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Bayer Schering
Pharma AG,
Müllerstraße 178,13353 Berlin, Germany
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(hereinafter
referred to as “BSP”)
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EPIX
Pharmaceuticals Inc.,
4 Maguire Rd
Lexington, MA 02421, USA
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(hereinafter
referred to as “EPIX”)
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TMC Pharma
Services, Ltd
Parfitts Farm, Chequers Lane
Eversley, Hants RG27 ONT, UK
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(hereinafter
referred to as “TMC”);
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Lantheus
Medical Imaging, Inc.
331 Treble Cove Road
North Billerica, MA
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(hereinafter
referred to as “Lantheus”)
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(BSP, EPIX, TMC
and Lantheus hereinafter collectively referred to as “the
Parties” and each a “Party”)
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WHEREAS,
BSP (previously acting under the name Schering AG) and EPIX entered
into a Strategic Collaboration Agreement dated June 9, 2000 as
amended on December 22, 2000 (hereinafter referred to as
“the Collaboration Agreement”) for the development and
commercialization of a blood pool magnetic contrast agent
designated as MS-325 (hereinafter referred to as “the
Compound”).
WHEREAS,
BSP obtained regulatory approval for and has been marketing a
product containing the Compound (hereinafter referred to as
“the Product”) under the trademark Vasovist
®
in the
European Union (hereinafter “EU”) and certain other
countries outside the United States.
WHEREAS,
BSP has terminated the Collaboration Agreement in accordance with
Section 13.4.1 of the Collaboration Agreement with effect as of
February 28, 2009.
WHEREAS,
pursuant to the Collaboration Agreement, EPIX will be granted
certain rights to continue commercialization of the
Product.
WHEREAS,
EPIX wishes certain marketing authorizations for the Product to be
transferred to TMC and TMC Associates (as defined
hereinafter).
WHEREAS,
EPIX and Lantheus wish to enter into an Asset Purchase Agreement
(and related agreements) pursuant to which EPIX is transferring its
rights to the Product in the United States, Puerto Rico, Canada and
Australia (the “Lantheus Territory”) to Lantheus (the
“Lantheus Transaction”).
WHEREAS,
the Parties wish to agree on certain details regarding the transfer
of marketing authorizations and certain other issues related to the
termination of the Collaboration Agreement and the Lantheus
Transaction.
Now,
therefore, the Parties agree as follows:
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1.1
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“Affiliate” means, with
respect to a Party, any person, corporation, firm, joint venture or
other entity which, directly or indirectly, through one or more
intermediates, controls, is controlled by or is under common
control with such Party. As used in this definition,
“control” means possession of the power to direct or
cause the direction of the management and policies of an entity,
whether through the ownership of the outstanding voting securities
or by contract or otherwise.
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1.2
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“Article 20
Procedure” means the referral under Article 20 of
Council Regulation (EC) 726/2004 for centrally authorised
gadolinium-containing contrast agents initiated on
November 21, 2008.
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1.3
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“BSP Territory” means
all countries of the world except the EPIX Territory. These
countries include the EU (including Norway and Iceland),
Switzerland, Canada, Australia, Bosnia-Herzegovina, Turkey, Korea,
Ukraine and Serbia.
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1.4
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“EPIX Territory” means
the United States.
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1.5
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“Marketing
Authorization” means, with respect to any country or
regulatory jurisdiction in the BSP Territory, the marketing
authorization application or similar application, registration or
certification necessary to import, market, sell and distribute the
Product in such country or regulatory jurisdiction, including
correspondence with regulatory authorities.
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1.6
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“TMC Associates” means
third parties acting on behalf of TMC as designated by EPIX in
writing on a country-by-country basis.
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17
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“Trademark” means
BSP’s trademark Vasovist ® .
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2
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1.8
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“Variations shall have the
meaning as set forth in Section 5.1.
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2.
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TERMINATION OF COMMERCIALIZATION BY
BSP
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2.1
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Subject to Sections 2.2, as of
March 1, 2009, BSP will no longer promote, sell, market or
distribute the Product in the BSP Territory.
