(Mark One) | ||
þ
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the fiscal year ended: December 31, 2010 | ||
Or
|
||
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period from to |
Delaware
(State or other jurisdiction of incorporation or organization) |
04-3324394
(I.R.S. Employer Identification No.) |
|
8 Sylvan Way
Parsippany, New Jersey (Address of principal executive offices) |
07054
(Zip Code) |
Title of Each Class | Name of Each Exchange on Which Registered | |
Common Stock, $.001 Par Value Per Share
|
NASDAQ Global Select Market |
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o | Smaller reporting company o |
1
3
F-20
Item 1.
Business
Product or Product
in Development
Development Stage
Mechanism/Target
Clinical Indication(s)
Marketed
Direct thrombin inhibitor
U.S. for use as an anticoagulant in combination
with aspirin in patients with unstable angina undergoing
percutaneous transluminal coronary angioplasty, or PTCA, and for
use in patients undergoing percutaneous coronary intervention,
or PCI, including patients with or at risk of heparin induced
thrombocytopenia and thrombosis syndrome, or HIT/HITTS
Europe for use as an anticoagulant in patients
undergoing PCI, adult patients with acute coronary syndrome, or
ACS, and for the treatment of patients with ST-segment elevation
myocardial infarction, or STEMI, undergoing primary PCI
Marketing Approval in the
United States; Marketing Authorization Application, or MAA,
submitted in European Union countries
Calcium channel blocker
Blood pressure reduction when oral therapy is not feasible or
not desirable
Phase 3
Antiplatelet agent
Prevention of platelet activation and aggregation
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Product or Product
in Development
Development Stage
Mechanism/Target
Clinical Indication(s)
Phase 3
Antibiotic
Treatment of serious gram-positive bacterial infections,
including acute bacterial skin and skin structure infections, or
ABSSSI
Phase 2
Serine protease inhibitor
Reduction of blood loss during surgery
Phase 1
Naturally occurring variant of a protein found in HDL
Reversal of atherosclerotic plaque development and reduction of
the risk of coronary events in patients with ACS
Ready-to-Use
Argatroban
NDA filed
Direct thrombin inhibitor
Anticoagulant for prophylaxis or treatment of thrombosis in
patients with or at risk for heparin induced thrombocytopenia,
or HIT, and for patients with or at risk for HIT undergoing PCI
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the cardiac catheterization laboratory, where coronary
angioplasties are performed;
the emergency department, where patients with ACS, including
chest pain and heart attacks, also known as myocardial
infarctions or MIs, are initially treated; and
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the operating room, where valve replacement and repair surgery
and CABG surgery are performed.
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a control arm, Arm A, providing for the administration of
heparin or enoxaparin with GP IIb/IIIa inhibitors;
a second arm, Arm B, providing for the administration of
Angiomax with planned use of GP IIb/IIIa inhibitors; and
a third arm, Arm C, providing for the administration of Angiomax
alone and permitting use of GP IIb/IIIa inhibitors only in
selected cases involving ischemic events during PCI.
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1.7 million medically managed patients were administered
intravenous antihypertensives;
1.1 million surgical intervention patients were
administered intravenous antihypertensives in connection with
surgical procedures, and of these, approximately
475,000 patients were treated with intravenous
antihypertensives in cardiac and vascular surgery; and
556,000 all other patients were administered
intravenous antihypertensives.
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target blood pressure was achieved in a median of 5.5 minutes;
changes in hematoma volume in patients with intracerebral
hemorrhage after blood pressure reduction and stroke scores in
the time period studied were minimal;
no meaningful increases or other clinically meaningful changes
were observed in intracranial pressure;
100% of patients achieved target blood pre
ss
ure within 30
minutes of Cleviprex initiation;
97% of patients did not need additional or alternative
intravenous antihypertensives during the initial
30-minute
period of Cleviprex therapy to reach the target blood
pressure; and
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there was no need for supplemental therapy to raise blood
pressure in the initial
30-minute
period of Cleviprex therapy.
Clopidogrel requires liver metabolism to form the active agent
which metabolism can be influenced by other medications;
therefore, the effect of clopidogrel can be delayed and variable.
