Medicis agrees that it shall not gain title of any kind in Ipsen's or any
Ipsen Affiliate's intellectual property rights in the Products, the
Products Regulatory Approval files and data contained in any applications
for Regulatory Approvals or Ipsen's or any Ipsen Affiliate's Know-How
including patents, which rights and titles shall all remain Ipsen's or
Ipsen's Affiliates' sole property.
12.2 All results whether patentable or not of the Development and Regulatory
Program shall be the sole property of Ipsen. Ipsen may independently,
after prior confidential consultation with Medicis and with Medicis's
reasonable assistance, seek at its own expense any patent or other
protection available in relation to such results and to the Products
(including without limitation any new use for any of the same).
12.3 Ipsen shall assign to Medicis the Trademark and goodwill (if any)
associated therewith in accordance with the terms of a Trademark
Assignment Agreement substantially in the form set out in Appendix 11.
Medicis may further select and include in Appendix 5 hereto, other trade
name(s) and trademark(s), to register, distribute and promote the
Product(s) or agreed future Product(s) in the Territory, and to which
Ipsen has no reasonable objection.
The Trademarks shall be the sole property of Medicis.
12.3.1 Subject to Article 8.8, Medicis grants to Ipsen a license to use the
Trademark(s) in accordance with the terms of the Trademark(s) License
Agreement attached as Appendix 9.
Any trademark further included in Appendix 5 in accordance with the terms
of this Article 12.3 shall be referred to herein as the Trademark(s) and
shall be deemed to be automatically licensed by Medicis to Ipsen under the
terms of the Trademark(s) License Agreement. Medicis undertakes to sign
any amendment as Ipsen may request to the Trademark(s) License Agreement
so as to formalize the inclusion of any such new Trademark in the scope of
the Trademark(s) License Agreement.
Any Product Extension included in Medicis's scope of appointment under
Article 2 in accordance with the provisions of Article 7.1 herein, and any
New Product which is the subject of an Agreement between Ipsen and Medicis
for its development and/or distribution in accordance with the provisions
of Article 7.2 of this Agreement, shall be deemed to be automatically
included in Exhibit B to the Trademark(s) License Agreement. Medicis
undertakes to sign any amendment as Ipsen may request to the Trademark(s)
License Agreement so as to formalize the inclusion of any such Product
Extension and/or New Product in the scope of the Trademark(s) License
Agreement.
In case the Trademark(s) License Agreement terminates or expires while
this Agreement is still in force, Medicis shall not grant any right under
the Trademark(s) to any Third Party or Affiliate outside the Territory,
nor shall Medicis make any use of the Trademark(s) outside the Territory.
The Trademark(s) License Agreement shall continue in full force and effect
notwithstanding the termination or expiry of this Agreement unless
otherwise expressly provided for in the Trademark(s) License Agreement.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
12.3.2 Ipsen shall not, and Ipsen shall ensure that its Affiliates do not,
register or use a trademark or trade name the same as or confusingly
similar to the Trademarks in the Territory, or outside the Territory but
in the Field. Neither party shall register or use, and each party shall
ensure that its respective Affiliates do not register or use, a
trademark or trade name the same as or confusingly similar to any
trademark or trade name proprietary to the other party or any of such
other party's Affiliates, or under which the other party or any of any
of its Affiliates markets Products or similar aesthetic products whether
in or outside the Territory.
12.3.3 Medicis hereby grants Ipsen, during the term of this Agreement, an
exclusive option which Ipsen may exercise from time to time during this
Agreement, to acquire the Trademarks in one or more countries outside
the Territory as indicated from time to time by Ipsen, under reasonable
commercial purchase conditions to be negotiated in good faith between
Medicis and Ipsen. Should Medicis and Ipsen be unable to reach agreement
with respect to such purchase conditions, Ipsen's option shall not be
extinguished and may be further exercised by Ipsen for the same and/or
other country/ies outside the Territory whenever Ipsen deems appropriate
during this Agreement
12.4 Each party shall notify the other in accordance with this Agreement
promptly upon becoming aware of the same that:
(i) there exists an actual or potential infringement or misappropriation
by Third Parties in the Territory of intellectual property rights
covering the Products, including the Know-How and the results of the
Regulatory and Development Program;
(ii) the Products or any intellectual property rights covering the
Products, including the Know-How and the results of the Regulatory and
Development Program, might or actually infringe or misappropriate, or
are dependent upon a Third Party intellectual property right in the
Territory.
12.4.1 With respect to the notification referenced in Article 12.4(i) above
and except if the actual or potential infringement relates to the
Trademark(s):
Ipsen shall have the right, but not the obligation, at its own
discretion and at its own expense, to institute, prosecute, and control
any action or proceedings with respect to such actual or potential
infringement or misappropriation. Medicis shall provide Ipsen with all
reasonable assistance for such purposes; further, Medicis shall have the
right to participate at its own expense in any such action or
proceedings in order to obtain damages for any loss or prejudice
suffered by its business but the control of such action or proceedings
shall remain with Ipsen. Any monetary remedy obtained by Ipsen as a
result of any proceedings taking place pursuant to the present Article,
shall belong solely to Ipsen, provided however that in case of Medicis's
participation in any such actions or proceedings at Medicis's cost,
Medicis shall be entitled to receive that portion of the remedy
corresponding to compensation of Medicis's prejudice reduced according
to the proportion of Medicis's financial contribution to the costs borne
by Ipsen for the entire action or proceeding.
In the event that Ipsen does not within a reasonable time period
intervene in relation to an infringement or misappropriation under
Article 12.4(i) above, then Medicis may, at its own discretion after
having liaised with Ipsen to this effect, commence such proceedings on
its own behalf, in which case Ipsen shall provide Medicis with all
reasonable assistance and support for such purposes including joining
the action where reasonably requested. Medicis shall be responsible for
the control of such proceedings and shall pay all expenses incurred in
connection therewith, subject however to permanent consultation and
co-ordination with Ipsen to take into account Ipsen's world-wide
strategy and image for the Products, including circulation to Ipsen of
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
any planned binding settlement so as to enable Ipsen to reasonably
comment thereupon. Any monetary remedy obtained by Medicis as a result
of such proceedings shall belong solely to Medicis.
12.4.2 With respect to the notification referenced in Article 12.4(ii) above:
Ipsen shall have the right but not the obligation, at its own discretion
and at its own expense to defend and control any action or proceedings
with respect to such actual or potential infringement or
misappropriation and Medicis shall provide Ipsen with all reasonable
assistance for such purposes including joining the action where
reasonably requested. Any monies that may be due to the Third Party as a
consequence of actions or proceedings under Article 12.4(ii) above,
shall be borne by the parties as set out in Article 12.6 hereof.
12.5 Each party shall notify the other in accordance with this Agreement
promptly upon becoming aware of the same that:
(i) there exists an actual or potential infringement by Third Parties in
the Territory of the Trademark(s);
(ii) the Trademark(s) might or actually infringe, or is dependent from,
a Third Party intellectual property right in the Territory.
