Exhibit
10.1


 


Confidential
Materials omitted and filed separately with the


Securities and
Exchange Commission. Asterisks denote omissions.


 


EXECUTION COPY


 


TERMINATION
AND TRANSITION AGREEMENT


 


This Termination and
Transition Agreement (the “Agreement”) is
effective as of 1st July 2007 (the “Effective
Date”) by and between THE MEDICINES COMPANY, a Delaware corporation
having offices at 8 Campus Drive, Parsippany, New Jersey  07054 (“TMC”), NYCOMED
DANMARK ApS, P.O. Box 88, Langebjerg 1 DK-4000 Roskilde, Denmark, a company
duly organized and existing under the laws of the Kingdom of Denmark (“Nycomed”), and NYCOMED HOLDING ApS, P.O. Box 88, Langebjerg
1 DK-4000 Roskilde, Denmark, a company duly organized and existing under the
laws of the Kingdom of Denmark (“Nycomed Parent”).


 


TMC and Nycomed shall be
referred to individually as a “Party” and
collectively as the “Parties”.


 


WITNESSETH:


 


WHEREAS, TMC is in the
business of developing, manufacturing and marketing pharmaceutical products;
and


 


WHEREAS, Nycomed is
engaged in, among other things, the distribution, promotion and marketing of
pharmaceutical products; and


 


WHEREAS, TMC and Nycomed
are parties to that certain Sales, Marketing and Distribution Agreement dated
as of March 25, 2002, as amended on May 28, 2003 (the “Former
Distribution Agreement”), pursuant to which, among other things:


 


•                                          TMC appointed Nycomed as its exclusive distributor in
the Territory (for purposes of these Recitals, as defined in the Former
Distribution Agreement) for the Product (as defined below);


•                                          TMC, as the market authorization holder in certain
countries of such Territory, agreed to manufacture and supply the Product to
Nycomed for distribution by Nycomed in such Territory; and


•                                          Nycomed agreed to promote, market and distribute the
Product in such Territory; and


 


WHEREAS, TMC desires to
terminate and reacquire the rights it granted to Nycomed under the Former
Distribution Agreement on the terms and conditions contained herein, and
Nycomed desires to terminate and transfer its rights in the Product under the
Former Distribution Agreement back to TMC on the terms and conditions set forth
herein, whereby, among other things:


 


1

















 


•                                          The Former Distribution Agreement and the Parties’
rights and obligations thereunder shall terminate, except to the extent
otherwise provided by this Agreement, and simultaneously therewith, the Parties
and Nycomed Parent shall enter into a New Distribution Agreement (as defined
below) and a Services Agreement (as defined below) and shall perform pursuant
to such agreements through the Transition Period (as defined below), unless
such agreements are terminated earlier in accordance with their terms;


•                                          TMC shall make certain payments to Nycomed as provided
herein; and


•                                          The Parties shall cooperate to effect the transfer
from Nycomed to TMC or TMC’s designee of Regulatory Filings (as defined below),
Approvals (as defined below) and data generated to support the foregoing, as
well as all Know-How (as defined below), intellectual property, marketing,
sales and customer data and certain contracts that relate to the Product,
either on the Effective Date or during the Transition Period, as provided
below;


 


NOW THEREFORE, in
consideration of the mutual agreements set forth herein, TMC and Nycomed hereby
agree as follows:


 


1.             DEFINITIONS


 


All capitalized terms
used in this Agreement not otherwise defined shall have the meanings and
definitions ascribed to them as listed below.


 


1.1.          “ACUITY Trial” has the meaning set forth in Section 8.3.


 


1.2.          “ADONIS Agreement” means the [**] dated as of [**].


 


1.3.          “Affiliate” means any corporation, company, joint venture,
partnership or other entity which, directly or indirectly, controls, is
controlled by, or is under common control with a Party to this Agreement. “Control”
means the ownership of at least 50% of the issued share capital or business
assets of another entity, the power to exercise at least 50% of the voting
rights of another entity, or the power to appoint more than 50% of the Board of
Directors of another entity.


 


1.4.          “Approvals” means and includes all approvals, registrations,
permits, licenses and authorizations related to the Product that are made with
or obtained from any Governmental Authority for the importation, sale,
marketing and promotion of the Product in the Territory or any part thereof,
including primarily, but without limitation, authorizations of medicinal
products for human use and approval of related labels and packaging, as well as
pricing and social health system reimbursement approvals.


 


1.5.          “Assigned Contract” has the meaning set forth in Section 6.8.


 


2

















 


1.6.          “Assigned Copyrightable Materials” has the meaning set forth
in Section 5.3.


 


1.7.          “Assigned Domain Names” has the meaning set forth in Section
5.2.


 


1.8.          “Assigned Know-How” has the meaning set forth in Section 5.4.


 


1.9.          “Assigned Intellectual Property” has the meaning set forth in
Section 5.4.


 


1.10.        “Assigned Trademark Registrations” has the meaning set forth
in Section 5.1.


 


1.11.        “Assignment Date” has the meaning set forth in Section 3.1.8.


 


1.12.        “Business Day” means any day on which the banks in the
Kingdom of Denmark are open for business.


 


1.13.        “Claims” means claims, demands, rights, causes of action,
protests, suits, or disputes of any kind.


 


1.14.        “Damages” means liabilities, claims, damages, losses, costs,
expenses, demands, suits and actions (including without limitation attorneys’
fees, expenses and settlement costs).


 


1.15.        “Domain Name” means any domain name which incorporates any of
the words “Angiomax,” “Angiox,” “Angionax,” or “The Medicines Company” or the
Marks (as defined in the New Distribution Agreement) or any variations thereof.


 


1.16.        “Effective Date” has the meaning set forth in the Recitals.


 


1.17.        “Existing  Inventory”
means all labeled and unlabeled vials of Product held by Nycomed or Nycomed’s
Affiliates in inventory on the Effective Date until sold or supplied by Nycomed
pursuant to Section 9 of the New Distribution Agreement.


 


1.18.        “Former Distribution Agreement” has the meaning set forth in
the Recitals.


 


1.19.        “Governmental Authority” means and includes all governmental
and regulatory bodies, agencies, departments or entities, whether or not
located in the Territory, which regulate, direct or control commerce in or with
the Territory, including Approvals.


 


1.20.        “Improvements” means authorized, updated or modified
manufacturing processes for the Product or its component substances, additional
dosage unit sizes or other similar authorized modifications to the production
and delivery of the Product as part of an Approval for the Product.


 


1.21.        “Inventory Purchase Price” has the meaning set forth in
Section 6.10.1.


 


1.22.        “ISAR Agreements” has the meaning set forth in the New
Distribution Agreement.


 


3

















 


1.23.        “Know-How” means all scientific and technical data,
instructions, processes, formulae, specifications, ingredient sources,
manufacturing procedures, methods, market research and other information
relating to the design, composition, formulation, pre-clinical evaluation,
clinical evaluation, manufacture, use, sale, packaging, formulation or
administration of the Product, including, but not limited to, pharmacological,
toxicological, analytical, stability and clinical data, specifications and drug
master files and/or health registration dossiers and any other premarket
application or registration.


 


1.24.        “Licensed Know-How” has the meaning set forth in Section 5.4.


 


1.25.        “New Agreements” means, collectively, the New Distribution
Agreement and the Services Agreement.


 


1.26.        “New Distribution Agreement” means the Distribution Agreement
between TMC, Nycomed and Nycomed Parent dated as of the Effective Date.


 


1.27.        “New Inventory” has the meaning set forth in the New
Distribution Agreement.


 


1.28.        “Non-Released Claims against Nycomed” has the meaning set
forth in Section 4.2.2.


 


1.29.        “Non-Released Claims against TMC” has the meaning set forth
in Section 4.2.1.


 


1.30.        “Nycomed Release Parties” means Nycomed, and its present/and
or past predecessors, successors, assigns, Affiliates, directors, officers,
agents, employees and representatives.


 


1.31.        “Ongoing Clinical Trials” has the meaning set forth in
Section 3.1.6.


 


1.32.        “Out-of-Pocket Costs” has the meaning set forth in Section
8.4.1.


 


1.33.        “PhV Agreements” means the Pharmacovigilance Agreement and
the Pharmacovigilance QP Agreement (each as defined in the Services Agreement).


 


1.34.        “Product” means Bivalirudin, being a highly specific and
reversible direct thrombin inhibitor, which operates by specific binding to
both the catalytic site and to the anion-binding exosite of circulating and
clot-bound thrombin. The active substance is a synthetic, twenty (20)-amino
acid peptide, whose chemical name is
D-phenylalanyl-Lprolyl-Larginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartly-L-phenylalanyl-L-glutamyl-L-glutamyl-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine-trifluoracetate
(salt) hydrate. Its molecular weight is 218.19 daltons (anhydrous free base
peptide). Product shall also include Improvements.


 


1.35.        “Product Documents and Records” has the meaning set forth in
Section 6.3.


 


1.36.        “Product Transition Committee” or “PTC”
have the meaning set forth in Section 6.1.


 


4

















 


1.37.        “QA Agreements” means, collectively, the AQRPA, the Release
Agreement and the Packaging Agreement (each as defined in the New Distribution
Agreement).


 


1.38.        “Quality Agreements” means, collectively, the QA Agreements
and the PhV Agreements. For the sake of clarity, with respect to each Quality
Agreement, all references to such Quality Agreement with respect to activities
pursuant to the Former Distribution Agreement (i.e., prior to the Effective
Date) shall mean such Quality Agreement unamended by the Transaction
Agreements, and all references to such Quality Agreement with respect to
activities on or after the Effective Date shall mean such Quality Agreement as
amended by the Transaction Agreements.


 


1.39.        “Regulatory Filings” means all applications, filings,
materials, studies, data and documents of any nature whatsoever filed with,
prepared in connection with or necessary to support any Approval process in any
country or territory, including any of the foregoing with respect to a clinical
trial conducted with the Product.


 


1.40.        “Services Agreement” means the Services Agreement between
TMC, Nycomed and Nycomed Parent dated as of the Effective Date.


 


1.41.        “Territory” has the meaning set forth in the New Distribution
Agreement.


 


1.42.        “TMC Release Parties” means TMC, and its present and/or past
predecessors, successors, assigns, Affiliates, directors, officers, agents,
employees and representatives.


 


1.43.        “Trademarks” has the meaning set forth in Section 3.1.14.


 


1.44.        “Transaction Agreements” means, collectively, this Agreement
and the New Agreements.


 


1.45.        “Transition Date” means (a) the first anniversary of the
Effective Date, (b) such date earlier than the first anniversary of the
Effective Date as TMC may notify Nycomed upon at least 30 calendar days prior
written notice, but in no event effective before December 31, 2007 or (c) such
date later than the first anniversary of the Effective Date as TMC may, at TMC’s
option, notify Nycomed upon at least 30 calendar days prior written notice in
the event that, notwithstanding the use of commercially reasonable efforts to
do so, TMC has not obtained any Approvals necessary to perform services and
functions performed by Nycomed under the New Agreements or Quality Agreements
by the first anniversary of the Effective Date; provided, however,
that in no event shall the Transition Date be later than 18 months after the
Effective Date. For clarity, the Transition Date shall not limit TMC’s right to
terminate the New Distribution Agreement or Services Agreement, in whole or in
part, prior to the Transition Date to the extent permitted by such agreements.


 


1.46.        “Transition Period” means the period commencing on Effective
Date and ending on the Transition Date.


 


5

















 


1.47.        “Up-Front Payment” has the meaning set forth in Section 8.1.


 


1.48.        “Vials of  Remaining Inventory”
has the meaning set forth in Section 6.10.1.


 


2.             DELIVERIES
UPON EXECUTION; AFFILIATES


 


2.1.          Deliveries
by Nycomed. Contemporaneously with the execution of this Agreement, Nycomed
shall:


 


(a)           execute and deliver the
New Agreements;


 


(b)           execute and deliver the
Trademark Assignment assigning the Assigned Trademark Registrations to TMC or
TMC’s designee substantially in the form attached hereto as Exhibit A;
and


 


(c)           execute and deliver the
Bill of Sale assigning the Assigned Intellectual Property (excluding the
Assigned Trademark Registrations) to TMC or TMC’s designee substantially in the
form attached hereto as Exhibit B.


 


2.2.          Deliveries
by TMC. Contemporaneously with the execution of this Agreement, TMC shall:


 


(a)           execute and deliver the
New Agreements; and


 


(b)           in the event the
Effective Date is a day that is both a Business Day and a day on which the
banks in the Commonwealth of Massachusetts are open for business, deliver the
Up-Front Payment by wire transfer in accordance with the wiring instructions
set forth on Schedule 2.2; provided, however, that in the event
the Effective Date is not a day that is both a Business Day and a day on which
the banks in the Commonwealth of Massachusetts are open for business, then the
Up-Front Payment shall be made on the next following day that is both a
Business Day and a day on which the banks in the Commonwealth of Massachusetts
are open for business.


 


2.3.          Application
to Affiliates.


 


2.3.1.       The Parties agree and
acknowledge that Nycomed has performed certain of its obligations under the
Former Distribution Agreement through Nycomed’s Affiliates and that Nycomed may
perform certain of its obligations under the Transaction Agreements and the
Quality Agreements, as well as any of its obligations that may survive
termination under the Former Distribution Agreement, through Nycomed’s
Affiliates. Nycomed shall cause its Affiliates to comply with all of Nycomed’s
obligations under the Transaction Agreements, the Quality Agreements and any of
Nycomed’s obligations that may survive termination under the Former
Distribution Agreement to the same extent that Nycomed is itself obligated to
perform


 


6

















 


hereunder or thereunder and Nycomed shall be responsible for any
failure by any Affiliate to do so. Except as otherwise expressly stated herein,
any references to Nycomed in the Transaction Agreements shall also apply to
Nycomed’s Affiliates to the extent such Affiliates have performed or will
perform Nycomed obligations hereunder or thereunder.


 


2.3.2.       TMC shall cause its
Affiliates to comply with all of TMC’s obligations under the Transaction
Agreements, the Quality Agreements and any of TMC’s obligations that may
survive termination under the Former Distribution Agreement to the same extent
that TMC is itself obligated to perform hereunder or thereunder and TMC shall
be responsible for any failure by any Affiliate to do so.


 


3.             REPRESENTATIONS,
WARRANTIES AND CERTAIN COVENANTS


 


3.1.          Nycomed
Representations, Warranties and Certain Covenants. Nycomed hereby
represents, warrants and covenants to TMC that:


 


3.1.1.       Corporate Power. Nycomed has the
corporate power and authority to execute and deliver the Transaction Agreements
and to perform the Transaction Agreements and the Quality Agreements. The
execution and delivery of the Transaction Agreements and the performance of the
Transaction Agreements and the Quality Agreements by Nycomed have been duly
authorized by all necessary corporate action of Nycomed.


 


3.1.2.       Validity. Each of the Transaction
Agreements, when executed and delivered by Nycomed, shall be, and each of the
Quality Agreements is, the legal, valid and binding obligation of Nycomed,
enforceable against Nycomed in accordance with its terms, except as such
enforceability may be limited by bankruptcy law and other similar laws
affecting creditors’ rights generally and by general principles of equity.


 


3.1.3.       Non-Contravention. The execution and
delivery of the Transaction Agreements and the performance of the Transaction
Agreements and the Quality Agreements by Nycomed do not and will not (i)
conflict with, or constitute a breach or default under, or require the consent
of any third party under, Nycomed’s charter documents or any material license,
loan or other agreement, contract, commitment or instrument to which Nycomed is
a party or any of its assets are bound, (ii) violate any provision of law,
statute, rule or regulation or any ruling, writ, injunction, order, judgment or
decree of any court, administrative agency or other governmental body, or (iii)
require the consent, approval or authorization of, or notice, declaration,
filing or registration with, any third party or any governmental or regulatory
authority.


 


3.1.4.       No Litigation. Except as set forth on
Schedule 3.1.4(a), there is no action or proceeding pending or, in so far as
Nycomed knows, threatened against Nycomed before any court, administrative
agency or other tribunal which could impact upon Nycomed’s right, power and
authority to enter into any of the Transaction Agreements or to carry out


 


7

















 


its obligations under any of the Transaction
Agreements or Quality Agreements. Except as set forth in Schedule 3.1.4(b), to
its knowledge, Nycomed has not received written notice of any Claims by third
parties that would result in Non-Released Claims Against TMC.


 


3.1.5.       Distribution Rights. Nycomed has not,
directly or indirectly, appointed any third party as a subdistributor of the
Product in the Territory pursuant to the Former Distribution Agreement.


 


3.1.6.       Clinical Trials.


 


(a)           Except as set forth on
Schedule 3.1.6: Nycomed is not currently conducting, funding, supplying Product
with respect to, sponsoring or otherwise engaged in, either itself or through
any subcontractor, any clinical trials or studies with respect to the Product,
and has not committed to do any of the foregoing. The clinical trials set forth
on Schedule 3.1.6 shall be referred to herein as the “Ongoing
Clinical Trials.”  For
purposes of the foregoing, any clinical trial shall be deemed ongoing through
the completion of data analysis, lock and transfer. With respect to each such
clinical trial, Schedule 3.1.6 sets forth a description of the clinical trial,
its current status (e.g., not yet started, enrollment phase, treatment phase,
data analysis/transfer phase), a description of any contract(s) Nycomed has
entered into with third parties with respect to the performance of such
clinical trials, a description of any Nycomed payment obligations with respect
thereto that will or may arise after the Effective Date, and a description of
any Nycomed obligations to supply Product with respect thereto that will or may
arise after the Effective Date. For the avoidance of doubt, Nycomed agrees
that, beginning on the Effective Date, it shall not conduct, fund, supply
Product with respect to, sponsor or otherwise engage in, any additional
clinical trials or studies with respect to the Product, or commit to do any of
the foregoing, without the express written consent of TMC.


 


(b)           The Parties acknowledge
that with respect to certain Ongoing Clinical Trials, the agreements between
Nycomed and third parties with respect thereto are Assigned Contracts hereunder
and that TMC or TMC’s designee shall therefore, in accordance with Section 6.8,
obtain any rights Nycomed may have thereunder to receive information, results
or data from such third parties with respect to such Ongoing Clinical Trials. With
respect to those Ongoing Clinical Trials which are not the subject of Assigned
Contracts, Nycomed shall, promptly upon Nycomed’s receipt thereof, provide TMC
with any information, results or data that Nycomed may receive with respect to
such Ongoing Clinical Trials. For the avoidance of doubt, Nycomed’s obligation
to provide such information, results and data to TMC shall survive the
termination or expiration of this Agreement.


