EXHIBIT 10.3
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
SALES, MARKETING AND DISTRIBUTION AGREEMENT
This Agreement is made 25th March 2002 (the "Effective Date") by and
between THE MEDICINES COMPANY, INC., a Delaware corporation having offices at 0
Xxxxxx Xxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 ("TMC") and NYCOMED DANMARK A/S, X.X.
Xxx 00, Xxxxxxxxxx 0 XX-0000 Xxxxxxxx, Xxxxxxx, a company duly organized and
existing under the laws of the Kingdom of Denmark ("Nycomed").
The parties hereunder 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, TMC desires to appoint Nycomed as the exclusive distributor in
the territory outlined in Exhibit A (the "Territory") for the Product and its
Improvements manufactured by TMC described herein and as amended from time to
time (the "Product"), and to sell the Product to Nycomed on the terms and
subject to the conditions described in this Agreement.
Whereas, Nycomed is engaged in the marketing of pharmaceutical products
and has represented to TMC that it has the facilities, personnel, and technical
expertise to promote, market and distribute the Product in all countries of the
Territory. Nycomed desires to accept such appointment as the exclusive
distributor and to promote, market and 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.
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 unintended, unfavorable clinical sign or symptom,
any new illness or disease or deterioration of existing illness or disease or
any clinically relevant
-1-
deterioration in laboratory variables (e.g., hematological, biochemical,
hormonal) or other clinical tests (e.g., ECG, X-ray), whether or not considered
treatment-related.
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. Notwithstanding this definition of control, Oy Leiras Finland
Ab shall be deemed an Affiliate of Nycomed .
1.3 "ANGIOMAX" means Angiomax(TM) 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 Products in the Territory or any part thereof, including
primarily, but without limitation, authorizations of medicinal products for
human use and approval of related labels and packaging, as well as pricing and
social health system reimbursement approvals.
1.5 "AVERAGE NET UNIT SELLING PRICE" means the sum of Nycomed's calendar quarter
Net Sales pursuant to this Agreement divided by such calendar quarter's number
of units sold by Nycomed pursuant to this Agreement (but in respect of such
units sold, excluding units which have been returned, rejected or reimbursed
because of defects).
1.6 "CHEMILOG" means bivalirudin drug substance manufactured according to UCB
Bioproducts SA process SF220, as defined in UCB bioproducts quality documents.
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 promotion, marketing, sales and customer service 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 "EMEA" means the European Agency for the Evaluation of Medicinal Products.
-2-
1.11 "FIRM ORDERS" means orders received from Nycomed and accepted by TMC in
writing for the purchase of Product.
1.12 "FIRST APPROVAL DATE" means the first date on which the Product is eligible
for sale in one or more countries of the Territory based on receipt of all
necessary Approvals from Government Authorities of one or more countries of the
Territory.
1.13 "FIRST LAUNCH DATE" means the date of Launch of the Initial Indication(s)
in any country of the Territory.
1.14 "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.
1.15 "GROSS SALES" means gross invoices on sales of the Product by Nycomed and
its Affiliates and Distributors to third parties.
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 Product as part of an Approval for the Product.
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 "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.
1.20 "MINIMUM TRANSFER PRICE", means the minimum price for purchase of the
Product by Nycomed, calculated in accordance with Exhibit B hereto.
1.21 "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) [**]; (ii) [**]; (iii) [**]; (iv) [**]; (v)
[**],
-3-
; and (vi) [**] 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 promotional
purposes, provided such transfer, distribution or disposition is not made in
exchange for lower 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 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.
1.22 "NON-REQUIRED TRIALS" means Product trials other than those trials required
to secure Approval for an Indication.
-4-
1.23 "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, as further identified
in Exhibit F hereto.
1.24 "PCI" means percutaneous coronary intervention.
1.25 "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).
1.26 "PRODUCT CONFIGURATION" means and includes any modifications to the package
insert, labeling, or packaging of the Product required by Government
Authority(s) of one or more countries of the Territory.
1.27 "PRODUCTION VOLUME DISCOUNT" shall have the meaning ascribed to it in
Exhibit B attached hereto.
1.28 "PTCA" means percutaneous coronary transluminal angioplasty.
1.29 "SERIOUS ADVERSE EVENT" means (i) an Adverse Event that at any dose,
results in death or is life-threatening, as well any Adverse Event that results
in persistent or significant disability/incapacity or requires in-patient
hospitalization or prolongs hospitalization, or (ii) any medically significant
event that, based upon appropriate medical judgment, may jeopardize the patient
and may require medical or surgical intervention.
1.30 "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 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.
1.31 "TMC-UK" means The Medicines Company of the United Kingdom, a limited
liability corporation located at Xxxxxx Court 0 Xxxx Xxx, Xxxxxx, Xxxxxx, Xxxxxx
Xxxxxxx XX0 OSZ or such other EU incorporated entity of TMC which TMC may
designate.
-5-
1.32 "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.
1.33 "UNIT", for the purpose of calculating the Average Net Unit Selling Price,
the Transfer Price and the Minimum Transfer Price, shall mean the metric
milligram (mg.).
1.34 "WAC" shall mean the U.S. Wholesale Acquisition Cost, as listed in the US
Red Book for hospital injectables.
STATEMENT OF AGREEMENT
In consideration of the mutual agreements set forth herein, TMC and
Nycomed hereby agree as follows:
2. APPOINTMENT OF NYCOMED
2.1 Appointment, General Diligence.
TMC hereby appoints Nycomed as the exclusive distributor of the Product
and any Improvements in the Territory for any and all Indications (whether or
not currently existing or planned) during the term of this Agreement and Nycomed
hereby accepts such appointment subject to the terms and conditions described in
this Agreement. In addition to the specific requirements of Articles 6 and 11
below, Nycomed shall promote and market the Product with no less effort than it
customarily applies in promoting and marketing other products in the Territory.
Nycomed shall have the right to appoint its Affiliates and other third parties
as subdistributors of the Product in the Territory.
2.2 Distribution Boundaries.
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) advertise or promote the
Product to potential buyers located outside the Territory, or in any language,
other than an official language of the Territory.
Particularly, Nycomed is cognizant of and recognizes the exclusive
distribution rights granted by TMC to Grupo Xxxxxx Internacional S.A. for Spain,
Portugal and Greece and for certain countries within Central and South America.
If Nycomed receives an order for, or inquiry concerning the Product from a
potential customer located outside the Territory and outside the EEA, and unless
such customer intends to resell the products within the EEA, Nycomed shall
immediately refer such order or inquiry to TMC.
-6-
2.3 Non-Competition.
During the term of this Agreement, or any renewals, 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 (5) years
after the First Launch Date. During the term of this Agreement, or any renewals,
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 2.3 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. MILESTONES
3.1. Distributor Fee
Upon execution of this Agreement, Nycomed shall (a) pay to TMC a non
refundable, non creditable distributor fee of Xxx Xxxxxxx Xxxx Xxxxxxx Xxxxxxxx
Xxxxxx Xxxxxx Dollars (US$1,500,000); and (b) purchase from TMC for an aggregate
purchase price of US$1,000,000 a number of shares of common stock of TMC
determined by dividing US$1,000,000 by the average closing sales price of TMC's
common stock as reported on the Nasdaq National Market for the ten trading days
ending on the date five trading days prior to the Effective Date. In connection
with such purchase of shares, Nycomed will execute an investment representation
letter in the form attached as Exhibit D.