12.5.1 With respect to the notification referenced in Article 12.5 (i) above:
Medicis shall have the right, but not the obligation, at its own
discretion and at its own expense, to institute, prosecute, and control
any action or proceedings with respect to such actual or potential
infringement. Ipsen shall provide Medicis with all reasonable assistance
for such purposes including joining such action where reasonably
requested; further, Ipsen shall have the right to participate at its own
expense in any such action or proceedings in order to obtain damages for
any loss or prejudice suffered by its business but the control of such
action or proceedings shall remain with Medicis. Any monetary remedy
obtained by Medicis as a result of any proceedings taking place pursuant
to the present Article, shall belong solely to Medicis, provided however
that in case of Ipsen's participation in any such actions or proceedings
at Ipsen's costs, Ipsen shall be entitled to receive that portion of the
remedy corresponding to compensation of Ipsen's prejudice reduced
according to the proportion of Ipsen's financial contribution to the
costs borne by Medicis for the entire action or proceeding.
In the event that Medicis does not within a reasonable time period
intervene in relation to an infringement under Article 12.5(i) above,
Ipsen may, at its own discretion after having liaised with Medicis to
this effect, commence such proceedings on its own behalf, in which case
Medicis shall provide Ipsen with all reasonable assistance and support
for such purposes including joining such action where reasonably
requested. Ipsen shall be responsible for the control of such
proceedings and shall pay all expenses incurred in connection therewith,
subject however to permanent consultation and co-ordination with Medicis
to take into account Medicis's strategy and image for the Trademark(s)
in the Territory, and subject to Ipsen seeking Medicis's written
approval prior to entering into any binding settlement or prior to
taking any irreversible decision applicable to, or omitting to perform
any action which could irreversibly affect, ongoing proceedings. Any
monetary remedy obtained by Ipsen as a result of such proceedings shall
belong solely to Ipsen.
12.5.2 With respect to the notification referenced in Article 12.5(ii) above:
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Medicis shall have the right but not the obligation, at its own discretion
and at its own expense to defend and control any action or proceedings
with respect to such actual or potential infringement and Ipsen shall
provide Medicis with all reasonable assistance for such purposes including
joining such action where reasonably requested, subject to written notice
to Ipsen of any planned binding settlement or definitive actions or
omission so as to enable Ipsen to reasonably comment thereupon. Any monies
that may be due to the Third Party as a consequence of actions or
proceedings under Article 12.5(ii) above, shall be borne by the parties as
set out in Article 12.6 hereof.
12.6 In case Ipsen is by virtue of a final court decision or binding settlement
entered into in compliance with the terms of this Agreement under actions
or proceedings referred to in Article 12.4(ii) and/or Article 12.5(ii)
under the obligation to pay any monies to a Third Party, Medicis shall
reimburse Ipsen the portion of the payment obligations which correspond to
Medicis's infringing sales or activities in the Territory.
In case Medicis is by virtue of a final court decision or binding
settlement achieved or entered into in compliance with the terms of this
Agreement under actions or proceedings referred to in Article 12.5(ii)
above under the obligation to pay any monies to a Third Party, Ipsen shall
reimburse Medicis the portion of the payment obligations which are based
upon Ipsen's infringing sales achieved under the Trademark(s) outside the
Territory.
12.7 The provisions of this Article 12 shall survive the termination or
expiration of this Agreement for a period of ten (10) years.
13. NON COMPETITION
13.1 For the whole duration of this Agreement, Medicis undertakes not directly
nor indirectly (such as through any Medicis Affiliate) to seek purchasers
for the Product outside the Territory, nor sell nor offer for sale the
Product for any use whatsoever outside the Territory, nor to seek
purchasers for nor sell, nor offer for sale the Product for use outside
the Field within the Territory; however, Medicis's marketing and promotion
over the internet, radio, television or other broad-based media that
spills over into countries outside the Territory shall not be a breach of
this provision.
13.2 Except to the extent permitted by Article 20.5(b), ***, neither Medicis
nor its Affiliates will promote or distribute, either directly or
indirectly, any product for sale in the Territory in the Field having the
same indications in the Field, the same active ingredient as the Products,
or a directly competing muscle paralyzing effect (hereinafter referred to
as Competitor). As an exception to this Article 13.2, Medicis and its
Affiliates may directly or indirectly promote or distribute Competitors
for sale in the Territory in the Field during the above defined duration,
in case this Agreement is terminated by Medicis under Article 19.2(ii) due
to Ipsen's fundamental breach under this Agreement, and Ipsen did not
contest being in fundamental breach.
14. WARRANTIES
14.1 Medicis represents and warrants to Ipsen that:
- it is duly incorporated under the laws of Bermuda and has the power and
authority to execute and deliver this Agreement as well as to perform its
obligations hereunder, and that it has taken all corporate action
necessary to ratify such power and authority,
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
- it or its Affiliates have the necessary qualified personnel, equipment
and other means to perform Medicis's duties under this Agreement in a
timely manner in accordance with the terms hereof and further covenants
that it will continue to do so throughout the term of this Agreement,
- it is not directly or indirectly through Affiliates of Medicis or
otherwise, presently involved in any manner whatsoever in the development,
registration, distribution, and/or promotion, of products containing
botulinum toxin other than for the purpose and under the terms of this
Agreement, nor is it in the process of becoming so, nor does it have the
benefit of an option to acquire rights thereon.
- the execution and delivery of this Agreement does not conflict with or
constitute a default under any applicable laws or regulations or under any
contract, agreement, policy, other arrangement or understanding to which
it is a party or by which it is bound,
- no approval of any governmental body or consent of any person not a
party to this Agreement is required or advisable on the part of Medicis or
Medicis's Affiliates for the due execution and delivery of this Agreement
by Medicis and the performance of its obligations hereunder, and
- when executed and delivered by Medicis, this Agreement will be the
legally valid and binding obligation of Medicis, enforceable against
Medicis in accordance with its terms, except as may be limited by
bankruptcy, insolvency, reorganization, moratorium or other similar laws
relating to or affecting creditors' rights generally.
14.2 Ipsen represents and warrants to Medicis that:
- it is duly incorporated under the laws of England and has the power and
authority to execute and deliver this Agreement as well as to perform its
obligations hereunder, and that it has taken all corporate action
necessary to ratify such power and authority,
- it has the necessary qualified personnel, equipment and other means to
perform its duties under this Agreement in a timely manner in accordance
with the terms hereof and further covenants that it will continue to do so
throughout the term of this Agreement,
- the execution and delivery of this Agreement does not conflict with or
constitute a default under any applicable laws or regulations or under any
contract, agreement, policy, other arrangement or understanding to which
it is a party or by which it is bound,
- no approval of any governmental body or consent of any person not a
party to this Agreement is required or advisable on the part of Ipsen for
the due execution and delivery of this Agreement by Ipsen and the
performance of its obligations hereunder, or the exercise by Medicis of
its rights under this Agreement,
- when executed and delivered by Ipsen, this Agreement will be the legally
valid and binding obligation of Ipsen, enforceable against Ipsen in
accordance with its terms, except as may be limited by bankruptcy,
insolvency, reorganization, moratorium or other similar laws relating to
or affecting creditors' rights generally,
- it has, and during the term of this Agreement will maintain, ownership
and possession of all necessary rights to use all Know-How or other
intellectual property to grant the rights to Medicis under this Agreement
and shall maintain all regulatory files and Regulatory Approvals for
Products,
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
- neither it nor any Ipsen Affiliate has granted or assigned, and during
the term of this Agreement neither Ipsen nor any Ipsen Affiliate will
grant or assign, to any Third Party or Affiliate any rights that will
conflict with Medicis's rights under this Agreement.
