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 1 st 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 25 th March, 2002, as amended May 28
th , 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;
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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.
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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.
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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
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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.
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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
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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.
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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.
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(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
Certificat
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