 


3.1.7.       Contracts. As of the Effective Date,
except for (a) agreements pertaining to the Ongoing Clinical Trials that are
described in Schedule 3.1.6 and (b) agreements between


 


8

















 


Nycomed and third parties committing Nycomed to the
activities that are to be performed by Nycomed pursuant to Schedule 2.1(b) of
the Services Agreement, Nycomed has not, directly or indirectly, entered into
any agreement, whether oral or written, with any third party that pertains
exclusively or primarily to the Product or exclusively or primarily to the
activities of Nycomed conducted under the Former Distribution Agreement or
Quality Agreements (each, a “Product-Specific Contract”)
to the extent any such Product-Specific Contract is material to the marketing,
sale and distribution of the Product in the Territory. As promptly after the
Effective Date as practicable, but in no event later than 60 days after the
Effective Date, Nycomed shall deliver to TMC a Schedule 3.1.7 that sets forth a
true and complete list of all Product-Specific Contracts, whether or not
material to the marketing, sale and distribution of the Product in the
Territory. With respect to each Product-Specific Contract that may be included
on Schedule 3.1.7 by Nycomed after the Effective Date, TMC may, at its option,
add such contract to Schedule 6.8 such that it will be deemed an Assigned
Contract hereunder. To the knowledge of Nycomed, as of the Effective Date,
there are no Product-Specific Contracts other than (x) agreements pertaining to
the Ongoing Clinical Trials that are described in Schedule 3.1.6 and (y)
agreements between Nycomed and third parties committing Nycomed to the
activities that are to be performed by Nycomed pursuant to Schedule 2.1(b) of
the Services Agreement. With respect to each Product-Specific Contract,
Schedule 3.1.7 will set forth the names of the contracting parties, a general
description of the agreement and a description of any Nycomed financial
obligations with respect thereto that will or may arise thereunder. Nycomed
agrees that, beginning on the Effective Date, it shall not enter into
additional agreements with third parties with respect to the Product, or with
respect to the activities of Nycomed conducted under the Transaction Agreements
or Quality Agreements, without the express written consent of TMC.


 


3.1.8.       Assigned Contracts. As of the date such
Assigned Contract is assigned to TMC or TMC’s designee hereunder (the “Assignment Date”), to the knowledge of Nycomed, each
Assigned Contract is valid and enforceable by Nycomed against the other parties
thereto, in each case in accordance with its terms, except as enforcement may
be limited by applicable bankruptcy, insolvency, reorganization, moratorium and
other laws affecting enforcement of creditors’ rights generally and except
insofar as the availability of equitable remedies may be limited by applicable
law. As of the relevant Assignment Date, neither Nycomed or, to the knowledge
of Nycomed, any other party to any Assigned Contract, is in material breach of
such Assigned Contract to which it is a party, nor has it received written
notice or, to the knowledge of Nycomed, oral notice of any material breach
under such Assigned Contract and, to the knowledge of Nycomed, there does not
exist any event, condition or omission that would constitute such a material
breach (whether by lapse of time or notice or both). Nycomed has provided TMC
with a complete and accurate copy of each Assigned Contract.


 


9

















 


3.1.9.       Approvals and Filings. Except as set
forth on Schedule 3.1.9, Nycomed does not hold any marketing authorizations,
and has not applied for any marketing authorizations, that pertain exclusively
or primarily to the Product. As promptly after the Effective Date as
practicable, but in no event later than 60 days after the Effective Date,
Nycomed shall deliver to TMC an updated Schedule 3.1.9 that sets forth a true
and complete list of all Approvals held by Nycomed, and all Regulatory Filings
made by Nycomed, that pertain exclusively or primarily to the Product or to the
activities of Nycomed conducted under the Former Distribution Agreement or
Quality Agreements. With respect to each Approval or Regulatory Filing that may
be included on Schedule 3.1.9 by Nycomed after the Effective Date, TMC may, at
its option, add such Approval or Regulatory Filing to Schedule 6.4 such that it
will be transferred to TMC or TMC’s designee hereunder. With respect to each
such marketing authorization or application therefor, or (if applicable) each
Approval or Regulatory Filing, Schedule 3.1.9 sets forth (or, if applicable,
shall set forth): (i) the holder or applicant of each item, as applicable, (ii)
the jurisdiction(s) in which the item is issued or registered or in which an
application for issuance or registration has been filed, (iii) the issuance,
registration or application numbers and date of filing, issuance or
registration, as applicable and (iv) the expiration date, if applicable. For
the avoidance of doubt, Nycomed agrees that, beginning on the Effective Date,
it shall not make additional Regulatory Filings or seek additional Approvals
without the express written consent of TMC.


 


3.1.10.     Ownership Rights. Nycomed owns the Assigned
Intellectual Property to be transferred to TMC or TMC’s designee on the
Effective Date pursuant to Section 5, as well as the Regulatory Filings and
Approvals to be transferred to TMC or TMC’s designee during the Transition
Period pursuant to Section 6, free and clear of any liens, encumbrances,
license, security interest or other rights of third parties of any kind; provided,
however, that certain authors of Assigned Copyrightable Materials or
Assigned Know-How may not have waived the moral rights granted to authors by applicable
law.


 


3.1.11.     Existing Inventory. Schedule 3.1.11 sets
forth a true, complete and correct statement of (i) the number of vials of
Existing Inventory, (ii) the number of vials of Existing Inventory which are
labeled and/or packaged and (iii) the number of vials of Existing Inventory
which are unlabeled, in each case, as of June 15, 2007. Within five Business
Days after the Effective Date, Nycomed shall deliver to TMC an updated Schedule
3.1.11  that sets forth the foregoing
information as of June 30, 2007. All Existing Inventory is and, until Nycomed
sells or supplies the Existing Inventory in accordance with Section 9 of the
New Distribution Agreement shall be, housed and maintained by Nycomed, at
Nycomed’s expense, at a facility(ies) owned or controlled by Nycomed and has
been or, promptly after the Effective Date, will be segregated and marked as
Existing Inventory.


 


10

















 


3.1.12.     No Patents. Nycomed does not own and has
not applied for any patent covering the making, using or selling of the Product.
Nycomed agrees that, beginning on the Effective Date, it shall not apply for
any such patents.


 


3.1.13.     No Registered Copyrights. Nycomed does not
own and has not applied for any registered copyright with respect to
copyrightable materials relating to the Product, including without limitation
marketing materials and translations thereof. Nycomed agrees that, beginning on
the Effective Date, it shall not apply for any such registered copyrights.


 


3.1.14.     Trademarks. Except as set forth on Schedule
3.1.14, Nycomed does not own and has not applied for or registered any
trademarks, service marks, trade names, logos or other proprietary symbols that
are used in connection with the Product, including the performance of
activities directed to obtaining Approvals, marketing, promoting, distributing,
importing or selling the Product (“Trademarks”). With
respect to each Trademark, Schedule 3.1.14 sets forth (i) the holder of the
registration or current applicant(s) of each item, as applicable; (ii) the
jurisdictions in which the item is issued or registered or in which an
application for issuance or registration has been filed; and (iii) the
issuance, registration or application numbers and date of filing, issuance or registration,
as applicable. For the avoidance of doubt, Nycomed agrees that, beginning on
the Effective Date, it shall not apply for or register any additional
Trademarks.


 


3.1.15.     Domain Names. As of the Effective Date,
Schedule 3.1.15 sets forth certain Domain Names which have been registered by
Nycomed. As promptly after the Effective Date as practicable, but in no event
later than 60 days after the Effective Date, Nycomed shall deliver to TMC an
updated Schedule 3.1.15 that sets forth a true and complete list of all Domain
Names which have been registered, or applied for, by Nycomed. With respect to
each Domain Name, Schedule 3.1.15 sets forth (or, if applicable, shall set
forth): (i) the owner(s) or current applicant(s) of the Domain Name, as
applicable; (ii) the entity with which the Domain Name has been registered or
with which an application for registration has been filed; and (iii) the
registration or application numbers and date of filing or registration, as
applicable. For the avoidance of doubt, Nycomed agrees that, beginning on the
Effective Date, it shall not apply for any additional Domain Names.


 


3.1.16.     No Infringement Proceedings. Nycomed has
not instituted any proceedings against any infringement or threatened
infringement by a third party of the Patents (as defined in the Former
Distribution Agreement) as permitted by Section 15 of the Former Distribution
Agreement.


 


3.1.17.     Trademark Licenses. Nycomed has not granted
a sublicense to any third party to use any Trademarks (as defined in the New
Distribution Agreement). For the avoidance


 


11

















 


of doubt, Nycomed agrees that, beginning on the
Effective Date, it shall not grant any additional such sublicenses to third
parties.


 


3.2.          TMC
Representations, Warranties and Certain Covenants. TMC hereby represents,
warrants and covenants to Nycomed that:


 


3.2.1.       Corporate Power. TMC has the corporate
power and authority to execute and deliver the Transaction Agreements and to
perform the Transaction Agreements and the Quality Agreements. The execution
and delivery of the Transaction Agreements and the performance of the
Transaction Agreements and the Quality Agreements by TMC have been duly
authorized by all necessary corporate action of TMC.


 


3.2.2.       Validity. Each of the Transaction
Agreements, when executed and delivered by TMC, shall be and each of the
Quality Agreements is the legal, valid and binding obligation of TMC,
enforceable against TMC in accordance with its terms, except as such
enforceability may be limited by bankruptcy law and other similar laws
affecting creditors’ rights generally and by general principles of equity.


 


3.2.3.       Non-Contravention. The execution and
delivery of the Transaction Agreements and the performance of the Transaction
Agreements and the Quality Agreements by TMC do not and will not (i) conflict
with, or constitute a breach or default under, or require the consent of any
third party under, TMC’s charter documents or any material license, loan or
other agreement, contract, commitment or instrument to which TMC is a party or
any of its assets are bound, (ii) violate any provision of law, statute, rule
or regulation or any ruling, writ, injunction, order, judgment or decree of any
court, administrative agency or other governmental body, or (iii) require the
consent, approval or authorization of, or notice, declaration, filing or
registration with, any third party or any governmental or regulatory authority.


 


3.2.4.       No Litigation. There is no action or
proceeding pending or, in so far as TMC knows, threatened against TMC or any of
its Affiliates before any court, administrative agency or other tribunal which
could impact upon TMC’s right, power and authority to enter into any of the
Transaction Agreements or to carry out its obligations under any of the
Transaction Agreements or the Quality Agreements. Except as set forth in
Schedule 3.2.4, to its knowledge, TMC has not received written notice of any
Claims by third parties that would result in Non-Released Claims Against
Nycomed.


 


3.3.          Knowledge.
Where a representation or warranty contained in this Section 3 is stated to
be to a Party’s knowledge, this shall mean to the actual knowledge of all of
the officers and appropriate key personnel of such Party or its Affiliates,
after reasonable inquiry.


 


3.4.          No
Other Warranties. EXCEPT FOR THE EXPRESS WARRANTIES CONTAINED IN THIS
AGREEMENT, THE NEW AGREEMENTS AND THE QUALITY AGREEMENTS,


 


12

















 


(a) NEITHER TMC NOR NYCOMED MAKES ANY WARRANTIES OR REPRESENTATIONS,
EXPRESS OR IMPLIED, IN FACT OR IN LAW, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT AND (b)
WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, NYCOMED PROVIDES THE ASSIGNED
INTELLECTUAL PROPERTY AND ASSIGNED CONTRACTS ON AN “AS-IS” BASIS.


 


3.5.          Survival
of Warranties. The provisions of this Section 3 shall survive the
expiration or sooner termination of this Agreement without limit.


 


4.             TERMINATION
OF FORMER DISTRIBUTION AGREEMENT; RELEASE OF CERTAIN CLAIMS; CONTINUATION OF
QUALITY AGREEMENTS


 


4.1.          Termination
of Former Distribution Agreement.


 


4.1.1.       Effective on the Effective
Date, the Former Distribution Agreement shall terminate and, except for those
rights and obligations of any party under the Former Distribution Agreement
that expressly survive the termination of such agreement pursuant to the terms
of such agreement (as modified by this Agreement), all rights and obligations
of any party under the Former Distribution Agreement shall cease to be
of further effect; provided, however, that the Parties agree that
any obligation of Nycomed to report information to TMC pertaining to any period
of time prior to the Effective Date shall survive the termination of the Former
Distribution Agreement and such reports shall be due on the same dates as they
would have otherwise been due pursuant to the Former Distribution Agreement.


 


4.1.2.       As to those rights and
obligations of any party under the Former Distribution Agreement that do expressly
survive the termination thereof, the Parties agree that they shall be modified
as follows:  notwithstanding Section 20.7
of the Former Distribution Agreement, Section 13 (Collection of Information on
Adverse and Serious Adverse Events/Reporting on Medical Safety/Recalls) and
Section 17 (Confidential Information) shall terminate upon the termination of
the Former Distribution Agreement. For the avoidance of doubt, simultaneously
with the termination of the Former Distribution Agreement, the New Agreements
and this Agreement shall become effective.


 


4.2.          Release
of Certain Claims.


 


4.2.1.       Nycomed, on behalf of the
Nycomed Release Parties, hereby forever compromises, settles, waives, releases,
and discharges with prejudice (on the terms and conditions set forth in this
Agreement) the TMC Release Parties from any and all Claims that the Nycomed
Release Parties have against the TMC Release Parties to the extent such Claims
(a) arise out of any events, occurrences, actions or any failures to act
preceding the Effective Date and (b) relate to (or are in any way connected
with) the Former Distribution Agreement or any Quality Agreement, whether known
or unknown, accrued or not accrued, foreseen or


 


13

















 


unforeseen, or matured or not matured (the “Release By
Nycomed”); provided, however, that the Release By
Nycomed shall not extend to:


 


(i)                                     any Claim by any Nycomed Release Party
against any TMC Release Party that arises out of or relates to a Claim of a
third party against such Nycomed Release Party (A) for which such Nycomed
Release Party is entitled to seek indemnification under the Former Distribution
Agreement or (B) that arises out of or relates to TMC’s breach or alleged
breach of any of its obligations under the Former Distribution Agreement or
Quality Agreements (the “Non-Released Claims
Against TMC”) or


 


(ii)                                  any Claim by any Nycomed Release Party
against any TMC Release Party with respect to (A) any payment obligation of TMC
under the Former Distribution Agreement or any Quality Agreement or (B) for the
avoidance of doubt, any obligation of TMC to perform under the Former
Distribution Agreement (to the extent such obligation survives termination
thereof either pursuant to the terms thereof or pursuant to this Agreement) or
any Quality Agreement, in each case to the extent such obligation to perform
arises on or after the Effective Date.


 


4.2.2.       TMC, on behalf of the TMC
Release Parties, hereby forever compromises, settles, waives, releases, and
discharges with prejudice (on the terms and conditions set forth in this
Agreement) the Nycomed Release Parties from any and all Claims that the TMC
Release Parties have against the Nycomed Release Parties to the extent such
Claims (a) arise out of any events, occurrences, actions or any failures to act
preceding the Effective Date and (b) relate to (or are in any way connected
with) the Former Distribution Agreement or any Quality Agreement, whether known
or unknown, accrued or not accrued, foreseen or unforeseen, or matured or not
matured (the “Release By TMC”); provided,
however, that the Release By TMC shall not extend to


 


(i)                                     any Claim by any TMC Release Party
against any Nycomed Release Party that arises out of or relates to a Claim of a
third party against such TMC Release Party (A) for which such TMC Release Party
is entitled to seek indemnification under the Former Distribution Agreement or
(B) that arises out of or relates to Nycomed’s breach or alleged breach of any
of its obligations under the Former Distribution Agreement or Quality
Agreements (the “Non-Released Claims Against Nycomed”)
or


 


(ii)                                  any Claim by any TMC Release Party
against any Nycomed Release Party with respect to (A) any payment obligation of
Nycomed under the Former Distribution Agreement or any Quality Agreement or (B)
for the avoidance of doubt, any obligation of Nycomed to perform under the
Former Distribution Agreement (to the extent such obligation survives
termination thereof either pursuant to the


 


14

















 


terms thereof or pursuant to this Agreement) or any Quality Agreement,
in each case to the extent such obligation to perform arises on or after the
Effective Date.


 


4.2.3.       Nycomed hereby agrees to
indemnify and hold harmless the TMC Release Parties from all Damages arising
out of the Non-Released Claims Against Nycomed and Nycomed shall pay promptly
to TMC any Damages to which the foregoing indemnification relates as they are
incurred; provided, however, that Nycomed shall not be obligated to indemnify
the TMC Release Parties with respect to the French Proceeding Amount (as
defined in the Services Agreement). For the sake of clarity, Nycomed retains
any obligation to pay or, if applicable, to indemnify the applicable TMC
Release Party with respect to, the amount of any fine or penalty imposed with
respect to the French Proceedings (as defined in the Services Agreement) beyond
the French Proceeding Amount. TMC hereby agrees to indemnify and hold harmless
the Nycomed Release Parties from all Damages arising out of the Non-Released
Claims Against TMC and TMC shall pay promptly to Nycomed any Damages to which
the foregoing indemnification relates as they are incurred. The indemnification
procedures set forth in Section 12.4 of this Agreement shall apply to any
claims for indemnification brought under this Section 4.2.3; provided, however,
that, with respect to the conduct of the French Proceedings, the provisions of
Section C of Schedule 2.1(b) of the Services Agreement shall apply and, to the
extent inconsistent with Section 12.4 of this Agreement, the provisions of such
Section C shall apply.


 


4.3.          Continuation
of Quality Agreements. For the avoidance of doubt, as of the Effective
Date, the Quality Agreements shall remain in full force and effect, as amended
by the New Agreements, unless and until terminated in accordance with their
respective terms or in accordance with the New Agreements.


 


5.             ASSIGNMENTS,
LICENSES AND TRANSFERS AS OF THE EFFECTIVE DATE


 


5.1.          Trademarks.
Effective as of the Effective Date, Nycomed shall and hereby does assign and
transfer to TMC or TMC’s designee all of Nycomed’s right, title and interest in
and to the registrations and applications for the Trademarks set forth on
Schedule 3.1.14, together with the goodwill symbolized by them, and the right
to sue and recover for past infringement of such Trademarks (the “Assigned Trademark Registrations”).