Ipsen warrants that to the best of Ipsen's reasonable knowledge as on the
Effective Date:
- the conception, development, and reduction to practice of the Current
Product was not a willful misappropriation of any Third Party's or
Affiliate's trade secrets or other intellectual property,
- the conception, development, and reduction to practice of the Current
Product was not a misappropriation of any trade secrets or other
intellectual property covered by the HPA License,
- the Know-How necessary for the conception, development and manufacturing
of the Current Product does not violate or infringe any patent, copyright
or trademark issued by any country that is a member of the Paris
Convention for the Protection of Industrial Property.
- that there is no litigation, claims, disputes or actions pending or
threatened, and no interference, no nullity actions pending or threatened
with respect to (i) the Know-How, or adversely affecting the Know-How, or
(ii) Ipsen's ability to undertake and perform its obligations under this
Agreement.
14.3 The provisions of this Article 14 shall survive termination or expiration
of this Agreement for a period of 18 months except when by its terms a
representation or warranty sets forth a different duration.
14.4 EACH OF THE PARTIES AGREES THAT THE REPRESENTATIONS AND WARRANTIES OF THE
OTHER PARTY CONTAINED IN THIS AGREEMENT ARE THE EXCLUSIVE REPRESENTATIONS
AND WARRANTIES MADE BY THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT
AND THE TRANSACTIONS CONTEMPLATED HEREBY AND THAT SUCH OTHER
REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS
AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTIES OR MERCHANTABILITY, FITNESS OR NON-INFRINGEMENT, ALL OF
WHICH ARE HEREBY EXPRESSLY EXCLUDED AND DISCLAIMED.
No employee or agent of either party is authorized to make any
modification, extension or addition to the representations and warranties
of such party contained in this Agreement or to modify or expand the
remedies available in connection with any breach of this Agreement.
Medicis agrees that it and its Affiliates will not make any representation
or warranty to the purchaser of any Product manufactured by or on behalf
of Ipsen pursuant to this Agreement that is more extensive than, or that
is otherwise inconsistent with, Ipsen's representations and warranties
contained in this Agreement or in Ipsen's standard terms and conditions
applicable to the Products.
15. IPSEN DELIVERY COVENANT
In the event Ipsen fails to have at least one manufacturing facility for a
Product FDA-inspected and FDA-approved, at the time marketing batches of the
Product are reasonably required by Medicis for distribution in the Field in the
Territory, and except as long as and while such failure is due to a Force
Majeure event or to FDA's failure to inspect the manufacturing facility or to
notify Ipsen of FDA's decision with this respect, Medicis shall have the right
to terminate this Agreement pursuant to Article 19.2(x)
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CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
below and Ipsen shall pay Medicis*** USD (***) in liquidated damages, it being
understood that such payment shall be Medicis's sole and exclusive remedy for
Ipsen's failure under this Article 15.
16. LIABILITIES - INDEMNIFICATION
16.1 Medicis shall defend, indemnify and hold Ipsen (and its Affiliates and
their directors, officers, employees and representatives) harmless from
and against any and all losses, liabilities, claims, damages, suits, costs
and expenses any of them suffers, including the cost and expense of
handling, defending and settling claims and suits, if and to the extent
arising from (a) clinical studies involving the Products including without
limitation clinical studies to be performed under the Development and
Regulatory Program and development works under Current Agreements
conducted by Ipsen on behalf of Medicis and in conformity with Medicis's
instructions pursuant to Article 3.1, (b) the marketing, promotion,
advertising, transportation, handling, storage or distribution of Products
by Medicis, any of its Affiliates or any of their respective
subcontractors or agents, (c) any defect or alleged defect in labeling of
the Products, (d) any defect or alleged defect in the design of the
Products to the extent such design results from the clinical studies
performed under the Development and Regulatory Program, or (e) the
material breach by Medicis of its obligations or warranties under this
Agreement, except in each case for: (i) any such loss, liability, claims,
damages, costs or expenses to the extent caused by a breach by Ipsen of
its obligations and warranties under this Agreement, (ii) such claims,
damages and expenses to the extent caused by the gross negligence or
willful misconduct of Ipsen, Ipsen's Affiliates or Ipsen's Third Party
contractors, and (iii) such matters expressly described in Article 16.2 of
this Agreement with respect to which Ipsen is obligated to defend,
indemnify and hold Medicis harmless.
Medicis shall inform Ipsen, promptly upon becoming aware of the same, of
any claim or action against Medicis or Ipsen for which Medicis is
obligated to defend, indemnify and hold Ipsen harmless.
16.2 Ipsen shall defend, indemnify and hold Medicis (and its Affiliates and
their directors, officers, employees and representatives) harmless from
any and all losses, liabilities, claims, damages, suits, costs and
expenses any of them suffers, including the cost and expense of handling,
defending and settling claims and suits, if and to the extent arising from
any defect or alleged defect or mishandling in the packaging, storage,
manufacturing, testing or formulation of the Products, or the material
breach by Ipsen of its obligations or warranties under this Agreement,
except in each case for: (i) any such loss, liability, claims, damages,
costs or expenses to the extent caused by a breach by Medicis of its
obligations and warranties under this Agreement, (ii) such claims, damages
and expenses to the extent caused by the gross negligence or willful
misconduct of Medicis, Medicis's Affiliates or Medicis's Third Party
contractors, and (iii) such matters expressly described in Article 16.1 of
this Agreement with respect to which Medicis is obligated to defend,
indemnify and hold Ipsen harmless.
16.3 Medicis shall, during the term of this Agreement and for a period of six
(6) years thereafter, maintain insurance coverage pursuant to one or more
insurance policies in form reasonably satisfactory to Ipsen and
underwritten by financially sound and reputable insurers reasonably
satisfactory to Ipsen, against errors and omissions, contractual
liability, product liability relating to the design or labeling of the
Products, including but not limited to those hazards specified in Article
16.1., and other hazards specified by Ipsen.