3.2. Approval Milestones
(a) Nycomed shall pay an additional non refundable, non creditable fee
to TMC in the amount of Xxx Xxxxxxx Xxxx Xxxxxxx Xxxxxxxx Xxxxxx
Xxxxxx Dollars (US$2,500,000) upon approval of the PCI indication by
any European Regulatory Agency. In the case of a centralized
application in respect of the Product, approval shall include the
receipt of a positive opinion from the Committee for Proprietary
Medicinal Products ("CPMP').
(b) If the fee described in Section 3.2 (a) above has not yet become
payable to TMC, then upon approval of the PTCA indication by any
European Regulatory Agency,
-7-
Nycomed shall pay an additional non refundable, non creditable fee
(beyond the milestone described in Section 3.2(a) above) to TMC in
the amount of Xxx Xxxxxxx Xxxx Xxxxxxx Xxxxxxxx Xxxxxx Xxxxxx
Dollars (US$1,500,000). In the case of a centralised application in
respect of the Product, approval shall include the receipt of a
positive opinion from the CPMP. For the sake of clarification,
Nycomed shall be required to pay one fee, as described in Sections
3.2(a) or (b) hereof, but shall not in any event be required to pay
both of those fees.
(c) If either of the Approvals described in Sections 3.2(a) or (b) above
is delayed beyond June 30, 2004, the amount payable to TMC upon the
occurrence of such Approval shall be reduced by [**] percent (
[**]%) for each six month (6) period which elapses between June 30,
2004 and such Approval. A reduction shall also be given, on a
pro-rated basis, for periods of less than six months which elapse
between June 30, 2004 and such Approval. By way of example, if the
Approval for the PCI Indication by a European Regulatory Agency is
delayed until March 31, 2005 (nine months after June 30, 2004), then
the fee described in Section 3.2(a) above shall be reduced by $
[**], calculated as follows: [**]% for the first six months and
[**]% for the remaining portion of the delay (which is one-half of a
second six (6) month period).
4. PRODUCT OPTIMIZATION COMMITTEE
4.1 Role of Product Optimization Committee Generally.
The Parties shall establish a Product Optimization Committee ("POC") no
later than sixty (60) days following the Effective Date. The POC shall consist
of four (4) voting members, comprising two (2) representatives of TMC and two
(2) representatives of Nycomed. The POC shall have two co-chairs, one from each
Party. TMC's appointees to the POC shall be determined by TMC. Nycomed's
appointees to the POC shall be determined by Nycomed and shall include
appropriate representation from its commercial organization. The POC shall meet
at least three (3) months prior to the beginning of each calendar year at such
time and place as mutually agreed upon by the Parties, and at such other dates
as may be agreed upon by the Parties. Should the Parties mutually agree to do
so, additional, non-voting members may be appointed to the POC and operating
subcommittees and project teams may be appointed by and report to the POC.
The primary responsibility of the POC is to provide unified strategic and
operating direction to the operating teams within TMC and Nycomed in a way that
optimizes the value of the Product and maintains brand consistency for the
Product in the Territory that is not in conflict with TMC's global
commercialization strategy for the Product in accordance with Section 12. The
POC shall also serve as a consensus-based decision-making unit of first resort
with regard to the commercialization of the Product in the Territory. The POC
shall be responsible for, among other things:
-8-
a) Working with TMC to determine the optimal clinical strategy for the
Product within the Territory, and where appropriate, how these
efforts will be initiated and funded within the Territory
b) Determining Product plans and establishing strategies for obtaining
Approvals as well as marketing and selling the Product for new and
approved Indications in Territory
c) Managing and directing operating subcommittees and project teams
appointed by the POC
d) Working with TMC and Nycomed to ensure that TMC can take full
advantage of and leverage the expertise and contacts that Nycomed
has in the EEA and other European countries, in order to facilitate
and expedite obtaining Approvals of the Product in the EEA and those
other countries
e) Monitoring TMC's compliance with rules, regulations and laws
applicable to the manufacture of the Product, based on periodic
information provided by TMC
In the event that a consensus decision cannot be reached by the POC, TMC
shall have final authority for decisions with respect to the development of the
Product for new Indications, Product trials, manufacturing and supply of the
Product and Approvals, and Nycomed shall have final authority for decisions with
respect to marketing and selling of the Product within the Territory, provided
Nycomed's decisions (other than in respect of pricing, which shall be at
Nycomed's entire discretion) are not in conflict with TMC's global
commercialization strategy for the Product. For the sake of clarification,
forecasts shall be provided by Nycomed, and shall not require any decision by
the POC.
4.2 Advisory Boards.
For the purpose of maximizing the medical community's knowledge and
awareness of the Product, if TMC maintains a European advisory board for the
Product, the members and meetings of such board shall be accessible to Nycomed's
personnel, and if Nycomed develops national or regional advisory boards for the
Product, the members and meetings of such boards shall be accessible to TMC's
personnel. Each Party's participation in any such boards shall be subject to the
confidentiality procedures imposed on other members of such boards.
4.3 Clinical Development.
(a) The POC shall create a joint clinical plan for the Product in the
Territory. For all Product trials included in that plan, the Parties shall share
the cost of conducting such trials based on where each trial is conducted (e.g.,
Nycomed paying in full for trials conducted in the Territory and TMC paying in
full for trials conducted outside the Territory); provided, however,
-9-
that (i) Nycomed shall not be required to pay for trials which are conducted
without a consensus decision of the POC; and (ii) if any such trial for which
Nycomed does not pay results in Approval of a new Indication, then within ninety
(90) days after receiving notice of such Approval, Nycomed shall pay TMC an
amount equal to (x) the amount which Nycomed would have paid for such trial if
the POC had reached a consensus, multiplied by (y) 1.125.
(b) Trials currently under consideration are ACS, CABG off pump and
HITS/CABG.
(c) Notwithstanding Section 4.3(a) above, TMC shall be fully responsible
for funding the costs of conducting the current REPLACE II trial and any
follow-up commitments which TMC undertakes as a condition to obtaining Approval
from CPMP for the Initial Indication of the Product. Data generated from such
trial may be used by Nycomed without charge in connection with obtaining
Approvals for countries in the Territory which are not members of the EEA.
4.4 Non-Required Trials.
Nycomed may from time to time propose Non-Required Trials to be conducted
in the Territory. The POC shall discuss the structure of Non-Required Trials to
be conducted in the Territory to expand approved Indications of the Product or
to provide data supporting usage of the Product in the market. Prior to
conducting any clinical evaluation of the Product, Nycomed shall furnish to all
members of the POC the protocols for such evaluation written in the English
language. TMC shall have final approval for Non-Required Trials. If approved by
the POC, Non-Required Trials will be conducted at Nycomed's expense. Results
from any such clinical evaluation shall not be publicly disclosed without TMC's
prior written approval, such approval not to be unreasonably withheld.