There does not appear to be a consistent relationship between
increased dosage of clopidogrel and intended effect across
different patient groups.
The inhibition of platelet function is irreversible, meaning the
agent remains bound to receptors for the life of the platelet,
which is typically five to ten days. This may impede patient
management and treatment flexibility, as well as increase the
potential for bleeding, especially if a patient requires other
interventions such as cardiac surgery, which would then be
delayed for days awaiting the generation
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and release of new platelets from the bone marrow. As a result,
physicians are reluctant to administer a long acting or
irreversible agent such as clopidogrel to patients with chest
pain before the treatment decision to perform PCI has been made.
Oral agents like clopidogrel are difficult to administer in the
acute and intensive care setting because they need to be
swallowed by patients who may have received light anesthesia.
This is especially true when there is a need for patients to
swallow multiple tablets in a restricted period of time.
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bacteria are increasingly becoming resistant to one or more of
these existing antibiotics;
some of these antibiotics, referred to as bacteriostatic drugs,
solely inhibit the growth of pathogens and rely on the immune
system to actually kill the bacteria. Bacteriostatic drugs are
less effective in treating patients with compromised immune
systems that cannot rid their bodies of the pathogens;
many of these antibiotics have a narrow spectrum, which is the
range of bacteria treated by a drug, and, as a result, are only
effective against some serious pathogens but not others;
many of the antibiotics used to treat serious infections are
difficult or inconvenient to administer, as they must be
administered twice daily for seven to 14 days, or longer,
with the patients being hospitalized for much or all of this
period; and
many of these antibiotics may cause serious side effects in some
patients, sometimes requiring discontinuation of therapy. Due to
these side effects, health care providers are required to engage
in costly and time-consuming monitoring of blood levels and
other parameters.
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pre-clinical laboratory tests, animal studies and formulation
studies;
submission to the FDA of an IND for human clinical testing,
which must become effective before human clinical trials may
begin;
adequate and well-controlled clinical trials to establish the
safety and efficacy of the drug for each indication;
submission to the FDA of an NDA or biologics license approval,
or BLA;
satisfactory completion of an FDA inspection of the
manufacturing facility or facilities at which the drug is
produced to assess compliance with current good manufacturing
practices, or cGMP; and
FDA review and approval of the NDA or BLA.
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evaluate dosage tolerance and appropriate dosage;
identify possible adverse effects and safety risks; and
evaluate preliminarily the efficacy of the drug for specific
indications.
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Decentralised procedure.
Using the
decentralised procedure, an applicant may apply for simultaneous
authorization in more than one European Union country of
medicinal products that have not yet been authorized in any
European Union country and that do not fall within the mandatory
scope of the centralised procedure.
Mutual recognition procedure.
In the mutual
recognition procedure, a medicine is first authorized in one
European Union member state, in accordance with the national
procedures of that country. Following this, further marketing
authorizations can be sought from other European Union countries
in a procedure whereby the countries concerned agree to
recognize the validity of the original, national marketing
authorization.
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Item 1A.
Risk
Factors
whether the federal district courts orders requiring
the PTO to consider our application to extend the term of the
404 patent timely filed is successfully challenged either
by APP in its pending appeal or by APP or a third party in a
separate challenge;
the outcome of our efforts to otherwise extend the patent term
of the 404 patent to 2014 and our ability to maintain
market exclusivity for Angiomax in the United States through our
other U.S. patents covering Angiomax;
the continued acceptance by regulators, physicians, patients and
other key decision-makers of Angiomax as a safe, therapeutic and
cost-effective alternative to heparin and other products used in
current practice or currently being developed;
our ability to further develop Angiomax and obtain marketing
approval of Angiomax for use in additional patient populations
and the clinical data we generate to support expansion of the
product label;
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the overall number of PCI procedures performed;
the impact of competition from competitive products;
to what extent and in what amount government and third-party
payors cover or reimburse for the costs of Angiomax; and
our success and the success of our international distributors in
selling and marketing Angiomax in Europe and in other countries
outside the United States.