All such insurance policies shall:
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
(i) provide for insurance coverage in an aggregate amount per year of not
less than USD 10 (ten) million for those matters described in Article 16.1
and in Article 16.3 first paragraph of this Agreement, arising before the
Product is first sold by Medicis in the Territory, and not less than USD
20 (twenty) million for those matters described in Article 16.1 and 16.3
first paragraph of this Agreement arising after the Product is first sold
by Medicis in the Territory;
(ii) include Ipsen as an additional named insured;
(iii) contain provisions that with respect to Ipsen, the insurance
policies may be cancelled only for nonpayment of premiums by Medicis after
not less than thirty (30) days notice of intent to cancel provided to
Ipsen; and,
(iv) contain provisions that the insurer will make payment to Ipsen as its
interests may appear under any such policy notwithstanding any defense
which such insurer may have against any of the other insureds on such
policy.
Medicis will furnish to Ipsen certificates of all such insurance policies:
- On the Effective Date (and within thirty (30) days of the date of each
anniversary of the related insurance certificate date), evidencing
coverage in accordance with this Article 16.3 including but not limited
to, insurance coverage in an aggregate amount per year of not less than
USD 10 (ten) million; and,
- at least sixty (60) days prior to the first Product sale by Medicis in
the Territory (and within thirty (30) days of the date of each anniversary
of the related insurance certificate date), evidencing insurance coverage
in accordance with this Article 16.3 including but not limited to,
insurance coverage in an aggregate amount per year of not less than USD 20
(twenty) million.
All such insurance certificates shall, among others, duly show that the
hazards referred to in this Article 16.3 are covered and insured, all of
which in compliance with the terms of this Article 16.3. Medicis shall not
commence work on any clinical trial with the Product nor achieve the first
Product sale in the Territory, without Ipsen's prior approval on Medicis's
related insurance coverage which Ipsen's consent to such policies shall
not be unreasonably withheld.
If Medicis is unable to secure or maintain all such insurance policies and
coverage as provided for herein, Ipsen may terminate this Agreement in
accordance with and subject to the cure periods under the provisions of
Article 19.2(ii).
16.4 Ipsen shall, commencing on the sixtieth (60th) day prior to the first
Product sale by Medicis in the Territory and then during the remainder of
the term of this Agreement and for a period of six (6) years thereafter,
maintain insurance coverage in an aggregate amount not less than USD ***,
pursuant to one or more insurance policies in form reasonably satisfactory
to Medicis and underwritten by financially sound and reputable insurers
reasonably satisfactory to Medicis, against errors and omissions,
contractual liability and products liability relating to the manufacture,
packaging, handling, storage, testing or formulation of the Products and
will furnish to Medicis certificates of all such insurance policies which
shall, among others, duly show that the hazards referred to in this
Article 16.4 are covered and insured, in compliance with the terms of this
Article 16.4.
16.5 Except as otherwise provided herein, in connection with any Third Party
claim for which either party hereto intends to seek indemnification from
the other party, the party requested to provide indemnification pursuant
to this Article 16 (the Indemnifying Party) shall have the sole control of
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
the defense, litigation or settlement of such claim, including the right
to intervene as co-defendant in legal proceedings and to conduct the
defense of any legal action on behalf of the other party, and shall have
the right to select the legal counsel who shall assist the parties with
respect to such claim. The Indemnifying Party shall consult with the other
party on the advancement of the proceedings and keep such other party
fully informed of all material developments in the proceedings. The
Indemnifying Party shall be excused from its obligation to defend and hold
harmless the other party with respect to Third Party claims, should such
other party:
(i) fail to give prompt notice to the Indemnifying Party of any such
claim and continuing information thereon, which failure materially
prejudices the defense of such claim; or
(ii) obtain release or indemnification from a Third Party from such
claim, but only to the extent of such other release or
indemnification.
The non-indemnifying party shall be entitled to undertake all protective
measures or actions this party may deem reasonably appropriate in order to
secure its factual or legal position, or to prevent the situation from
aggravating; provided that the non-indemnifying party may not settle,
consent to any judgment or otherwise admit liability in connection with
any claim without the prior written consent of the Indemnifying Party,
which consent shall not be unreasonably withheld.
Notwithstanding the foregoing, if Ipsen determines in good faith that a
claim or action by a Third Party with respect to which it may be entitled
to seek indemnification from Medicis pursuant to this Article 16 is
reasonably likely to have a material adverse effect on any Regulatory
Approval held by Ipsen outside the Territory or Field, or on Ipsen's
marketing or distribution of the Products outside the Territory or Field,
then upon delivering notice of such determination to Medicis (i) Ipsen
shall be entitled to control the defense of such claim or action
(including any settlement of such claim or action) with counsel selected
by Ipsen, (ii) Ipsen shall consult with Medicis on the advancement of the
proceedings and keep Medicis fully informed of all material developments
in the proceedings, (iii) Medicis shall be entitled to participate in (but
not control) the defense of such claim or action at its expense with
separate counsel of Medicis's choosing and (iv) Ipsen shall be entitled,
without impairing its rights to indemnification hereunder, to settle or
compromise such claim or action without the consent of Medicis provided
that it does so in a commercially reasonable manner and such settlement or
compromise does not involve any admission of liability or fault of any
kind on the part of Medicis or its Affiliates.
16.6 Notwithstanding any provision of this Agreement to the contrary, neither
party shall be entitled in connection with any breach or violation of this
Agreement to recover from the other party any [(i) punitive, exemplary or
other special damages or (ii) any indirect, incidental or consequential
damages, or (iii) damages relating to loss of profit, business opportunity
or business reputation. Each party, as a material inducement to the other
party to enter into and perform its obligations under this Agreement,
hereby expressly waives its right to assert any claim against the other
party relating to such damages and agrees not to seek to recover such
damages in connection with any action, suit or proceeding relating to this
Agreement. The foregoing shall not limit the right of either party to be
indemnified in accordance with the provisions of this Article 16 with
respect to all components of any claim, award or judgment against such
party by any Third Party not affiliated with either party to this
Agreement or recover direct damages.
16.7 The provisions of this Article 16 shall survive expiration or termination
of this Agreement..
16.8 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, THE REMEDIES
FOR BREACH OF THIS AGREEMENT SET FORTH IN THIS ARTICLE 16 CONSTITUTE THE
SOLE AND EXCLUSIVE RECOURSE AND REMEDY OF EACH PARTY FOR MONETARY
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
DAMAGES WITH RESPECT TO ANY BREACH OF THE OBLIGATIONS OR WARRANTIES OF THE
OTHER PARTY PROVIDED IN THIS AGREEMENT.
17. CONFIDENTIALITY
17.1 Medicis shall keep absolutely secret and confidential and shall not use or
disclose for purposes other than the performance of the present Agreement,
all confidential or trade secret information communicated to it by Ipsen
whatever its nature or form, and all information to which Medicis has
access, or which comes to Medicis' knowledge, whether before or after the
Effective Date, concerning without limitation the Product, the Know-How,
the Development and Regulatory Program and results thereof, or Ipsen's
activities whatever the field and any information related to this
Agreement.
