Exhibit
10.2


 


Confidential
Materials omitted and filed separately with the


Securities and
Exchange Commission. Asterisks denote omissions.


 


EXECUTION
COPY


 


DISTRIBUTION
AGREEMENT


 


This Agreement is made
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;


 


Whereas, Nycomed and TMC
were parties to that Sales, Marketing and Distribution Agreement, dated 25th
March, 2002, as amended May 28th, 2003 (the “Former Distribution
Agreement), pursuant to which Nycomed was responsible for distribution,
marketing, promotional and certain other services with respect to the Product
(as defined herein) in the Territory (for purposes of these Recitals, as
defined in the Former Distribution Agreement);


 


Whereas, pursuant to that
Termination and Transition Agreement between the Parties and Nycomed Parent,
dated the Effective Date (the “Transition Agreement”), the Parties and
Nycomed Parent agreed, among other things, to terminate the Former Distribution
Agreement and to enter this Agreement, as well as a Services Agreement, dated
the date hereof (the “Services Agreement”), in order to continue certain
activities of Nycomed under the Former Distribution Agreement without
interruption;


 


Whereas, Nycomed is
engaged in, among other things, the distribution of pharmaceutical products and
has represented to TMC that it has the facilities, personnel, and technical
expertise to distribute the Product in all countries of the Territory (as
defined herein);


 


Whereas, TMC desires to
appoint Nycomed as TMC’s exclusive distributor in the territory outlined in Exhibit
A (the “Territory”) for the Product, and to sell the Product to
Nycomed on the terms and subject to the conditions described in this Agreement
and the Transition Agreement;


 


1

















 


Whereas, Nycomed desires
to accept such appointment as an exclusive distributor of the Product in the
Territory and to distribute the Product in the Territory, and to purchase the
Product from TMC on the terms and subject to the conditions described in this
Agreement;


 


Whereas, Nycomed’s role
as a distributor under this Agreement shall include the following activities
with respect to the Product: 
importation, warehousing, logistical/handling, transportation, packaging
and labeling, QA and QC (including release analysis), follow-up stability
studies, order entry activities, booking of sales, billing and collection,
product recall (as provided herein) and any other activities performed under
the Former Distribution Agreement and Quality Agreements and not considered a “Service”
under the Services Agreement; and


 


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.          “Adverse Event” means any untoward medical occurrence in a patient administered a
medicinal product and which does not necessarily have to have a causal
relationship with this treatment. An Adverse Event can therefore be any
unfavorable and unintended sign (for example, an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal product,
whether or not considered related to such medicinal product.


 


1.2.          “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.


 


1.3.          “Angiomax”
means Angiomax®, Angiox®, Angionax® or any
other Trademark selected by TMC for the Product in the Territory.


 


1.4.          “Approvals”
means and includes all filings, approvals, registrations, permits, licenses and
authorizations related to the Product which are necessary or which, in the
reasonable opinion of TMC, are desirable, to be 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.


 


2

















 


1.5.          “AQRPA” means
the Analysis, Quality Release and Packaging Agreement, entered into as of March
24, 2004, between TMC and Nycomed.


 


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


 


1.7.          “Combination Product” means a product containing one or more active
ingredients or components in addition to the Product.


 


1.8.          “Distributor” means a person or entity in a country who (i) purchases Product from
Nycomed or one of its Affiliates, and (ii) assumes responsibility for a portion
of the sales effort related to Product in that country, and (iii) under an
implied or express sublicense, sells Product in that country.


 


1.9.          “EEA”
means any current member countries of the European Union and Norway, Iceland,
and Liechtenstein.


 


1.10.        “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.


 


1.11.        “Existing Subdistributors” means those Nycomed Affiliates appointed by Nycomed
prior to the Effective Date, in accordance with the Former Distribution
Agreement, as Distributors of the Product in the Territory, and such additional
Nycomed Affiliates and other third parties appointed as Distributors of the
Product in the Territory in accordance with Section 2.1.


 


1.12.        “First Launch Date” means the date of Launch of the Initial Indication(s)
in any country of the Territory.


 


1.13.        “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.


 


1.14.        “Gross Sales” means gross invoices on sales of the Product by Nycomed and its
Affiliates and Distributors to third parties.


 


1.15.        “Grupo Ferrer”
means Grupo Ferrer Internacional S.A.


 


1.16.        “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.


 


3

















 


1.17.        “Indication”
means a particular use for the Product which has received Approval from a
Governmental Authority in one or more countries of the Territory.


 


1.18.        “Initial Indication” means the Product’s first Indication receiving
Approval in one or more countries of the Territory.


 


1.19.        “Inventory”
means the Existing Inventory and the New Inventory, collectively.


 


1.20.        “ISAR Agreements”
means:


 


(a)           [**], effective as of [**] (the “ISAR-4
Agreement”);


 


(b)           [**], effective as of [**] (the “Munich
ISAR-3 Agreement”);


 


(c)           [**], effective as of [**] (the “Bad
Krozingen ISAR-3 Agreement”);


 


(d)           [**], with last signature dated [**] (the
“ISAR-3 Reload Agreement”; the Munich ISAR-3 Agreement, Bad Krozingen
ISAR-3 Agreement and the ISAR-3 Reload Agreement, collectively, the “ISAR-3
Agreements”).


 


1.21.        “Launch”
means the date of announcement to prescribers of pharmaceuticals, of the
availability of Product upon prescription to treat an Initial Indication or a
subsequent Indication in any country in Territory.


 


1.22.        “Net Sales”
shall mean the gross amount invoiced (not dependent on whether such invoices
have been actually paid) on sales of the Product by Nycomed and its Affiliates
and Distributors to third parties, less the following items, as determined from
the books and records of Nycomed or its Affiliates or Distributors, provided
that such items do not exceed reasonable and customary amounts in the respective
country(s) of the Territory in which such sale or other disposition
occurred:  (i) freight, insurance and
other transportation charges, if billed separately; (ii) amounts repaid or
credited by reason of returns, rejections, defects, recalls or because of
retroactive price reductions; (iii) sales taxes, excise taxes, value-added
taxes and other taxes (other than income taxes) levied on the invoiced amount;
(iv) import and export duties; (v) cash, trade and quantity discounts actually
given or made; and (vi) rebates paid pursuant to government regulations. A sale
of the Product by Nycomed to an Affiliate or Distributor for resale of the
Product by such Affiliate or Distributor shall not be considered a sale for the
purposes of this provision, but the resale of such Product by the Affiliate or
Distributor to a third party who is not an Affiliate or Distributor of Nycomed
shall be a sale for the purposes of this Agreement.


 


For
the purposes of this Agreement, “sale” shall mean any transfer or other
distribution or disposition, but shall not include transfers or other
distributions or dispositions of Product, at no charge, for pre-clinical,
clinical or regulatory purposes or to physicians or hospitals for


 


4

















 


promotional purposes,
provided such transfer, distribution or disposition is not made in exchange for
higher prices on other Nycomed products or for other non-cash consideration. In
the event that consideration in addition to or in lieu of money is received for
the sale of Product in an arms-length transaction, the fair market value of
such consideration shall be included in the determination of Net Sales. To the
extent that the Product is sold in other than an arms-length transaction, Net
Sales for such sale shall be the average sales price of the Product if sold in
an arms-length transaction during the applicable reporting calendar quarter in
the country of the Territory in which the non-arms-length transaction occurred.