the extent to which Angiomax is commercially successful globally;
whether the federal district courts order requiring the
PTO to consider our application to extend the term of the
404 patent timely filed is successfully challenged either
by APP in its pending appeal or by APP or a third party in a
separate challenge;
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the outcome of our efforts to otherwise extend the patent term
of the 404 patent to 2014 and our ability to maintain
market exclusivity for Angiomax in the United States through our
other U.S. patents covering Angiomax;
the terms of any settlements with Biogen Idec, HRI or the law
firm with which we have not settled our claims with respect to
the 404 patent and the PTOs initial denial of our
application to extend the term of the patent;
our ability to resupply the U.S. market with Cleviprex and
re-launch the product on the time frames we expect and the
extent to which Cleviprex is commercially successful in the
United States;
the extent to which we can successfully establish a commercial
infrastructure outside the United States;
the consideration paid by us in connection with acquisitions and
licenses of development-stage products, approved products, or
businesses, and in connection with other strategic arrangements;
the progress, level, timing and cost of our research and
development activities related to our clinical trials and
non-clinical studies with respect to Angiomax, Cleviprex and our
products in development;
the cost and outcomes of regulatory submissions and reviews for
approval of Angiomax in additional countries and for additional
indications, of Cleviprex outside the United States, Australia,
New Zealand and Switzerland and of our products in development
globally;
the continuation or termination of third-party manufacturing and
sales and marketing arrangements;
the size, cost and effectiveness of our sales and marketing
programs globally;
the amounts of our payment obligations to third parties as to
Angiomax, Cleviprex and our products in development; and
our ability to defend and enforce our intellectual property
rights.
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continue to improve operating, administrative, and information
systems;
accurately predict future personnel and resource needs to meet
contract commitments;
track the progress of ongoing projects; and
attract and retain qualified management, sales, professional,
scientific and technical operating personnel.
our customers ability to obtain reimbursement for
procedures using our products in foreign markets;
the burden of complying with complex and changing foreign legal,
tax, accounting and regulatory requirements;
language barriers and other difficulties in providing long-range
customer support and service;
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longer accounts receivable collection times;
significant foreign currency fluctuations, which could result in
increased operating expenses and reduced revenues;
reduced protection of intellectual property rights in some
foreign countries; and
the interpretation of contractual provisions governed by foreign
laws in the event of a contract dispute.
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the Federal Anti-Kickback Law, which prohibits persons from
knowingly and willfully soliciting, offering, receiving or
providing remuneration, directly or indirectly, in cash or in
kind, to induce either the referral of an individual or
furnishing or arranging for a good or service for which payment
may be made under federal health care programs such as Medicare
and Medicaid;
other Medicare laws and regulations that prescribe the
requirements for coverage and payment for services performed by
our customers, including the amount of such payment;
the Federal False Claims Act, which imposes civil and criminal
liability on individuals and entities who submit, or cause to be
submitted, false or fraudulent claims for payment to the
government;
the Federal False Statements Act, which prohibits knowingly and
willfully falsifying, concealing or covering up a material fact
or making any materially false statement in connection with
delivery of or payment for health care benefits, items or
services; and
various state laws that impose similar requirements and
liability with respect to state healthcare reimbursement and
other programs.
39
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delay or prevent the successful commercialization of any of the
products or product candidates in the jurisdiction for which
approval is sought
diminish our competitive advantage; and
defer or decrease our receipt of revenue.
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our clinical trials may produce negative or inconclusive
results, and we may decide, or regulators may require us, to
conduct additional clinical trials which even if undertaken
cannot ensure we will gain approval;
data obtained from pre-clinical testing and clinical trials may
be subject to varying interpretations, which could result in the
FDA or other regulatory authorities deciding not to approve a
product in a timely fashion, or at all;
the cost of clinical trials may be greater than we currently
anticipate;
regulators or institutional review boards may not authorize us
to commence a clinical trial or conduct a clinical trial at a
prospective trial site;
we, or the FDA or other regulatory authorities, might suspend or
terminate a clinical trial at any time on various grounds,
including a finding that participating patients are being
exposed to unacceptable health risks. For example, we have in
the past voluntarily suspended enrollment in one of our clinical
trials to review an interim analysis of safety data from the
trial; and
the effects of our product candidates may not be the desired
effects or may include undesirable side effects or the product
candidates may have other unexpected characteristics.
delay in approving or refusal to approve a product;
product recall or seizure;
suspension or withdrawal of an approved product from the market;
delays in, suspension of or prohibition of commencing, clinical
trials of products in development;
interruption of production;
operating restrictions;
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untitled or warning letters;
injunctions;
fines and other monetary penalties;
the imposition of civil or criminal penalties; and
unanticipated expenditures.