17.2 Ipsen shall keep absolutely secret and confidential and shall not use or
disclose for purposes other than the performance of the present Agreement,
all confidential or trade secret information communicated to it by
Medicis' whatever its nature or form, and all information to which Ipsen
has access, or which comes to Ipsen knowledge, whether before or after the
Effective Date, concerning without limitation the Medicis Customer Base,
or Medicis's activities whatever the field and any information related to
this Agreement.
17.3 Without limiting Section 17.2, each party shall give access to the above
mentioned information only to those of its directors, officers, employees,
attorneys, agents, auditors, lenders, actual or prospective financing
sources, distributors, Third Party contractors and Affiliates (hereinafter
all referred to as Recipients), who have a need to know such confidential
information, and who have agreed to confidentiality obligations no less
constraining than those contained herein and each party shall require
compliance by those Recipients with the confidentiality obligations
mentioned in this Article 17.
Medicis undertakes that its distributors and Third Party contractors
engaged in activities relating to this Agreement, will be bound by and
respect the confidentiality obligations mentioned in this Article 17.
Notwithstanding anything contained in this Agreement, Medicis and Ipsen
shall be free to disclose information regarding this Agreement and the
transactions contemplated herein as may be necessary to comply with the
applicable rules of the U.S. Securities Exchange Commission (SEC), the
French Autorites des Marches Financiers (AMF), and/or any securities
exchange or quotation system on which its securities may be listed or
quoted, subject to prior notice to the other party and, whenever
reasonably feasible, to proceeding to such disclosure under
confidentiality measures available with the concerned authority or system.
In case Medicis determines that it must disclose this document pursuant to
SEC rules in the United States, it shall use commercially reasonable
efforts to obtain confidential status for the terms and conditions of this
Agreement to the greatest extent possible under applicable law. Medicis
shall notify Ipsen of its decision to make such disclosure, shall consult
with Ipsen on such issue to the extent reasonably practicable and shall
keep Ipsen fully informed as to the status of Medicis's efforts to
maintain the confidential character of the terms and conditions hereof. In
case Ipsen determines that it must disclose this document pursuant to the
listing rules of the AMF, it shall use commercially reasonable efforts to
obtain confidential status for the terms and conditions of this Agreement
to the greatest extent possible under applicable law. Ipsen shall notify
Medicis of its decision to make such disclosure, shall consult with
Medicis on such issue to the extent reasonably practicable and shall keep
Medicis fully informed as to the status of Ipsen's efforts to maintain the
confidential character of the terms and conditions hereof.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
17.4 Each party shall have no obligation to maintain the confidentiality of any
specific item of information that is:
- in the public domain or otherwise available to the public without
restriction on its use, or,
- publicly known through no fault of such party or the Affiliates and
Third Parties identified in Article 17.3 above, or,
- available to the concerned party without restriction on its use, from a
person not having a direct or indirect confidential relationship with the
other party.
17.5 The confidentiality obligations mentioned hereabove shall survive the
expiration or termination of this Agreement for so long as each item of
confidential obligation does not meet any of the criteria identified in
Article 17.4.
18. PUBLICATION - ANNOUNCEMENT
18.1 Each party or its Affiliates may make public communication or scientific
publications relating to the existence and subject matter of this
Agreement, to the Development and Regulatory Program and the results
thereof, or to their activities under this Agreement, but only provided
they have both agreed on the draft publication or announcement, which
agreement shall not be unreasonably withheld by either party.
Each party shall endeavor to control publications by Third Parties in this
respect and shall endeavor to insert appropriate wording in its agreements
with such Third Parties to this effect.
18.2 All publications shall be submitted to the other party at least thirty
(30) days prior to the intended communication or publication date.
All publications and communications made by a party or its Affiliates
shall state each party's collaboration to the Development and Regulatory
Program unless the concerned party otherwise decides, and shall state the
origin of the Product in a wording agreeable to Ipsen unless Ipsen decides
otherwise.
Unless expressly approved in advance and in writing such approval not to
be unreasonably withheld, neither party shall make reference to this
Agreement (including without limitation its financial terms) in any
publicly available statement.
18.3 Notwithstanding the provisions of this Article 18, neither party may take
any action including but not limited to disclosing any information to any
Third Party which will or might jeopardize the ability of either party to
obtain any patent or other protection which that party is entitled to
obtain pursuant to this Agreement.
18.4 This Article 18 shall survive termination or expiration of this Agreement
for a period of ten (10) years).
19. TERM - TERMINATION
19.1 This Agreement shall come into force as of the Effective Date. Unless
earlier terminated as expressly permitted herein, the term of this
Agreement shall expire on 28 September 2019. Ipsen shall use its
commercially reasonable efforts to negotiate an extension of the duration
of its ***, beyond 28 September 2019. If and when Ipsen obtains such
extension, the term of this
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Development and Distribution Agreement will be automatically adjusted to
the same duration (the Initial Term).
Recognizing that if the Agreement is not terminated before expiry of the
Initial Term, Medicis will have made substantial investments in developing
the Current Product sales in the Territory in the Field, Medicis shall
have a first right of refusal over Third Parties to renew this Agreement
after the Initial Term for subsequent additional periods of *** each,
under the following conditions:
- Medicis shall notify in writing to Ipsen of its intention to renew this
Agreement at least one (1) year prior to the expiry of the Initial Term or
of any subsequent *** period;
- Ipsen and Medicis shall mutually agree upon and execute any required
amendment to this Agreement at least six (6) months prior to the expiry of
the Initial Term or of any subsequent *** period, during which period the
parties shall negotiate in good faith with respect to any such amendment;
- Failing execution by both Ipsen and Medicis of the necessary amendment
to this Agreement within the above delay, Ipsen shall be free to entrust
any Third Party or Affiliates with the promotion, distribution and sale of
the Products (including the Current Products) in the Territory in the
Field or to conduct such activities itself.
19.2 Early Termination by either Party: This Agreement may be terminated prior
to expiration of the term hereof in accordance with the following:
(i) by either party, with immediate effect, if the other party becomes
insolvent, is declared bankrupt, put into liquidation, whether
voluntarily or by court decision, is obliged to make an assignment
of its assets to the benefit of its creditors, or requests the
appointment of a receiver or is subject to a similar procedure, upon
written notice with immediate effect;
(ii) by either party, if the other party is in breach of any of its
fundamental obligations hereunder and, where that breach is capable
of remedy has not cured such breach, within sixty (60) days from the
receipt of a notice sent to it to that effect by the terminating
party without further notice; provided that the terminating party is
not itself in breach of any of its fundamental obligations under
this Agreement;
(iii) by either party, immediately upon notice to the other party, if
force majeure events, as hereinafter defined, prevent either party
from fulfilling its obligations hereunder during a period of more
than six (6) consecutive months;
(iv) by Medicis, in accordance with Article 3.2.3 above;
(v) by Ipsen in accordance with Article 3.2.4 above;
(vi) by Medicis, as to the rights and obligations of the parties under
this Agreement with respect to Canada or Japan, as applicable, in
accordance with Article 3.3.1 above;
(vii) by Medicis, as to the rights and obligations of the parties under
this Agreement with respect to Canada or Japan, as applicable, in
accordance with Article 3.3.3 above;
(viii)by Ipsen, as to the rights and obligations of the parties under
this Agreement with respect to Canada or Japan, as applicable, in
accordance with Article 3.3.4 above;
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
(ix) by Ipsen, in accordance with Article 6.1.9 above;
(x) by Medicis, in accordance with Article 15 above; and
(xi) as to a Product Extension or New Product, by either party,
immediately upon notice to the other party, if the terminating party
in good faith reasonably believes, based on objective, demonstrable
evidence that serious adverse effects not known on the Effective
Date or at the time Ipsen grants rights to Medicis on any such
Product Extension or New Product, attributable to the Product are
likely to occur or have occurred; in such case, the terminating
party shall provide to the non-terminating party written evidence
warranting such belief.
