<PAGE>
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.
<PAGE>
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
<TABLE>
<S> <C>
<C>
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
</TABLE>
<TABLE>
<S>
<C>
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)
</TABLE>
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
***.
8
<PAGE>
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
9
<PAGE>
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.
10
<PAGE>
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
<PAGE>
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
12
<PAGE>
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).
13
<PAGE>
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.
14
<PAGE>
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 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.
15
<PAGE>
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
16
<PAGE>
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.
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
17
<PAGE>
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.
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