 


5.2.          Domain
Names. Effective as of the Effective Date, or as promptly after the
Effective Date as practicable, Nycomed shall and hereby does assign and
transfer to TMC or TMC’s designee all of Nycomed’s right, title and interest in
and to the domain names set forth (or to be set forth) on Schedule 3.1.15,
together with all registrations or applications therefore (the “Assigned Domain Names”).


 


5.3.          Copyrightable
Materials. Effective as of the Effective Date, Nycomed shall and hereby
does assign and transfer to TMC or TMC’s designee all of Nycomed’s right, title
and interest in


 


15

















 


and to all copyrightable materials relating to the Product, including
without limitation marketing materials and translations thereof, whether
existing as of the Effective Date or whether created, developed or acquired by
Nycomed during the Transition Period (the “Assigned  Copyrightable Materials”).


 


5.4.          Know-How.


 


5.4.1.       Effective as of the
Effective Date, Nycomed shall and hereby does assign and transfer to TMC or TMC’s
designee all of Nycomed’s right, title and interest in and to all Know-How,
including all clinical and other data, analyses and reports, that relates
exclusively or primarily to the Product, whether existing as of the Effective
Date or whether created, developed or acquired by Nycomed during the Transition
Period (the “Assigned Know-How” and, together
with the Assigned Trademark Registrations, Assigned Domain Names, Assigned
Copyrightable Materials, the “Assigned Intellectual
Property”).


 


5.4.2.       Effective as of the
Effective Date, Nycomed shall and hereby does grant to TMC or TMC’s designee a
worldwide, fully paid-up, royalty-free, non-exclusive, perpetual, irrevocable,
sublicensable license to use any Know-How owned by Nycomed and that relates to
the Product (but that does not exclusively or primarily relate to the Product),
whether existing as of the Effective Date or whether created, developed or
acquired by Nycomed during the Transition Period (“Licensed
Know-How”).


 


5.4.3.       Nothing in this Section 5.4
shall be interpreted as creating an obligation for Nycomed to generate
translations or new data, analyses or reports.


 


5.5.          Further
Assurances. As of the Effective Date, or as promptly thereafter as
practicable, Nycomed will prepare, execute and deliver to TMC (and where
required by law, TMC will execute and deliver to Nycomed) such additional
documents and take such other action as may be reasonably necessary or
desirable to transfer the Assigned Intellectual Property to TMC or TMC’s
designee, as applicable.


 


6.             OBLIGATIONS
DURING THE TRANSITION PERIOD


 


6.1.          Transition
Managers; Product Transition Committee.


 


6.1.1.       Transition Managers.
Each Party shall appoint a senior representative who possesses a full
understanding of the relevant operational, regulatory, commercial and legal
issues to act as its Transition Manager (each, a “TM”
or “Transition Manager”). The initial
Transition Manager for each Party is set forth on Schedule 6.1. Any
replacements or proxies for the foregoing persons shall be equivalently senior
personnel. Each Party’s Transition Manager will be the primary contact with the
other Party in connection with the ongoing, day-to-day implementation of this
Agreement, the New Agreements and the Quality Agreements, and for obtaining any
consents or approvals of the other Party required hereby. The TMs shall be


 


16

















 


responsible for: (a) seeking consensus (both internally, within his/her
respective Party’s organization, as well as between the Parties) regarding key
transition issues that arise under this Agreement, the New Agreements and the
Quality Agreements; (b) identifying and raising issues to the PTC in a timely
manner; (c) assisting the PTC co-chairs in setting appropriate meeting agendas,
attending PTC meetings and preparing meeting minutes, as appropriate, in a
format agreed upon with the PTC; and (d) in collaboration with the other TM,
drafting and revising on a regular basis a monthly executive summary of the
status of the transition hereunder, in a format agreed upon with the PTC, and
providing such summary to the PTC.


 


6.1.2.       Product Transition
Committee. The Parties hereby establish a Product Transition Committee (“PTC”) which shall remain in place during the Transition
Period and which shall be responsible for the smooth and effective
implementation of the activities contemplated by this Agreement, the New
Agreements and the Quality Agreements, for developing and executing a plan to
effect the transfers to take place pursuant to this Section 6 and for
overseeing the implementation of this Agreement, the New Agreements and the
Quality Agreements. The PTC shall consist of [**] voting members, comprising [**]
representatives of TMC and [**] representatives of Nycomed (which
representatives may also serve as the TMs). The PTC shall have two co-chairs,
one from each Party. The initial representatives on the PTC for each Party are
set forth on Schedule 6.1. TMC’s appointees to the PTC shall be determined by
TMC. Nycomed’s appointees to the PTC shall be determined by Nycomed and shall
include appropriate representation from its [**] and, if appropriate, its [**].
Any replacements or proxies for the foregoing persons shall be equivalently
senior personnel. The PTC shall meet at least [**] (in person or by telephone,
as mutually agreed by the Parties) at such time and, with respect to in-person
meetings, place as mutually agreed upon by the Parties, and at such other dates
as may be agreed upon by the Parties. In addition, the Parties shall cause
their respective members of the PTC to make themselves available, in person or
by telephone, as reasonably necessary to carry out such implementation. Should
the Parties mutually agree to do so, additional, non-voting members may be
appointed to the PTC and operating subcommittees and project teams may be
appointed by and report to the PTC.


 


6.1.3.       In the event that a
consensus decision cannot be reached by the PTC, then, except to the extent
inconsistent with any provision of this Agreement, the New Agreements or the
Quality Agreements, TMC shall have final authority for all decisions with
respect to the Product, other than in respect of pricing in each country in the
Territory during the term of the New Distribution Agreement with respect to
such country; provided, however, that (a) the foregoing shall not
be interpreted to require Nycomed to allocate personnel resources to the
performance of the Services (as defined in the Services Agreement) beyond the
then-current Commitment (as defined in the Services Agreement); (b) Nycomed
shall have no obligation to act in accordance with TMC’s directions if doing so
would violate any applicable provision of law, statute, rule or regulation, as
determined by Nycomed in good faith, or would cause Nycomed to breach any
obligation owed to a third party under an agreement entered into by Nycomed in
good faith; (c) Nycomed shall perform and fund the activities specified to be


 


17

















 


performed and funded, respectively, by Nycomed in Schedule 2.1(b) of
the Services Agreement and TMC shall perform and fund the activities specified
to be performed and funded, respectively, by TMC in Schedule 2.1(b) of the
Services Agreement; and (d) the foregoing shall not be interpreted as giving
TMC any authority to amend any provision of any Transaction Agreement.


 


6.2.          Transition
of Activities in General. The Parties, via the PTC, will agree upon
procedures to ensure a smooth transition from Nycomed to TMC on or before the
Transition Date of the activities required to be undertaken by the holder of
the Approvals for the Product, including without limitation adverse experience
reporting, quarterly and annual reports with Governmental Authorities,
complaint and sample tracking, product recalls and communication with health
care professionals and customers. Without limiting the generality of the
foregoing, the Parties will cooperate with each other in a commercially
reasonable manner to notify relevant key opinion leaders and other relevant
parties interested in the Product of the transition contemplated by this
Agreement.


 


6.3.          Provision
of Reports, Documents and Access.


 


6.3.1.       During the Transition
Period, Nycomed shall provide TMC and any third party that may potentially or
actually subsequently perform services and functions performed by Nycomed under
the New Agreements or Quality Agreements (the “New Distributors”),
with reasonable access to all information, documents, records and facilities
and, subject to clause (iii) below, all personnel, contractors and agents, in
each case as reasonably necessary (a) to complete a reasonable review and
analysis of activities performed by Nycomed with respect to the Product
(including activities directed to obtaining Approvals, marketing, promoting,
distributing, importing or selling the Product) as customary to evaluate the
scope and nature of the services and functions to be performed by TMC or the
New Distributor and (b) to reasonably assist TMC in TMC’s efforts to build its
commercial operations with respect to the Product, including without limitation
TMC’s efforts to obtain for TMC or for any New Distributor any Approvals
necessary to perform services and functions performed by Nycomed under the New
Agreements or Quality Agreements. Without limiting the generality of the
foregoing:


 


(i)                                     During the Transition Period, Nycomed
will provide TMC with frequent and complete ongoing reports with respect to all
activities performed by Nycomed under the Transaction Agreements and Quality
Agreements, including registration efforts and other regulatory matters, and
activities in connection with the marketing, promotion, distribution,
importation and sale the Product. To the extent applicable, the format of such
reports shall be consistent with past practice and shall contain at least as
much detail as in similar reports generated by Nycomed under the Former
Distribution Agreement.


 


(ii)                                  On or before the Transition Date, or with
respect to any item below, on such earlier date as is reasonably practicable
following notice by TMC to Nycomed,


 


18

















 


Nycomed shall provide to TMC or any New Distributor
all documents and records related to the Product within the possession or
control of Nycomed, in each case whether existing as of the Effective Date or
whether created, developed or acquired by Nycomed during the Transition Period
(the “Product Documents and Records”),
including without limitation:


 


(A)          documents and records related to
Regulatory Filings and Approvals (including documents and records relating to
clinical trials and adverse events) and any withdrawals or rejections of
applications for Approvals, including without limitation all documents, files
and databases with respect to the clinical trials set forth on Schedule 6.3.1;


 


(B)           documents (and conversation logs) of
communications with Governmental Authorities (excluding communications with
respect to registrations and applications for the Assigned Trademark
Registrations, which are separately addressed by clause (D) below);


 


(C)           marketing, pricing, sales and customer
information, data and materials, including without limitation: customer lists,
marketing, distribution and sales plans, methods and systems, sales figures and
sales projections, training materials and promotional and advertising
materials, and all translations of the foregoing; and


 


(D)          registrations and applications for the
Assigned Trademark Registrations and Assigned Domain Names, Nycomed’s file with
respect to any pending applications for the Assigned Trademark Registrations,
and the contact information for the law firms or other agents Nycomed has used
with respect to filing and maintaining the registrations and applications for
the Assigned Trademark Registrations.


 


All Product Documents and Records shall be provided in
a timely manner and Nycomed shall deliver such information in electronic (if
existing) or hard copy versions, as TMC may reasonably request. Nycomed may
retain one archival copy of the Product Documents and Records solely for
purposes of performing its obligations under this Agreement, the New Agreements
and the Quality Agreements (for so long as they remain in effect), interpreting
and enforcing its rights under the Transaction Agreements and Quality
Agreements or as necessary to comply with applicable law. Nycomed may and shall
modify the Product Documents and Records provided to TMC pursuant to the foregoing
to remove any individually identifiable information to the extent required to
comply with applicable law. Nycomed may also redact the Product Documents and
Records provided to TMC pursuant to the foregoing to the extent required to
comply with


 


19

















 


any applicable law or any Nycomed contractual
obligation of confidentiality to a third party that exists as of the Effective
Date.


 


Notwithstanding any provision of this Agreement that
may require Nycomed to provide such Product Documents and Records to TMC
earlier, to the extent Nycomed requires continued access to any Product
Documents and Records in order to perform under this Agreement, the New
Agreements and the Quality Agreements, and to the extent that retention by
Nycomed of a copy of such Product Documents and Records for such purpose or
Nycomed’s right of access and right of reference provided for in Section 6.7
are not sufficient for Nycomed to do so, Nycomed shall be permitted to retain
any such Product Documents and Records for so long as reasonably necessary for
such performance, provided that, during such timeframe, TMC shall have a right
of access (including the right to make copies of records) and right of
reference to all such Product Documents and Records.


 


(iii)                               Upon reasonable advance notice to the Nycomed TM,
Nycomed shall provide TMC or any New Distributor with reasonable access to: (A)
personnel and contractors (if any) responsible for obtaining and maintaining
Approvals for marketing, promoting, distributing, importing or selling the
Product and (B) any other personnel engaged in activities under the Transaction
Agreements and Quality Agreements, including promotional, marketing, sales,
detailing and distribution activities. Any such access shall be scheduled
during normal business hours; and


 


(iv)                              As reasonably requested by TMC, Nycomed
shall provide access to facilities owned or operated by Nycomed (or its
subcontractors, if any) used for the distribution of Product.


 


6.3.2.       During the Transition
Period, Nycomed shall give TMC at least seven to ten Business Days prior
written notice of (or such shorter notice as is practicable in light of the
amount of notice Nycomed itself receives of the meeting), and grant TMC and any
New Distributor reasonable access to, and the right to participate in, (a)
meetings and any other communications with any third parties (other than
Governmental Authorities, which meetings shall be governed by Section 6.6) and
(b) material scheduled internal meetings, in each case regarding clinical
trials and registration efforts (in each case, to the extent Nycomed is
expressly authorized to engage in such activities by TMC hereunder) and
promotional, marketing, sales, detailing and distribution activities relating
to the Product.


 


6.4.          Transfer
of Regulatory Filings and Approvals. The Parties shall use commercially
reasonable efforts to complete the transfer of all Regulatory Filings set forth
on Schedule 6.4  (including Approvals
that may result therefrom during the Transition Period) and Approvals set forth
on Schedule 6.4 to TMC or TMC’s designee on the Transition Date or, with
respect to any


 


20

















 


given Regulatory Filing or Approval, upon such earlier date as TMC may
request, provided that such earlier date is reasonably practicable. To the
extent that TMC expressly authorizes Nycomed to make additional Regulatory
Filings during the Transition Period, the Parties shall update Schedule 6.4
accordingly.


 


6.5.          Maintenance
and Registration Efforts. During the Transition Period, Nycomed shall
continue to maintain the Approvals set forth on Schedule 6.4 and any Approvals
that may result from the Regulatory Filings set forth on Schedule 6.4 until
such time as such Approvals and Regulatory Filings are transferred to TMC or
TMC’s designee pursuant to Section 6.4. As of the Effective Date, Nycomed shall
no longer be obligated or have the right to pursue new Approvals with respect
to the Product other than in support of Regulatory Filings set forth on
Schedule 6.4; provided, however, that TMC may, at any time during
the Transition Period, direct Nycomed to withdraw or, if practical, to cease to
actively pursue, any such Regulatory Filing(s) pending further instruction from
TMC. Subject to the foregoing and subject to Section 6.6, during the Transition
Period, Nycomed shall continue to use commercially reasonable efforts to seek
Approvals with respect to such Regulatory Filings, except to the extent that
the applicable Regulatory Filing is transferred to TMC or a TMC designee in
accordance with Section 6.4, in which event TMC or such designee shall be
responsible for the conduct of any such activities. In the event TMC or a TMC
designee assumes such responsibility, Nycomed shall assist TMC or such designee
in seeking such Approvals by supplying TMC or such designee with copies of all
relevant documents and communications, and informing TMC or such designee of
the status of the applicable Regulatory Filings. The Parties agree that during
the Transition Period, or until such earlier time as TMC or a TMC designee may
assume responsibility for such activities, Nycomed’s activities with respect to
seeking the foregoing Approvals shall be subject to reasonable coordination
with TMC; provided, however, that Nycomed shall not be required
to take any action that Nycomed determines in good faith would jeopardize its
standing and reputation with any Governmental Authority or violate any
applicable provision of law, statute, rule or regulation.


 


6.6.          Communications
with Governmental Authorities.


 


6.6.1.       In addition to its
obligations under the New Agreements and the Quality Agreements, during the
Transition Period:


 


(a)           Nycomed shall give TMC
at least seven to ten Business Days prior written notice and the right to
attend any meeting between Nycomed and any Governmental Authority relating to
the Product, or such shorter notice as is practicable in light of the amount of
notice Nycomed itself receives of the meeting.


 


(b)           Nycomed shall provide
TMC with a copy of each proposed communication that will be made between
Nycomed and any Governmental Authority that relates to the Product and the
right to review such communication with as much advance notice as practicable. Nycomed
shall follow the instructions and comments of TMC with respect


 


21

















 


to any such proposed
communication; provided, however, that Nycomed shall not be
required to take any action that Nycomed determines in good faith would
jeopardize its standing and reputation with any Governmental Authority or
violate any applicable provision of law, statute, rule or regulation. Nycomed
shall permit TMC to participate in any response to any such communication.


 


(c)           Nycomed shall be
responsible for making presentations to any Governmental Authority that relate
to Approvals and Regulatory Filings in Nycomed’s name during any joint meetings
and for responding to questions and comments from such Governmental Authority
with respect to its Approvals and Regulatory Filings, but shall solicit and
follow the instructions of TMC prior to making such a presentation or response;
provided, however, that Nycomed shall not be required to take any
action that Nycomed determines in good faith would jeopardize its standing and
reputation with any Governmental Authority or violate any applicable provision
of law, statute, rule or regulation.


 


(d)           Nycomed shall, within
five Business Days, provide TMC with a copy of each written communication
Nycomed receives from any Governmental Authority related to the Product. Nycomed
shall, within five Business Days, provide TMC with notes from any in-person or
teleconference meeting with any Governmental Authority related to the Product
at which TMC is not present.


 


6.6.2.       Notwithstanding the foregoing,
upon a transfer in accordance with Section 6.4 of an Approval or Regulatory
Filing  prior to the Transition Date, (i) TMC
shall assume all responsibility for presentations to and communications with
the relevant Governmental Authority that relate to the Product and (ii) Nycomed
shall be relieved of any responsibility therefor. For the avoidance of doubt,
this Section 6.6 pertains only to Approvals and Regulatory Filings (including
Approvals that may result therefrom during the Transition Period) that exist as
of the Effective Date and is not intended to grant any authority to Nycomed to
file or seek new Approvals or Regulatory Filings.


 


6.7.          Delivery
of Know How and Clinical Data. As promptly as possible after the Effective
Date (or, if applicable, as promptly as possible after the creation,
development or acquisition of any such item), and in any event no later than
the Transition Date, Nycomed shall provide to TMC or TMC’s designee the
physical embodiments of all Assigned Know-How and copies of the physical
embodiments of all Licensed Know-How; provided, however, that (i)
to the extent Nycomed requires access to Assigned Know-How to comply with
applicable legal requirements pertaining to Nycomed’s performance under the New
Agreements, Quality Agreements or this Agreement, subject to Section 11
(Confidential Information), TMC or TMC’s designee, as applicable, shall allow
Nycomed a right of access (including the right to make copies of records) and
right of reference to all such Assigned Know-How, (ii) Nycomed may retain one
archival copy of each such item of Assigned Know-How solely for purposes of
interpreting and enforcing its rights under the Transaction Agreements and
Quality Agreements or as necessary


 


22
















to comply with applicable law, (iii) Nycomed may and shall modify such
items of Know-How provided to TMC pursuant to the foregoing to remove any
individually identifiable information to the extent required to comply with
applicable law and (iv) Nycomed may redact such items of Know-How provided to
TMC pursuant to the foregoing to the extent required to comply with any
applicable law or any Nycomed contractual obligation of confidentiality to a
third party that exists as of the Effective Date. In addition to transferring
the physical embodiments (or copies thereof) of such items of Know-How, Nycomed
shall provide TMC with reasonable access to Nycomed personnel and contractors
in accordance with Section 6.3.1(iii), including for the purpose of answering
TMC’s questions related to the Know-How provided pursuant this Section 6.7.