19.3 If the relevant government authorities of the Territory suspend,
withdraw or cancel any of the Products Regulatory Approvals for any
reason whatsoever, Ipsen and Medicis shall discuss in good faith the
necessary amendments to the terms and conditions of this Agreement in
connection with the concerned Product, and Ipsen shall have the right to
withdraw the countries concerned from the Territory or to terminate this
Agreement should all Regulatory Approvals be withdrawn, cancelled, or
suspended and not reinstated within 365 days.
19.4 Any and all amounts outstanding at the date of termination or expiry of
this Agreement, shall remain due and be paid by Medicis or Ipsen, as
appropriate, in due time.
19.5 Consequences of termination or expiration:
This Article 19.5 shall apply in case this Agreement is terminated or
expires in accordance with its terms.
19.5.1 (i) In the event of early termination or expiry of this Agreement
Medicis shall (and Medicis shall cause its Affiliates to) forthwith,
upon Ipsen's request: (a) refrain from developing, using, promoting,
selling and distributing, directly or indirectly, the Product in the
Territory, or using any of the Know-How or of the results of the
Development and Regulatory Program; and (b) perform, on behalf of Ipsen
and at Ipsen's expense, for a period of six (6) weeks from the date of
receipt of the termination notice, all on-going studies of the
Development and Regulatory Program, or subcontract such on-going studies
of the Development and Regulatory Program, to a Third Party to which
Ipsen has no reasonable objection, so as to smoothly transfer all such
commitments to Ipsen during such six (6) week period;
(ii) In the event of early termination or expiry of this Agreement
Medicis shall transfer to Ipsen within three (3) months at the latest as
from the date of termination or expiration of this Agreement: (a) all
artwork including layout, print pattern, and films, relating to the
Products promotional material conceived by Medicis for purposes of this
Agreement; (b) all Products promotional material supplied by Ipsen to
Medicis; (c) a list of Medicis's (and/or Medicis's distributors' or
Third Party contractors') Field Customers; and (d) a report on Medicis's
(and/or Medicis's distributors' or Third Party contractors') sales and
promotional activities, if such report has not been issued within the
twelve-month period preceding the date of termination or expiration of
this Agreement.
19.5.2 Upon the termination or expiration of this Agreement (for reasons other
than Ipsen's bankruptcy or Ipsen's uncured fundamental breach), Medicis
hereby grants Ipsen and Ipsen's Affiliates, for a period of ninety (90)
days a royalty-free right to use and reproduce the Products promotional
artworks and other promotional items conceived by Medicis for the
purpose of this Agreement, for the promotion by Ipsen or any Affiliated
or appointed Third Party, of the Products in the Territory
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
in the Field, provided however that Ipsen shall adapt such artwork so
as to avoid any reproduction of Medicis's logo or name, as well as to
avoid any reproduction of the Trademark(s) in the Territory except as
otherwise permitted in accordance with the Trademark(s) License
Agreement.
19.5.3 Ipsen and Medicis shall discuss in good faith and agree, within thirty
(30) days after notice of termination is served by one party to the
other or within the three (3) months before expiry of this Agreement,
upon a time table for rapid transfer of the Products physical
distribution in the Territory from Medicis to Ipsen or any of Ipsen's
designee (to the exception of the Products promotion which shall be
governed by the provisions of Article 19.5.5) in order to avoid any
interruption of the Products distribution in the Territory. Unless this
Agreement is terminated by Medicis for fundamental breach by Ipsen
under this Agreement, in which case the following provisions shall be
at Medicis's option, should Ipsen so requests, Medicis undertakes to
keep distributing the Products in the Territory during a minimum period
of six (6) weeks as from the date when this Agreement expires.
19.5.4 In all cases, when Medicis ceases distributing the Products in the
Territory (whether immediately upon termination of after the
transitional period referred to in Article 19.5.3), Medicis shall, at
Ipsen's option, destroy all unsold quantities of Products and provide
to Ipsen the corresponding certificate of destruction hereof, or return
any unsold stock to Ipsen or its nominee provided said stock is in good
saleable condition. Conditions for destruction of the stocks of
Products shall be defined in the Technical Agreement specified in
Article 5.14 and shall be binding on Medicis.
All expenses and costs of such return shall be borne by Ipsen unless
termination of this Agreement occurs as a result of Medicis being in
uncured fundamental breach under this Agreement.
Ipsen shall repurchase all such returned stock of Products at the
Products sale price from Ipsen to Medicis referred to in Article 5
above (or as further revised under Article 6.4), plus a *** percent
(***%) stocking fee, to be paid to Medicis within thirty (30) days
after invoice for return of unsold Products. Should the Products not be
in good saleable condition, Medicis shall destroy all such remaining
stock subject to Ipsen's prior written agreement, and provide to Ipsen
the corresponding certificate of destruction hereof.
19.5.5 Unless Ipsen waives application of this Article 19.5.5, Medicis shall
have the option to continue or to cease the promotion of the Products
in the Territory during the term of the notice of termination (if any).
Medicis shall inform Ipsen of its decision within two (2) weeks after
the date of the notice of termination. Should Medicis decide not to
promote the Products during such term of notice (i) Medicis hereby
grants Ipsen or Ipsen's designee for the promotion of the Products in
the Territory, during the term of the notice plus three (3) months, a
royalty free right to use all Medicis's Products promotional materials,
even though such materials bear Medicis's name and logo or the
Trademark(s), and (ii) Medicis shall provide Ipsen with sufficient
quantities of Products promotional materials to cover the promotion of
the Products during the aforesaid period.
This Article 19.5.5 is without prejudice to any further rights which
Medicis may grant to Ipsen on the Trademark(s) in the Territory under
the Trademark(s) License Agreement.