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delay or otherwise adversely impact the manufacturing,
development or commercialization of Angiomax, Cleviprex, our
products in development or any additional products or product
candidates that we may acquire or develop;
require us to seek a new collaborator or undertake unforeseen
additional responsibilities or devote unforeseen additional
resources to the manufacturing, development or commercialization
of our products; or
result in the termination of the development or
commercialization of our products.
reliance on the third party for regulatory compliance and
quality assurance;
the possible breach of the manufacturing agreement by the third
party; and
the possible termination or nonrenewal of the agreement by the
third party, based on its own business priorities, at a time
that is costly or inconvenient for us.
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obtain and maintain U.S. and foreign patents, including
defending those patents against adverse claims;
secure patent term extension for the patents covering our
approved products;
protect trade secrets;
operate without infringing the proprietary rights of
others; and
prevent others from infringing our proprietary rights.
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manufactured or produced economically;
successfully commercialized; or
widely accepted in the marketplace.
49
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changes in securities analysts estimates of our financial
performance;
changes in valuations of similar companies;
variations in our operating results;
acquisitions and strategic partnerships;
announcements of technological innovations or new commercial
products by us or our competitors;
disclosure of results of clinical testing or regulatory
proceedings by us or our competitors;
the timing, amount and receipt of revenue from sales of our
products and margins on sales of our products;
governmental regulation and approvals;
developments in patent rights or other proprietary rights,
particularly with respect to our U.S. Angiomax patents;
the extent to which Angiomax is commercially successful globally;
whether the federal district court order requiring the PTO to
consider our application to extend the term of the 404
patent timely filed is successfully challenged either by APP in
its pending appeal or by APP or a third party in a separate
challenge;
the terms of any settlements with Biogen Idec, HRI or the law
firm with which we have not settled our claims with respect to
the 404 patent and the PTOs initial denial of our
application to extend the term of the patent;
developments or issues with our contract manufacturers;
changes in our management; and
general market conditions.
50
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Item 1B.
Unresolved
Staff Comments
Item 2.
Properties
Item 3.
Legal
Proceedings
51
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53
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Item 4.
(Removed
and Reserved)
Item 5.
Market
for Registrants Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities Market Information and
Holders
Common Stock
Price
High
Low
$
16.77
$
8.73
11.50
6.15
12.12
7.36
11.24
7.00
$
10.45
$
6.91
8.99
6.82
15.43
7.24
15.33
11.65
54
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among
The Medicines Company, NASDAQ Composite Index
and The NASDAQ Biotechnology Index
*
Fiscal year ended December 31.
12/05
12/06
12/07
12/08
12/09
12/10
100.00
181.78
109.80
84.41
47.79
80.97
100.00
111.74
124.67
73.77
107.12
125.93
100.00
99.71
103.09
96.34
106.49
114.80
55
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Item 6.
Selected
Financial Data
Year Ended
December 31,
2010
2009
2008
2007
2006
(In thousands, except per share
data)
$
437,645
$
404,241
$
348,157
$
257,534
$
213,952
129,299
118,148
88,355
66,502
51,812
85,241
117,610
105,720
77,255
63,536
158,690
193,832
164,903
141,807
88,265
373,230
429,590
358,978
285,564
203,613
64,415
(25,349
)
(10,821
)
(28,030
)
10,339
(267
)
(2,818
)
5,235
10,653
7,319
64,148
(28,167
)
(5,586
)
(17,377
)
17,658
40,487
(48,062
)
(2,918
)
(895
)
46,068
$
104,635
$
(76,229
)
$
(8,504
)
$
(18,272
)
$
63,726
$
1.98
$
(1.46
)
$
(0.16
)
$
(0.35
)
$
1.27
$
1.97
$
(1.46
)
$
(0.16
)
$
(0.35
)
$
1.25
52,842
52,269
51,904
51,624
50,300
53,184
52,269
51,904
51,624
51,034
As of
December 31,
2010
2009
2008
2007
2006
(In thousands)
$
247,923
$
177,113
$
217,542
$
223,711
$
198,231
239,251
156,103
212,222
208,568
228,523
474,124
374,776
387,404
361,516
318,568
(239,542
)
(344,177
)
(267,948
)
(259,444
)
(241,172
)
357,598
240,389
298,025
277,896
269,951
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Item 7.