 


In
the event that the Product is sold in the form of a Combination Product, Net
Sales for the Combination Product shall be determined by multiplying actual Net
Sales of the Combination Product (determined by reference to the definition of
Net Sales set forth above) during the calendar quarter period by the fraction
A/A+B where A is the average sale price of Product when sold separately in
finished form, and B is the average sale price of the other active ingredients
or components when sold separately in finished form, in each case during the
applicable reporting calendar quarter in the country in which the sale of the
Combination Product was made, or if sales of both the Product and the other
active ingredients or components did not occur in such period, then in the most
recent calendar quarter in which sales of both occurred. In the event that such
average sale price cannot be determined for both Product and all other active
ingredients or components included in the Combination Product, Net Sales for
purposes of determining payments under this Agreement shall be calculated by
multiplying the Net Sales of the Combination Product by the fraction C/C+D
where C is the standard fully-absorbed cost of the Product portion of the
Combination Product and D is the sum of the standard fully-absorbed costs of
all other active components or ingredients included in the Combination Product,
in each case as determined by TMC using its standard accounting procedures
consistently applied. In no event shall Net Sales of a Product included in a
Combination Product be reduced to less than fifty percent (50%) of actual Net
Sales of such Combination Product (determined by reference to the definition of
Net Sales set forth above) by reason of any adjustment provision set forth in
this paragraph.


 


1.23.        “New Inventory” means any vials of Product bought by Nycomed from TMC after the
Effective Date in accordance with Section 8.1.


 


1.24.        “Packaging Agreement” means the Quality (GMP) Agreement for Third Party
Contract Manufacture, entered into as of April 24, 2002, between TMC and
Nycomed.


 


1.25.        “Patents” means
patents and applications in any and all countries for patents (including
provisional applications) and all reissues, divisions, renewals, extensions,
continuations and continuations-in-part thereof and patent extensions with
respect to the Product in the Territory.


 


1.26.        “Pharmacovigilance Agreement” means the Pharmacovigilance Agreement on
Bivalirudin®, entered into as of September 16, 2004, between TMC and Nycomed.


 


5

















 


1.27.        “Pharmacovigilance QP Agreement” means the Agreement between The Medicines Company and
Nycomed Denmark A/S on the role of the Qualified Person for Pharmacovigilance
in the European Union for Angiox, entered into as of August 16, 2004, between
TMC and Nycomed.


 


1.28.        “PhV Agreements” means the Pharmacovigilance Agreement and the Pharmacovigilance QP
Agreement.


 


1.29.        “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.


 


1.30.        “Product Configuration” means and includes any modifications to the package
insert, labeling, or packaging of the Product required by Governmental
Authority(s) of one or more countries of the Territory.


 


1.31.        “PTC”
means the Product Transition Committee, as defined in the Transition Agreement.


 


1.32.        “QA Agreements” means, collectively, the AQRPA, the Release Agreement and the
Packaging Agreement.


 


1.33.        “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.


 


1.34.        “Release Agreement” means the Quality (GMP) Agreement for Third Party
Contract Quality Release, entered into as of February 24, 2004, among TMC,
Nycomed and Nycomed Austria GmbH.


 


1.35.        “Thrombin Inhibitor” means any pharmaceutical with a mechanism of action
involving the partial or complete inhibition of thrombin in the clotting
cascade. Thrombin inhibitors shall include direct acting compounds including
but not limited to lepirudin, desirudin and other


 


6

















 


members of the
hirudin family as well as melagatran and small molecule direct thrombin
inhibitors such as argatroban. Thrombin inhibitors shall also include indirect
acting thrombin inhibitors which inhibit thrombin in conjunction with a
co-factor such as AT-III. Such indirect thrombin inhibitors shall include but
not be limited to unfractionated heparins and low molecular weight heparins
such as enoxaparin sodium, dalteparin sodium, fondaparinux and reviparin sodium
but shall exclude Warfarin.


 


1.36.        “TMC-UK”
means The Medicines Company UK Limited, a limited liability corporation located
at Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, or such
other EU incorporated entity of TMC which TMC may designate.


 


1.37.        “Trademarks”
means trademarks, trade names, service marks, and other proprietary symbols
owned or controlled by TMC and as designated by TMC in Exhibit C hereto.


 


1.38.        “Transaction Agreements” means, collectively, this Agreement, the Services
Agreement and the Transition Agreement.


 


1.39.        “Transfer Percentage” means (a) with respect to sales of Inventory made on
or before June 30, 2008, [**]%, and (b) with respect to sales of Inventory on
or after July 1, 2008, [**]%; provided, however, that if TMC
requires Nycomed to perform quality analysis activities on more than [**]
batches per year, the Parties shall negotiate a reasonable fee to be paid by
TMC to Nycomed with respect to such activities, reflecting Nycomed’s actual
costs to perform such activities, marked up by [**]%, but in no event more than
€[**] per analysis.


 


1.40.        “Transfer Price”
has the meaning set forth in Exhibit B.


 


2.             APPOINTMENT
OF NYCOMED


 


2.1.          Appointment, General Diligence.


 


TMC hereby appoints
Nycomed as an exclusive distributor of the Product in the Territory for any and
all Indications (whether or not currently existing or planned, but subject to
Section 3.1.8 of the Transition Agreement) during the term of this Agreement
and Nycomed hereby accepts such appointment subject to the terms and conditions
described in this Agreement. For the sake of clarity, such appointment includes
the right and obligation for Nycomed to conduct the following activities with
respect to the Product in the Territory in accordance with Nycomed’s past
practice under the Former Distribution Agreement and Quality Agreements:  importation, warehousing,
logistical/handling, transportation, packaging and labeling, QA and QC
(including release analysis), follow-up stability studies, order entry
activities, booking of sales, billing and collection, product recall (as provided
herein) and any other activity performed under the Former Distribution
Agreement and Quality Agreements which is not considered a “Service” under the
Services Agreement, and expressly excludes the


 


7

















 


right and obligation to
conduct promotion, marketing, detailing and other Services (as defined in the
Services Agreement) with respect to the Product in the Territory, except as
expressly provided in the Services Agreement. In addition, Nycomed shall have
no right or obligation to purchase Product except in accordance with Section
8.1. Nycomed shall have the right to retain the Existing Subdistributors as
subdistributors of the Product in the Territory. Nycomed may appoint Nycomed’s
Affiliates or third parties as subdistributors of the Product in the Territory.
Promptly after any such appointment, Nycomed shall notify TMC in writing of the
name and address of each Nycomed Affiliate or third party so appointed as a
subdistributor.


 


2.2.          Application to Affiliates.


 


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 this Agreement, the QA Agreements and
the Pharmacovigilance Agreement through Nycomed’s Affiliates. Nycomed shall
cause its Affiliates to comply with all of Nycomed’s obligations under this
Agreement, the QA Agreements and the Pharmacovigilance Agreement to the same
extent that Nycomed is itself obligated to perform 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 this
Agreement, the QA Agreements and the Pharmacovigilance Agreement shall also
apply to Nycomed’s Affiliates to the extent such Affiliates have performed or
will perform Nycomed obligations hereunder or thereunder.


 


2.3.          General Obligations and Limitations with respect to
Distribution.


 


(a)           Subject to the applicable regulations in
the Territory and to the extent permitted by law, Nycomed shall not (i)
establish or maintain any distribution facility for the Product outside the
Territory or (ii) except as permitted under the Services Agreement, actively
advertise or promote the Product to potential buyers, whether located within or
outside the Territory. Nycomed agrees and acknowledges that, as between Nycomed
and Nycomed’s Affiliates, on the one hand, and TMC and TMC’s Affiliates, on the
other hand, TMC and its Affiliates shall be responsible for the advertising,
promotion, detailing and marketing of the Product to potential buyers in the
Territory, and, except to the extent specified in the Services Agreement,
Nycomed, Nycomed’s Affiliates and any Existing Subdistributors shall have no
right or obligation to conduct such activities. Particularly, Nycomed is
cognizant of and recognizes the exclusive distribution rights granted by TMC to
Grupo Ferrer for Spain, Portugal and Greece and for certain countries within
Central and South America.


 


(b)           Nycomed shall not seek Approval for the
Product anywhere in any country in the world, except as provided in the
Transition Agreement or with TMC’s prior written consent with respect to a
particular country.


 


8

















 


(c)           Nycomed shall not bundle the Product with
other products.


 


(d)           Nycomed shall use commercially reasonable
efforts to distribute and sell the Products in the Territory and in doing so to
maximize the Net Sales of the Product. Nycomed shall use all reasonable efforts
to continue to follow the sales and pricing practice and policies with respect
to the Product in the Territory that Nycomed has followed in the 12 month
period immediately prior to the Effective Date, except to the extent it has
just cause to deviate from the same.