19.6 Termination of this Agreement by either Party under this Article 19
shall not require resort to any court or compliance with any other
formality than as provided for herein, and shall not prejudice the
right of either party to recover any damages for breach of the present
Agreement.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
20. MISCELLANEOUS
20.1 Except where otherwise noted, correspondence, notices and payments
pursuant to this Agreement shall be in writing and shall be sent by
international overnight courier and by fax, addressed to the following
attention:
- For Ipsen:
Ipsen Ltd, 190 Bath Road, Slough, Berkshire SL1 3XE, United Kingdom -
Attention Company Secretary
Copy to: SCRAS S.A.S., Attention General Counsel, 24 rue Erlanger,
75016 Paris, France
- For Medicis:
Aesthetica Ltd., Dorchester House, 7 Church Street, Hamilton HM 11,
Bermuda - Attention President
Copy to: General Counsel, Medicis Pharmaceutical Corporation, 8125
North Hayden Road, Scottsdale, Arizona 85258, United States of America
Or such other address, email or facsimile as a party shall from time to
time advise at the above address.
Such correspondence and notice shall be deemed to have been received on
the earlier of the date of the confirmed transmission of any fax or two
business days after the date when sent by international overnight
courier.
20.2 This Agreement will be executed in duplicate originals and may be
executed in two counterparts, and all of such counterparts taken
together shall be deemed to constitute one and the same agreement.
20.3 This Agreement, together with the Appendices hereto, sets forth the
complete and final agreement between Ipsen and Medicis with regard to
its subject matter and supersedes and terminates all prior agreements,
arrangement, undertakings, and understandings, arrangements with regard
to the same or related subject matter between the parties, whether oral
or in writing, other than the letter signed by the parties of even date
herewith.
20.4 The waiver by any party of any default under this Agreement or of any
covenant, agreement or condition contained herein shall not be
construed to constitute a waiver of any other default or breach whether
similar or not.
20.5 (a) Subject to Section 20.5(b), neither party shall have the right to
assign or delegate any of its obligations hereunder to any Third Party
without the prior written consent of the other, which will not be
unreasonably withheld or delayed. Notwithstanding the foregoing, in
connection with a Change-of-Control of either party, the party subject
to the Change-of-Control transaction may assign this Agreement, and/or
delegate its obligations hereunder, to the Third Party assuming control
of such party without the consent of the other party unless the Third
Party seeking to obtain control is an actual or potential competitor
whether inside or outside the Territory for the Product, i.e., is
either marketing or promoting a product having the same active
ingredient or having a directly competing muscle paralyzing effect, or
is developing one or more formulations of botulinum toxins for
aesthetic or other medical applications and/or has announced a plan or
intention to market such a product whether inside or outside the
Territory. For purposes of this Agreement, a Change-of-Control means
(i) the acquisition by any person of a majority of the
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
voting securities of a party , (ii) a merger, reorganization or other
business combination in which the stockholders of the party
beneficially own less than a majority of the voting securities of the
surviving entity, (iii) the sale, conveyance transfer, lease or other
disposition of all or substantially all of the assets of a party to a
non-Affiliate party, or (iv) the sale, conveyance, transfer, lease or
other disposition of the party's botulinum toxin products business.
(b) Before giving effect to the prohibitions of Section 20.5(a) and
before giving effect to Article 13.2, in the event that Medicis or
Medicis's Affiliate is subject to a Change-of-Control or comes under
common control with a Third Party that has direct or indirect ownership
or control of a product that contains botulinum toxin, then within
ninety (90) days following such event, unless extended by mutual
consent with Ipsen, (i) Medicis (or, if applicable, Medicis's
Affiliate) and such Third Party shall seek and complete divestiture of
such Third Party's product that contains botulinum toxin or (ii) the
parties and such Third Party shall use commercially reasonable efforts
to ascertain whether they can, and, if so, negotiate in good faith
towards a mutually acceptable arrangement whereby they can, in
compliance with applicable laws, jointly exploit such Third Party's
product that contains botulinum toxin together with the Product. In the
event that neither (i) nor (ii) is capable of completion, Ipsen shall
have the right to terminate this Agreement and Ipsen shall be entitled
to retain all such consideration and/or milestone payments that shall
have been paid by Medicis to Ipsen under this Agreement, prior to any
such termination, it being understood that, in such event, Medicis
shall not be entitled to any compensation or restitution, whatsoever.
20.6 This Agreement does not constitute an agency, joint venture or
partnership and does not entitle a party to bind the other or to hold
itself out as the representative of the other.
20.7 If any provision of this Agreement shall for any reason be held to be
void, invalid, illegal or unenforceable in any respect, no other
portion of this Agreement shall be affected thereby; provided however,
that the parties shall in such case promptly negotiate in good faith
such adjustments in this Agreement as shall be necessary to make it
fair and equitable to the parties.
20.8 Each party shall, without further charge, perform all such acts and/or
execute all such documents (or, where necessary procure the same) as
are necessary to give full effect to this Agreement.
20.9 Force majeure: Non-performance of a party (other than for the payment
of money) shall be excused to the extent that performance is rendered
commercially impracticable by strike, fire, earthquake, flood,
governmental acts or orders or restrictions, terrorist acts, war,
failure of suppliers, or any other reason where failure to perform
could not be reasonably foreseen, is beyond the reasonable control, and
is not caused by the negligence, intentional conduct or misconduct of
the non-performing party; provided, however, that the non-performing
party shall use commercially reasonable efforts to resume performance
as soon as reasonably practicable.
20.10 This Agreement shall be governed and construed in accordance with the
laws of the State of New York (United States of America) as if all
parties and actions occurred within New York, i.e., without the
application of New York's law regarding choice of external law.
20.11 The parties agree that all disputes arising in connection with or
related to this Agreement, including failure by the parties to reach
agreement with respect to the matters described in Article 5.12, 9.1 or
10.3 (a Dispute), shall be resolved in accordance with this Article
20.11 and Articles 20.12 and 20.13, as applicable. Failure by the
parties to reach agreement with respect to matters described in
Articles 6.1.5 and 6.4 shall be resolved solely in accordance with
Article 20.12.
42
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
Upon the written request of either party, both parties shall appoint a
designated representative, who shall be a senior executive of such
party with relevant knowledge and authority with respect to the subject
matter of the Dispute, whose task it will be to meet for the purpose of
endeavoring to resolve such Dispute (Level 1 Review). The designated
representatives, together with any other attendants or secretaries
appointed by either party, shall meet as often as the parties
reasonably deem necessary to discuss the Dispute and negotiate in good
faith in an effort to resolve the Dispute without the necessity of any
formal proceeding. Any resolutions reached as to any Dispute pursuant
to the Level 1 Review process shall be binding, final and conclusive on
the parties.
20.12 In the case of any Dispute arising under Article , 6.1.5, 6.4, 9.1 or
10.3, if resolution of the Dispute cannot be reached within thirty (30)
days after the first Level 1 Review meeting when applicable (the Level
1 Termination Date) or within the time period assigned for discussions
in Articles 6.1.5 and 6.4, the parties shall refer such Dispute to a
Third Party expert jointly appointed by the parties. In the case of any
Dispute arising under Article 6.4, 9.1 or 10.3, the Third Party expert
appointed by the parties shall be a qualified accounting firm not the
regular accounting firm of either party. In the case of any Dispute
arising under Article 5.12, the Third Party expert shall be a
pharmaceutical industry qualified consulting legal entity or
individual, with adequate knowledge in the matters covered by such
Article 5.12. In the case of any Dispute arising under Article 6.1.5,
the Third Party expert shall be a qualified pharmaceutical industry
business consulting legal entity or individual with adequate knowledge
in the matters covered by Article 6.1.5. Should the parties fail to
agree upon a Third Party expert, either party may request the American
Arbitration Association to appoint the Third Party expert, which
appointment shall be made by the American Arbitration Association
within 15 (fifteen) calendar days at the latest after either party's
request thereto.