5. REGULATORY AUTHORIZATIONS AND REGULATORY COMPLIANCE
5.1. Approvals within the EEA
To the extent allowable by law, TMC-UK or its designated agent, at its own
expense, will have primary responsibility for obtaining and maintaining all
Approvals of the Product within the EEA. TMC-UK shall register the Product under
TMC-UK's name or when required by law, the names of Nycomed, its agents and/or
Distributors.
TMC-UK shall prepare applications, make submissions in the EEA, and
conduct negotiations with Governmental Authority(s) regarding Approvals.
TMC-UK may require Nycomed to provide assistance to TMC-UK in the Approval
process for one or more countries of the Territory within the EEA.
-10-
TMC-UK will determine whether a centralized filing through the EMEA or
filings through the principle of mutual recognition of national authorizations
is optimal for the Product.
5.2. Approvals outside the EEA.
Nycomed, at its own expense, will be responsible for obtaining and
maintaining all Approvals of the Product within the Territory, but outside of
the EEA.
The Parties will jointly determine, through the POC, the appropriate legal
and regulatory approval plan to gain Approvals of the Product in such countries.
5..3 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. MINIMUM ANNUAL PURCHASES
6.1 The required minimum purchases Nycomed must make from TMC (the "Minimum
Purchases") shall be defined as follows:
By Specified Anniversary of First Approval Date Minimum Purchases
----------------------------------------------- -----------------
First US$ [**]
Second US$ [**]
Third US$ [**]
In the event that Nycomed from time to time exercises its option under Section
12 or 20.2(b) below to terminate this Agreement with respect to any of Germany,
France, Italy or the United Kingdom, then the Minimum Purchases stated above
shall be decreased by the following percentages, depending on which country or
countries have been terminated: (a) Germany [**]%; (b) France [**]%; (c) Italy
[**]%; and (d) the United Kingdom [**]%.
All purchases by Nycomed from TMC shall be counted towards these Minimum
Purchase targets, regardless of the country in the Territory for which Nycomed
makes those purchases.
For each year subsequent to the third anniversary of the First Approval
Date, the POC shall set a new Minimum Purchase target. Such target shall be set
no later than sixty (60) days prior to the beginning of each such year. If the
POC does not set such target for any year (measured from the First Approval
Date) by such date, then (i) the Minimum Purchase target shall be US$ [**] for
the fourth (4th) year; (ii) the Minimum Purchase target shall be US$ [**]
-11-
for the fifth (5th) year; and (iii) thereafter, the Minimum Purchase target
shall be equal to the greater of: (A) US$ [**]; or (B) [**] percent ( [**]%) of
the actual purchases of the Product by Nycomed from TMC during the immediately
preceding year.
6.2. If Nycomed does not achieve the required Minimum Purchases for any one year
period, then:
(a) in the first instance, Nycomed shall, at its election, within sixty
(60) days after the end of such year, either purchase or make a cash
payment for a sufficient amount of Product at the then-current
Minimum Transfer Price so as to satisfy such requirement. If Nycomed
does not make such purchases or cash payment by the end of such
sixty (60) day period, TMC shall have the option to terminate this
Agreement with written notice to Nycomed, effective immediately;
(b) in the second instance, Nycomed shall, at its election, within sixty
(60) days after the end of such year, either purchase or make a cash
payment for a sufficient amount of Product at the then-current
Minimum Transfer Price so as to satisfy such requirement. If Nycomed
does not make such purchases or cash payment by the end of such
sixty (60) day period, TMC shall have the option to terminate this
Agreement with written notice to Nycomed, effective immediately; and
(c) in the third instance, Nycomed shall within sixty (60) days after
the end of such year, purchase a sufficient amount of Product at the
then-current Minimum Transfer Price so as to satisfy such
requirement. If Nycomed does not make such purchases by the end of
such sixty (60) day period, TMC shall have the option to terminate
this Agreement with written notice to Nycomed, effective
immediately. If Nycomed make such purchases by the end of such sixty
(60) day period, TMC shall have the option to convert Nycomed's
rights hereunder from exclusive to non-exclusive rights.
6.3 If after Nycomed's rights hereunder have been converted from exclusive to
non-exclusive rights in accordance with Section 6.2(c) above, Nycomed does not
achieve the required Minimum Purchases for any subsequent one year period, then
TMC shall have the option to terminate this Agreement with written notice to
Nycomed, effective immediately.
6.4. For the sake of clarification, Nycomed shall not be deemed to have failed
to achieve the required Minimum Purchases for any one-year period, for the
purposes of Section 6.2 above, if Firm Orders (as per Articles 7 and 8
hereunder) are sufficient for Nycomed to achieve the required Minimum Purchases
but the required Minimum Purchases are not achieved as a result of Product
supply limitations (including both non-delivery of ordered Product as well as
delivery of non-conforming Product which must be replaced). In the event that
TMC delivers less than [**]% of the volumes of the Product covered by Firm
Orders forecasted by Nycomed, then the one-year period in question shall be
measured from the date on which those Product supply limitations are resolved
and the required Minimum Purchases for such one-year period shall be
-12-
deemed to be reduced by a percentage of what the required Minimum Purchases
would have been for such one-year period pursuant to Section 6.1 above and each
subsequent one-year period pursuant to Section 6.1 above until Nycomed
reestablishes the weighted (that is -- Germany [**]%; France [**]%; Italy [**]%;
and the United Kingdom [**]%.) average of the market shares of the Product in
Germany, France, Italy and the United Kingdom for the full calendar quarter
immediately preceding the commencement of any such supply limitation. Such
percentage reduction shall be equal to the weighted (that is -- Germany [**]%;
France [**]%; Italy [**]%; and the United Kingdom [**]%.) average reduction in
market share of the Product in Germany, France, Italy and the United Kingdom, if
any. For purposes of determining market share, IMS data (or equivalent data
where IMS data is not available) of the full calendar quarter immediately
preceding the commencement of any such supply limitation shall be compared with
IMS data (or equivalent data where IMS data is not available) for the first full
calendar quarter immediately following the resolution of such supply limitation.
By way of example, if the market share of the Product in Germany is reduced from
[**]% to [**]% for the relevant quarters, it shall be deemed to be a [**]%
reduction in market share, for the purposes of computing the German portion of
the above weighted average. Once Nycomed re-establishes the weighted average of
the market shares of the Product in Germany, France, Italy and the United
Kingdom. as described above, the POC (or failing agreement, the Presidents of
the Parties) shall meet and agree on revised required Minimum Purchases for
subsequent years. Until the POC or the Parties reach such an agreement, the
immediately preceding one-year period's Minimum Purchases (as adjusted pursuant
to this Section 6.4) shall continue to apply.
7. FORECASTS
Nycomed shall provide TMC with a twenty four (24) month Product forecast
no later than six (6) months prior to the anticipated First Launch Date and
shall thereafter update such forecast on a rolling quarterly basis. The rolling
forecasts are to be broken down to single months. Nycomed shall use its
reasonable commercial efforts to provide accurate forecasts to TMC.
The first six (6) months of each forecast (months 1 through 6) are Firm
Orders and cannot be changed, by subsequent forecasts or otherwise.
The forecast for the remaining months (months 7 through 24) is not
binding.