 


2.4.          Non-Competition.


 


During
the term of this Agreement, none of Nycomed, its Affiliates or its Distributors
shall manufacture, distribute or sell any Thrombin Inhibitor in the Territory; provided,
however, that with respect to countries in the Territory which are
included in the EEA, this sentence shall only apply from the First Launch Date
until the date which is five years after the First Launch Date. During the term
of this Agreement, Nycomed shall notify TMC regarding new pharmaceutical
products (excluding line extensions and new formulations) Nycomed or its
Affiliates intend to directly or indirectly sell, market or promote in the
Territory. Notwithstanding the above, Nycomed shall be entitled to distribute
any product for the same Indications as approved for the Product, other than
abciximab, eptifibatide, or enoxaparin sodium, that may be used with the
Product and/or which may be used in circumstances where the Product is not
currently indicated or is contraindicated. Notwithstanding anything contained
herein to the contrary, Nycomed shall not be deemed to be in breach of this
Section 2.4 if any of the customers of Nycomed, its Affiliates or its
Distributors outside the Territory resell any Thrombin Inhibitor in the
Territory which they purchased from Nycomed, its Affiliates or its
Distributors.


 


3.             RELATIONSHIP
WITH CERTAIN OTHER AGREEMENTS


 


3.1.          Former Distribution Agreement.


 


Except with respect to
the services to be provided by Nycomed pursuant to the Services Agreement and
except as otherwise expressly provided herein, Nycomed shall perform hereunder
all activities which Nycomed had performed under the Former Distribution
Agreement without interruption and in accordance with Nycomed’s practice under
the Former Distribution Agreement. Nycomed shall maintain the infrastructure
and personnel necessary to perform its obligations under this Agreement.


 


9

















 


3.2.          QA and Pharmacovigilance Agreements.


 


The QA Agreements and the
Pharmacovigilance Agreement shall remain in effect unless terminated in
accordance with Section 20 of this Agreement; provided, however,
that the QA Agreements and the Pharmacovigilance Agreement are hereby amended
as follows:


 


(a)           All references in the AQRPA, the Release
Agreement, the Packaging Agreement and the Pharmacovigilance Agreement to the
Former Distribution Agreement or “SMD” (as defined in such Quality Agreements)
shall instead refer to this Agreement; provided, however, that
(i) all references in the AQRPA to Section 8.2 of the SMD with respect to the
authorized manufacturer of the Product or the analyses for import and final
release of the Product in the Territory shall instead refer to Section 8.1 of
this Agreement, and (ii) all references in the AQRPA to Sections 8.2 and 8.3 of
the SMD with respect to final packaging of the Product shall instead refer to
Sections 8.2 and 10.3(b) of this Agreement.


 


(b)           The “Termination” section and the “Consideration:  For the Release” section in the AQRPA is
hereby deleted in its entirety.


 


(c)           Appendix 2 to the Release Agreement is
revised to refer to the TMC Specifications and TMC-UK Specifications agreed
upon by the Parties and approved in the Territory.


 


(d)           For the sake of clarity, Nycomed shall
continue, unless requested to the contrary by TMC, the arrangements that were
in place with respect to Grupo Ferrer during the term of the Former
Distribution Agreement in accordance with past practice during such term,
including the performance of services under this Agreement, the QA Agreements
and the Pharmacovigilance Agreement and the sale of Product to Grupo Ferrer.


 


4.             PTC,
TMs AND ADVISORY BOARDS


 


4.1.          Coordination.


 


As described in the Transition Agreement, the Transition Managers (as
defined in the Transition Agreement) and the PTC shall be responsible for
coordinating the Parties’ activities under this Agreement. The QP (as defined
in the relevant QA Agreement) shall cooperate with the PTC as requested by TMC.


 


4.2.          Advisory Boards.


 


For the purpose of maximizing the medical community’s knowledge and
awareness of the Product, to the extent Nycomed has developed national or
regional advisory boards for the Product pursuant to the Former Distribution
Agreement, the members and meetings of such


 


10

















 


boards shall be accessible to TMC’s personnel. For the avoidance of
doubt, Nycomed shall no longer have any right to develop new national or
regional advisory boards, but may maintain the existing boards in accordance
with this Section 4.2 until termination or expiration of this Agreement, at
which point such boards shall be disbanded.


 


5.             COMPLIANCE
WITH GOVERNMENTAL REGULATIONS 


 


TMC and Nycomed shall each comply with all laws, rules and regulations
of every Governmental Authority having jurisdiction over its respective
activities, as contemplated by this Agreement.


 


6.             INTENTIONALLY
OMITTED


 


7.             FORECASTS



 


Until [**] (or, if earlier, the termination of
this Agreement), Nycomed shall provide TMC with a [**] Product forecast,
updated on a rolling quarterly basis. The rolling forecasts are to be broken
down to [**]. Nycomed shall use its reasonable commercial efforts to provide
accurate forecasts to TMC. Such forecasts shall be non-binding.


 


8.             INVENTORY
MANAGEMENT AND SUPPLY


 


8.1.          New Inventory.


 


(a)           At TMC’s request from time to time,
Nycomed shall buy New Inventory from TMC, based on TMC’s good faith belief as
to the anticipated demand for the Product in the Territory during the remaining
term of this Agreement. Nycomed shall pay TMC for such New Inventory in
accordance with Section 10 of this Agreement. TMC shall supply the New
Inventory as a sterile lyophilized formulation in 10 ml glass vials containing
material that, when reconstituted, will deliver 250mg of bivalirudin per 5ml. Each
250mg vial constitutes a single unit of Product.


 


(b)           The New Inventory shall be provided to
Nycomed by TMC in 250 mg naked (unlabeled) vials in quantities determined by
TMC. Naked vials shall be shipped to an agreed location in the European Union. TMC
shall be responsible for the cost of filling the naked vials at Ben Venue
Laboratories. Additionally, TMC may designate another qualified company in
Europe or elsewhere that shall be responsible for filling the naked vials, and
TMC shall provide all required technical know-how to the designated company for
such purposes. TMC shall be responsible for the cost of filling, both at Ben
Venue and at any such additional site. As marketing authorization holder, TMC
shall be responsible for designating an authorized manufacturer and/or site of
European batch release for the Product; provided, however, that


 


11

















 


TMC has designated Nycomed to act in this capacity in accordance with
the Release Agreement; provided, however, that TMC also reserves
the right to designate other third parties as appropriate.


 


(c)           TMC shall deliver New Inventory into the
possession of a common carrier designated by TMC. Title, risk of loss and
damage to such Product shall pass to Nycomed upon such Product’s removal from
TMC’s designated filling location. In accordance with Section 10.3(a), TMC
shall be responsible for shipping and insurance costs incurred in connection
with transporting the New Inventory from TMC’s fill point to the agreed
location in the European Union. The New Inventory shall be packed for shipment
and storage in accordance with TMC’s standard commercial practices.


 


(d)           For the avoidance of doubt, Nycomed shall
be the importer of record with respect to the New Inventory. Until Nycomed
sells or supplies the New Inventory in accordance with Section 9, the New
Inventory shall be housed and maintained by Nycomed, at Nycomed’s expense, at a
facility(ies) owned or controlled by Nycomed and will be segregated and marked
as New Inventory.


 


(e)           The terms and conditions set forth in
this Agreement shall apply to all purchases of New Inventory by Nycomed, and to
the extent such terms and conditions conflict with those set forth in any
purchase order or invoice for Product, the terms and conditions set forth in
this Agreement shall govern.


 


(f)            TMC shall not be liable to Nycomed for
any losses or damages arising from TMC’s failure to provide any quantity of
Product.


 


8.2.          Product Packaging, Product Configuration and
Destination Instructions.


 


(a)           Nycomed will be responsible for the
Product Configuration except with respect to those countries in the Territory
in which TMC holds the marketing authorization for the Product. TMC shall
approve all labeling and package insert proofs prior to their use.