 


6.8.          Assignment of
Assigned Contracts.


 


6.8.1.       On the Transition Date or, with respect
to any such contract, on such earlier date as is reasonably practicable
following notice by TMC to Nycomed, in each case subject to obtaining any
necessary third party consents in accordance with Section 6.8.4, Nycomed shall
assign and transfer to TMC or TMC’s designee all of Nycomed’s right, title and
interest in and to the contracts set forth on Schedule 6.8 (the “Assigned Contracts”). TMC or the applicable TMC designee
shall assume and become responsible for, from and after the relevant Assignment
Date, all obligations of Nycomed arising after the relevant Assignment Date
under the Assigned Contracts; provided, however, that (a)
although such obligations may arise before the relevant Assignment Date, TMC
shall be responsible for the payment obligations of Nycomed (and of TMC as the
successor-in-interest to Nycomed) arising after the Effective Date under (i)
the ISAR 4-Agreement (as defined in the New Distribution Agreement), up to €
[**], (ii) the ISAR-3 Reload Agreement (as defined in the New Distribution
Agreement), up to € [**], and (iii) the ADONIS Agreement, up to € [**], and (b)
although such obligations may arise after the relevant Assignment Date, Nycomed
shall be responsible for, and to the extent paid by TMC shall promptly
reimburse TMC for, the payment obligations of Nycomed (and of TMC as the
successor-in-interest to Nycomed) arising after the Effective Date under (i)
the Munich ISAR-3 Agreement (as defined in the New Distribution Agreement) and
(ii) the Bad Krozingen
ISAR-3 Agreement (as defined in the New Distribution Agreement). For the
sake of clarity, Nycomed retains any obligation to pay any amount (x) arising
under the ISAR-4 Agreement beyond the € [**] maximum amount payable by TMC
pursuant to Section 6.8.1(a)(i), (y) arising under the ISAR-3 Reload Agreement
beyond the € [**] maximum amount payable by TMC pursuant to Section
6.8.1(a)(ii) or (z) arising under the ADONIS Agreement beyond the € [**]
maximum amount payable by TMC pursuant to Section 6.8.1(a)(iii).


 


6.8.2.       Except to the extent expressly provided
otherwise in Section 6.8.1 with respect to post-Effective Date payment
obligations under the ISAR 4 Agreement, the ISAR-3 Reload Agreement and the
ADONIS Agreement, TMC or the applicable TMC designee shall not assume or become
responsible for, and Nycomed shall remain liable for, all liabilities and
obligations of Nycomed arising prior to the relevant Assignment Date under the
Assigned Contracts, including all obligations to make payment thereunder
accruing prior to the relevant


 


23

















 


Assignment Date, and all liabilities for any breach, act or omission by
Nycomed prior to the relevant Assignment Date under any Assigned Contract. For
the avoidance of doubt, except to the extent expressly provided otherwise in
Section 6.8.1 with respect to post-Effective Date payment obligations under the
ISAR 4 Agreement, the ISAR-3 Reload Agreement and the ADONIS Agreement, TMC or
the applicable TMC designee does not and will not assume any liabilities of
Nycomed  arising from (i) defaults
under or breaches of any Assigned Contract prior to the relevant Assignment
Date, including any failure by Nycomed to make any payment due prior to the
Assignment Date or to perform any obligation required prior to the Assignment
Date, or (ii) events occurring prior to the
relevant Assignment Date, which, after notice or lapse of time or both, would
constitute a default or breach of such Assigned Contract, in each case whether
a claim for such default or breach is made prior to or following the assignment
date. For the avoidance of doubt, as of the relevant Assignment Date, TMC shall
obtain all rights of Nycomed under each Assigned Contract, whether accruing
before or after the relevant Assignment Date.


 


6.8.3.       Upon the assignment of any Assigned
Contract, Nycomed and TMC or the applicable TMC designee shall execute such
further instruments of conveyance as may be necessary to assign and transfer
such Assigned Contracts to TMC or TMC’s designee, as applicable.


 


6.8.4.       Nycomed shall use commercially reasonable
efforts to obtain any consents required from third parties, and to give all
such notices to third parties, in each case as promptly as practicable after
the Effective Date, as are required to effect the assignment of the Assigned
Contracts to TMC or TMC’s designee, as applicable.


 


6.8.5.       From and after the Effective Date until
the assignment of each Assigned Contract, (i) except to the extent Nycomed
retains responsibility for obligations under the Assigned Contracts in
accordance with Sections 6.8.1 or 6.8.2 or Nycomed is required to perform
activities under the New Distribution Agreement or the Services Agreement with
respect to the Assigned Contracts, TMC or TMC’s designee shall perform and
fulfill, on a subcontractor basis, the obligations of the Nycomed to be
performed under such Assigned Contract, and (ii) Nycomed shall use commercially
reasonable efforts to provide TMC with all of Nycomed’s rights and benefits
under each Assigned Contract. Without limiting the foregoing, (a) Nycomed shall
enforce, at the request of, for the account of and at the expense of TMC, any
rights of Nycomed arising from any such Assigned Contract against any third
party, including the right to elect to terminate in accordance with the terms
thereof upon the instruction of TMC and (b) Nycomed shall not enter into any
amendment to any Assigned Contract, or waive any rights of Nycomed thereunder,
without the prior written consent of TMC.


 


6.9.          Termination or
Amendment of Regulatory Filings and Approvals.


 


6.9.1.       On or immediately following the
Transition Date or, as to a particular country or group of countries within the
Territory (including the countries within the European Economic 


 


24

















 


Area), such earlier date as Nycomed is no longer authorized to
distribute the Product in such country or group of countries under the New
Distribution Agreement, Nycomed shall (a) terminate all Approvals held in
Nycomed’s name that pertain to such country or group of countries and that are
exclusively related to the Product to the extent that such Approvals have not
been transferred, and are not in the process of being transferred, to TMC or
TMC’s designee in accordance with Section 6.4 and (b) amend all Approvals held
in Nycomed’s name that pertain to such country or group of countries and are
not exclusively related to the Product so as to exclude any reference to the
Product.


 


6.9.2.       On or immediately following the
Transition Date, or such earlier date as Nycomed is no longer authorized to
distribute the Product in the applicable country under the New Distribution
Agreement, Nycomed shall (a) withdraw all Regulatory Filings held in Nycomed’s
name that are exclusively related to the Product to the extent that such
Regulatory Filings (i) have not been transferred, and are not in the process of
being transferred, to TMC or TMC’s designee in accordance with Section 6.4 or
(ii) have not been otherwise earlier withdrawn, and are not in the process of
being withdrawn, in accordance with Section 6.5, and (b) amend all Regulatory
Filings held in Nycomed’s name that are not exclusively related to the Product
so as to exclude any reference to the Product; provided, however,
that if, with respect to any Regulatory Filing set forth on Schedule 6.4, the
relevant Governmental Authority has not yet granted a corresponding Approval as
of the Transition Date, and if such Regulatory Filing cannot be transferred to
TMC prior to such grant, then Nycomed shall, at the request of TMC, either
withdraw the Regulatory Filing or, at the ongoing discretion of TMC and in
accordance with the provisions of Sections 6.4, 6.5 and 6.6, continue to pursue
the grant of such Regulatory Filing to the Approval stage and, upon such grant,
transfer the Approval to TMC or TMC’s designee and TMC shall reimburse Nycomed’s
Out-of-Pocket Costs with respect to the foregoing activities in accordance with
Section 8.4.


 


6.10.        Inventory.


 


For the avoidance of
doubt, references in this Section 6.10 to Nycomed Danmark ApS shall refer
solely to such entity and, notwithstanding Section 2.3, shall not be deemed to
include any Affiliates of such entity.


 


6.10.1.     Pursuant to the New Distribution Agreement,
during the term thereof, Nycomed Danmark ApS and its Affiliates shall continue
to sell the Existing Inventory and may also sell New Inventory in accordance
with the terms thereof. The “Vials of  Remaining Inventory” means all vials of the Existing
Inventory and/or New Inventory held by Nycomed Danmark ApS or its Affiliates in
inventory upon the expiration or termination date of the New Distribution
Agreement. Immediately and automatically upon expiration or termination of the
New Distribution Agreement in its entirety: (a) Nycomed Danmark ApS shall
obtain title and ownership of any Vials of Remaining Inventory that may be held
by its Affiliates, (b) TMC or TMC’s designee shall purchase, and shall be
deemed to have purchased from Nycomed and Nycomed to have sold to TMC or TMC’s
designee, any Vials of Remaining Inventory from


 


25

















 


Nycomed Danmark ApS at a price of US$[**] per vial of Existing
Inventory and at no charge (US$0) for vials of New Inventory (the aggregate
purchase price for all such vials being the “Inventory
Purchase Price”) and (c) title to the Vials of Remaining Inventory
shall pass to TMC or TMC’s designee. On such termination date, Nycomed Danmark
ApS shall execute and deliver the Bill of Sale with respect to the Vials of
Remaining Inventory to TMC or TMC’s designee, as applicable, in the form
attached hereto as Exhibit C.


 


6.10.2.     Nycomed shall deliver the Vials of
Remaining Inventory into the possession of a common carrier designated by TMC
within five Business Days after the expiration or termination of the New
Distribution Agreement. If TMC does not designate a common carrier before the
expiration or termination date, then Nycomed may designate a common carrier on
behalf of TMC. Risk of loss and damage to the Vials of Remaining Inventory
shall pass to TMC or TMC’s designee, as applicable, upon possession by the
common carrier. The Vials of Remaining Inventory shall be delivered FCA
(Incoterms 2000) the applicable Nycomed distribution facility. The Vials of
Remaining Inventory shall be packed for shipment and storage in accordance with
Nycomed’s standard commercial practices. Nycomed shall deliver all Vials of
Remaining Inventory in good and merchantable quality and in saleable condition
in the ordinary of course of business as conducted in accordance with Nycomed’s
past practice.


 


6.10.3.     Upon shipment of the Vials of Remaining
Inventory, Nycomed Danmark ApS shall invoice TMC or TMC’s designee, as
applicable, for the Inventory Purchase Price. The Inventory Purchase Price
shall be paid in U.S. Dollars and shall be paid in accordance with Section 8.5.
Taxes now or hereafter imposed with respect to TMC or TMC’s designee’s purchase
of the Vials of Remaining Inventory contemplated hereunder (with the exception
of income taxes or other taxes imposed upon Nycomed and measured by the gross
or net income of Nycomed) shall be the responsibility of TMC as between TMC and
Nycomed Danmark ApS, and if paid or required to be paid by Nycomed Danmark ApS,
the amount thereof shall be added to and become a part of the amounts payable
by TMC hereunder. Nycomed Danmark ApS remains responsible however to the local
VAT authorities for introducing any periodical VAT returns and paying any VAT
due on TMC’s or TMC’s designee’s purchase of the Vials of Remaining Inventory,
if required to do so under the applicable VAT law and regulations. Notwithstanding
the foregoing, if TMC is required to withhold taxes from any amount payable by
TMC to Nycomed Danmark ApS with respect to the purchase of the Vials of
Remaining Inventory, then TMC shall pay to Nycomed Danmark ApS an additional
amount as may be necessary so that Nycomed Danmark ApS will receive, after
deduction of such withholding tax, the amount which Nycomed Danmark ApS would
have received in the absence of such withholding tax. Nycomed Danmark ApS will
promptly  credit to TMC any withholding tax
Nycomed Danmark ApS recovers through a foreign tax credit that Nycomed Danmark
ApS actually uses to reduce its tax liabilities, up to the additional amount as
described above, that TMC has paid to Nycomed Danmark ApS with respect to that
recovered tax.


 


26

















 


6.11.        Level of Efforts.


 


6.11.1.     Nycomed shall use commercially reasonable
efforts to fulfill its obligations under the Transaction Agreements and Quality
Agreements, including the allocation of sufficient human and corporate
resources to such tasks; provided, however, that the foregoing
shall not be interpreted to require Nycomed to allocate personnel resources to
the performance of the Services (as defined in the Services Agreement) beyond
the then-current Commitment (as defined in the Services Agreement).


 


6.11.2.     TMC will use commercially reasonable
efforts to complete the transition of the services and functions performed by
Nycomed under the New Agreements and Quality Agreements to TMC or to a New
Distributor as soon as reasonably practicable after the Effective Date, and in
no event later than the Transition Date.


 


7.             OBLIGATIONS DURING AND
AFTER THE TRANSITION PERIOD


 


Both during the
Transition Period and after the termination of this Agreement:


 


7.1.          Regulatory
Approval Information. For a period of one year following the Transition
Date, (a) Nycomed shall provide to TMC such information in Nycomed’s possession
or control as may be reasonably requested by TMC for TMC to obtain Approvals
throughout the Territory, including without limitation all documents, files and
databases with respect to the clinical trials set forth on Schedule 3.1.6. and
(b) subject to the provisions of Section 6.6, Nycomed shall also provide such
information to any examiners or agents from any Governmental Authority who may
request such information from either Nycomed or TMC;


 


7.2.          Adverse Event
Reporting. Without a limit as to duration, Nycomed shall inform TMC within
72 hours of all customer complaints, adverse reaction information or
notifications, correspondence, etc. with respect to the use of the Product that
may come to Nycomed’s attention;


 


7.3.          Infringement of
Third Parties. For a period of one year following the Transition Date,
Nycomed shall notify TMC should it become aware that the manufacture, use,
sale, offering for sale or import of the Product infringes any patents, patent
rights, patent applications, inventions, trademarks, service marks or
tradenames, copyrights, confidential information, trade secrets or any other
proprietary rights or processes of any third party; and


 


7.4.          Infringement by
Third Parties. For a period of one year following the Transition Date,
Nycomed shall notify TMC should it become aware that there is infringement by a
third party of a patent involving the Product.


 


27

















 


8.             PAYMENTS; EXPENSES.


 


8.1.          Up-Front Payment. In accordance with Section 2.2,
either on the Effective Date or on the first day after the Effective Date that
is both a Business Day and a day on which the banks in the Commonwealth
of Massachusetts are open for business, TMC shall make a non-creditable,
non-refundable payment to Nycomed by wire transfer in the amount of Twenty
Million U.S. Dollars (US $20,000,000) (the “Up-Front
Payment”).


 


8.2.          Transition Payments. On January 15, 2008, TMC shall
make an additional non-creditable, non-refundable payment to Nycomed in the
amount of Fifteen Million U.S. Dollars (US $15,000,000). On the first day after
the Second Transition Payment Date that is both a Business Day and a day
on which the banks in the Commonwealth of Massachusetts are open for business, TMC shall make an additional
non-creditable, non-refundable payment to Nycomed in the amount of Five Million
U.S. Dollars (US $5,000,000). The “Second Transition Payment
Date” means the earlier of (a) the Transition Date or (b) June 30,
2008.


 


8.3.          Milestone Payment. TMC shall make an additional
non-creditable, non-refundable payment to Nycomed in the amount of Five Million
U.S. Dollars (US $5,000,000) (the “Milestone Payment”)
within [**]
Business Days after TMC’s receipt of notice of a decision by the European
Commission, approving a positive opinion from the Committee for Human Medicinal
Products (“CHMP Positive Opinion”), that the
Product may be marketed for the indication of treatment in patients with Acute
Coronary Syndromes (unstable angina/non-ST segment elevation myocardial
infarction (UA/NSTEMI)) (the “Additional Indication”)
in the event that: (a) the Additional Indication has been granted based
substantially upon the results of the Acute Catheterization and Urgent
Intervention Triage Strategy clinical trial (Protocol No. TMC-BIV-02-08) (the “ACUITY Trial”), (b) the Additional Indication is approved on
or before December 31, 2009 and (c) the CHMP Positive Opinion is issued on or
before December 31, 2008. In the event that a CHMP opinion requires TMC to
perform additional Clinical Trial(s) other than the ACUITY Trial as a condition
of obtaining the Additional Indication and such additional Clinical Trial(s) is
required prior to the issuance of the Additional Indication, and if TMC
performs such additional Clinical Trial(s) and subsequently the conditions in
clauses (a), (b) and (c) above are met, then, the Milestone Payment shall be
reduced by an amount equal to 50% of TMC’s costs of performing such additional
Clinical Trials(s). For purposes of this Section 8.3, “Clinical
Trial” means, in accordance with European Union directives, an
investigation, in accordance with a protocol approved by the appropriate
authorities, in human subjects intended to discover or verify the clinical,
pharmacological and/or other pharmacodynamics effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational
product(s), and/or to study absorption, distribution, metabolism, and excretion
of an investigational product(s) with the objective of ascertaining its safety
and/or efficacy.


 


28

















 


For purposes of this Section 8, description of a
payment as non-refundable or non-creditable shall not be interpreted to negate
the right of the paying party to offset amounts due to it hereunder from the
payee party against such payment.


 


8.4.          Out-of-Pocket Costs.


 


8.4.1.       Each Party shall be responsible for its own
expenses of performing under this Agreement. Notwithstanding the foregoing, TMC
shall be responsible for any out-of-pocket costs owed to a third party and
incurred by Nycomed after the Effective Date to the extent solely attributable
and directly related to: (a) Nycomed’s transfer of Approvals and Regulatory
Filings to TMC or TMC’s designee pursuant to Section 6.4, (b) Nycomed’s
maintenance of Approvals pursuant to Section 6.5, (c) Nycomed’s registration efforts with respect to
Regulatory Filings pursuant to Section 6.5, (d) Nycomed’s withdrawal or amendment of
Regulatory Filings pursuant to Section 6.5 or 6.9.2, (e) Nycomed’s termination or amendment of
Approvals pursuant to Section 6.9, (f) Nycomed’s transfer of the Assigned
Trademark Registrations
to TMC or TMC’s designee pursuant to Section 5.1, (g) Nycomed’s maintenance of
the Assigned Trademark Registrations prior to such transfer and (h) Nycomed’s transfer of the Assigned
Domain Names to TMC or TMC’s designee pursuant to Section 5.2 (the “Out-of-Pocket Costs”); provided, however, that
such Out-of-Pocket Costs shall be incurred in the ordinary course of business
and consistent with Nycomed’s past practice and shall be substantially in
accordance with the budget set forth as Schedule 8.4.1 (as the same may be
amended from time to time with the prior written approval of TMC, which
approval will not be unreasonably withheld); and provided, further,
that Nycomed shall maintain adequate supporting documentation to substantiate
all Out-of-Pocket Costs billed to TMC and shall provide the foregoing to TMC
upon request.