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2.2
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Notwithstanding Section 2.1,
until May 31, 2009, BSP shall have the right to manufacture
packaging materials for, package and supply Product to fulfill any
orders for Product in the BSP Territory accepted prior to
March 1, 2009. If, however, the transfer of the Marketing
Authorization in any country is completed prior to May 31,
2009, BSP will cease to distribute Product in those countries. In
addition, any contracts entered by BSP prior to March 1, 2009
relating to investigator initiated studies involving the Product
will continue to be fulfilled by BSP after February 28, 2009,
and shall not be transferred to EPIX. BSP will not enter into any
new contracts relating to investigator initiated studies (or other
studies) involving the Product after March 1, 2009.
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2.3
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With regard to the EPIX Territory,
BSP and EPIX agree that even prior to March 1, 2009, BSP is
and was not obliged to undertake any further pre-launch or launch
activities relating to the Product after re-submission of the NDA
in July 2008. The Parties agree further that should EPIX enter
into an agreement relating to the Product with regard to the EPIX
Territory, subject to Section 10 all rights and obligations of
BSP with regard to commercialization of the Product in the EPIX
Territory shall cease as of execution of such agreement.
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3.
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TRANSFER OF MARKETING
AUTHORIZATIONS
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3.1
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For
purposes of this Termination Agreement (hereinafter
“Agreement”), the transfer of a Marketing Authorization
in a specific country is not complete until all applicable
regulatory requirements relating to the transfer have been met and
TMC, Lantheus or a designated third party is approved as the
Marketing Authorization Holder for the Product by the appropriate
regulatory authority in the country.
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3.2
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Immediately after execution of this
Agreement, the Parties shall cooperate with the purpose of
completing as quickly as possible a transfer of the Marketing
Authorization for countries in the EU (EMEA centralized MAA) to
TMC. Should a transfer to TMC (or any other third party designated
by EPIX) not have been completed by November 30, 2009, BSP
shall be entitled to withdraw the Marketing Authorization for the
EU. However, if due to the Article 20 Procedure the transfer
of the Marketing Authorization is delayed in a way so that the
transfer is not completed by November 30, 2009, BSP shall
remain Marketing Authorization Holder in the EU an additional month
after November 30, 2009 for each month of Delay. For the
purpose of this Section 3.2, Delay means any period after
execution of this Termination Agreement where, due to the
Article 20 Procedure, a notification for the transfer of the
Marketing Authorization in the EU can not be filed or is not
processed by the EMEA.
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3.3
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BSP
has already initiated, upon agreement with EPIX, the transfer of
the Marketing Authorization for Switzerland to a TMC Associate.
Immediately after execution of this Agreement and receipt of the
amount of USD 10,500,000 in
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3
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accordance with Section 10.2,
the Parties shall cooperate and use commercially reasonable efforts
with the purpose of completing as quickly as possible a transfer of
the Marketing Authorization for Canada and Australia to Lantheus as
set forth herein. Should a transfer of the Marketing Authorization
to Lantheus not have been completed by November 30, 2009 for
the respective countries, BSP shall be entitled to withdraw the
Marketing Authorization for the respective countries.
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3.4
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With regard to Bosnia-Herzegovina,
Turkey, Korea, Ukraine and Serbia, BSP shall remain the holder of
the Marketing Authorization and without any obligation to market
the Product, until EPIX has designated in writing a third party to
whom the Marketing Authorization shall be transferred. Should a
transfer of the Marketing Authorization to a designated third party
not have been completed by November 30, 2009, BSP shall be entitled
to withdraw the Marketing Authorization for the respective
countries. However, if due to the pending approval of the
Variations the transfer of the Marketing Authorization is delayed
in a way so that the transfer is not completed by November 30,
2009, BSP shall remain Marketing Authorization Holder in the
respective country an additional month after November 30, 2009 for
each month of Delay. For the purpose of this Section 3.4,
Delay means any period after receipt of EPIX’ notice to whom
the Marketing Authorization shall be transferred where, due to the
pending approval of the Variations, a notification for the transfer
of the Marketing Authorization can not be filed or is not processed
by the regulatory authorities.
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3.5
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BSP
has in agreement with EPIX withdrawn pending applications for
Brazil, Thailand, Malaysia, Nicaragua, Russia, Guatemala, Indonesia
and China (CTA). Furthermore, BSP shall withdraw pending
applications for South Africa, Sri Lanka and El Salvador. If
withdrawal is not possible due to the advanced registration
process, the Marketing Authorization should be handled as described
in Section 3.4 of this Agreement and the pharmacovigilance
obligations should be handled as described in the Pharmacovigilance
Agreement Regarding Vasovist ® signed by BSP, EPIX, and TMC on
March 2, 2009 (hereinafter “Pharmacovigilance
Agreement”).