 


(b)           Nycomed shall package and label the
Product in Inventory in accordance with TMC’s instructions, Nycomed’s past
practices with respect thereto, the provisions of this Agreement and the
Packaging Agreement, and applicable Territory laws and regulations.


 


8.3.          Inspection; Repurchase; Possession.


 


(a)           TMC shall have the right to enter the
applicable distribution facilities at all reasonable times to inspect the
Inventory and Nycomed’s records with respect thereto. At TMC’s request from
time to time, Nycomed shall provide TMC with a report of the quantity of
saleable Inventory and such other information reasonably requested by TMC with
respect to the Inventory.


 


12

















 


(b)           Upon TMC’s request at any time, (i)
Nycomed Danmark ApS shall obtain title and ownership of any of the then-current
New Inventory that may be held by its Affiliates, (ii) TMC or TMC’s designee
shall purchase, and shall be deemed to have purchased, the then-current New
Inventory from Nycomed Danmark ApS at no charge (US$0) and (iii) title to the
then-current New Inventory shall pass to TMC or TMC’s designee. Nycomed Danmark
ApS shall execute and deliver to TMC or TMC’s designee, as applicable, a bill
of sale with respect to such then-current New Inventory substantially in the
form attached to the Transition Agreement as Exhibit C (with relevant changes
to refer to the then-current New Inventory). Nycomed shall deliver such vials
of New Inventory into the possession of a common carrier designated by TMC
within five Business Days after Nycomed’s receipt of TMC’s request. If TMC does
not designate a common carrier before such date, then Nycomed may designate a
common carrier on behalf of TMC. Title, risk of loss and damage to such vials
of New Inventory shall pass to TMC or TMC’s designee, as applicable, upon
possession by the common carrier. Such vials of New Inventory shall be
delivered FCA (Incoterms 2000) the applicable Nycomed distribution facility. Such
vials of New Inventory shall be packed for shipment and storage in accordance
with Nycomed’s standard commercial practices. Nycomed shall deliver such vials
of New 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. Nycomed agrees that, if Nycomed does not comply with Nycomed’s
obligations under this Section 8.3(b), TMC has the right to enter the Nycomed
distribution facilities, take possession of any or all of the New Inventory and
remove any or all of the New Inventory from such facilities, without further
notice or court hearings, which rights, if any, are hereby waived, upon
expiration or termination of this Agreement. For the sake of clarity, TMC’s
rights and Nycomed’s obligations under this Section 8.3(b) are independent of
and in addition to the Parties’ rights and obligations under Section 6.10 of
the Transition Agreement.


 


8.4.          Certificates of Analysis.


 


Except to the extent that Nycomed is responsible for performing the
relevant activities pursuant to the QA Agreement, (a) TMC shall provide
Certificates of Analysis for each lot of Product in Existing Inventory (to the
extent not already provided prior to the Effective Date) or delivered to Nycomed
as New Inventory, to demonstrate that such lot was tested and released prior to
delivery, and (b) TMC shall make available for review by Nycomed full batch
documentation, including batch production records and manufacturing and
analytical records, for the Inventory.


 


9.             SALES
AND OTHER SUPPLY BY NYCOMED


 


9.1.          Sales of Product by Nycomed.


 


Nycomed shall be responsible for accepting orders for purchases of
Product within the Territory (whether such orders are presented to Nycomed
directly from a potential buyer or


 


13

















 


indirectly through TMC or an Affiliate of TMC) and, except as expressly provided
herein, in accordance with Nycomed’s practice under the Former Distribution
Agreement; provided, however, that Nycomed shall not accept any
purchase order in a quantity greater than that which can be filled from the
then-current Inventory.


 


9.2.          Supply of Product by Nycomed to Certain Clinical
Trials.


 


Until such time as the
ISAR Agreements are assigned to TMC pursuant to the Transition Agreement,  Nycomed shall be responsible for supply of Product to the
hospitals and professors which are parties to the ISAR Agreements
(collectively, “ISAR”), in accordance with the
ISAR Agreements and otherwise in accordance with Nycomed’s practice under the
Former Distribution Agreement. Nycomed represents that it has supplied [**]
vials of Product to ISAR prior to the Effective Date and that TMC has neither
reimbursed Nycomed’s cost for any such vials nor replaced any such vials
in-kind at no cost to Nycomed. With respect to such [**] vials, TMC shall
reimburse Nycomed at US$[**] per vial for an aggregate reimbursement amount of
US$[**], which amount shall be paid in accordance with Section 8 of the
Transition Agreement.


 


9.3.          Order of Sale and Supply.


 


Nycomed shall sell to customers, or supply to ISAR as permitted under
Section 9.2, the vials of Product in Inventory in the following order, to the
extent practicable:  first, the Existing Inventory until all the
Existing Inventory has been sold or supplied, then the New Inventory; and with
respect to each of the Existing Inventory and the New Inventory, the labeled
vials shall be sold or supplied first until all then-labeled vials in the
relevant category of Inventory have been sold or supplied, then the unlabeled
vials (which Nycomed shall have first labeled in accordance with Section 8.2);
and with respect to each of the categories of Inventory and with respect to
each of the categories of labeled and unlabeled vials therein, vials with the
shortest period of time remaining until the expiration date for the Product
therein shall be sold or supplied first. Upon sale or supply by Nycomed, the
sold or supplied vials of Product shall no longer be considered Inventory
hereunder.


 


9.4.          Billing and Collection.


 


Nycomed shall be solely responsible for billing of, and collection of
payments from, buyers of the Product in the Territory.


 


10.          FEES
AND PAYMENT AMOUNTS


 


10.1.        Transfer Price.


 


(a)           For each vial of Product sold by Nycomed,
Nycomed’s Affiliates or Distributors 
from New Inventory or Existing Inventory in accordance with Section 9.1,
upon such sale,


 


14

















 


Nycomed shall owe TMC the applicable Transfer Price as calculated
according to Exhibit B attached hereto. The Transfer Price for sold
vials shall be paid on a quarterly basis in accordance with Section 8 of the
Transition Agreement.


 


(b)           For each vial of Product supplied by
Nycomed to ISAR following the Effective Date in accordance with Section 9.2,
upon supply by Nycomed to ISAR, TMC shall owe Nycomed (a) US$[**], with respect
to each such vial supplied from Existing Inventory, or (b) no charge (US$0),
with respect to each such vial supplied from New Inventory. The foregoing
amount for supplied vials shall be paid on a quarterly basis in accordance with
Section 8 of the Transition Agreement.


 


(c)           If any Net Sales are stated in a currency
other than United States Dollars during such quarter, then, for the purpose of
calculating the Transfer Price for such quarter such Net Sales 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, such Net Sales
shall be deemed to be equal to the Net Sales for the Product most recently
charged by Nycomed in United States Dollars.


 


10.2.        Payment Form.


 


(a)           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.


 


(b)           Taxes now or hereafter imposed with
respect to the importation by, or sale to, Nycomed of New Inventory hereunder
(with the exception of income taxes or other taxes imposed upon TMC and
measured by the gross or net income of TMC) shall be the responsibility of
Nycomed as between TMC and Nycomed, and if paid or required to be paid by TMC,
the amount thereof shall be added to and become a part of the amounts payable
by Nycomed hereunder. Nycomed, as the importer of record with respect to the
Product, remains responsible to the local VAT authorities for introducing any
periodical VAT returns and paying any VAT due on the importation by or sale of
New Inventory to Nycomed hereunder, if required to do so under the applicable
VAT law and regulations.


 


(c)           Taxes now or hereafter imposed with
respect to the distribution and sale of the Product, or the shipment of the
Product to ISAR, by Nycomed, Nycomed’s Affiliates or Distributors in any
country in the Territory shall be the responsibility of Nycomed as between TMC
and Nycomed, and if (for whatever reason) paid or required to be paid by TMC,
the


 


15

















 


amount thereof shall be added to and become a part of the amounts
payable by Nycomed hereunder. Nycomed is responsible to the local VAT and
customs authorities for the customs clearance (if applicable) and introducing
any periodical VAT returns and paying any VAT due in the framework of the
distribution and sale of the Product, or the shipment of the Product to ISAR,
by Nycomed, Nycomed’s Affiliates or Distributors, if required to do so under
the applicable VAT and/or customs law and regulations.