 


8.4.2.       Taxes now or hereafter imposed with
respect to TMC’s reimbursement of the Out-of-Pocket Costs contemplated
hereunder (with the exception of income taxes or other taxes imposed upon
Nycomed and measured by the gross or net income of Nycomed) shall be the
responsibility of TMC as between TMC and Nycomed Danmark ApS, and if paid or
required to be paid by Nycomed Danmark ApS, the amount thereof shall be added
to and become a part of the amounts payable by TMC hereunder. Nycomed Danmark
ApS remains responsible however to the local VAT authorities for introducing
any periodical VAT returns and paying any VAT due on the reimbursement of the
Out-of-Pocket Costs, if required to do so under the applicable VAT law and
regulations. Notwithstanding the foregoing, if TMC is required to withhold
taxes from any amount payable by TMC to Nycomed Danmark ApS under Section
8.4.1, then TMC shall pay to Nycomed Danmark ApS an additional amount as may be
necessary so that Nycomed Danmark ApS will receive, after deduction of such
withholding tax, the amount which Nycomed Danmark ApS would have received in
the absence of such withholding tax. Nycomed Danmark ApS will promptly credit
to TMC any withholding tax Nycomed Danmark ApS recovers through a foreign tax
credit that Nycomed Danmark ApS actually uses to reduce its tax liabilities, up
to the additional amount as described above, that TMC has paid to Nycomed
Danmark ApS with respect to that recovered tax.


 


29

















 


8.4.3.       The Out-of-Pocket Costs incurred by Nycomed
during each calendar quarter shall be calculated by Nycomed at the end of such
quarter, shall be reported by Nycomed to TMC after the end of each such
calendar quarter as follows: within five Business Days after the end of each
quarter, Nycomed shall report such information with respect to the first two
months of such quarter and shall provide estimates with respect to the third
month of such quarter, and within ten Business Days after the end of each
quarter, Nycomed shall report such information with respect to the third month
of such quarter. The Out-of-Pocket Costs shall be paid by TMC in accordance
with Section 8.5.


 


8.4.4.       If
any portion of the Out-of-Pocket
Costs are stated in a currency other than United States Dollars during
such quarter, then, for the purpose of calculating and reporting the Out-of-Pocket Costs for such
quarter, such portion of the Out-of-Pocket
Costs  shall be converted into United States Dollars at the exchange
rate between those two currencies most recently quoted in the European Central
Bank in Frankfurt as of the last Business Day of such calendar quarter. If no
such exchange rate has been quoted in the European Central Bank in Frankfurt at
any time during the 12-month period preceding the last Business Day of such
quarter, the Parties shall determine in good faith a reasonable exchange rate
to be applied to such portion of the Out-of-Pocket Costs.


 


8.5.          Quarterly True-Up Payments.


 


8.5.1.       After the end of each calendar quarter,
Nycomed shall submit a report to TMC containing the following information as
follows:


 


(a)           With five Business Days after the end
of each quarter, the aggregate Transfer Price (as defined in the New
Distribution Agreement) due from Nycomed to TMC pursuant to Section 10.1(a) of
the New Distribution Agreement  with respect
to vials of Product sold by Nycomed, Nycomed Affiliates or Distributors (as
defined in the New Distribution Agreement) during such calendar quarter
(including any taxes due by Nycomed to TMC with respect thereto);


 


(b)           Within five Business Days after the
end of each quarter, the aggregate amount due from TMC to Nycomed pursuant to
Section 10.1(b) of the New Distribution Agreement with respect to vials of
Product supplied by Nycomed under the ISAR Agreements during such calendar
quarter;


 


(c)           Within five Business Days after the
end of each quarter, Nycomed shall report such information with respect to the
first two months of such quarter and shall provide estimates with respect to
the third month of such quarter, and within ten Business Days after the end of
each quarter, Nycomed shall report such information with respect to the third
month of such quarter: The Service Fee (as defined in the Services Agreement)
due from TMC to Nycomed pursuant to Section 10.1 of the Services Agreement in
consideration of services


 


30

















 


performed by Nycomed thereunder during such calendar quarter (as
reported pursuant to Section 10.2 of the Services Agreement);


 


(d)           Within five Business Days after the
end of each quarter, Nycomed shall report such information with respect to the
first two months of such quarter and shall provide estimates with respect to
the third month of such quarter, and within ten Business Days after the end of
each quarter, Nycomed shall report such information with respect to the third
month of such quarter: The Out-of-Pocket Costs due from TMC to Nycomed for such
calendar quarter, as reported pursuant to Section 8.4.3 of this Agreement
(including any taxes due by TMC to Nycomed with respect thereto);


 


(e)           Within five Business Days after the
end of the applicable quarter: If the Inventory Purchase Price was invoiced by
Nycomed during such calendar quarter pursuant to Section 6.10.3 of this
Agreement, the Inventory Purchase Price due from TMC to Nycomed (including any
taxes due by TMC to Nycomed with respect thereto); and


 


(f)            Within five Business Days after the
end of September 30, 2007: the US[**] due from TMC to Nycomed pursuant to
Section 9.2 of the New Distribution Agreement.


 


8.5.2.       If the amount described in paragraph (a)
above is greater than the sum of the amounts described in paragraphs (b), (c),
(d), (e) and (f) above, then, within 30 calendar days after delivery of the
final report required by Section 8.5.1, based on the information contained therein,
Nycomed shall pay to TMC the difference.


 


8.5.3.       If
the sum of the amounts described in paragraphs (b), (c), (d), (e) and (f) above
is greater than the amount described in paragraph (a) above, then, within 30
calendar days after receipt of the final report required by Section 8.5.1,
based on the information contained therein, TMC shall pay to Nycomed the
difference.


 


8.6.          Interest. Additionally,
all payments due under any Transaction Agreement that are not paid when due
shall bear interest which is the lesser of: 
(i) the rate of Citibank N.A.’s prime rate plus 2% per annum or (ii) the
maximum lawful interest rate permitted under applicable law. Such interest
shall accrue on the balance of unpaid amounts from time to time outstanding
from the date on which portions of such amounts become due and owing until
payment thereof in full.


 


8.7.          Payment Form.
All payments between the Parties shall be in US Dollars and shall be made by bank wire transfer in
next day available funds to the bank account designated in writing by the
receiving Party from time to time. For the sake of clarity, TMC shall
pay any amounts due by TMC hereunder only to Nycomed Danmark ApS and TMC shall
have no obligation to make any payments to any Nycomed Affiliate.


 


31

















 


8.8.          Audit and
Inspection; Cooperation with respect to Financial Information. For a period
of [**] next following each calendar year, Nycomed shall keep, and shall cause
each of its Affiliates involved with the activities under this Agreement to
keep, full, true, and accurate books and records containing all particulars
relevant to such activities during such year in sufficient detail to enable TMC
to verify the amounts payable by TMC to Nycomed hereunder. TMC shall have the right,
[**] during any calendar year, to have such books and records of Nycomed
audited by a qualified nationally-recognized, independent accounting firm of
TMC’s choosing, during normal business hours upon reasonable notice, for the
sole purpose of verifying the accuracy of the amounts paid by TMC to Nycomed
hereunder. In the event that an audit shows that Nycomed has overcharged or
underpaid TMC by [**] percent ([**]%) or more, then Nycomed shall pay for all
costs of such audit, otherwise the costs of such audit shall be borne by TMC. In
all cases, Nycomed shall reimburse to TMC any overcharged or underpaid amounts
promptly, together with interest calculated in accordance with Section 8.6, and
TMC shall promptly pay to Nycomed any amounts which the audit shows Nycomed has
undercharged or overpaid TMC. Nycomed will cooperate with TMC, at TMC’s cost
and expense, to assist TMC, as reasonably requested by TMC, in the preparation
of any financial information or statements required by TMC as a result of the
consummation of the transactions contemplated by the Transition Agreements.


 


9.             EMPLOYEES


 


The Parties have considered
the possibility of whether TUPE is triggered by this Agreement, and have agreed
as follows:


 


9.1.          For purposes of this Section 9:


 


9.1.1.       “Assigned Employees” means employees of Nycomed or any
subcontractor (of whatever tier), in any jurisdiction, who are at the Effective
Date assigned (sufficiently for the purposes of TUPE) to the services provided
by Nycomed to TMC.


 


9.1.2.       “Unexpected Employee” has the meaning set forth in Section
9.7.


 


9.1.3.       “Unexpected Employee Liability” has the meaning set forth in
Section 9.8.


 


9.1.4.       “Termination” means any of: the expiration of any of the
Transaction Agreements or the Quality Agreements; or the full or partial
termination by either Party of Nycomed’s provision of any services under any of
the Transaction Agreements or the Quality Agreements (at any time, and with or
without cause).


 


9.1.5.       “TUPE” means, as appropriate, (a) the European Union’s
Acquired Rights Directives Nos. 77/187/EEC and/or 01/23/EC; (b) the Transfer of
Undertakings (Protection of Employment) Regulations 2006; (c) the legislation
enacted in any Member State of the European Union, or in any State within the
European Economic Area which is not a Member


 


32

















 


State of the European Union,
giving effect to the said Directives; and (d) any similar legislation in those
or any other jurisdiction; as amended, updated, re-enacted or extended from time-to-time.


 


9.1.6.       “Successor Provider” means any third party (including without
limitation any Affiliate of TMC) who, at any time after the Termination,
provides similar services to those provided, or carries out tasks which were
undertaken, by Nycomed (itself and/or using a third party) under the
Transaction Agreements and the Quality Agreements.


 


9.1.7.       “Protected Unexpected Employee” means any Unexpected Employee
who cannot be dismissed and remains employed with or is reinstated by TMC or a
Successor Provider, for the reasons set out in Section 9.8.5.


 


9.1.8.       “Dismissed Employee” means any employee of TMC or a Successor
Provider who is dismissed because a Protected Unexpected Employee cannot be
dismissed, or is reinstated, for the reasons set out in Section 9.8.5.


 


9.2.          Given that the effect of this Agreement is to transfer
certain detailing, promotion and marketing activities to TMC, but the Services
Agreement also provides that Nycomed will provide TMC with services to assist
TMC in performance of such activities so transferred and there being no
intervening point at which such services will be carried out by anyone other
than Nycomed, the Parties believe that there is neither the transfer of an
economic entity, nor the transfer of an activity, by which this Agreement
triggers the application of TUPE.


 


9.3.          Strictly without prejudice to and without limiting Nycomed’s
obligations under the Services Agreement, Nycomed shall ensure that neither the
employment of any person (including any Assigned Employee), nor any liabilities
relating thereto, shall transfer by operation of TUPE from Nycomed and/or any
subcontractor (of whatever tier) of Nycomed to TMC or any Successor Provider,
as a consequence of (a) the execution of this Agreement or (b) the Termination.


 


9.4.          Nycomed represents and warrants that Schedule 9.4 sets
forth a full and accurate list of all Assigned Employees, anonymized where
necessary to comply with applicable data protection laws.


 


9.5.          Nycomed will ensure that other than as permitted or required
by Section 9.6 of this Agreement or Section 4.1(c) of the Services Agreement:
(a) there shall be no changes to the Assigned Employees; (b) no person shall
cease to be an Assigned Employee other than by reason of their dismissal or
resignation from employment by Nycomed; and (c) no person shall become an
Assigned Employee, except, in each case, with the written agreement of TMC,
such agreement not to be unreasonably withheld or delayed.


 


33

















 


9.6.          For the avoidance of doubt, to the extent such assignments
are otherwise permitted pursuant to Section 4.1(c) of the Services Agreement,
Nycomed shall be permitted to wholly or partially assign Assigned Employees
(with their agreement if necessary) to other work (as well as or instead of
services to be performed under any Transaction Agreement or Quality Agreement),
provided that Nycomed’s obligations under the Services Agreement are satisfied.


 


9.7.          It is agreed that in the event that any person (including
any Assigned Employee) (an “Unexpected Employee”)
alleges or establishes that his employment with Nycomed or any subcontractor
(of whatever tier), or any liabilities or obligations relating to his
employment or its termination, transfers to TMC or any Successor Provider, by
virtue of the application of TUPE, upon the Effective Date or upon Termination:


 


9.7.1.       where
either Party becomes aware of such allegation or finding, that Party will
notify the other Party as soon as reasonably practicable;


 


9.7.2.       TMC
will then allow Nycomed or any subcontractor (of whatever tier) 21 calendar
days either to offer employment to the Unexpected Employee or take other steps
so as to effect a written withdrawal of the allegations or a settlement of the
Unexpected Employee’s relevant claims (in the event that such settlement
requires TMC to be a party for it to validly settle claims against TMC, TMC
will co-operate with this and Nycomed indemnifies TMC for TMC’s liabilities
under such settlement agreement);


 


9.7.3.       if at the end of such 21-day period the
Unexpected Employee is or still alleges to be an employee of TMC or any
Successor Provider, then within 14 calendar days of the end of such 21-day
period TMC or the Successor Provider (as appropriate) shall elect in writing to
Nycomed to follow either (a) or (b) below:


 


(a)           If TMC or the Successor Provider (as
appropriate) elects option (a), it shall thereafter employ the Unexpected
Employee; and notwithstanding the definition of Unexpected Employee Liability
set out below, no costs, claims, losses, damages, liabilities, reasonable
expenses, payments made under reasonable settlement agreements, statutory
redundancy pay, contractual redundancy pay or entitlements (such as
pension-related entitlements) triggered by redundancy, which relate to the
period after the date of the written election of this option (a), shall
constitute Unexpected Employee Liabilities.


 


(b)           If TMC or the Successor Provider (as
appropriate) elects option (b), then TMC shall, or shall procure that any
Successor Provider (as appropriate) shall, dismiss the Unexpected Employee, as
follows. During the 21 days after such written election, Nycomed may upon
notification to TMC conduct (on TMC’s or the Successor Contractor’s behalf, and
with reasonable co-operation by TMC or the Successor Contractor, including in
the provision of appropriate information to Nycomed) any process in relation to
such dismissal as it reasonably considers necessary to reduce the chances of
legal action by the Unexpected Employee in relation to his/her dismissal. After
such 21 day period (or earlier if notified in writing by


 


34

















 


Nycomed) TMC (or the Successor Contractor, as appropriate) shall
dismiss the Unexpected Employee.


 


9.8.          For purposes of this Section 9, “Unexpected
Employee Liability” means any costs (including without limitation
all salary, benefit, pension and other employment costs), claims, losses,
damages, liabilities, reasonable expenses (including without limitation all
legal and court costs), payments made under reasonable settlement agreements,
statutory redundancy pay, contractual redundancy pay, and any entitlements
(such as pension-related entitlements) triggered by redundancy, relating to:


 


9.8.1.       any
Unexpected Employee (other than any Protected Unexpected Employee) being
employed by TMC or a Successor Provider;


 


9.8.2.       any
Protected Unexpected Employee being employed by TMC or a Successor Provider up
to the date of the dismissal of his or her corresponding Dismissed Employee;


 


9.8.3.       any
Unexpected Employee’s dismissal by TMC or a Successor Provider in accordance
with Section 9.7.3(b);


 


9.8.4.       Nycomed’s
conduct of any process under Section 9.7.3(b);


 


9.8.5.       TMC’s
(or a Successor Provider’s, as appropriate) dismissal of any other employee in
the event that an Unexpected Employee cannot be dismissed, and remains or is
reinstated as a TMC (or a Successor Provider’s) employee, because of national
laws which set an order of social selection for dismissal or which otherwise
prevent (as opposed to merely rendering unlawful) the dismissal of the
Unexpected Employee;


 


9.8.6.       any
Unexpected Employee’s allegations or claims relating to periods prior to the
alleged transfer of undertaking; and/or


 


9.8.7.       information
and consultation obligations generally under TUPE in respect of the TUPE
transfer or potential transfer of which the Unexpected Employee claims to be a
part.


 


9.9.          Nycomed shall fully indemnify, keep indemnified and, within
30 calendar days of invoice, reimburse TMC and any Successor Provider (as
appropriate) for all Unexpected Employee Liabilities incurred by TMC and/or any
Successor Provider subject to Nycomed’s receipt of reasonable written evidence
from TMC or the Successor Provider (as applicable) for such Unexpected Employee
Liabilities having been incurred.


 


10.          NO
RIGHTS BY IMPLICATION


 


No rights or licenses
with respect to the Product or the Trademarks (as defined in the New
Distribution Agreement) are granted or deemed granted hereunder or in
connection herewith, other than those rights expressly granted in this
Agreement.


 


35

















 


11.          CONFIDENTIAL
INFORMATION


 


11.1.        Definition of
Confidential Information.


 


In
connection with the business relationship between TMC and Nycomed pursuant to
the Former Distribution Agreement, and in connection with the performance of
the Transaction Agreements and Quality Agreements, Nycomed may have gained
access in the past, or may gain access in the future, to proprietary
information of TMC which may be considered confidential by TMC (“TMC Confidential Information”). Without limiting the
generality of the foregoing, TMC Confidential Information shall include without
limit all Assigned Know-How and all Product Documents and Records. In
connection with the business relationship between TMC and Nycomed pursuant to
the Former Distribution Agreement, and in connection with the performance of
the Transaction Agreements and Quality Agreements, TMC may have gained access
in the past, or may gain access in the future, to proprietary information of
Nycomed with respect to Nycomed employees which may be considered confidential
by Nycomed (“Nycomed Confidential Information”).
“Confidential Information” means either
TMC Confidential Information or Nycomed Confidential Information, as
applicable.


 


11.2.        Obligations to
Keep Confidential and Not Use.


 


Each Party (the “Receiving Party”) shall: (a) disclose Confidential
Information of the other Party (the “Disclosing Party”)
only to the agents and employees of the Receiving Party, its Affiliates and its
Distributors (as defined in the New Distribution Agreement) who have a
reasonable need to know such information in order to perform their duties under
the Transaction Agreements and Quality Agreements and who are bound by obligations
of confidentiality and restricted use substantially similar to those set forth
in this Section 11, and (b) shall not use such Confidential Information except
in connection with performing its duties and exercising its rights under the
Transaction Agreements and Quality Agreements. Such obligations of
confidentiality and non-use shall terminate [**] years after the term of this
Agreement. Nothing in this Agreement shall limit the use or disclosure by a
Party of its own proprietary or confidential information.