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3.6
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EPIX agrees to reimburse BSP for all
costs incurred by BSP or its Affiliates for any activities
regarding the Product that occur after February 28, 2009 and
that are requested by government regulatory authorities in the BSP
Territory while BSP remains the holder of the Marketing
Authorization (or becomes the holder pursuant to Section 2.5
of this Agreement) in the respective country of the BSP Territory,
provided that such activities do not arise from any gross
negligence or wilful misconduct of BSP or any of BSP’s
Affiliates, contractors or agents or a material breach by BSP of
any written agreement between BSP and EPIX.
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4.1
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The
Parties shall cooperate with each other with regard to activities
required by the Article 20 Procedure. BSP will remain the sole
contact partner for EMEA until the transfer of the Marketing
Authorization for the EU has been completed. All costs associated
with the Article 20 Procedure will be paid by BSP until the
transfer of the Marketing Authorization is completed. Once the
transfer of the Marketing Authorization is complete, TMC/EPIX will
become the sole contact partner for all correspondence with the
EMEA and take over all responsibilities as the holder of the
Marketing Authorization.
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4.2
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BSP
has prepared the initial response to the Article 20 Procedure,
including the requested risk management plan, and, until the
transfer of the Marketing Authorization for the EU has been
completed, it will prepare any future answers to such questions
which are retrospective. Regarding future questions and requests,
TMC will prepare and send to BSP on behalf of EPIX any documents
relating to future activities concerning the Product. Each Party
will give the other Party the opportunity to review and comment on
the documents prepared by it before submission to EMEA and will not
unreasonably ignore any comments received from the other Party,
provided, however, that until completion of the transfer of the
Marketing Authorization for the EU, BSP will have the final say.
BSP shall, however, have no responsibility for the accuracy or
completeness of responses prepared by it and will not be in any way
liable to EPIX TMC or any third party for any economic
consequences, damages or losses resulting from the outcome of the
Article 20 Procedure. After completion of the transfer of the
Marketing Authorization in the EU (implementation date as agreed
with EMEA) the entire responsibility for the Article 20
response, including the actions resulting from the Article 20
Procedure will be assumed by TMC/EPIX.
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4.3
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Any
preclinical data not related to the Product and made available to
EPIX and/or TMC within the Article 20 Procedure may not be
used by EPIX or TMC for any other purpose.
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5.1
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Promptly after execution of this
Agreement and receipt of the amount of USD 10,500,000 in accordance
with Section 10.2, BSP shall submit to EPIX and Lantheus all
documents as a complete CTD application, necessary for the filing
of type II variations no. 2781 and 2784 as specified in
Appendices 1 and 2 (hereinafter “the
Variations”). EPIX will contract with TMC or TMC Associates
to file such Variations in the EU and Switzerland at BSP’s
cost as soon as possible after completion of the transfer of the
Marketing Authorization. As the holder of such Marketing
Authorizations TMC or TMC Associates will take over all
responsibilities in connection with the filing of such Variations,
provided that BSP will reimburse TMC for the filing fees associated
with these Variations within thirty (30) business days of
written confirmation of completion in each country and receipt of a
respective invoice. Lantheus will file such Variations in Canada
and Australia at BSP’s cost as soon as possible after
completion of the transfer of the Marketing Authorization. As the
holder of such Marketing Authorizations, Lantheus will take over
all responsibilities in connection with the filing of such
Variations, provided that BSP will reimburse Lantheus for the
filing fees associated with these Variations within thirty
(30) business days of written confirmation of completion in
each country and receipt of a respective invoice.
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5.2
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If
EMEA rejects the transfer of the Marketing Authorization in the EU
during the ongoing Article 20 Procedure, BSP shall file the
above mentioned type II Variations in the countries specified in
Section 5.1 immediately after receipt of such clarification
from EMEA. In addition, BSP will file such Variations in any other
countries of the BSP Territory, except Switzerland, Canada and
Australia. Once the transfer of the Marketing Authorization is
completed in a specific country, the transferee
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