 


(d)           Notwithstanding Sections 10.2(b) or (c),
if Nycomed is required to withhold taxes from any amount payable by Nycomed to
TMC, then Nycomed shall pay to TMC an additional amount as may be necessary so
that TMC will receive, after deduction of such withholding tax, the amount
which TMC would have received in the absence of such withholding tax. TMC will
promptly credit to Nycomed any withholding tax TMC recovers through a foreign
tax credit that TMC actually uses to reduce its tax liabilities, up to the
additional amount as described above, that Nycomed has paid to TMC with respect
to that recovered tax. TMC shall provide Nycomed with a certificate of
residence and other documents which Nycomed may reasonably request in order to
demonstrate that TMC is a tax resident of the United States.


 


10.3.        Responsibilities for Expenses.


 


(a)           TMC shall be responsible for:  (i) the cost of bulk material; (ii) shipping
and insurance costs incurred in connection with transporting the New Inventory
from TMC’s fill point to the agreed location in the European Union; (iii) all
license fees and royalties payable to third parties in connection with the
manufacture, use or sale of the Product, in accordance with agreements between
TMC and third parties; (iv) fill costs (excluding labeling and packaging
costs); and (v) regulatory filing and maintenance costs within the Territory,
including release testing required pursuant to the Approvals for the EEA (excluding
country-specific local testing and excluding any such costs incurred by Nycomed
pursuant to the QA Agreements and the Pharmacovigilance Agreement).


 


(b)           Nycomed shall be responsible for:  (i) any third party payment obligations
(including without limitation fees associated with customs clearance and, if
necessary, local release testing for Product) incurred by Nycomed in connection
with distributing the Product in any country in the Territory; (ii) labeling
and packaging costs and other costs incurred by Nycomed pursuant to the QA
Agreements or the Pharmacovigilance Agreement; (iii) its own incidental costs
in assisting TMC in obtaining Approvals for countries in the Territory; and
(iv) other costs incurred by Nycomed pursuant to the Quality Agreements and the
activities to be performed by Nycomed under this Agreement, as described in
Section 2.1.


 


10.4.        All Inclusive. Other
than the payment obligations in this Section 10, TMC shall have no other
payment obligations to Nycomed with respect to the activities performed by
Nycomed under this Agreement, the QA Agreements and the Pharmacovigilance
Agreement. For the sake of clarity, the portion of Net Sales retained by
Nycomed covers, without any additional charge to


 


16

















 


TMC, the costs of
performing the Nycomed activities hereunder (including all financing costs and
costs of scrapping packages, labels or other materials), consistent with
Nycomed’s past practices under the Former Distribution Agreement and the manner
in which Nycomed supports its other employees performing similar activities.


 


11.          REPORTING
BY NYCOMED


 


11.1.        Within [**] Business Days after the end of each month,
Nycomed shall submit a written report to TMC including  the
following information for such month:


 


(a)           Market shares of the Product for the
Territory, when and where available, on a country-by-country basis; and


 


(b)           Product orders received or fulfilled by
Nycomed, specifying, with respect to each customer, the number of vials of
Product ordered and the name and address of such customer (including any
Existing Subdistributor, if applicable, and any ultimate customer of such
Existing Subdistributors).


 


11.2.        Within [**] Business Days after the end of each
calendar quarter, Nycomed shall submit a written report to TMC including  the following information for such quarter:


 


(a)           the number of vials of Existing Inventory
sold, on a country-by-country basis, and on a vial-by-vial basis;


 


(b)           the number of vials of New Inventory
sold, on a country-by-country basis, and on a vial-by-vial basis;


 


(c)           the number of vials of Existing Inventory
supplied by Nycomed to ISAR pursuant to Section 9.2;


 


(d)           the number of vials of New Inventory
supplied by Nycomed to ISAR pursuant to Section 9.2;


 


(e)           the number of vials of Existing Inventory
sold by Nycomed to Grupo Ferrer pursuant to Section 3.2(d) quarter;


 


(f)            the number of vials of New Inventory sold
by Nycomed to Grupo Ferrer pursuant to Section 3.2(d); and


 


(g)           Gross Sales, Net Sales (and the
calculation thereof) and the calculation of each applicable Transfer Price, on
a vial-by-vial and aggregate basis.


 


17
















12.                               INTENTIONALLY
OMITTED


 


13.                               COLLECTION
OF INFORMATION ON ADVERSE AND SERIOUS ADVERSE EVENTS/REPORTING ON MEDICAL
SAFETY RECALLS


 


13.1.                        Obligations regarding Regulatory
Reporting (“Pharmacovigilance”).


 


To the extent permitted
by applicable law, Nycomed shall have sole responsibility for Pharmacovigilance
and for submitting Adverse Event/medical safety reports in the Territory, as
may be required by the Governmental Authorities or regulations.


 


                                                Such
activities shall be conducted by Nycomed in accordance with past practice, the
Pharmacovigilance Agreement and applicable law. The Parties agree that Nycomed
is conducting such activities on behalf of TMC in those countries in the
Territory in which TMC holds the marketing authorization for the Product.


 


Nycomed shall not submit
Adverse Event or safety reports to Governmental Authorities without first
consulting TMC’s designated drug surveillance and information contact.


 


13.2.                        Cooperation/Procedures.


 


TMC shall also be
responsible for maintaining a central Adverse Event/medical safety database for
the Product. To the extent required by law, reports based on this database will
be made available to Nycomed during the term of the Agreement to meet the
requirements of Governmental Authorities in the Territory.


 


13.3.                        Recalls.


 


In the event that either
Party determines that an event, incident or circumstance has occurred which may
result in the need for a recall or other removal of the Product, or any lot or
lots thereof, from the market, such Party shall advise the other and the
Parties shall consult with respect thereto in accordance with the Quality
Agreements, as applicable. Except to the extent not permitted by applicable
law, TMC shall have authority to decide whether a recall or other removal of
such Product shall be made. The cost of recall and removing and destroying the
Products recalled shall be borne by TMC. TMC shall, at Nycomed’s discretion,
reimburse or credit the vials of Products recalled to Nycomed at the applicable
Transfer Price paid by Nycomed for such vials, whether pursuant to the Former
Distribution Agreement (if such vials have not been sold or supplied by Nycomed
pursuant to this Agreement) or this Agreement.


 


18

















 


14.                               TRADEMARKS


 


14.1.                        Right to Use.


 


Nycomed shall use the
Trademarks on an exclusive basis with respect to Exhibit C part a) and
on a non-exclusive basis with respect to Exhibit C part b) during the
term of this Agreement in the Territory solely to perform Nycomed’s obligations
in accordance with this Agreement. Nycomed shall not at any time do or permit
any act to be done which may in any way impair the rights of TMC in the
Trademarks. TMC shall at all times retain sole and exclusive ownership of the
Trademarks. TMC agrees that, if required by the laws of any country of the
Territory, recordal of Nycomed’s license with respect to the Trademarks or
other recording of Nycomed’s rights as a user of the Trademarks shall be
permitted with the prior written consent of TMC, such consent not to be
unreasonably withheld. Nycomed shall promptly inform TMC of any infringement or
challenge of the Trademarks in the Territory. TMC shall have the sole and
exclusive right to bring all actions or proceedings relating to the Trademarks,
and Nycomed shall not take any legal action against a third party based on
infringement of the Trademarks, unless so authorized by TMC. Furthermore,
Nycomed shall provide all reasonable assistance to TMC, at TMC’s request and
expense, towards defending the Trademarks from infringement or challenge by or
against third parties. TMC shall be responsible for all application and
registration procedures for the Trademarks in the Territory. Should such
procedures be unsuccessful, TMC’s obligation towards Nycomed shall only be limited
to registering a new Trademark for the Product.