 


11.3.        Exceptions. Such
obligations of confidentiality and non-use pursuant to Section 11.2 shall not
pertain to Confidential Information of the Disclosing Party that:


 


(a)                                  Was known to the Receiving Party, as
shown by written evidence, at the time of receipt from the Disclosing Party,


 


(b)                                 Was available to
the public at the time of receipt from the Disclosing Party,


 


(c)                                  Subsequently becomes available to the
public without the Receiving Party breaching this Agreement,


 


36

















 


(d)                                 Is disclosed to the Receiving Party by a
third party who/which is under no confidentiality obligation to the Disclosing
Party,


 


(e)                                  Is independently developed by the
Receiving Party, or


 


(f)                                    Is disclosed pursuant to and only to the
extent of court order or as otherwise compelled by law after giving the
Disclosing Party notice and reasonable assistance in opposing or limiting such
disclosure; provided, however, that information disclosed
pursuant to this Section 11.3(f) shall remain Confidential Information for the
purposes of this Agreement.


 


11.4.        Additional
Exception.


 


Either Party may provide the other Party’s Confidential Information to
actual or potential investors, lenders or acquirors who have a need to know
such Confidential Information in order to assess the status of their investment
in such Party or to determine whether to invest in such Party, provided that
(i) the information is of a type customarily disclosed to investors, lenders or
acquirors and (ii) the investors, lenders or acquirors to whom the information
is disclosed are bound by obligations of confidentiality and non-use with
respect to such information at least as stringent as those set forth in this
Section 11.


 


12.          INDEMNIFICATION


 


12.1.        Nycomed hereby agrees
to indemnify, defend and hold harmless TMC, all Affiliates of TMC and all
officers, directors, employees and agents thereof from all Damages arising out
of: (i) Nycomed’s breach of any of its representations, warranties or
obligations under this Agreement; or (ii) any negligent or otherwise tortious
act or omission by Nycomed in connection with the performance or observation of
any covenant, agreement, obligation or provision in this Agreement, any other
Transaction Agreement or the Quality Agreements to be performed or observed by
Nycomed.


 


12.2.        TMC hereby agrees to
indemnify, defend and hold harmless Nycomed, Affiliates of Nycomed and all
officers, directors, employees and agents thereof from all Damages arising out
of (i) TMC’s breach of any of its representations, warranties or obligations
under this Agreement; or (ii) any
negligent or otherwise tortious act or omission by TMC in connection with the
performance or observation of any covenant, agreement, obligation or provision
in this Agreement, any other Transaction Agreement or the Quality Agreements to
be performed or observed by TMC.


 


12.3.        In the event a claim
is based partially on an indemnified claim described in Sections 12.1 and/or
12.2 and partially on a non-indemnified claim, or is based partially on a claim
described in Section 12.1 and partially on a claim described in Section 12.2,
any payments and reasonable


 


37

















 


attorney fees incurred in connection with such claims are to be
apportioned between the Parties in accordance with the degree of cause
attributable to each Party.


 


12.4.        The indemnified Party
under this Section 12 hereby agrees that (i) it will give written notice to the
indemnifying Party of each claim for which it seeks indemnification hereunder
and that the indemnifying Party shall have sole control and authority with
respect to the defense and settlement of any such claim; and (ii) the
indemnified Party shall cooperate fully with the indemnifying Party, at the
indemnifying Party’s sole cost and expense, in the defense of any such claim. The
indemnifying Party will not consent to the entry of any judgment and shall not
accept any settlement with respect to such claim which imposes liability not
covered by this indemnification or restrictions on the indemnified Party
without the indemnified Party’s prior written consent, which consent shall not
be unreasonably withheld or delayed. The indemnified Party shall have the right
and option to participate in the defense of, or in any negotiations or
proceedings to settle, any claim for which it seeks indemnification hereunder,
with separate counsel at its election and cost. If the indemnifying Party fails
or declines to assume the defense of any claim within ten (10) Business Days
after notice thereof, the indemnified Party may assume the defense thereof for
the account and at the risk of the indemnifying Party; provided; however,
that the indemnified Party will not consent to the entry of any judgment or
accept any settlement with respect to such claim or cease to defend such claim
without the prior written consent of the indemnifying Party (which consent
shall not be unreasonably withheld).


 


13.          TERM
AND TERMINATION


 


13.1.        Term. The term
of this Agreement shall commence on the Effective Date and shall expire on the
Transition Date.


 


13.2.        Termination for
Breach. In the event of a breach of this Agreement by either Party and such
Party’s failure to remedy such breach within [**] calendar days after receiving
notice thereof from the non-breaching Party which specifies the circumstances
that constitute the breach, then the non-breaching Party may terminate this
Agreement with immediate effect upon written notice to the breaching Party; provided,
however, that such [**] day period shall be reduced to [**] calendar
days with respect to any failure by a Party to pay amounts due under this
Agreement on the date when such amounts become due.


 


13.3.        Termination upon
Bankruptcy. This Agreement may be terminated by either Party with immediate
effect upon the filing of a petition in bankruptcy, insolvency or
reorganization against or by the other Party, or such other Party becoming
subject to a composition for creditors, whether by law or agreement, or such
other Party going into receivership or otherwise becoming insolvent, or any
analogous event occurring under the laws of the jurisdiction in which a Party
is incorporated.


 


13.4.        Effect of
Termination; Survival of Terms. The termination or expiration of this
Agreement shall have no effect on any transactions completed under this
Agreement prior to 


 


38

















 


such termination or expiration and, for example, any agreement
terminated or amended by this Agreement shall remain so amended or terminated
upon the termination or expiration of this Agreement. The following shall
survive the expiration or sooner termination of the term of this Agreement: (a)
any payment obligations of the parties under this Agreement accruing prior to
the date of expiration or termination, including any obligation with respect to
the payment or reimbursement of taxes, and (b) any other provision herein
expressly surviving expiration or termination or necessary to interpret the
rights and obligations of the parties in connection with the expiration or
termination of the term of this Agreement. Without limiting the foregoing, the
Parties agree that Sections 2.3, 3, 4.1.1, 4.1.2, 4.2, 5.2, 5.4.2, 5.5, 6.8.3,
6.8.4, 6.8.5, 6.9, 6.10, 7, 8.3 (until December 31, 2008), 8.6, 8.7, 8.8, 9.1,
9.3, 9.4, 9.7, 9.8, 9.9, 10, 11, 12, 13.4, 14, 15, 16, 17, 18, 19, 20, 21, 22,
23, 24 and 25 shall survive the termination and expiration of this Agreement. 


 


14.          COMPLIANCE WITH LAWS


 


Each of Nycomed and TMC
covenants that all of its activities under or pursuant to this Agreement shall
comply with all applicable laws, rules and regulations.


 


15.          DISPUTE
RESOLUTION


 


Prior to submission to
arbitration, the Parties shall negotiate in good faith within the PTC any
disagreements or controversies arising out of or relating to this Agreement. Should
the PTC be unable to resolve an issue, the President of TMC and the President
of Nycomed Parent shall meet, either by telephone or in person, to discuss and
attempt resolution of the issue.


 


If the representative of
the Parties cannot, within ten calendar days of their initial discussion, reach
a resolution through informal channels of the issue in dispute, then such
dispute, controversy or claim arising out of or relating to this Agreement, or
the breach, termination or invalidity thereof, shall be finally settled by
binding arbitration conducted in the English language in Cambridge,
Massachusetts, U.S.A. under the commercial arbitration rules of the United
Nations Commission on International Trade Law. Each Party shall appoint an arbitrator
and the two arbitrators so appointed shall jointly appoint a third arbitrator; provided,
however, that if they cannot agree (or if one Party refuses to appoint
an arbitrator) within 30 calendar days after the initiation of the arbitration,
then this third arbitrator shall be appointed by the Presiding Judge of the
London Court of International Arbitration. Disputes about arbitration procedure
shall be resolved by the arbitrators or failing agreement, by the Presiding
Judge of the London Court of International Arbitration in London, England. The
arbitrators may proceed to an award notwithstanding the failure of a Party to
participate in the proceedings. Discovery shall be limited to mutual exchange
of documents relevant to the dispute, controversy or claim; depositions shall
not be permitted unless agreed to by both Parties. The arbitrators shall be
authorized to grant interim relief, including to prevent the destruction of
goods or documents involved in the dispute, protect trade secrets and provide for
security for a prospective monetary award. In no event shall punitive or
multiple damages be assessed against either Party. The


 


39

















 


prevailing Party shall be entitled to an award of reasonable attorney
fees incurred in connection with the arbitration in such amount as may be
determined by the arbitrators. The award of the arbitrators shall be the sole
and exclusive remedy of the Parties and shall be enforceable in any court of
competent jurisdiction, subject only to revocation on grounds of fraud or clear
bias on the part of the arbitrators. Notwithstanding anything contained in this
Section 15 to the contrary, TMC shall have the right to institute judicial
proceedings against Nycomed or against or anyone acting by, through or under
Nycomed, in order to enforce TMC’s rights hereunder through specific
performance, injunction or similar equitable relief.


 


16.          RELATIONSHIP
OF THE PARTIES


 


The relationship among
the Parties is and shall be that of independent contractors. This Agreement
does not establish or create a partnership or joint venture among the Parties,
and neither Party shall hold itself out as an agent or employee of the other
Party. Neither Party shall have authority to make any statements, representations,
warranties or commitments of any kind, or to take any action, which shall be
binding on the other Party.


 


17.          NOTICES


 


Any notice or other
communication required or desired to be given to any Party under the Agreement
shall be in writing and shall be directed to the attention of the Chief
Financial Officer if sent to TMC (with a copy to the General Counsel of TMC at
the address specified above or via facsimile at 1-973-401-9541) or to the
attention of the President if sent to Nycomed (with a copy to the General
Counsel of Nycomed, at BYK-Gulden-Str 2 78467 Konstanz, Germany or via
facsimile at +49 (0) 7531-842982). Such notice or communication shall be deemed
given upon the earlier of (a) two Business Days after it is delivered to
Federal Express, Airborne, or any other similar express delivery service for
delivery to the receiving Party at the address provided for such Party set
forth at the beginning of this Agreement, (b) on the day sent if sent via
facsimile transmission sent to the facsimile number provided for the receiving
Party at the end of this Agreement, with a copy delivered on the same day to
Federal Express, Airborne, or any other similar express delivery service for
delivery to such Party at the address provided for such Party set forth at the
beginning of this Agreement, or (c) on the day actually received by the
receiving Party. Any Party may change its address, facsimile number or contact
person for notices and communications under this Agreement by giving the other
Party notice of such change.


 


18.          GOVERNING
LAW


 


All questions concerning
the validity or meaning of this Agreement or relating to the rights and
obligations of the Parties with respect to performance under this Agreement
shall be construed and resolved under, and any arbitration or court action
hereunder shall apply, the laws of the Commonwealth of Massachusetts, excluding
(i) its conflicts of law principles; and (ii) the United Nations Convention on
Contracts for the International Sale of Goods.


 


40

















 


19.          SEVERABILITY


 


The intention of the
Parties is to comply fully with all laws and public policies, and this
Agreement shall be construed consistently with all laws and public policies to
the extent possible. If and to the extent that any arbitration panel or any
court of competent jurisdiction determines that it is impossible to construe
any provision of this Agreement consistently with any law or public policy and
consequently holds that provision to be invalid, inoperative, unenforceable, or
to render other, material, provisions of this Agreement invalid, inoperative or
unenforceable, such provision shall be set aside, without, however, in any way
affecting the validity of the other provisions of this Agreement, which shall
remain in full force and effect.


 


20.          FORCE
MAJEURE


 


A Party shall be excused from performing its obligations under this
Agreement (other than payment obligations) if its performance is prevented by
any cause beyond its control, including but not limited to, Acts of God, fire,
explosion, weather, war, insurrection, riots, or government action.
Performances shall be excused only to the extent of and during the reasonable
continuance of such disability. All obligations of both Parties shall
return to being in full force and effect upon the termination of such cause.


 


21.          COMPLETE
AGREEMENT; ORDER OF PRECEDENCE; MODIFICATIONS


 


This Agreement, the New
Agreements and the Quality Agreements contain the entire agreement between the
Parties, and, except as expressly provided herein, supersede all prior or
contemporaneous discussion, negotiations, representations, warranties, or
agreements, relating to the subject matter of this Agreement. In the event of
any conflict between this Agreement and the New Agreements or the Quality
Agreements, the provisions of this Agreement will control. No changes to this
Agreement will be made or be binding on either Party unless made in writing and
signed by each Party.


 


22.          ASSIGNMENT


 


Subject to Section 2.3,
Nycomed shall not assign, transfer or otherwise dispose of this Agreement in
whole or in part to any third party without the prior written consent of TMC. TMC
shall not assign, transfer or otherwise dispose of this Agreement in whole or
in part to any third party without the prior written consent of Nycomed; provided,
however, that such consent shall not be required with respect to
assignments, transfers or other dispositions by TMC of its rights or
obligations under this Agreement, in whole or in part, to (i) any Affiliate or
Affiliates of TMC; or (ii) an acquiror of all or substantially all of the
capital stock or assets of TMC related to the Product, through purchase,
merger, consolidation, or otherwise. Subject to the foregoing, this Agreement
shall inure to the benefit of the permitted successors and assigns of each
Party.


 


41

















 


23.          PUBLIC
STATEMENTS.


 


23.1.        TMC may issue an
initial press release with respect to the transactions contemplated by the
Transaction Agreements; provided that those portions of such press
release applicable to the transactions contemplated by the Transaction
Agreements shall be substantially in the form of Exhibit D. Thereafter,
neither Party shall make any other publication, news release or other public
announcement relating to the execution of this Agreement or the New Agreements,
or to the performance of the Parties under this Agreement, any Transaction
Agreement or the Quality Agreements, without obtaining the other Party’s prior
written consent; provided, however, that (a) TMC may disclose on
an ongoing basis the results of operations in the Territory with respect to the
Product; and (b) either Party may publicly disclose any information that has
been previously disclosed in TMC’s initial press release or that has otherwise
been previously approved by the other Party for disclosure pursuant to the
foregoing.


 


23.2.        Notwithstanding
Section 23.1, if either Party is required (as reasonably determined by its
legal counsel) by regulation, law or legal process, including without
limitation by the rules or regulations of the United States Securities and
Exchange Commission or similar regulatory agency in a country other than the
United States or of any stock exchange or Nasdaq, to disclose the existence of
this Agreement or any Transaction Agreement or Quality Agreement and/or any
information related to the terms and conditions of this Agreement, any
Transaction Agreement or the Quality Agreements, such Party shall provide prior
written notice of such intended disclosure to the other Party, which notice
shall include a copy of the proposed disclosure. Upon receipt of such notice,
the other Party shall have a reasonable period to review and comment on the
proposed disclosure (not to exceed five Business Days), and the Party required
to disclose shall in good faith consider any changes or modifications to the
proposed disclosure requested by the other Party. In the event that the legal
requirements compelling such disclosure will not reasonably allow for a review
period of five Business Days,
the notice provided by the Party required to disclose shall, to the extent
permitted by law, specify a shorter period for review (of not less than one
Business Day) necessary under such circumstances. The Party legally required to
disclose shall use commercially reasonable efforts to obtain confidential
treatment (to the extent available) of the other Party’s Confidential
Information proposed to be disclosed, and to disclose only such Confidential
Information of the other Party as is required to be disclosed in order to
comply.


 


24.          FURTHER
ASSURANCES.


 


TMC and Nycomed will each, at and after the Effective Date, without
further consideration, do, execute, acknowledge, deliver and file, or will
cause to be done, executed, acknowledged, delivered and filed, all such further
acts, deeds, assignments, transfers, conveyances, powers of attorney and
assurances as may be reasonably required (a) for transferring, conveying and
assigning to TMC or TMC’s designee, or to their respective successors or
assigns, the items to be transferred pursuant to Sections 5 and 6 hereof and
(b) to otherwise implement the transactions contemplated by this Agreement. Without
limiting the generality of the foregoing,


 


42

















 


in the event that at any time after the termination or expiration of
this Agreement Nycomed discovers any Product Documents and Records or Know-How
that it was obligated to provide to TMC hereunder but did not, Nycomed shall
promptly provide the foregoing to TMC.


 


25.          MISCELLANEOUS


 


25.1.        Waiver. None
of the conditions or provisions of this Agreement shall be held to have been
waived by any act or knowledge on the part of either Party, except by an
instrument in writing signed by a duly authorized officer or representative of
such Party. Further, the waiver by either Party of any right hereunder or the
failure to enforce at any time any of the provisions of this Agreement, or any
rights with respect thereto, shall not be deemed to be a waiver of any other
rights hereunder or any breach or failure of performance of the other Party.


 


25.2.        Counterparts. This
Agreement may be executed in one or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.


 


25.3.        Headings. Headings
and captions are included in this Agreement for reference purposes only, and
shall not be used in order to interpret or construe this Agreement.


 


[Execution Page to Follow]


 


43

















 


IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed under seal by their
respective duly authorized representative as of the date set forth above.