8. PLACING ORDERS AND SUPPLY
8.1 Increases in Firm Orders.
TMC shall use commercially reasonable efforts to deliver Product covered
by Firm Orders. TMC shall make every reasonable effort to comply with unplanned
increases in Firm Orders, but shall not be held liable for its inability to do
so. In each Firm Order for any month,
-13-
Nycomed shall state, after consultation with TMC, a reasonable delivery schedule
for Product to be delivered in that month.
8.2 Quantities.
Product shall be provided to Nycomed by TMC and shall be ordered by
Nycomed in 250 mg naked (unlabelled) vials. Naked vials shall be shipped to an
agreed location in the European Union or Norway. 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. Subsequent to further negotiations and approval, TMC may designate
Nycomed to act in this capacity; provided, however, that TMC also reserves the
right to designate other third parties as appropriate.
Nycomed shall be responsible for: (a) the shipping and insurance costs
incurred in connection with transporting the Product from TMC's fill point to
the agreed location in the European Union or Norway; and (b) the labeling and
packaging costs of vials of Product, which shall be prepared by Nycomed in a
manner consistent with the provisions of this Agreement, and applicable
Territory laws and regulations.
8.3 Product Packaging, Product Configuration and Destination Instructions
The Product will be supplied as a sterile lyophilized formulation in 10 xx
xxxxx vials containing material that, when reconstituted, will deliver 250mg of
bivalirudin per 5ml. Each 250mg vial constitutes a single unit of Product.
Nycomed will be responsible for the Product Configuration. TMC shall approve all
labeling and package insert proofs prior to their use.
TMC shall not be obligated to fulfill any Product Configuration request
for less than [**] vials.
8.4 Cancellations, Cutbacks, No Liability.
The terms and conditions set forth in this Agreement shall apply to all
purchases of Product 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. Nycomed shall not
change or cancel an order without the prior written consent of TMC.
If the Products are in limited supply or otherwise unavailable in the
quantities requested by Nycomed, TMC will make its reasonable efforts to supply
Nycomed. Specifically, TMC
-14-
shall allocate the available supply of Product among TMC, Nycomed and other TMC
distributors in proportion to the relative shares of TMC's supply of Product
resold by TMC itself or purchased by Nycomed and those other distributors during
the immediately preceding twelve (12) month period. TMC shall not be liable to
Nycomed for any losses or damages arising from TMC's inability to fill or accept
any Firm Order as originally scheduled.
9. DELIVERY AND ACCEPTANCE
9.1 Delivery.
Except as set forth below, all Firm Orders shall be delivered FCA
(INCOTERMS 2000) TMC's designated filling location(s). TMC shall only be
required to deliver Product to Nycomed once in each month, with a [**]unit
minimum delivery quantity. With respect to Firm Orders, lead time for the first
delivery of the Product shall be three (3) months, and lead time for subsequent
deliveries shall be one (1) month. TMC reserves the right to defer delivery of
Product to Nycomed until Nycomed's cumulative Firm Orders for such Product
Configuration exceed [**] units. Unless Nycomed requests otherwise, all Firm
Orders shall be packed for shipment and storage in accordance with TMC's
standard commercial practices. All Product delivered by TMC at the FCA
(INCOTERMS 2000) point shall have a minimum expiry of [**] percent ( [**]%) of
its approved shelf life in the EEA, as measured from the date of delivery. The
aforementioned term shall be proportionally increased from time to time in
accordance with improved stability data. It is Nycomed 's obligation to notify
TMC of any special packaging requirements (which shall be at Nycomed 's
expense). TMC shall provide Certificates of Analysis for each lot of Product
delivered to Nycomed to demonstrate that such lot was tested and released prior
to delivery. Full batch documentation, including batch production records and
manufacturing and analytical records, shall be available for review by Nycomed.
TMC shall deliver Product into the possession of a common carrier designated by
Nycomed, on the relevant Firm Order for such Product. If Nycomed does not
designate a common carrier before the delivery date indicated on a Firm Order,
then TMC may designate a common carrier on behalf of Nycomed. Title, risk of
loss and damage to a Product shall pass to Nycomed upon such Product's removal
from TMC's designated filling location.
The Parties shall enter into a separate technical agreement within thirty
(30) days after the Effective Date.
TMC shall be entitled to withhold delivery of any unpaid Firm Order if
either (i) payment is overdue for any Firm Order, or (ii) TMC has objective
reasons for fearing that Nycomed might not be able to pay for the Products
delivered or to be delivered.
9.2 Acceptance.
Nycomed shall have thirty (30) days from receipt at the designated
location in the European Union to examine such Product. Nycomed shall promptly
notify TMC of short
-15-
shipments or any visually defective Product and shall return to or otherwise
dispose of any defective shipments in accordance with TMC's instructions, at
TMC's cost and expense. TMC shall provide for replacement delivery within one
(1) month from existing production stock, if available, and if not available,
within three (3) months therefrom. Such replacement shall be Nycomed 's sole and
exclusive remedy with respect to short shipments and visually defective Product
delivered by TMC hereunder. Such limitations will not apply in case of latent
defects.
10. FEES AND PAYMENT AMOUNTS
10.1 Transfer Price.
a) For each quantity of Product sold by Nycomed, Nycomed shall pay TMC
the transfer price for such quantity as calculated according to
Exhibit B attached hereto.
b) The Average Net Unit Selling Price and Net Sales for each calendar
quarter shall be calculated by Nycomed at the end of such quarter
and shall be reported by Nycomed to TMC within five (5) working days
after the end of each such calendar quarter. If any Net Sales are
stated in a currency other than United States Dollars during such
quarter, then, for the purpose of calculating the Average Net Unit
Selling 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 (that is - a day on which
banks are open in Frankfurt) of such calendar quarter. If no such
exchange rate has been quoted in the European Central Bank in
Frankfurt at any time during the twelve (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.
c) Notwithstanding anything in this Agreement to the contrary, TMC's
Transfer Price from the First Launch Date until the end of the
then-current calendar quarter shall be at US$ [**] per unit.
d) Within forty-five (45) days after the end of each calendar year, TMC
and Nycomed shall compute any Production Volume Discounts earned by
Nycomed during such calendar year, in accordance with Exhibit B
attached hereto. TMC will within forty-five (45) days after the end
of such calendar year make a payment to Nycomed to reflect the
amount of the Production Volume Discount earned by Nycomed during
such calendar year.
-16-
10.2 Payment Form.
All payments between the Parties shall be in US Dollars. Taxes now or
hereafter imposed with respect to the transactions contemplated 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, 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. Notwithstanding the
foregoing, 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 credit to Nycomed any withholding tax TMC recovers through a foreign tax
credit that TMC actually uses to reduce its US 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 Payment Dates; Interest on Overdue Amounts.
Nycomed shall pay TMC's invoices for the Product as follows: (a) within
sixty (60) days after receiving such invoice, the Minimum Transfer Price; and
(b) within twenty (20) working days after the end of each calendar quarter, the
amount, if any, by which the Transfer Price described in Exhibit B attached
hereto exceeds such Minimum Transfer Price; provided, however, that with respect
to the twelve (12) month period immediately following the First Launch Date, (i)
US$ [**] per unit shall be due within forty-five (45) days after Nycomed
receives TMC's invoice; and (ii) the balance of the Transfer Price per unit
(including without limitation the amount, if any, by which the Transfer Price
described in Exhibit B attached hereto exceeds such Minimum Transfer Price)
shall be due within ninety (90) days after Nycomed receives TMC's invoice.