Managements
Discussion and Analysis of Financial Condition and Results of
Operations
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Upon approval from the European Medicines Agency, or EMA, of an
MAA for oritavancin for the treatment of ABSSSI on or before
December 31, 2013, approximately $10.5 million in the
aggregate.
Upon final approval from the FDA of a new drug application, or
NDA, for oritavancin for the treatment of ABSSSI on or before
December 31, 2013, approximately $10.5 million in the
aggregate.
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Upon final FDA approval of an NDA for the use of oritavancin for
the treatment of ABSSSI administered by a single dose
intravenous infusion on or before December 31, 2013,
approximately $14.7 million in the aggregate. This payment
may become payable simultaneously with the payment described in
the previous bullet above.
If aggregate net sales of oritavancin in four consecutive
calendar quarters ending on or before December 31, 2021
reach or exceed $400 million, approximately
$49.4 million.
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Year Ended
December 31,
Change
Change
2010
2009
$
%
(In thousands)
$
413,044
$
385,939
$
27,105
7.0
%
24,601
18,302
6,299
34.4
%
$
437,645
$
404,241
$
33,404
8.3
%
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Year Ended
December 31,
% of Total
% of Total
2010
Cost
2009
Cost
(In thousands)
(In thousands)
$
29,868
23
%
$
28,520
24
%
86,218
67
%
77,786
66
%
13,213
10
%
11,842
10
%
$
129,299
100
%
$
118,148
100
%
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Year Ended
December 31,
% of
% of
2010
Total R&D
2009
Total R&D
(In thousands)
(In thousands)
$
6,439
7
%
$
5,335
4
%
4,466
5
%
12,467
11
%
2,381
3
%
4,437
4
%
13,286
15
%
22,239
19
%
1,545
2
%
4,758
4
%
1,777
2
%
1,443
1
%
1,835
2
%
5,025
4
%
5,157
6
%
11,226
9
%
9,232
11
%
21,680
19
%
1,998
2
%
2,665
2
%
7,328
9
%
4,640
4
%
18,558
22
%
28,985
25
%
6,196
7
%
4,593
4
%
8,199
10
%
3,587
3
%
7,609
9
%
3,086
3
%
22,004
26
%
11,266
10
%
2,056
2
%
2,129
2
%
1,475
2
%
1,042
1
%
4,288
5
%
2,717
2
%
4,329
5
%
5,182
4
%
(1,403
)
(1
)%
(1,432
)
(1
)%
10,745
13
%
9,638
8
%
689
1
%
0
%
2,716
3
%
0
%
608
1
%
0
%
0
%
17,500
15
%
4,013
5
%
17,500
15
%
316
0
%
0
%
629
1
%
0
%
0
%
5,000
4
%
945
1
%
5,000
4
%
10,533
12
%
11,756
10
%
$
85,241
100
%
$
117,610
100
%
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66
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the scope, rate of progress and cost of our clinical trials and
other research and development activities;
future clinical trial results;
the terms and timing of any collaborative, licensing and other
arrangements that we may establish;
the cost and timing of regulatory approvals;
the cost and timing of establishing and maintaining sales,
marketing and distribution capabilities;
the cost of establishing and maintaining clinical and commercial
supplies of our products and product candidates;
the effect of competing technological and market
developments; and
the cost of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights.