 


14.2.                        Quality Control.


 


In
order to comply with TMC’s quality control standards, Nycomed shall:  (i) use the Trademarks in compliance with all
relevant laws and regulations; (ii) obtain TMC’s prior written approval of each
such use; (iii) provide, at TMC’s request, reasonable quantities of samples of
labels or other materials on which the Trademarks are affixed, in order to
allow TMC to confirm that Nycomed’s use of such Trademarks is in compliance
with TMC’s applicable standards and guidelines which are then in effect; and
(iv) not modify any of the Trademarks in any way and not use any of the
Trademarks on or in connection with any goods or services other than the
Product.


 


14.3.                        Internet Sales.


 


Nycomed
shall not engage in active sales of the Product outside the Territory via the
Internet. All Internet sales activities shall be in accordance with local laws
and guidelines. The Parties agree that at least the following behavior shall
constitute breach of this Section 14.3: 


 


(a)                                  the use on the Internet of a language
other than any official language of the Territory;


 


19

















 


(b)                                 the use on the Internet of banners or
links specifically available to customers other than customers in the
Territory;


 


(c)                                  the use on the Internet of any other
symbol or denomination of any currency than those for the currencies of the
Territory;


 


(d)                                 the use on the Internet of any other
trademarks for the Product other than the Trademarks;


 


(e)                                  the use on the Internet of any other
package of the Product than the packages of the Product for the Territory.


 


For the avoidance of
doubt, this Section 14.3 shall not be interpreted as creating any right or
obligation for Nycomed to advertise, promote, detail or market the Product
under this Agreement.


 


14.4.                        Domain Names, Marks, Corporate Names and
Meta-Tags. 


 


In no event shall
Nycomed:  (i) establish, operate,
sponsor, or contribute content to any site on the Internet which incorporates
the word “Angiomax”, “Angiox”, “Angionax” or “The Medicines Company”, any of
TMC’s trademarks, service marks or trade names identified in Exhibit E
hereto (the “Marks”) or any variation of such Marks as its URL address
or any part of such address; (ii) register any domain name which incorporates
any of the words “Angiomax”, “Angiox”, “Angionax” or “The Medicines Company” or
the Marks (and Nycomed hereby agrees to transfer such domain name to TMC if it
breaches this provision); (iii) register any of the Marks or any Marks that are
confusingly similar to any of the words “Angiomax”, “Angiox”, “Angionax” or “The
Medicines Company” or the Marks; (iv) form (or change the name of) any
corporation or other entity under or to a name which incorporates any of the
words “Angiomax”, “Angiox”, “Angionax” or “The Medicines Company” or any of the
Marks; or (v) at any time during or after the term of this Agreement, in order
to attract visitors to any site on the Internet, (A) use “Angiomax”, “Angiox”, “Angionax”
or “The Medicines Company”, any of the Marks or any variation thereof as a
meta-tag or invisible text or on any unused frame or bridge page,  (B) purchase “Angiomax”, “Angiox”, “Angionax”
or “The Medicines Company”, any of the Marks or any variation thereof as a
search term from any search engine; or (C) engage in any other practice
designed to direct web browsers using search engines to different web pages or
versions of web pages than the pages corresponding to search terms entered by
the user (including without limitation “bridge pages”, “cloaking” or “pagejacking”).



 


14.5.                        Equitable Relief.


 


Nycomed
acknowledges and agrees that due to the unique nature of domain names, there
can be no adequate remedy at law for any breach of its obligations under this
Section 14, and 


 


20

















 


that any breach may allow Nycomed or third parties to unfairly compete
with TMC, and therefore, that upon any breach by Nycomed or threat thereof, TMC
shall be entitled to appropriate equitable relief in addition to whatever
remedies it might have at law. Nycomed shall notify TMC in writing immediately
upon the occurrence of any such breach or any threat thereof of which it is
aware.


 


15.                               PATENTS


 


TMC
may, in its discretion, defend and maintain at its cost the Patents in the
Territory on the Product. All damages, including interest, profits and other
recoveries awarded to the prosecuting party shall be retained by TMC.


 


16.                               NO
RIGHTS BY IMPLICATION


 


No rights or licenses
with respect to the Product or the Trademarks are granted or deemed granted by
TMC under this Agreement, the QA Agreements or the Pharmacovigilance Agreement
or in connection herewith or therewith, other than those rights expressly
granted in this Agreement.


 


17.                               INTENTIONALLY
OMITTED


 


18.                               WARRANTY
AND INDEMNIFICATION


 


18.1.                        Product Warranty.


 


TMC hereby warrants that
the Product is and shall be manufactured and delivered to Nycomed in conformity
with (i) the specifications for the Product, (ii) the U.S. Federal Food, Drug
and Cosmetic Act, as amended, (iii) the European Union Council Regulation No.
2309/93 of July 22, 1993 and any amendment thereof, (iv) the European Market
Authorization granted to the Product and any extension thereof, and (v) any
other regulations applicable to the Product in the EEA. In addition, upon
Nycomed notifying TMC of additional requirements imposed by countries within
the Territory but not members of the EEA which must be complied with for the
Product to be delivered to Nycomed in conformity with the regulations of such
countries, TMC shall use commercially reasonable efforts to comply with those
requirements, at TMC’s expense.


 


18.2.                        Disclaimer.


 


EXCEPT
AS STATED IN SECTION 18.1 ABOVE, TMC DISCLAIMS ALL REPRESENTATIONS AND
WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE
PRODUCT OR OTHERWISE UNDER THIS AGREEMENT OR THE QUALITY AGREEMENTS, INCLUDING
WITHOUT LIMITATION 


 


21

















 


ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR
PURPOSE AND NON-INFRINGEMENT.


 


18.3.                        Indemnifications.


 


(a)                                  Nycomed hereby agrees to indemnify,
defend and hold harmless TMC, all Affiliates of TMC and all officers,
directors, employees and agents thereof from all liabilities, claims, damages,
losses, costs, expenses, demands, suits and actions (including without
limitation attorneys’ fees, expenses and settlement costs) (collectively, “Damages”)
arising out of:  (i) Nycomed’s breach of
any of its obligations under this Agreement, the QA Agreements or the
Pharmacovigilance Agreement; or (ii) Nycomed’s making representations or
warranties which are not authorized by TMC hereunder.


 


(b)                                 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 obligations
under this Agreement, the QA Agreements or the Pharmacovigilance Agreement;
(ii) the Product infringing on the intellectual property rights of third parties
or misappropriating any trade secrets of third parties; or (iii) personal
injuries or damages suffered by third parties due to the Product not conforming
to the warranty set forth in Section 18.1 above.


 


(c)                                  In the event a claim is based partially
on an indemnified claim described in Sections 18.3(a) and/or 18.3(b) above and
partially on a non-indemnified claim, or is based partially on a claim
described in Section 18.3(a) above and partially on a claim described in
Section 18.3(b) above, any payments and reasonable 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.


 


(d)                                 The indemnified Party under this Section
18.3 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
shall not accept any settlement 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.


 


(e)                                  In the event that the Product is held in
a suit or proceeding to infringe any intellectual property rights or
misappropriate any trade secrets of a third party and the use of such Product
is enjoined, or TMC reasonably believes that it is likely to be found to
infringe or constitute a misappropriation or likely to be enjoined, then TMC shall,
at its sole cost and


 


22

















 


expense, either (i) procure for Nycomed the right to continue
distributing the Product; or (ii) modify the Product so that it becomes
non-infringing. If TMC determines, in its reasonable discretion, that neither
(i) nor (ii) are commercially practicable, then TMC may terminate this
Agreement upon giving Nycomed ninety (90) days prior written notice.


 


(f)                                    TMC shall have no obligation for any
claim of infringement or misappropriation arising from:  (i) any combination by Nycomed of the Product
with products not supplied or approved in writing by TMC, where such
infringement would not have occurred but for such combination; (ii) the
adaptation or modification of the Product not performed by TMC, where such
infringement would not have occurred but for such adaptation or modification;
(iii) the use of the Product for an Indication for which it was not approved,
where such infringement would not have occurred but for such use; or (iv) a claim
based on intellectual property rights owned by Nycomed or any of its
Affiliates.