For purposes of resolving Disputes submitted to the Third Party expert,
the parties may retain such professionals and experts, and submit such
documentary evidence or testimony, as they may reasonably require,
subject to the directions and orders of the Third Party expert and
subject to compliance with the procedures and limitations specified in
Articles 6.1.5 and 6.4, which shall govern and control the resolution
of any Dispute arising under such Articles. Any determinations by the
Third Party expert shall be binding, final and conclusive on the
parties. Each of the parties shall bear their own costs and expenses
and shall share the expert's expenses equally. In his or her
discretion, the expert may award the prevailing party its reasonable
fees, costs and other expenses from the other party.
20.13 In the case of any Dispute not subject to Third Party expert resolution
pursuant to Article 20.12, if resolution of the Dispute cannot be
reached within thirty (30) days after the Level 1 Termination Date, the
parties shall submit the Dispute to mediation in accordance with the
Commercial Mediation Rules of the American Arbitration Association
(AAA) and shall bear equally the costs of the mediation. The parties
will act in good faith to jointly appoint a mutually acceptable
mediator, seeking assistance in such regard from the AAA within thirty
(30) days after the Level 1 Termination Date. The parties agree to
participate in good faith in the mediation and negotiations related
thereto for a period of thirty (30) days commencing with the selection
of the mediator and any extension of such period as may be mutually
agreed to by the parties.
If the parties cannot agree to a mediator within thirty (30) days after
the Level 1 Termination Date or if the Dispute is not resolved within
forty-five (45) days after the beginning of the mediation and any
extension of such periods as mutually agreed to by the parties, the
Dispute shall be referred to and conclusively resolved by arbitration
under the Rules of Commercial Arbitration of the AAA, which rules are
deemed to be incorporated by reference herein.
43
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
The arbitration shall be conducted by a single arbitrator who shall be
chosen jointly by the parties or, in the event they cannot agree, in
accordance with the then-applicable AAA rules. The place of arbitration
shall be in New York, New York, or such other place as the parties may
agree upon in writing and the arbitration shall be conducted in the
English language.
Either party may file any award rendered by the AAA arbitrator, and may
obtain enforcement of it, in any court of competent jurisdiction.
Notwithstanding the referral of any Dispute arising out of or in
connection with this Agreement to mediation or arbitration pursuant to
this Article 20.13, both parties shall remain free to apply to any
competent judicial authority for interim, injunctive or conservatory
relief, provided that the making of any order by the relevant judicial
authority in this regard shall not in any way prejudice the above
tribunals' powers to make a determination on the matter referred to
them in accordance with the Rules of Commercial Arbitration of the AAA.
Each party acknowledges that monetary damages may not be a sufficient
remedy for the violation of the non-competition covenants set forth in
Article 13 of this Agreement or the unauthorized disclosure of
information in violation of the covenants set forth in Article 17 of
this Agreement, and that the other party be entitled, without waiving
any other rights or remedies, to such injunctive and other equitable
relief (without bond and without the necessity of showing actual
monetary damages) as may be deemed proper by a court of competent
jurisdiction.
If either party employs attorneys to enforce any rights arising out of
or relating to this Agreement, the prevailing party shall be entitled
to recover reasonable attorneys' fees.
20.14 Articles 20.10 to 20.14 shall survive termination or expiry of this
Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement,
through their duly appointed and authorized representatives, to be
executed in duplicate.
[Signature Page Follows]
44
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AND EXCHANGE COMMISSION.
Ipsen Ltd.
/s/ Alistair Stokes
- ----------------------------------------
Name: Alistair Stokes
Title: Chief Executive Officer
Date: March 17, 2006
Aesthetica, Ltd.
/s/ Mark A. Prygocki, Sr.
---------------------------------------
Name: Mark A. Prygocki, Sr.
Title: President
Date: March 17, 2006
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
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AND EXCHANGE COMMISSION.
APPENDIX 1
IPSEN BIOPHARM LIMITED
SPECIFICATIONS FOR DYSPORT FINISHED PRODUCT
***
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AND EXCHANGE COMMISSION.
APPENDIX 2 - U.S. PROGRAM
(NON-U.S. PROGRAM TO BE ATTACHED IN ACCORDANCE WITH ARTICLE 3.3.1)
***
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(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
APPENDIX 4
PRODUCT DATA FORWARDED TO MEDICIS
***
APPENDIX 5 - TRADEMARK(S)
Serial/Application Registration
Trademark Country Status Number Number
- ---------- ------------- ---------- ------------------ ------------
RELOXIN United States Registered 78267163 2920018
RELOXIN Australia Registered 1031310 1031310
RELOXIN Hong Kong Registered 300325449 300325449
RELOXIN Japan Registered 2004-107417 4883778
RELOXIN New Zealand Registered 721857 721857
RELOXIN Singapore Registered T0420477B T0420477B
RELOXIN Argentina Pending 2,556,368
RELOXIN Brazil Pending 826989420
RELOXIN Canada Pending 1225120
RELOXIN China Pending 4404754
RELOXIN European Pending 3550878
Community
RELOXIN Mexico Pending 689658
RELOXIN Russian Pending 2004727366
Federation
RELOXIN South Korea Pending 40-2004-53609
RELOXIN Taiwan Pending 093054832
APPENDIX 6 - MEDICIS DISTRIBUTION SYSTEM
Medicis contracts with McKesson for distribution services.
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CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
APPENDIX 7 - LIST OF INITIAL MEMBERS OF REVIEW COMMITTEE
IPSEN's appointed members on the Review Committee :
***
MEDICIS's appointed members on the Review Committee :
***
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
APPENDIX 8 - CURRENT PRODUCT SUPPLY PRICE
For the first *** vials of *** units of botulinum toxin type A activity
per vial delivered to MEDICIS in any calendar year: USD *** per vial.
For the next *** vials of *** units of botulinum toxin type A activity per
vial delivered to MEDICIS in the same calendar year: USD *** per vial.
For any vial of *** units of botulinum toxin type A activity per vial in
excess of *** vials of *** units of botulinum toxin type A activity per
vial delivered to MEDICIS in a same calendar year: USD ** per vial.
The Current Product supply price is expressed before any valued added tax
(VAT) or other taxes whatsoever based on the supply price.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A TRIPLE ASTERISK
(***). THE CONFIDENTIAL PORTIONS HAVE BEEN SEPARATELY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
APPENDIX 12 - LIST OF CURRENT AGREEMENTS
INAMED CORPORATION RELOXIN-RELATED THIRD PARTY CONTRACTS
***