Year Ended
December 31,
Change
Change
2010
2009
$
%
(In thousands)
$
158,690
$
193,832
$
(35,142
)
(18.1
)%
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Year Ended
December 31,
Change
Change
2010
2009
$
%
(In thousands)
$
(267
)
$
(2,818
)
$
2,551
90.5
%
Year Ended
December 31,
Change
Change
2010
2009
$
%
(In thousands)
$
40,487
$
(48,062
)
$
88,549
184.2
%
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Year Ended
December 31,
Change
Change
2009
2008
$
%
(In thousands)
$
385,939
$
334,582
$
51,357
15.3
%
18,302
9,750
8,552
87.7
%
3,825
(3,825
)
(100
)%
$
404,241
$
348,157
$
56,084
16.1
%
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Year Ended
December 31,
% of Total
% of Total
2009
Cost
2008
Cost
(In thousands)
(In thousands)
$
28,520
24
%
$
22,518
25
%
77,786
66
%
53,642
61
%
11,842
10
%
12,195
14
%
$
118,148
100
%
$
88,355
100
%
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Year Ended
December 31,
% of
% of
2009
Total R&D
2008
Total R&D
(In thousands)
(In thousands)
$
5,335
4
%
$
4,959
5
%
12,467
11
%
3,924
4
%
4,437
4
%
3,711
3
%
22,239
19
%
12,594
12
%
4,758
4
%
3,031
3
%
1,443
1
%
2,484
2
%
5,025
4
%
6,214
6
%
11,226
9
%
11,729
11
%
21,680
19
%
37,090
35
%
2,665
2
%
2,661
3
%
4,640
4
%
4,658
4
%
28,985
25
%
44,409
42
%
4,593
4
%
0
%
3,587
3
%
0
%
3,086
3
%
0
%
11,266
10
%
0
%
2,129
2
%
0
%
1,042
1
%
0
%
2,717
2
%
1,180
1
%
0
%
21,373
20
%
5,182
4
%
0
%
(1,432
)
(1
)%
0
%
9,638
8
%
22,553
21
%
17,500
15
%
0
%
17,500
15
%
0
%
5,000
4
%
0
%
5,000
4
%
0
%
11,756
10
%
14,435
14
%
$
117,610
100
%
$
105,720
100
%
71
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72
Table of Contents
Year Ended
December 31,
Change
Change
2009
2008
$
%
(In thousands)
$
193,832
$
164,903
$
28,929
17.5
%
Year Ended
December 31,
Change
Change
2009
2008
$
%
(In thousands)
$
(2,818
)
$
5,235
$
(8,053
)
(153.8
)%
Year Ended
December 31,
Change
Change
2009
2008
$
%
(In thousands)
$
(48,062
)
$
(2,918
)
$
(45,144
)
(1,547.1
)%
73
Table of Contents
the extent to which Angiomax is commercially successful globally;
whether the federal district courts order requiring the
PTO to consider our application to extend the term of the
404 patent timely filed is successfully challenged either
by APP in its pending appeal or by APP or a third party in a
separate challenge;
the outcome of our efforts to otherwise extend the patent term
of the 404 patent to 2014 and our ability to maintain
market exclusivity for Angiomax in the United States through our
other U.S. patents covering Angiomax;
the terms of any settlements with Biogen Idec, HRI or the law
firm with which we have not settled our claims with respect to
the 404 patent and the PTOs initial denial of our
application to extend the term of the patent;
our ability to resupply the U.S. market with Cleviprex and
re-launch the product on the time frames we expect and the
extent to which Cleviprex is commercially successful in the
United States;
the extent to which we can successfully establish a commercial
infrastructure outside the United States;
the consideration paid by us in connection with acquisitions and
licenses of development-stage products, approved products, or
businesses, and in connection with other strategic arrangements;
74
Table of Contents
the progress, level, timing and cost of our research and
development activities related to our clinical trials and
non-clinical studies with respect to Angiomax, Cleviprex and our
products in development;
the cost and outcomes of regulatory submissions and reviews for
approval of Angiomax in additional countries and for additional
indications, of Cleviprex outside the United States, Australia,
New Zealand and Switzerland and of our products in development
globally;
the continuation or termination of third-party manufacturing and
sales and marketing arrangements;
the size, cost and effectiveness of our sales and marketing
programs globally;
the amounts of our payment obligations to third parties as to
Angiomax, Cleviprex and our products in development; and
our ability to defend and enforce our intellectual property
rights.