Additionally, all payments due under this Article 10 but not paid when due shall
bear interest which is the lesser of: (i) the rate of Citibank N.A.'s prime rate
plus 2% per annum or (ii) the maximum lawful interest rate permitted under
applicable law. Such interest shall accrue on the balance of unpaid amounts from
time to time outstanding from the date on which portions of such amounts become
due and owing until payment thereof in full.
10.4. Responsibilities for Expenses.
(a) TMC shall be responsible for: (i) the cost of bulk material; (ii) 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; (iii) fill costs (excluding labeling and packaging
costs); (iv) regulatory filing and maintenance costs within the EEA, including
release testing required pursuant to the Approvals for the EEA (excluding
country-specific local testing); and (v) its own incidental costs in assisting
Nycomed in obtaining Approval outside the EEA.
-17-
(b) Nycomed shall be responsible for: (i) any third party payment
obligations (including without limitation fees associated with obtaining
Approval in countries in the Territory which are not members of the EEA, customs
clearance and, if necessary, local release testing for Product) incurred by
Nycomed in connection with distributing and marketing the Product in any country
in the Territory; (ii) sales, marketing, labeling and packaging costs; (iii) its
own incidental costs in assisting TMC in obtaining Approvals for countries which
are members of the EEA; and (iv) regulatory filing and maintenance costs for
countries in the Territory which are not members of the EEA.
11. MARKETING/PROMOTION RIGHTS AND RESPONSIBILITIES/REPORTING
11.1 Pre-Launch.
Nycomed shall assume all pre-launch marketing responsibility and
expenditures with regard to the Product in the Territory. On or before an
Approval is obtained from the EMEA for the Product with respect to any
Indication, Nycomed shall have in place either an Affiliate or Distributor in
Norway and in each member country of the European Union which is included in the
Territory.
11.2 Cooperation
Each Party shall cause its product manager for the Product to cooperate
and share information (including without limitation Product-related market
research) with the other Party during the development of Product-level planning,
positioning and marketing strategies.
11.3. Promotional Materials
(a) Nycomed shall be responsible for creating all promotional materials
for the Product, including, but not limited to sales materials. All
such materials shall be in keeping with local laws and regulations
and the Approval requirements regarding Product documentation and
subject to TMC's prior written approval and shall be submitted to
TMC in English and in the intended language for its review at least
twenty (30) days prior to the proposed first use of such materials.
Materials shall be deemed approved if no objection is received
within ten (10) days after its submission by Nycomed to TMC.
(b) TMC shall make its U.S. marketing materials available to Nycomed.
Nycomed shall not use any adaptation of such marketing materials
without TMC's prior written approval of such adaptations.
-18-
11.4. Press Releases.
Any press release regarding the Product which Nycomed desires to release
shall be submitted to TMC for review prior to the proposed release date. The
release of such information is subject to the prior written consent of TMC,
which consent shall not be unreasonably withheld. Press releases will be deemed
approved if no objection is received within five (5) days after its submission
by Nycomed to TMC.
11.5 INTENTIONALLY OMITTED.
11.6 INTENTIONALLY OMITTED
11.7. Business Reporting by Nycomed.
Nycomed agrees to submit a written report to TMC for each calendar
quarter, within thirty (30) days after the end of such quarter (except that
information on Net Sales and Average Net Unit Selling Price shall be provided on
or before the fifth working day after the end of such quarter). Such quarterly
reports shall begin no later than ninety (90) days from the First Launch Date.
Such reports shall include information, on a country-by-country basis,
with respect to the units of the Product sold and Gross Sales, Net Sales and
Average Net Unit Selling Price (and the calculation thereof) for such units, and
in addition:
(a) Market shares of the Product for the Territory, when and where
available;
(b) Nycomed developed and/or commissioned market research on the
Product, if any, information on any markets Nycomed currently
operates in or is considering operating in and plans concerning all
publication and medical education activities; and
(c) A breakdown of marketing and sales resources and costs expended by
Nycomed for Germany, France, Italy, the United Kingdom and other
countries designated by the POC vs. Nycomed's marketing plan as
outlined in Article 12.
11.8. TMC Reporting Obligations.
TMC agrees to update Nycomed within thirty (30) days after the end of each
calendar quarter with regard to:
(a) Changes to planned publication activities;
(b) Manufacturing ordering status for the Product, and any anticipated
supply problems or delays;
-19-
(c) Clinical trials' status;
(d) Study reports;
(e) Regulatory status in the EEA;
(f) Product stability; and
(g) Preclinical reports.
12. NYCOMED'S COMMERCIAL CAMPAIGN
Subject to TMC's timely delivery of Product, Nycomed shall use its
commercially reasonable efforts consistent with standard practices of an
international pharmaceutical company to advertise, actively promote the sale of
and sell the Product in each country in the Territory. Should Nycomed not Launch
the Product in any member of the EEA within [**] years after the First Launch
Date for any reason (including without limitation lack of required Approvals in
such country) or should Nycomed not file for Approval in any country in the
Territory which is outside the EEA within [**] after the First Launch Date or,
after obtaining such an Approval in a country, not Launch the Product in such
country within [**] after receiving such Approval, then TMC shall have the
option to terminate this Agreement, effective immediately, with all rights
granted to Nycomed hereunder for such country reverting to TMC; provided,
however, if a centralized application in respect of the Product is not filed
with the EMEA, then the Parties shall in good faith agree upon an appropriate
extension to the [**] year period discussed above. Notwithstanding anything
else in this Article 12 to the contrary, Nycomed shall not be obligated to
continue to market or distribute the Product in any country of the Territory
(and Nycomed shall have the option to terminate this Agreement with respect to
such country, effective immediately, with all rights granted to Nycomed
hereunder for such country reverting to TMC) in which Nycomed's actual realized
gross profit from such marketing and distribution efforts is equal to or less
than: (a) [**] percent ( [**]%), based on Net Sales in such country; or (b) US$
[**] vial. Nycomed, through the POC, shall furnish TMC with a detailed
marketing plan with respect to the Product, six (6) months before the First
Launch Date and three (3) months prior to the beginning of each calendar year
thereafter.
TMC shall have the right to audit the books and records of Nycomed, its
Distributors and its Affiliates that market the product, in order to confirm
that Nycomed has made these required efforts.
13. COLLECTION OF INFORMATION ON ADVERSE AND SERIOUS ADVERSE EVENTS/REPORTING ON
MEDICAL SAFETY/ RECALLS.
13.1 Nycomed's Obligations regarding Regulatory Reporting ("Pharmacovigilance").
-20-
To the extent permitted by 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 Government Authorities or regulations.
Nycomed shall not submit Adverse Event or safety reports to Government
Authorities without first consulting TMC's designated drug surveillance and
information contact.
The Parties shall enter into a separate Pharmacovigilance agreement within
thirty (30) days after the Effective Date.