 


	
  THE MEDICINES COMPANY

  	
   

  	
  NYCOMED
  DANMARK ApS

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By: 

  	
      /s/ Clive Meanwell

  	
   

  	
   

  	
  By: 

  	
        /s/ Ghita Astrop

  	
   

  
	
  Name: 

  	
   

  	
  Clive Meanwell

  	
   

  	
   

  	
  Name: 

  	
   

  	
  Ghita Astrop

  	
   

  
	
  Title: 

  	
    CEO

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Facsimile: 

  	
    973-401-9541

  	
   

  	
   

  	
  Facsimile:

  	
    Managing
  Director

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By: 

  	
        /s/ Kerstin
  Valinder

  	
   

  
	
   

  	
   

  	
  Name: 

  	
   Kerstin Valinder

  	
   

  
	
   

  	
   

  	
  Title: 

  	
      EVP

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Nycomed Parent joins
  in this Agreement as a 

  co-obligor with Nycomed as to all of 

  Nycomed’s obligations hereunder:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  NYCOMED HOLDING ApS

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:
  

  	
        /s/ Bent
  Korscher

  	
   

  
	
   

  	
   

  	
  Name:
  

  	
    Bent Korscher

  	
   

  
	
   

  	
   

  	
  Title:
  

  	
    VP
  Nycomed

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By: 

  	
         /s/
  Kerstin Valinder

  	
   

  
	
   

  	
   

  	
  Name: 

  	
   Kerstin Valinder

  	
   

  
	
   

  	
   

  	
  Title: 

  	
     EVP

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile:

  	
   

  	
   

  
																							



 


44
















Exhibit A


Form of
Trademark Assignment


 


TRADEMARK
ASSIGNMENT


 


WHEREAS, Nycomed Danmark
ApS, a company duly organized and existing under the laws of the Kingdom of
Denmark (“Assignor”) and The Medicines Company, a
Delaware corporation (“Assignee”), are
parties to that certain Termination and Transition Agreement dated July 1, 2007
(the “Termination and Transition Agreement”),
the terms defined therein having the same meanings in this Trademark
Assignment; and


 


WHEREAS, pursuant to the
terms of the Termination and Transition Agreement, Assignee desires to acquire
the Assigned Trademark Registrations (as listed on Exhibit 1 hereto) and
Assignor desires to transfer and cause the transfer of the Assigned Trademark
Registrations to Assignee;


 


NOW, THEREFORE, for good
and valuable consideration, receipt and sufficiency of which is acknowledged,
and subject in all respects to the terms of the Termination and Transition
Agreement, the Assignor, on behalf of itself and its Affiliates, assigns,
transfers, and conveys to Assignee the entire right, title and interest of
Assignor and its Affiliates in the Assigned Trademark Registrations, together
with all registrations or applications for said trademarks, together with the
goodwill of the business symbolized by them, and the rights to sue and recover
for past infringement of said trademarks.


 


Assignor agrees that upon
request it will, in a timely manner, execute or arrange for execution of such
further assignment documents as may be required, if any, from Assignor or its
Affiliates to permit Assignee to record the assignment of the Assigned
Trademark Registrations.


 


[Execution Page to
Follow]


 


45

















 


IN WITNESS WHEREOF,
Assignor has caused this Trademark Assignment to be executed under seal by its
duly authorized representative as of the date set forth above.


 


	
  NYCOMED DANMARK ApS

  
	
   

  
	
   

  
	
  By: 

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title: 

  	
   

  	
   

  
					



 


46

















 


Exhibit 1


 


Assigned
Trademark Registrations


 


ANGIONAX


 


	
  Country

  	
   

  	
  Countr.comm.

  	
   

  	
  Appl. no.

  	
   

  	
  Priority date

  	
   

  	
  Reg. no.

  	
   

  	
  Renewal

  	
   

  	
  Renw.comm:

  	
   

  	
  Class

  
	
  Armenia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Azerbaijan

  	
   

  	
   

  	
   

  	
  20040229

  	
   

  	
  24.10.2003

  	
   

  	
  20050227

  	
   

  	
  07.04.2005

  	
   

  	
   

  	
   

  	
  05

  
	
  Belarus

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Bosnia-Herzegovina

  	
   

  	
   

  	
   

  	
  BAZ 047692A

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Bulgaria

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  China

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
  05

  
	
  Croatia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  
	
  Denmark

  	
   

  	
   

  	
   

  	
  VA 2004 01045

  	
   

  	
  26.11.2003

  	
   

  	
  VR 2004 01045

  	
   

  	
  17.06.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Europ. Community

  	
   

  	
   

  	
   

  	
  003444494

  	
   

  	
  24.10.2003

  	
   

  	
  003444494

  	
   

  	
  24.10.2013

  	
   

  	
   

  	
   

  	
  05

  
	
  Georgia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Hong Kong

  	
   

  	
   

  	
   

  	
  300199701

  	
   

  	
  24.10.2003

  	
   

  	
  300199701

  	
   

  	
  15.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Iceland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  International

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Kazakhstan

  	
   

  	
   

  	
   

  	
  26784

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Kyrgyzstan

  	
   

  	
   

  	
   

  	
  20040162.3

  	
   

  	
  24.10.2003

  	
   

  	
  7326

  	
   

  	
  09.04.2005

  	
   

  	
   

  	
   

  	
  05

  
	
  Liechtenstein

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Macedonia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Moldavia, the

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Norway

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2004

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
  05

  
	
  Romania

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Russia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Serbia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Switzerland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
  05

  
	
  Tajikistan

  	
   

  	
   

  	
   

  	
  04006625

  	
   

  	
  24.10.2003

  	
   

  	
  TJ 6341

  	
   

  	
  07.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Turkey

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Turkmenistan

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Ukraine

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  USA

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  abandoned

  	
   

  	
  05

  
	
  Uzbekistan

  	
   

  	
   

  	
   

  	
  MGU20040247

  	
   

  	
  24.10.2003

  	
   

  	
  mgu 13538

  	
   

  	
  12.04.2014

  	
   

  	
   

  	
   

  	
  05

  



 


47

















 


ANGIOX


 


	
  Country

  	
   

  	
  Countr.comm.

  	
   

  	
  Appl. no.

  	
   

  	
  Priority date

  	
   

  	
  Reg. no.

  	
   

  	
  Renewal

  	
   

  	
  Renw.comm:

  	
   

  	
  Class

  
	
  Armenia

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
  28.06.2015

  	
   

  	
   

  	
   

  	
  05

  
	
  Armenia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Azerbaijan

  	
   

  	
  Cyrillic

  	
   

  	
  2005 0744

  	
   

  	
  18.05.2005

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Azerbaijan

  	
   

  	
   

  	
   

  	
  20040230

  	
   

  	
  24.10.2003

  	
   

  	
  20050228

  	
   

  	
  07.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Belarus

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Belarus

  	
   

  	
  IR Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Bosnia-Herzegovina

  	
   

  	
   

  	
   

  	
  BAZ 047691A

  	
   

  	
  14.10.2004

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Bulgaria

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  China

  	
   

  	
  IR, refusal

  	
   

  	
  200410198

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Croatia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Denmark

  	
   

  	
   

  	
   

  	
  VA 2004 01044

  	
   

  	
  24.10.2003

  	
   

  	
  VR 2004 01924

  	
   

  	
  17.06.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Denmark

  	
   

  	
  Cyrillic letters

  	
   

  	
  VA200501576

  	
   

  	
  15.04.2005

  	
   

  	
  VR 2005 01741

  	
   

  	
  18.05.2015

  	
   

  	
   

  	
   

  	
  05

  
	
  Europ. Community

  	
   

  	
   

  	
   

  	
  003448347

  	
   

  	
  24.10.2003

  	
   

  	
  003448347

  	
   

  	
  24.11.2013

  	
   

  	
   

  	
   

  	
  05

  
	
  Georgia

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
  28.06.2015

  	
   

  	
   

  	
   

  	
  05

  
	
  Georgia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Hong Kong

  	
   

  	
   

  	
   

  	
  300192320

  	
   

  	
  24.10.2004

  	
   

  	
  300192320

  	
   

  	
  06.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Iceland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  International

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
  28.06.2015

  	
   

  	
   

  	
   

  	
  05

  
	
  International

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825 735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Kazakhstan

  	
   

  	
   

  	
   

  	
  26785

  	
   

  	
  24.10.2003

  	
   

  	
  19320

  	
   

  	
  08.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Kazakhstan

  	
   

  	
  Cyr

  	
   

  	
  31491

  	
   

  	
  22.04.2005

  	
   

  	
  22003

  	
   

  	
  31.01.2015

  	
   

  	
   

  	
   

  	
  05, 10

  
	
  Kyrgyzstan

  	
   

  	
   

  	
   

  	
  20040161.3

  	
   

  	
  24.10.2003

  	
   

  	
  7370

  	
   

  	
  09.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Kyrgyzstan

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Liechtenstein

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Macedonia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Moldavia, the

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Moldavia, the

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Norway

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Romania

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Russia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Russia

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Serbia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  
	
  Switzerland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Tajikistan

  	
   

  	
   

  	
   

  	
  04006624

  	
   

  	
  24.10.2003

  	
   

  	
  tj 6340

  	
   

  	
  07.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Turkey

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Turkmenistan

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  



 


48

















 


	
  Turkmenistan

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Ukraine

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  Ukraine

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  
	
  USA

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  3,046,278

  	
   

  	
  17.01.2016

  	
   

  	
   

  	
   

  	
  05

  
	
  Uzbekistan

  	
   

  	
   

  	
   

  	
  MGU20040246

  	
   

  	
  24.10.2003

  	
   

  	
  MGU 13535

  	
   

  	
  12.04.2014

  	
   

  	
   

  	
   

  	
  05

  
	
  Uzbekistan

  	
   

  	
  Cyr

  	
   

  	
  2005 0436

  	
   

  	
  22.04.2005

  	
   

  	
   

  	
   

  	
  14260 30.06.2016

  	
   

  	
   

  	
   

  	
  05

  



 


49

















 


Exhibit B


Form of Bill of Sale


 


BILL OF SALE


From


NYCOMED DANMARK ApS


To


THE MEDICINES COMPANY


 


KNOW ALL
MEN BY THESE PRESENTS, that NYCOMED DANMARK
ApS, a company duly organized and existing under the laws of the
Kingdom of Denmark  (“Assignor”), for the consideration specified in the
Termination and Transition Agreement, dated July 1, 2007 (the “Termination Agreement”), by and between Assignor and The Medicines Company, a Delaware
corporation (“Assignee”), and for other good and
valuable consideration, the receipt of which is hereby acknowledged, has this
day, effective as of the Effective Date, and subject to the terms and
conditions set forth herein and in the Termination Agreement, on behalf of
itself and its Affiliates, sold, conveyed, transferred and assigned, and by
these presents does hereby sell, convey, transfer and assign to Assignee  all
right (contractual and otherwise), title and interest of Assignor and its
Affiliates in, to and under the Assigned Intellectual Property (excluding the
Assigned Trademark Registrations) free and clear of any liens, encumbrances,
license, security interest or other rights of third parties of any kind.


 


THIS BILL
OF SALE, and all questions concerning the validity or meaning
of this Bill of Sale or relating to the rights and obligations of the parties
with respect to performance under this Bill of Sale, shall be construed and
resolved under, and any arbitration or court action hereunder shall apply, the
laws of the Commonwealth of Massachusetts, excluding (i) its conflicts of law
principles; and (ii) the United Nations Convention on Contracts for the
International Sale of Goods.


 


This
Bill of Sale is an instrument of transfer contemplated by, and is executed
pursuant to, the Termination Agreement. Nothing in this Bill of Sale shall be
deemed to supersede, amend or modify any of the terms, conditions or provisions
of the Termination Agreement or any rights or obligations of the parties under
the Termination Agreement and, to the extent of any conflict between the
Termination Agreement and this Bill of Sale, the terms and provisions of the
Termination Agreement shall prevail. Capitalized terms used herein without definition
shall have the meanings attributed to them in the Termination Agreement.


 


[Execution Page to Follow]


 


50

















 


IN WITNESS WHEREOF,
Assignor has caused this Bill of Sale to be executed under seal by its duly
authorized representative as of the date set forth above.


 


	
  NYCOMED DANMARK ApS

  
	
   

  
	
   

  
	
  By: 

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title: 

  	
   

  	
   

  
	
   

  
	
   

  
	
  ACCEPTED:

  
	
   

  
	
  THE
  MEDICINES COMPANY

  
	
   

  
	
   

  
	
  By: 

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title: 

  	
   

  	
   

  
								



 


51

















 


Exhibit C


Form of Bill of Sale


 


BILL OF SALE


From


NYCOMED DANMARK ApS


To


THE MEDICINES COMPANY


 


KNOW ALL
MEN BY THESE PRESENTS, that NYCOMED
DANMARK ApS, a company duly organized and existing under the laws of
the Kingdom of Denmark  (“Assignor”), for the consideration specified in the
Termination and Transition Agreement, dated July 1, 2007 (the “Termination Agreement”), by and between Assignor and [The Medicines Company], a Delaware
corporation (“Assignee”), [If TMC requests assignment to a designee, the assignee entity may
change.] and for other good and valuable consideration,
the receipt of which is hereby acknowledged, has, effective as of [Insert termination of date of New Distribution
Agreement], 20      , and
subject to the terms and conditions set forth herein and in the Termination
Agreement, sold, conveyed, transferred and assigned, and by these presents does
hereby sell, convey, transfer and assign to Assignee  all of
Assignor’s right (contractual and otherwise), title and interest in, to and
under the Vials of Remaining Inventory free and clear of any liens,
encumbrances, license, security interest or other rights of third parties of
any kind.


 


THIS BILL
OF SALE, and all questions concerning the validity or meaning
of this Bill of Sale or relating to the rights and obligations of the parties
with respect to performance under this Bill of Sale, shall be construed and
resolved under, and any arbitration or court action hereunder shall apply, the
laws of the Commonwealth of Massachusetts, excluding (i) its conflicts of law
principles; and (ii) the United Nations Convention on Contracts for the
International Sale of Goods.


 


This
Bill of Sale is an instrument of transfer contemplated by, and is executed
pursuant to, the Termination Agreement. Nothing in this Bill of Sale shall be
deemed to supersede, amend or modify any of the terms, conditions or provisions
of the Termination Agreement or any rights or obligations of the parties under
the Termination Agreement and, to the extent of any conflict between the
Termination Agreement and this Bill of Sale, the terms and provisions of the
Termination Agreement shall prevail. Capitalized terms used herein without
definition shall have the meanings attributed to them in the Termination
Agreement.


 


[Execution Page to Follow]


 


52

















 


IN WITNESS WHEREOF,
Assignor has caused this Bill of Sale to be executed under seal by its duly
authorized representative as of the date set forth above.


 


	
  NYCOMED DANMARK ApS

  
	
   

  
	
   

  
	
  By: 

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title: 

  	
   

  	
   

  
	
   

  
	
   

  
	
  ACCEPTED:

  
	
   

  
	
  THE
  MEDICINES COMPANY

  
	
   

  
	
   

  
	
  By: 

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
  Title: 

  	
   

  	
   

  
							



 


53

















 


Exhibit D


TMC Initial Press Release


 


	
  Contact:

  	
  Michael
  Mitchell

  
	
   

  	
  Executive
  Director, Corporate Affairs

  
	
   

  	
  The
  Medicines Company

  
	
   

  	
  973-656-1616

  
	
   

  	
  investor.relations@themedco.com

  



 


FOR IMMEDIATE RELEASE: 


 


THE MEDICINES COMPANY REACQUIRES ANGIOX®
(BIVALIRUDIN) RIGHTS 

IN EUROPE FROM NYCOMED


 


Company
Announces Global Expansion Starting in Europe and 

Provides Second Quarter and Full-Year Revenue Guidance


 


PARSIPPANY, NJ, July 2, 2007 (BUSINESS WIRE) – The
Medicines Company (NASDAQ: MDCO) announced today that it has reacquired all
development, commercial and distribution rights for its product Angiox®
(bivalirudin) in Europe from Nycomed. Angiox is an anticoagulant used in
patients undergoing percutaneous coronary interventions (PCI), commonly
referred to as angioplasty. The product is approved in 26 European markets.


 


The Medicines Company currently sells Angiomax®
(bivalirudin) in the United States, which comprises approximately one-third of
the worldwide PCI market with approximately one million procedures annually. This
transaction gives The Medicines Company a direct presence in European markets
where more than one million PCI procedures are performed annually, with an
estimated annual growth rate above 10 percent. Another one million PCI patient
procedures are performed annually in the rest of the world.


 


“This is our first step directly into international
markets. By selling Angiox ourselves in Europe, where the product’s patent
extends through mid-2015, we can anticipate product growth well into the next
decade,” said Clive Meanwell, Chairman and CEO of The Medicines Company. “Establishing
operations in Europe also sets up the channel for commercialization of our
pipeline of acute care product candidates, including CleviprexTM (clevidipine)
and cangrelor. We appreciate the contributions made by Nycomed to the
establishment of Angiox in Europe, and we look forward to our collaboration
during the transition period.”


 


Under terms of the agreement, The Medicines Company
will pay Nycomed:


 


•                  $20 million
today,


•                  $5 million upon
European health regulators approving an expanded Angiox product label to
include findings of the ACUITY trial, and


•                  $20 million in
2008.


 


The Medicines Company will assume control of marketing
for Angiox and will recognize additional revenue from sales starting July 1.
At the same time, the Company will begin to incur operating expenses, including
reimbursement of commercial services provided by Nycomed during a transition
period. Sales operations will transition to The Medicines Company by the end of
2007, and product distribution will transition during 2008.


 


54

















 


“We believe the value proposition for Angiox is
universal,” said John Kelley, President and COO of The Medicines Company. “Based
on results from global clinical studies such as REPLACE-2 and ACUITY, PCI
patients throughout the world, including Europe, benefit with improved outcomes
and lower costs when heparin is replaced by Angiomax/Angiox. We expect to
leverage these advantages using our team’s broad and deep experience in global
product commercialization.”


 


Last month, the European Society of Cardiology (ESC)
published new guidelines on the treatment of acute coronary syndromes (ACS)
recommending use of Angiox to replace heparins (unfractionated or low-molecular
weight) and platelet GP IIb/IIIa inhibitors in ACS patients undergoing PCI. This
builds on earlier ESC guidelines recommending use of Angiox to replace heparins
in patients undergoing PCI. An application for marketing authorization is
currently under review with European regulatory authorities to expand the
approved uses of Angiox to include the emergency use of Angiox in ACS patients
undergoing PCI.


 


“Angiox is a strong
product that has enabled Nycomed to create a significant position within the
European hospital specialist sector,” said Kerstin Valinder, Executive Vice
President, Business Development, Nycomed. “We reviewed our product portfolio
following the acquisition of ALTANA Pharma and have agreed with The Medicines
Company that the timing was appropriate for this transition. Nycomed remains
committed to a strategy of strengthening its product pipeline through both
in-house research and in-licensing partnerships.”


 


Financial Impact of Transaction


 


Nycomed will not order additional product during the
second half of 2007 under the terms of the agreement. Therefore full-year
international revenue guidance for Angiomax/Angiox is lowered from $10 million
to $5 to $7 million. Also in 2007, The Medicines Company expects to incur
approximately $10 to $12 million in commercial and distribution services paid
to Nycomed.


 


The Medicines Company expects full-year international
sales of Angiomax/Angiox in 2008 to be in the range of $15 to $20 million and
to have a dilutive impact on after-tax net income of $0.15 to $0.20 per share
before amortization of transaction costs.


 


The Company expects after-tax net income before
amortization of transaction costs to be accretive in 2009. The Company expects
to incur costs relating to the amortization of the transaction in 2007, 2008,
and 2009 that will impact after-tax net income, but is not yet able to estimate
the timing or amount of such costs.