 


(g)                                 This Section 18.3 states Nycomed’s sole
remedy and TMC’s exclusive liability in the event that a Product infringes on
the intellectual property rights of, or misappropriates the trade secrets of,
any third party.


 


18.4.                        Insurance.


 


Each Party shall:  (a) maintain public liability insurance
including but not limited to premises/operations, contractual (for contracts
made in the ordinary course of business), personal injury, and independent
contractor liability coverages with a combined single limit of liability of at
least US $6,000,000 per occurrence and an aggregate amount of US $7,000,000 and
written on the so-called “occurrence” form (except that Nycomed’s insurance may
be written on the so-called “claims made” form) and products/completed
operations liability with a combined single limit of liability of at least US
$20,000,000 per occurrence and an aggregate amount of US $20,000,000 and
written on the so-called “claims made” form, such insurance to be provided by
insurer(s) licensed and in good standing in the Territory for Nycomed and in
the United States for TMC; (b) upon reasonable request, provide the other Party
with a properly executed certificate of insurance evidencing this coverage; and
(c) notify the other Party in writing at least ten days in advance of any
cancellation, non-renewal, modification of coverage or exhaustion of limits of
liability for the above required coverages.


 


19.                               LIMITATIONS
ON LIABILITY


 


19.1.                        Limitation on Direct Damages.


 


EXCEPT
AS STATED IN SECTION 18.3(b)(ii) and (iii), TMC’S LIABILITY FOR DAMAGES TO
NYCOMED FOR ANY CAUSE WHATSOEVER UNDER THIS AGREEMENT, REGARDLESS OF THE FORM
OF ANY CLAIM OR ACTION, SHALL NOT EXCEED THE AGGREGATE PRICE PAID TO TMC BY
NYCOMED FOR PRODUCT


 


23

















 


UNDER THE FORMER DISTRIBUTION AGREEMENT OR THIS AGREEMENT, AS
APPLICABLE, DURING THE PRECEDING TWELVE (12) MONTHS.


 


19.2.                        No Indirect Damages.


 


EXCEPT AS STATED IN SECTION 18.3(b)(ii) and (iii), TMC SHALL IN NO
EVENT BE LIABLE FOR ANY LOSS OF PROFITS OR USE OF THE PRODUCT, OR FOR ANY
SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, MULTIPLE OR OTHER INDIRECT
DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE
PRODUCT OR PERFORMANCE OR TERMINATION OF THIS AGREEMENT OR THE QUALITY
AGREEMENTS OR TMC’S FAILURE OR DELAY IN SUPPLYING THE PRODUCT, EVEN IF TMC HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES.


 


19.3.                        Personal Injuries.


 


FOR PERSONAL INJURIES RESULTING FROM THE PRODUCT NOT
CONFORMING TO THE SPECIFICATIONS FOR THE PRODUCT, SECTIONS 19.1 AND 19.2 SHALL
NOT APPLY AND TMC’S LIABILITY SHALL BE IN ACCORDANCE WITH APPLICABLE LAWS AND
REGULATIONS.


 


20.                               TERM
AND TERMINATION


 


20.1.                        Term.


 


Without
prejudice to TMC’s termination rights under Sections 20.2, 20.3 or 20.4 or
Nycomed’s termination rights under Sections 20.3 or 20.4, this Agreement shall
begin on the Effective Date, and this Agreement, along with the QA Agreements
and the Pharmacovigilance Agreement, shall continue until the Transition Date
(as defined in the Transition Agreement).


 


The term of this
Agreement, the QA Agreements and the Pharmacovigilance Agreement may be
extended upon further mutual written agreement of the Parties.


 


20.2.                        TMC’s Additional Termination Rights.


 


Provided
that such termination, and TMC’s or TMC’s designee’s continuation of activities
performed by Nycomed hereunder and thereunder, comply with applicable law, TMC
may terminate this Agreement, the QA Agreements and the Pharmacovigilance
Agreement, or any activities hereunder or thereunder, at any time, on a
country-by-country basis or with respect to this Agreement, the QA Agreements
and the Pharmacovigilance Agreement in their entirety, by providing Nycomed at
least 30 days prior written notice; provided, however, that a
termination by TMC of this Agreement, the QA Agreements and the
Pharmacovigilance 


 


24

















 


Agreement, or any activities hereunder or thereunder, with respect to
Austria shall be deemed to be a termination of this Agreement, the QA
Agreements and the Pharmacovigilance Agreement, or such activities, with
respect to all countries in the Territory. In the event that TMC terminates
some, but not all, activities under this Agreement, the QA Agreements or the
Pharmacovigilance Agreement, the Transfer Percentage will be equitably adjusted
to reflect the reduction in Nycomed’s obligations; provided, however, that, in
the event the Parties are unable to agree upon such adjustment, the provisions
of Section 22 shall apply.


 


20.3.                        Termination for Breach.


 


In the event of a breach
of this Agreement, the QA Agreements or the Pharmacovigilance Agreement by
either Party and such Party’s failure to remedy such breach within 30 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, the QA Agreements and the Pharmacovigilance Agreement
with immediate effect upon written notice to the breaching Party; provided,
however, that such 30 day period shall be reduced to 20 days with
respect to any failure by Nycomed to pay amounts due under this Agreement on
the date when such amounts become due.


 


20.4.                        Termination upon Bankruptcy.


 


This
Agreement, the QA Agreements and the Pharmacovigilance 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 such other Party is incorporated.


 


20.5.                        Payment Obligations Continue.


 


Termination
or expiration of this Agreement, the QA Agreements and the Pharmacovigilance
Agreement shall not result in the reimbursement of non refundable, non
creditable payments or affect the obligation of either Party to pay the other
all amounts owing or to become owing as a result of the Product sold to Nycomed
by TMC on or before the date of such termination or expiration or to pay
reimbursements for expenses as required by this Agreement, the QA Agreements
and the Pharmacovigilance Agreement, as well as (a) interest thereon in
accordance with Section 8.6 of the Transition Agreement to the extent any such
amounts are paid after the date they became or will become due pursuant to this
Agreement and (b) any obligation with respect to the payment or reimbursement
of taxes.


 


25

















 


20.6.                        No Post-Termination Compensation for Loss
of Good Will.


 


Except to the extent
provided in Section 9 of the Transition Agreement:


 


(a)                                  In the event of a termination pursuant to
any of these provisions or upon expiration of this Agreement, TMC shall not
have any obligation to Nycomed, or to any employee, agent, representative or
sub-distributor of Nycomed or its Affiliates, for compensation or for damages
of any kind, whether on account of the loss by Nycomed or such employee, agent,
representative or sub-distributor of present or prospective sales, investments,
compensation or goodwill as a result of termination or expiration in accordance
with the terms of this Agreement, the QA Agreements or the Pharmacovigilance
Agreement.


 


(b)                                 Nycomed, for itself and on behalf of each
of its and its Affiliates’ employees, agents, representatives or Distributors,
hereby waives any rights that may be granted to it or them under the laws and
regulations of the Territory or otherwise which are not granted to it or them
by this Agreement, the QA Agreements or the Pharmacovigilance Agreement.


 


(c)                                  Nycomed hereby indemnifies and holds TMC
harmless from and against any and all claims, costs, damages and liabilities
whatsoever asserted by any employee, agent, 
representative or Distributor of Nycomed or its Affiliates under any
applicable termination, labor, social security or other laws or regulations
other than those for which TMC is obligated to indemnify Nycomed under Section
18.3(b) above.