13.2. Cooperation/Procedures.
TMC shall also be responsible for maintaining a central Adverse
Event/medical safety database for the Product. The Parties shall cooperate
towards establishing and maintaining such database. Reports based on this
database will be made available to Nycomed during the term of the Agreement, as
necessary, to meet the requirements of Government Authorities in the Territory.
Without limiting the generality of the foregoing, Nycomed and TMC shall work
together to develop standard operating procedures for exchange of information
concerning Adverse Events and Product safety information derived from Product
use in the Territory and each Party shall at all times comply with the
procedures developed.
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 technical agreement between the Parties. 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
Products recalled to Nycomed at the Transfer Price paid by Nycomed for such
Products.
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 for display,
advertising, labeling and packaging purposes in connection with marketing,
selling and distributing the Product 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
-21-
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. 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 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 (and TMC hereby
approves Nycomed's use of the Trademarks in correspondence with health care
providers in its ordinary course of business pursuant to this Agreement); (iii)
provide, at TMC's request, reasonable quantities of samples of advertisements
and other promotional 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 Promotion on Internet.
Nycomed shall not engage in active sales of the Product outside the
Territory via the Internet and TMC shall not engage in active sales of the
Product in the Territory. 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;
(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;
-22-
(e) the use on the Internet of any other package of the Product than the
packages of the Product for the Territory.
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" 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" 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 TMC's Marks or any Marks that are
confusingly similar to any of the words "Angiomax" or "The Medicines Company" or
TMC's 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" or "The
Medicines Company" or any of TMC's 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" or "The Medicines Company", any of TMC's Marks or
any variation thereof as a meta-tag or invisible text or on any unused frame or
bridge page, (B) purchase "Angiomax" or "The Medicines Company", any of TMC's
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 Article 14, and 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 will defend and maintain at its cost the Patents in the Territory on
the Product. At TMC's cost, TMC shall file patent extension applications and
prosecute and maintain all such extensions for those countries in the Territory
and in Spain, Portugal and Greece identified by Nycomed at least forty-five (45)
days prior to the date that such extensions must be filed. If TMC does not take
appropriate actions against any infringement or threatened infringement by a
third party of the Patents, within ninety (90) days of Nycomed's request to do
so, Nycomed will have the right to institute such proceedings at its own cost
and expense. All damages, including
-23-
interest, profits and other recoveries awarded to the prosecuting party shall be
retained by such party.
16. NO RIGHTS BY IMPLICATION
No rights or licenses with respect to the Product or the Trademarks are
granted or deemed granted hereunder or in connection herewith, other than those
rights expressly granted in this Agreement.
17. CONFIDENTIAL INFORMATION
17.1 Obligations to Keep Confidential and Not Use.
In connection with the ongoing business relationship between TMC and
Nycomed, each Party (the "receiving Party") may gain access to proprietary
information of the other Party (the "disclosing Party"), which may be considered
confidential by the disclosing Party ("Confidential Information"). The receiving
Party shall: (a) disclose Confidential Information of the disclosing Party only
to the agents and employees of the Receiving Party, its Affiliates and its
Distributors who have a reasonable need to know such information in order to
perform their duties hereunder, and (b) shall not use such Confidential
Information except in connection with performing its duties and exercising its
rights hereunder. Such obligations of confidentiality and non-use shall
terminate five (5) years after the term of this Agreement.
17.2 Exceptions.
Such obligations of confidentiality and non-use pursuant to Section 17.1
above shall not pertain to Confidential Information of the disclosing Party
that:
(a) Was known to the receiving Party, as shown by written evidence, at
the time of receipt from the disclosing Party,
(b) Was available to the public at the time of receipt from the
disclosing Party,
(c) Subsequently becomes available to the public without the receiving
Party breaching this Agreement,
(d) Is disclosed to the receiving Party by a third party who/which is
under no confidentiality obligation to the disclosing Party,
(e) Is independently developed by the receiving Party, or
(f) Is disclosed pursuant to and only to the extent of court order or as
otherwise compelled by law after giving the disclosing Party notice
and reasonable
-24-
assistance in opposing or limiting such disclosure; provided,
however, that information disclosed pursuant to this Section 17.2(e)
shall remain Confidential Information for the purposes of this
Agreement.
17.3 The Terms of the Agreement.
Either Party may provide to potential investors, lenders or acquirors who
have a need to know the Confidential Information in order to assess the status
of their investment in such Party or to determine whether to invest in such
Party, provided that (i) the information is of a type customarily disclosed to
investors, lenders or acquirors and (ii) the investors, lenders or acquirors to
whom the information is disclosed are bound by obligations of confidentiality
and non-use with respect to such information at least as stringent as those set
forth within Section 17.1 above.
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 manufactured and delivered to Nycomed in
conformity with the regulations of such countries, (a) TMC shall use
commercially reasonable efforts to comply with those requirements, and (b)
Nycomed shall reimburse TMC for any additional costs which it may incur in
connection with such efforts.
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, INCLUDING, WITHOUT LIMITATION, 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
-25-
(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; 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; (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 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; provided,
however, that before resuming the marketing and distribution of the
Product in the Territory, (A) Nycomed shall have a ninety (90) days
right of first refusal
-26-
with respect to such rights, without the payment of any up-front or
additional milestone payments; and (B) if Nycomed does not exercise
such right of first refusal, then TMC shall not offer terms more
favorable to a third party without first offering those more
favorable terms to Nycomed in accordance with (A) above.
(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 $
[**] per occurrence and an aggregate amount of US $ [**] 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 $ [**] per occurrence
and an aggregate amount of US $ [**] 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) 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 (10) 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, REGARDLESS OF THE
-27-
FORM OF ANY CLAIM OR ACTION, SHALL NOT EXCEED (a) PRIOR TO THE FIRST
ANNIVERSARY OF THE FIRST LAUNCH DATE, US$1,000,000; AND (b) THEREAFTER,
THE AGGREGATE PRICE PAID FOR PRODUCT UNDER THIS AGREEMENT 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 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 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 Article 6 above or
Sections 20.3 or 20.4 below or Nycomed's termination rights under Section 20.2,
20.3 or 20.4 below, this Agreement shall begin on the Effective Date and shall
continue on a country by country basis until the later of:
a) the expiration of the last to expire Patent (and any extensions
thereof) covering the Product or processes relating to the Product,
or
b) 10 years after Launch of the Product in such country.
The term of this Agreement may be extended upon further mutual written agreement
of the Parties.
20.2 Nycomed's Additional Termination Rights.
(a) Should Nycomed decide to terminate this Agreement, other than pursuant
to Section 20.3 or 20.4 below, Nycomed must provide TMC at least twelve (12)
months prior written notice, except as provided in Section 20.2(b) below.
-28-
(b) Nycomed shall have the right to terminate this Agreement, for a
specific country in the Territory, without indemnifying TMC, with six (6) months
written notice if Approval for the Product in such country is not obtained in
such country within thirty-six (36) months following the filing of a complete
Approval application for the Product for such country.