 


By 2011, the Company expects full-year international
sales of Angiox to be in the range of $90 to $110 million.


 


Revenue Guidance


 


Based upon available hospital discharge data, The
Medicines Company estimates a six-percent decline in PCI procedure volume in
the United States for 2007 compared to 2006. As a result, the Company is
revising its full-year U.S. Angiomax sales guidance to $250 to $260 million
from a previously reported $266 to $276 million. Including international
revenues noted above, the revised full-year Angiomax sales guidance is $255 to
$267 million, compared to a previously reported $276 to $286 million. For the
quarter ended June 30, 2007, the Company expects total net revenue to be in the
range of $56 to $58 million.


 


The Medicines Company plans to announce second quarter
2007 financial results later in July. At that time the Company will provide an
update on expected 2007 full-year expenses and net income based upon completion
of analysis of transaction and transition costs from the Nycomed transaction.


 


55

















 


Conference Call


 


There will be a conference call with management of The
Medicines Company today at 9:00 A.M. Eastern Time to discuss the agreement with
Nycomed, European expansion plans, financial guidance and outlook. The
conference call will be available via phone and webcast. The webcast can be
accessed at The Medicines Company website at www.themedicinescompany.com.


 


The dial in information is listed below:


 


	
  U.S. Dial In:

  	
  800-289-0572

  
	
  International Dial In:

  	
  913-981-5543

  



 


Replay is available from noon Eastern Time following
the conference call through July 23, 2007. To hear a replay of the call, dial
888-203-1112 (U.S.) and 719-457-0820 (international). The passcode for both
dial in numbers is 1262410.


 


About Angiomax/Angiox


 


Angiomax/Angiox is a direct thrombin inhibitor with a
naturally reversible mechanism of action. In clinical trials, Angiomax has
demonstrated efficacy plus reductions in bleeding complications compared to
heparin as the foundation anticoagulant in the contemporary catheterization lab
setting. These reductions in bleeding complications remain evident even in
high-risk patients.


 


In the United States, Angiomax is indicated for use as
an anticoagulant in patients with unstable angina undergoing percutaneous
transluminal coronary angioplasty (PTCA) and with provisional GPIIb/IIIa
inhibition in patients undergoing PCI. Angiomax is also indicated in patients
with, or at risk of, HIT/HITTS undergoing PCI. Angiomax is intended for use
with aspirin. The most common adverse events for Angiomax in clinical trials
comparing Angiomax and heparin were back pain, pain, nausea, headache, and
hypotension. The incidence of these adverse events was comparable in both the
Angiomax and heparin groups in these trials. An unexplained fall in blood
pressure or hematocrit, or any unexplained symptom, should lead to serious
consideration of a hemorrhagic event and cessation of Angiomax administration.
Angiomax is contraindicated in patients with active major bleeding or
hypersensitivity to Angiomax or its components. Please see full prescribing
information available at http://www.angiomax.com.


 


MDCO-G


 


About The Medicines Company

The Medicines Company meets the demands of the world’s most
advanced medical practitioners by developing products that improve acute
hospital care. The Company markets Angiomax® (bivalirudin) in the U.S. and
other countries for use in patients undergoing coronary angioplasty, a
procedure to clear restricted blood flow in arteries around the heart. The
Medicines Company creates value using its range of clinical and commercial
skills to develop products acquired from leading life science innovators. The
Company’s website is http://www.themedicinescompany.com.


 


Statements
contained in this press release about The Medicines Company and Angiomax®/Angiox®
that are not purely historical, and all other statements that are not purely
historical, may be deemed to be forward-looking statements for purposes of the
safe harbor provisions under The Private Securities Litigation Reform Act of
1995. Without limiting the foregoing, the words “believes,” “anticipates,” “expects,”
“estimates,” “projects” and similar expressions are intended to identify
forward-looking statements, and all guidance to future revenues, expenses and
income are forward-looking statements. These forward-looking statements involve
known and unknown risks and uncertainties that may cause the Company’s actual
results, levels of activity, performance or achievements to be materially
different from those expressed or implied by the forward-looking statements. For
example, the revenue results for the quarter ended June 30, 2006 are
preliminary and subject to change. Important factors that may cause or contribute
to such differences include the extent of the commercial success of Angiomax;
the Company’s success in taking over the commercial functions previously
performed by Nycomed in Europe and Nycomed’s success in its performance of
sales and distribution functions during the transition period described above;
the impact of FAS 123R on the Company’s financial results; whether clinical
trial results of the Company’s product candidates will warrant submission of
applications for regulatory approval on a timely basis or at all; whether the
Company’s product candidates will receive approvals from regulatory agencies on
a timely basis or at all; whether physicians will accept clinical trial
results; the impact of government regulation on the Company’s business; the
potential impact of health care


 


56

















 


reform
on the Company’s business; and the effects of exchange rate fluctuations and
other international economic, political and other risks. Such factors and
others are set forth in the risk factors detailed from time to time in the
Company’s periodic reports and registration statements filed with the
Securities and Exchange Commission including, without limitation, the risk
factors detailed in the Company’s Quarterly Report on Form 10-Q filed on May 9,
2007, which are incorporated herein by reference. The Company specifically
disclaims any obligation to update these forward-looking statements in the
future. These forward-looking statements should not be relied upon as representing
the Company’s estimates or views as of any date subsequent to the date of this
press release.


 


# # #


 


57

















 


Schedule 2.2


Nycomed Wiring Instructions


 


The wiring instructions for Nordea Bank


Strandgade 3


0900 Cph


 


	
  Account:

  	
  [**]

  
	
  IBAN:

  	
  [**]

  
	
  Swift-code:

  	
  [**]

  



 


58

















 


Schedule 3.1.4(a)


Litigation and Claims


 


Proceedings related to
[**] with [**] regarding [**].


 


59

















 


Schedule 3.1.4(b)


Nycomed Knowledge of Third Party
Claim


 


None.


 


60

















 


Schedule 3.1.6


Ongoing Clinical Trials


 


Local
Nycomed-sponsored studies


 


	
  Study

  	
   

  	
  Agreement

  	
   

  	
  Country

  	
   

  	
  Status

  	
   

  	
  Involvement/Financial Obligation/Supply 

  Obligation

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  



 


Investigator-initiated studies


 


	
  Study

  	
   

  	
  Agreement

  	
   

  	
  Country

  	
   

  	
  Status

  	
   

  	
  Involvement

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  



 


61

















 


Investigator-initiated studies


 


	
  Study

  	
   

  	
  Study

  	
   

  	
  Study

  	
   

  	
  Study

  	
   

  	
  Study

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  



 


[**]


 


62
















 


Schedule 3.1.7


Product-Specific Contracts


 


To be completed after the Effective Date.


 


63

















 


Schedule 3.1.9


 


Product-Specific Approvals and
Regulatory Filings


 


	
  Territory

  	
   

  	
  MA status

  	
   

  	
  Launch date

  
	
  Switzerland

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  Ukraine

  	
   

  	
  [**]

  	
   

  	
  [**]

  
	
  Kazakhstan

  	
   

  	
  [**]

  	
   

  	
   

  
	
  Russia

  	
   

  	
  [**]

  	
   

  	
   

  



 


64

















 


Schedule 3.1.11


Existing Inventory (as of June
15, 2007)


 


# naked bulk vials (LINZ): [**] vials


 


# packed+labeled = finished packed goods in
countries:  approximately [**] vials.


 


65

















 


Schedule 3.1.14


Assigned Trademark Registrations


 


In each case, registration holder or applicant is Nycomed Danmark ApS.


 


ANGIONAX


 


	
  Country

  	
   

  	
  Countr.comm.

  	
   

  	
  Appl. no.

  	
   

  	
  Priority date

  	
   

  	
  Reg. no.

  	
   

  	
  Renewal

  	
   

  	
  Renw.comm:

  	
   

  	
  Class

  	
   

  
	
  Armenia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Azerbaijan

  	
   

  	
   

  	
   

  	
  20040229

  	
   

  	
  24.10.2003

  	
   

  	
  20050227

  	
   

  	
  07.04.2005

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Belarus

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Bosnia-Herzegovina

  	
   

  	
   

  	
   

  	
  BAZ 047692A

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Bulgaria

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  China

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
  05

  	
   

  
	
  Croatia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Denmark

  	
   

  	
   

  	
   

  	
  VA 2004 01045

  	
   

  	
  26.11.2003

  	
   

  	
  VR 2004 01045

  	
   

  	
  17.06.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Europ. Community

  	
   

  	
   

  	
   

  	
  003444494

  	
   

  	
  24.10.2003

  	
   

  	
  003444494

  	
   

  	
  24.10.2013

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Georgia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Hong Kong

  	
   

  	
   

  	
   

  	
  300199701

  	
   

  	
  24.10.2003

  	
   

  	
  300199701

  	
   

  	
  15.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Iceland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  International

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Kazakhstan

  	
   

  	
   

  	
   

  	
  26784

  	
   

  	
  24.10.2003

  	
   

  	
  05

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Kyrgyzstan

  	
   

  	
   

  	
   

  	
  20040162.3

  	
   

  	
  24.10.2003

  	
   

  	
  7326

  	
   

  	
  09.04.2005

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Liechtenstein

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Macedonia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Moldavia, the

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Norway

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2004

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
  05

  	
   

  
	
  Romania

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Russia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Serbia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  



 


66

















 


	
  Switzerland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
  05

  	
   

  
	
  Tajikistan

  	
   

  	
   

  	
   

  	
  04006625

  	
   

  	
  24.10.2003

  	
   

  	
  TJ 6341

  	
   

  	
  07.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Turkey

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Turkmenistan

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Ukraine

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825946

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  USA

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  abandoned

  	
   

  	
  05

  	
   

  
	
  Uzbekistan

  	
   

  	
   

  	
   

  	
  MGU20040247

  	
   

  	
  24.10.2003

  	
   

  	
  mgu 13538

  	
   

  	
  12.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  



 


67

















 


ANGIOX


 


	
  Country

  	
   

  	
  Countr.comm.

  	
   

  	
  Appl. no.

  	
   

  	
  Priority date

  	
   

  	
  Reg. no.

  	
   

  	
  Renewal

  	
   

  	
  Renw.comm:

  	
   

  	
  Class

  	
   

  
	
  Armenia

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
  28.06.2015

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Armenia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Azerbaijan

  	
   

  	
  Cyrillic

  	
   

  	
  2005 0744

  	
   

  	
  18.05.2005

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Azerbaijan

  	
   

  	
   

  	
   

  	
  20040230

  	
   

  	
  24.10.2003

  	
   

  	
  20050228

  	
   

  	
  07.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Belarus

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Belarus

  	
   

  	
  IR Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Bosnia-Herzegovina

  	
   

  	
   

  	
   

  	
  BAZ 047691A

  	
   

  	
  14.10.2004

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Bulgaria

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  China

  	
   

  	
  IR, refusal

  	
   

  	
  200410198

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Croatia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Denmark

  	
   

  	
   

  	
   

  	
  VA 2004 01044

  	
   

  	
  24.10.2003

  	
   

  	
  VR 2004 01924

  	
   

  	
  17.06.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Denmark

  	
   

  	
  Cyrillic letters

  	
   

  	
  VA200501576

  	
   

  	
  15.04.2005

  	
   

  	
  VR 2005 01741

  	
   

  	
  18.05.2015

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Europ. Community

  	
   

  	
   

  	
   

  	
  003448347

  	
   

  	
  24.10.2003

  	
   

  	
  003448347

  	
   

  	
  24.11.2013

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Georgia

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
  28.06.2015

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Georgia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Hong Kong

  	
   

  	
   

  	
   

  	
  300192320

  	
   

  	
  24.10.2004

  	
   

  	
  300192320

  	
   

  	
  06.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Iceland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  International

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
  28.06.2015

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  International

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825 735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Kazakhstan

  	
   

  	
   

  	
   

  	
  26785

  	
   

  	
  24.10.2003

  	
   

  	
  19320

  	
   

  	
  08.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Kazakhstan

  	
   

  	
  Cyr

  	
   

  	
  31491

  	
   

  	
  22.04.2005

  	
   

  	
  22003

  	
   

  	
  31.01.2015

  	
   

  	
   

  	
   

  	
  05, 10

  	
   

  
	
  Kyrgyzstan

  	
   

  	
   

  	
   

  	
  20040161.3

  	
   

  	
  24.10.2003

  	
   

  	
  7370

  	
   

  	
  09.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Kyrgyzstan

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  864005

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Liechtenstein

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Macedonia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Moldavia, the

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Moldavia, the

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Norway

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Romania

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  



 


68

















 


	
  Russia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Russia

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Serbia

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Switzerland

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Tajikistan

  	
   

  	
   

  	
   

  	
  04006624

  	
   

  	
  24.10.2003

  	
   

  	
  tj 6340

  	
   

  	
  07.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Turkey

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Turkmenistan

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  825735

  	
   

  	
  30.03.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Turkmenistan

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Ukraine

  	
   

  	
  IR, Cyr

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Ukraine

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  USA

  	
   

  	
  IR

  	
   

  	
   

  	
   

  	
  24.10.2003

  	
   

  	
  3,046,278

  	
   

  	
  17.01.2016

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Uzbekistan

  	
   

  	
   

  	
   

  	
  MGU20040246

  	
   

  	
  24.10.2003

  	
   

  	
  MGU 13535

  	
   

  	
  12.04.2014

  	
   

  	
   

  	
   

  	
  05

  	
   

  
	
  Uzbekistan

  	
   

  	
  Cyr

  	
   

  	
  2005 0436

  	
   

  	
  22.04.2005

  	
   

  	
  14260

  	
   

  	
  30.06.2016

  	
   

  	
   

  	
   

  	
  05

  	
   

  



 


69

















 


Schedule 3.1.15


Assigned Domain Names


 


angiox.ch,
registration held by Nycomed Danmark ApS


angiox.com,
registration held by Nycomed A/S


angiox.eu,
registration held by Nycomed A/S


 


70

















 


Schedule 3.2.4


TMC Knowledge of Third Party
Claims


 


Written claims to Nycomed from [**] regarding [**].


 


No written claims received from [**], but TMC has raised concerns with
Nycomed re: same.


 


71

















 


Schedule 6.1


Transition Mangers and PTC
Members


 


For TMC:


 


[**]


 


For Nycomed:


 


[**]


 


72

















 


Schedule 6.3.1


Clinical Trial Data to be
Provided


 


1.             All documents,
files and databases with respect to the [**] clinical trial [**], which was a
new European registry of [**] consecutive patients [**] bivalirudin. Patients
were included between [**] and [**] and as of the Effective Date the trial is
complete. Prior to providing the foregoing data to TMC, Nycomed shall remove
all individually identifiable patient information to the extent required to
comply with applicable law.


 


2.             All documents,
files and databases, including audit data, with respect to the ACUITY Trial. As
of the Effective Date, the ACUITY Trial is complete.


 


73

















 


Schedule 6.4


Approvals and Regulatory Filings
to be Transferred


 


See Schedule 3.1.9 (Product-Specific Approvals and Regulatory Filings)


 


74

















 


Schedule 6.8


Assigned Contracts


 


ADONIS Agreement (as defined in the body of this Agreement)


 


ISAR-3 Agreements (as defined in the New Distribution Agreement)


 


ISAR-4 Agreement (as defined in the New Distribution Agreement)


 


For further information with respect to each of the foregoing, see
Schedule 3.1.6 (Ongoing Clinical Trials).


 


75

















 


Schedule 8.4.1


Out-of-Pocket Costs


 


All costs
below are in Euros


 


Angiox


 


	
  Regulatory Expenses

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Switzerland

  	
   

  	
  Per variation fee

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**] EUR

  	
   

  
	
   

  	
   

  	
  ACS indication filing printing in Switzerland (assuming 3 set)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**] EUR

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Translation

  	
   

  	
  Per language (22)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**] EUR

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Susanne Pilegaard
  Nielsen

  	
   

  	
  Support to registration EUR equal to one month

  	
   

  	
  [**]

  	
   

  	
  FTE

  	
   

  	
  FTE rate of [**]

  	
   

  	
  [**] EUR

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Russia & Kazachstan

  	
   

  	
  Support from Susanne Pilegaard Nielsen

  	
   

  	
  [**]

  	
   

  	
  FTE

  	
   

  	
  FTE rate of [**]

  	
   

  	
  [**]EUR

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]EUR

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacovigilance Expenses

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ADRS

  	
   

  	
   

  	
   

  	
  pr item

  	
   

  	
  Variable

  	
   

  	
   

  	
   

  	
  [**] EUR

  	
   

  
	
  Periodic Safety updates

  	
   

  	
  review and Approval

  	
   

  	
   

  	
   

  	
  once

  	
   

  	
   

  	
   

  	
  [**] EUR

  	
   

  
	
  QP function

  	
   

  	
  Pr month we suggest eur [**]

  	
   

  	
   

  	
   

  	
  variable

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  If PV inspection then EUR [**] on top

  	
   

  	
   

  	
   

  	
  once

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Travel and other out of pocket

  	
   

  	
  To be paid by TMC as per
  Nycomed’s travel guideline

  	
   

  	
   

  	
   

  	
  Variable

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Based pr incident

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Trademark / Domaine name Expenses

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Angiox NL and DE

  	
   

  	
  DKK

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**] EUR

  	
   

  



 


76

















 


	
   

  	
   

  	
  Angiomax names

  	
   

  	
  DKK

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**] EUR

  	
   

  
	
   

  	
   

  	
  Angiomax mag

  	
   

  	
  DKK

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**] EUR

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Total

  	
   

  	
   

  	
   

  	
  [**]EUR

  	
   

  



 


77

















 


Schedule 9.4


Assigned Employees


 


	
  Nycomed Employee

  and Location

  (including Country)

  	
   

  	
  Services to be Provided

  by Nycomed Employee

  and, if applicable,

  Function

  	
   

  	
  Employee Percentage

  	
   

  
	
  Germany

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Italy

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  France

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  UK

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Eire

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Switzerland

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Finland

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sweden

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Norway

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Denmark

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  



 


78

















 


	
  Nycomed Employee

  and Location

  (including Country)

  	
   

  	
  Services to be Provided

  by Nycomed Employee

  and, if applicable,

  Function

  	
   

  	
  Employee Percentage

  	
   

  
	
  Austria

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Netherlands

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Belgium

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Hungary

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ukraine

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Baltics

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  International

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  



 


79