 


20.7.                        Survival of Terms.


 


Notwithstanding
anything else in this Agreement to the contrary, the Parties agree that
Sections 2.2, 5, 8.1(f), 8.3, 10.4, 11 (with respect to the month and quarter
in which this Agreement expires or terminates), 14.4, 14.5, 15, 16, 18, 19,
20.5, 20.6, 20.7, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 and 31 shall survive
the termination and expiration of this Agreement, as well as 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. In addition, if requested
by TMC, Nycomed shall promptly ship to TMC or TMC’s designee, at TMC’s cost and
expense, all label and packaging materials, upon this Agreement expiring or
being terminated in its entirety. Following expiration or termination of this
Agreement with respect to a country, Nycomed shall promptly notify TMC of any
Adverse Event, notices from Governmental Authorities or other communications
with respect to the Product with respect to such country. Following expiration
or termination of this Agreement with respect to a country, Nycomed shall
immediately transmit to TMC any order for Product with respect to such country
for acceptance or rejection, which acceptance or rejection shall be at TMC’s
sole discretion.


 


26

















 


21.                               COMPLIANCE
WITH LAWS


 


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


 


22.                               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,
the QA Agreements or the Pharmacovigilance 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 10 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 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 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 22 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.


 


27

















 


23.                               AUDIT
AND INSPECTION


 


During the term of this
Agreement, upon reasonable prior notice and during normal business hours and no
more frequently than [**], TMC shall be entitled to audit and inspect at its
cost those relevant records and facilities which are maintained by Nycomed in
direct connection with its performance under this Agreement.


 


For a
period of [**] next following each calendar year, Nycomed shall keep, and shall
cause each of its Affiliates involved with distribution of the Product and each
Distributor to keep, full, true, and accurate books and records containing all
particulars relevant to sales of the Product during such year in sufficient detail
to enable TMC to verify the amounts payable by Nycomed to TMC hereunder. TMC
and its licensors shall have the right, [**] during any calendar year, to have
the books and records of Nycomed related to the sales of Product 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 Nycomed to TMC hereunder. In the
event that an audit shows that Nycomed has 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 pay to
TMC any underpaid compensation promptly, together with interest calculated in
accordance with Section 8.6 of the Transition Agreement, and TMC shall promptly
pay to Nycomed any overpaid compensation.


 


24.                               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.


 


25.                               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


 


28

















 


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.


 


26.                               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.


 


27.                               SEVERABILITY


 


The intention of the
Parties is to comply fully with all laws and public policies, and this
Agreement, the QA Agreements and the Pharmacovigilance 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, the QA Agreements or the Pharmacovigilance 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, the QA Agreements or the Pharmacovigilance 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, the QA Agreements or the Pharmacovigilance Agreement, which
shall remain in full force and effect.


 


28.                               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.


 


29.                               COMPLETE
AGREEMENT


 


This Agreement, the other
Transaction Agreements and the Quality Agreements contain the entire agreement
between the Parties and, except as expressly stated herein or therein, 


 


29

















 


supersedes all prior or contemporaneous discussion, negotiations,
representations, warranties, or agreements, relating to the subject matter of
this Agreement, the other Transaction Agreements and the Quality Agreements. No
changes to this Agreement will be made or be binding on either Party unless
made in writing and signed by each Party.


 


30.                               ASSIGNMENT


 


Subject to Section 2.2,
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) an 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. This Agreement shall inure to the benefit
of the permitted successors and assigns of each Party.


 


31.                               MISCELLANEOUS


 


(a)                                  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.


 


(b)                                 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.


 


(c)                                  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.


 


(d)                                 Affiliates. For the sake of clarity and without limitation to the provisions of
the Transition Agreement, Nycomed shall cause Nycomed Austria GmbH to comply
with the amendments to the Release Agreement herein and Nycomed shall be
responsible for any failure by Nycomed Austria GmbH to do so.


 


[Remainder of Page Intentionally Left Blank]


 


30

















 


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:

  	
    Managing
  Director

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Facsimile: 

  	
    973-401-9541

  	
   

  	
   

  	
  Facsimile:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  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:

  	
   

  	
   

  
																							



 


31

















 


EXHIBIT A


 


Countries
Included in Territory


 


Original Countries
Constituting the Territory


 


•                  The
following countries of the European Union: Austria, Belgium, Denmark, Estonia,
Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania
Luxembourg, Malta, the Netherlands, Poland, the United Kingdom and Sweden; but
not Greece, Portugal and Spain.


•                  Iceland.


•                  Liechtenstein.


•                  Norway.


•                  The
Russian Federation and all other former Soviet Republics (excluding Latvia,
Lithuania and Estonia)


•                  Switzerland.


•                  Turkey


 


Additional
Countries of the Territory


 


The below countries are included in the Territory with
the qualification that prior to registration and launch of the Product in any
of these countries, TMC and NYCOMED shall agree that such actions are
reasonable and advisable from a commercial and intellectual property
perspective:


 


•                  Cyprus;


•                  Czech
Republic;


•                  Slovakia;


•                  Romania;


•                  Bulgaria;


•                  Slovenia;


•                  Croatia;


•                  Bosnia
Herzegovina;


•                  Serbia;


•                  Montenegro;


•                  Macedonia.


 


Notwithstanding
the foregoing, upon termination of this Agreement with respect to a country,
the Territory shall thereafter exclude such country.


 


32

















 


EXHIBIT B


 


Transfer
Price


 


1.                                       New Inventory in General. With respect to the New Inventory sold
to third parties other than Grupo Ferrer, the “Transfer
Price” shall be the applicable Transfer Percentage of the Net Sales
of vials of such New Inventory sold in such calendar quarter.


 


2.                                       Existing Inventory in General. With respect to the Existing Inventory
sold to third parties other than Grupo Ferrer, the “Transfer
Price” shall be the applicable Transfer Percentage of the Net Sales
of vials of such Existing Inventory sold in such calendar quarter, minus
US$[**] per such vial sold.


 


3.                                       Grupo Ferrer.


 


(a)                                  With respect to the Existing Inventory sold
to Grupo Ferrer, the “Transfer Price”
shall be 100% of the Net Sales of vials of such Existing Inventory sold in such
calendar quarter, minus US$[**] per such vial sold.


 


(b)                                 With respect to the New Inventory sold to
Group Ferrer, the “Transfer Price”
shall be 100% of the Net Sales of vials of such New Inventory sold in such
calendar quarter.


 


By way of example:


 


If, with respect to a calendar quarter,
Nycomed or any Distributor sells [**] vials of the Product to third parties
other than Grupo Ferrer, as follows:


 


	
  Number of Vials Sold

  	
   

  	
  Inventory Status of 

  such Vials

  	
   

  	
  Net Sales for such 

  Vials

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  



 


And, given that the amount paid by
Nycomed to TMC for each vial of Existing Inventory pursuant to the Former
Distribution Agreement was US$[**],


 


And if the applicable Transfer Percentage
is [**]%,


 


Then Nycomed shall pay to TMC the
following amounts:


 


	
  Number of Vials 

  Sold

  	
   

  	
  Inventory Status of 

  such Vials

  	
   

  	
  Net Sales for such 

  Vials

  	
   

  	
  Aggregate Transfer Price

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  	
   

  	
  [**]

  



 


33

















 


	
  Number of Vials 

  Sold

  	
   

  	
  Inventory Status of 

  such Vials

  	
   

  	
  Net Sales for such 

  Vials

  	
   

  	
  Aggregate Transfer Price

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  US$[**]

  	
   

  	
  [**]

  
	
  Total Aggregate Transfer Price:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  US$[**]

  



 


34

















 


EXHIBIT C


 


Trademarks


 


(a)                                  TMC trademarks subject to exclusive use by
Nycomed in the Territory:


 


Angiomax®,
Angiox®, Angionax® or any other trademark selected by TMC
for the Product in the Territory


 


(b)                                 TMC trademarks subject to non-exclusive use
by Nycomed in the Territory:


 


The
Medicines Company® (and its logo)


 


REPLACE
HEPARIN, IMPROVE OUTCOMESTM


 


The logo:


 





 


 





 


 





 


35

















 


EXHIBIT D


 


INTENTIONALLY
OMITTED


 


36

















 


EXHIBIT E


 


TMC Marks


 


each of the Trademarks
identified in Exhibit C


 


Hirulog


 


37