(c) Upon Nycomed's giving of notice pursuant to either Section 20.2(a) or
(b) above, all of Nycomed's rights under this Agreement shall immediately become
non-exclusive for the Territory for a termination under Section 20.2(a), or
non-exclusive for the terminated country for a termination under Section
20.2(b), as the case may be. Nycomed agrees to, during such notice period,
cooperate with TMC to transition all Product-related responsibilities in an
orderly fashion, to TMC or a third party designated by TMC. At the end of such
notice period, Nycomed shall be discharged from all further payment obligations
under this Agreement beyond those amounts owed to TMC in accordance with Section
20.5 below.
20.3 Termination for Breach.
In the event of a breach of this Agreement by either Party and such
Party's failure to remedy such breach within thirty (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 with immediate effect upon written notice to the breaching Party;
provided, however, that such thirty (30) day period shall be reduced to twenty
(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 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.
20.5 Payment Obligations Continue.
Termination or expiration of this 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 delivered by TMC on or before the date of such
termination or expiration or to pay reimbursements for expenses as required by
this Agreement, as well as interest thereon at the rate specified in Section
10.3 above to the extent any such amounts are paid after the date they became or
will become due pursuant to this Agreement. TMC will have the option but not the
obligation to repurchase, within thirty (30) days after such termination or
expiration, saleable inventory at the Transfer Price paid by Nycomed for such
inventory.
-29-
20.6 No Post-Termination Compensation for Loss of Good Will.
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, 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.
Nycomed, for itself and on behalf of each of its 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. 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 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 5.3, 11.4, 14.3, 14.4, 14.5, 20.5, 20.6 and 20.7 and
Articles 13, 17, 18, 19, 21, 22, 23, 24, 25, 26, 27, 28 and 31 shall survive the
termination and expiration of this Agreement. In addition, ownership of any
filings and Approvals for the Product obtained by Nycomed in Nycomed or TMC's
name for a particular country or countries of the Territory shall be transferred
at no charge or expense to TMC upon this Agreement expiring or being terminated
with respect to such country or countries.
21. COMPLIANCE WITH LAWS
Each of Nycomed and TMC covenants that all of its activities under or
pursuant to this Agreement shall comply with all applicable laws, rules and
regulations.
22. DISPUTE RESOLUTION
Prior to submission to arbitration, the Parties shall negotiate in good
faith within the POC any disagreements or controversies arising out of or
relating to this Agreement. Should the POC be unable to resolve an issue, the
President of TMC and the President of Nycomed Holding A/S shall meet, either by
telephone or in person, to discuss and attempt resolution of the issue.
If the representative of the Parties cannot, within ten (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
-30-
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 thirty (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.
23. AUDIT AND INSPECTION
During the term of this Agreement, upon reasonable prior notice and during
normal business hours and no more frequently than once a year, 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 three (3) years 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, not more than once
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 five percent (5%) 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 and with
interest annualized at the prime rate then in effect at Citibank N.A., plus two
percent (2%), and TMC
-31-
shall promptly pay to Nycomed any overpaid compensation. All information and
data reviewed in any audit conducted under this Article 23 shall be used only
for the purpose of verifying the amounts due to TMC under this Agreement and
shall be treated as Confidential Information of Nycomed subject to the terms of
this Agreement.
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 Xxx
Xxxxx of Xxxx and Xxxx LLP, 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000 via e-mail at
xxxxxxx.xxxxx@xxxxxxxx.xxx or via facsimile at x0-000-000-0000) or to the
attention of the President if sent to Nycomed (with a copy to the General
Counsel of Nycomed, Xxxxxxxxxx. 00, XX-0000 Xxxxx, Xxxxxx via e-mail at
xxx@xxxxxxx.xxx or via facsimile at x00 00 00 00 00). Such notice or
communication shall be deemed given (a) seven (7) days after it is mailed
registered, return receipt, first-class postage prepaid, and addressed to such
Party at the address for such Party set forth at the beginning of this
Agreement, (b) two (2) days after it is delivered to Federal Express, Airborne,
or any other similar express delivery service for delivery to such Party at such
address, or (c) on the day sent if sent via electronic mail to the electronic
mail address provided for such Party at the end of this Agreement, accompanied
by facsimile copy sent to the facsimile number provided for such Party at the
end of this Agreement. Any Party may change its address, electronic mail
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.
-32-
27. SEVERABILITY
The intention of the Parties is to comply fully with all laws and public
policies, and this Agreement shall be construed consistently with all laws and
public policies to the extent possible. If and to the extent that any
arbitration panel or any court of competent jurisdiction determines that it is
impossible to construe any provision of this Agreement consistently with any law
or public policy and consequently holds that provision to be invalid,
inoperative, unenforceable, or to render other, material, provisions of this
agreement invalid, inoperative or unenforceable, such provision shall be set
aside, without, however, in any way affecting the validity of the other
provisions of this Agreement, which shall remain in full force and effect.
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 contains the entire agreement between the Parties and
supersedes all prior or contemporaneous discussion, negotiations,
representations, warranties, or agreements relating to the subject matter of
this Agreement. 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
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;
provided, however, that such consent shall not be required with respect to
assignments, transfers or other dispositions by Nycomed to (i) an Affiliate of
Nycomed; or (ii) an acquiror of all or substantially all of the capital stock or
assets of Nycomed related to the Product, through purchase, merger,
consolidation, or otherwise, unless such acquiror is a competitor of TMC, in
which case TMC's consent shall still be required. 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 to (i) an Affiliate 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.
-33-
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.
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, INC NYCOMED DANMARK A/S
By: Xxxxx Xxxxxxxx By: Bent Kjaersgaard
-------------- ----------------
Xxxxx Xxxxxxxx Bent Kjaersgaard
Executive Chairman President
(Xxxxx.Xxxxxxxx@xxxxxxxx.xxx) (xxx@xxxxxxx.xxx)
0 (000) 000-0000 (+ 45 46 75 69 68)
NYCOMED HOLDING A/S
By: Xxxxx Xxxxxxxxx
---------------
Xxxxx Xxxxxxxxx
CEO
(xxxx@xxxxxxx.xxx)
(x00 00 00 00 00)
-34-
EXHIBIT A
COUNTRIES INCLUDED IN TERRITORY
- The following countries of the European Union : Austria, Belgium, Denmark,
Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, the
United Kingdom and Sweden; but not Greece, Portugal and Spain.
- Iceland.
- Liechtenstein.
- Malta.
- Norway.
- Poland.
- The Russian Federation and all other former Soviet Republics (excluding
the Baltic States)
- Baltic States (i.e., Latvia, Lithuania and Estonia)
- Switzerland.
- Turkey
- Hungary
EXHIBIT B
TRANSFER PRICE
1. Upon Product delivery, Nycomed shall pay to TMC, pursuant to the terms and
conditions of the Agreement, the greater of:
(a) [**]% of the Average Net Unit Selling Price of the Product x the
Number of Product units sold by Nycomed (in US dollars based on the
applicable exchange rate(s)); and
(b) A Minimum Transfer Price of $ [**] per unit of Product until the
third (3rd) anniversary of the First Launch Date, with the Minimum
Transfer Price increased annually thereafter by the annual
percentage increase in TMC's manufacturing costs (excluding
royalties on sale payable to Biogen or its successor) for the
Product, if any, after such third (3rd) anniversary date, such
increase not to exceed [**]% per annum.
2. Nycomed (a) may be entitled to the following discount (a "Production Volume
Discount") in a particular calendar year:
Annual Global Chemilog % discount off Average Net Unit
Production by TMC for all Purchasers Selling Price
------------------------------------ -------------------------------
[**] kilos [**]%
More than [**]kilos - [**] kilos [**]%
More than [**] kilos - [**] kilos [**]%
More than [**] kilos [**]%
(b) so long as Nycomed 's total purchases of the Product (in kilos) from TMC
during such calendar year equals or exceeds the following minimum percentage of
TMC's total annual global Chemilog production (in kilos) of the Product during
such calendar year:
Calendar Year Minimum Percentage
------------- ------------------
Calendar year during which First
Launch Date occurs [**]%
All calendar years thereafter [**]%
For the sake of clarification, (i) if Nycomed does not equal or exceed such
minimum percentage in a calendar year, then Nycomed shall not be entitled to a
Production Volume Discount during such calendar year; and (ii) by way of
example, if TMC's annual global Chemilog Production for Nycomed and all of its
other purchasers is greater than [**] kilos during a calendar year (and assuming
that Nycomed has equaled or exceeded the minimum percentage for such year), then
for such year Nycomed shall have earned a [**]% discount off of the Average Net
Unit Selling Price for Product which Nycomed sells during such calendar year,
reducing the reference in Paragraph 1(a) above from [**]% of the Average Net
Unit Selling Price to [**]% of the Average Net Unit Selling Price for Product
sold by Nycomed during such year; provided, however, that notwithstanding any
Production Volume Discount earned hereunder, in no event shall Nycomed pay less
than the Minimum Transfer Price on any unit of Product.
3. For the purposes of computing the Production Volume Discount, the Annual
Global Chemilog Production levels under Paragraph 2(a) above and the minimum
percentage under Paragraph 2(b) above for the calendar year during which the
First Launch Date occurs shall be pro rated to reflect a partial year. By way of
example, if the First Launch Date occurs on July 1 of a calendar year, then for
the purposes of that calendar year only, (a) Annual Global Chemilog Production
levels in the chart above shall be adjusted to [**] and over [**] kilos to
determine which percentage discount shall apply; and (b) the minimum percentage
shall be reduced to [**]% to determine whether Nycomed is entitled to such
percentage discount.
4. For the purposes of computing the minimum percentage under Paragraph 2(b)
above for a calendar year, all units of Product delivered to Nycomed during such
calendar year will be counted towards Nycomed's total purchases of Product
during such calendar year.
EXHIBIT C
TRADEMARKS
(a) TMC trademarks subject to exclusive use by Nycomed in the Territory:
Angiomax(R)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(TM)(and its logo)
REPLACE HEPARIN, IMPROVE OUTCOMES(TM)
EXHIBIT D
INVESTMENT REPRESENTATION LETTER
The Medicines Company
Dear Sirs:
In order to induce The Medicines Company, a Delaware corporation (the
"Company"), to issue and sell to [Nycomed] the number of shares of Common Stock
of the Company set forth below (the "Shares"), pursuant to the ____________
Agreement dated as of ___________, [Nycomed] represents, warrants and covenants
as follows:
(a) It is purchasing the Shares for its own account for investment only,
and not with a view to, or for sale in connection with, any distribution of the
Shares in violation of the Securities Act of 1933 (the "Securities Act"), or any
rule or regulation under the Securities Act.
(b) It has had such opportunity as it has deemed adequate to obtain from
representatives of the Company such information as is necessary to permit it to
evaluate the merits and risks of its investment in the Company.
(c) It has sufficient experience in business, financial and investment
matters to be able to evaluate the risks involved in the purchase of the Shares
and to make an informed investment decision with respect to such purchase.
(d) It can afford a complete loss of the value of the Shares and is able
to bear the economic risk of holding such Shares for an indefinite period.
(e) It understands that (i) the Shares have not been registered under the
Securities Act and are "restricted securities" within the meaning of Rule 144
under the Securities Act, (ii) the Shares cannot be sold, transferred or
otherwise disposed of unless they are subsequently registered under the
Securities Act or an exemption from registration is then available; (iii) in any
event, the exemption from registration under Rule 144 or otherwise may not be
available for at least one year and even then will not be available unless a
public market then exists for the Common Stock, adequate information concerning
the Company is then available to the public, and other terms and conditions of
Rule 144 are complied with; and (iv) there is now no registration statement on
file with the Securities and Exchange Commission with respect to any
stock of the Company and the Company has no obligation or current intention to
register the Shares under the Securities Act.
(f) A legend substantially in the following form will be placed on the
certificate representing the Shares:
"The shares represented by this certificate have not been registered
under the Securities Act of 1933, as amended, and may not be sold,
transferred or otherwise disposed of in the absence of an effective
registration statement under such Act or an opinion of counsel
satisfactory to the corporation to the effect that such registration
is not required."
Very truly yours,
NYCOMED DANMARK A/S
Number of Shares: ________ ___________________________________
(Signature)
Date _____________________ ___________________________________
Bent Kjaersgaard
___________________________________
President
NYCOMED HOLDING A/S
By:_____________________________
Xxxxx Xxxxxxxxx
CEO
EXHIBIT E
TMC MARKS
each of the Trademarks identified in Exhibit C
Hirulog
EXHIBIT F
PATENTS
STATUS OF PATENTS RELATING TO HIRULOG(R) (B135)
"HIRUDIN ANALOGS"
STATUS
COUNTRY PATENT/APPLN. NO. (EXPIRATION DATE)
------- ----------------- -----------------
Austria 90912754.0 Granted
E137246 (17-AUG-2010)
Belgium 90/912754 Granted
489070 (17-AUG-2010)
Denmark 90912754.0 Granted
489070 (17-AUG-2010)
EPO 90912754.0 Granted
489070 (17-AUG-2010)
Finland 920672 Granted
102183 (17-AUG-2010)
France 90912754.0 Granted
489070 (17-AUG-2010)
Great Britain 90912754.0 Granted
489070 (17-AUG-2010)
Germany 90912754.0 Granted
69026715.0-08 (17-AUG-2010)
Hungary P/P00684 Granted
211158 (17-AUG-2010)
Italy 90912754.0 Granted
489070 (17-AUG-2010)
Luxembourg 90912754.0 Granted
489070 (17-AUG-2010)
Netherlands 90912754.0 Granted
489070 (17-AUG-2010)
Norway 19920616 Granted
310.294 (17-AUG-2010)
Sweden 90912754.0 Granted
489070 (17-AUG-2010)
Switzerland 90912754.0 Granted
489070 (17-AUG-2010)
STATUS OF PATENTS RELATING TO IMPROVED THROMBIN INHIBITORS (B159)
APPL. NO./ XXX. NO./
COUNTRY DATE DATE EXP. DATE
------- ---- ---- ---------
EPO* 529031 2/3/2012
5/28/2000
Finland 000000
Xxxxxxx P9203500 218 831 2/3/2012
* EPO application is designating the countries: Austria, Belgium, Denmark,
France, Germany, Great Britain, Italy, Luxembourg, Netherlands, Sweden and
Switzerland.