75
Table of Contents
76
Table of Contents
the nature of the estimate or assumption is material due to the
level of subjectivity and judgment necessary to account for
highly uncertain matters or the susceptibility of such matters
to change; and
the impact of the estimates and assumptions on financial
condition or operating performance is material.
77
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78
Table of Contents
Product returns.
Our customers have the right
to return any unopened product during the
18-month
period beginning six months prior to the labeled expiration date
and ending 12 months after the labeled expiration date. As
a result, in calculating the accrual for product returns, we
must estimate the likelihood that product sold might not be used
within six months of expiration and analyze the likelihood that
such product will be returned within 12 months after
expiration. We consider all of these factors and adjust the
accrual periodically throughout each quarter to reflect actual
experience. When customers return product, they are generally
given credit against amounts owed. The amount credited is
charged to our product returns accrual.
Chargebacks and rebates.
Although we primarily
sell products to ICS in the United States, we typically enter
into agreements with hospitals, either directly or through group
purchasing organizations acting on behalf of their hospital
members, in connection with the hospitals purchases of
products.
Fees-for-service.
We
offer discounts to certain wholesalers and ICS based on
contractually determined rates for certain services. We estimate
our
fee-for-service
accruals and allowances based on historical sales, wholesaler
and distributor inventory levels and the applicable discount
rate. Our discounts are accrued at the time of the sale and are
typically settled with the wholesalers or ICS within
60 days after the end of each respective quarter. Our
fee-for-service
accruals and allowances were $2.6 million and
$3.1 million at December 31, 2010 and
December 31, 2009, respectively. A 10% change in our
fee-for-service
accruals and allowances would have had an approximately
$0.3 million effect on our net revenue for the year ended
December 31, 2010.
79
Table of Contents
Cash
Fees-for-
Discounts
Returns
Chargebacks
Rebates
Service
$
507
$
3,060
$
597
$
1,662
$
1,657
7,510
138
5,628
1,413
6,562
159
123
(506
)
(261
)
(720
)
(1,397
)
(721
)
(2,121
)
(6,829
)
(4,442
)
(1,247
)
(5,542
)
682
975
1,186
431
1,956
8,291
3,764
13,439
212
9,582
274
(648
)
(1,249
)
(1,174
)
(275
)
(1,670
)
(7,661
)
(8,787
)
(357
)
(6,743
)
664
3,764
4,664
11
3,125
9,817
3,420
53,756
10,976
1,163
(688
)
(3,811
)
(4,041
)
(3,051
)
(8,674
)
(3,909
)
(40,516
)
(8,416
)
$
1,119
$
627
$
13,863
$
11
$
2,634
80
Table of Contents
81
Table of Contents
Assumption
Method of Estimating
Employees historical exercise
experience and, at times, estimates of future exercises of
unexercised options based on the midpoint between the vesting
date and end of the contractual term
Historical price of our common stock and
the implied volatility of the stock of our peer group
Yields of U.S. Treasury securities
corresponding with the expected life of option grants
Historical forfeiture data
our deferred tax assets primarily relate to U.S. net
operating losses and tax credits, the oldest of which will not
expire until 2028;
for the most recent three fiscal years, our reported cumulative
U.S. income before income taxes totaled approximately
$95 million and we utilized approximately $137 million
of net operating loss carryforwards in our U.S. income tax
returns;
82
Table of Contents
in 2010, our operating income exceeded $64 million and we
expect to be profitable in 2011;
in August 2010, the U.S. District Court for the Eastern
District of Virginia ordered the PTO to consider our patent
extension application for the 404 patent that covers
Angiomax timely filed;
in August 2010, the PTO granted a one-year interim extension of
the term of the 404 patent that covers Angiomax;
the PTO and FDA thereafter initiated the regulatory process to
reach a final determination of the extension of the term of the
404 patent, which is proceeding as set forth in the
regulations;
in October 2010, the period for the U.S. government to
appeal the federal district courts August 2010 decision
expired and the U.S. government did not appeal;
additional U.S. patents that cover Angiomax exist through July
2028;
in February 2011, we entered into a settlement agreement with
one of our law firms resolving our potential claims related to
the 404 patent. Terms of the settlement include
$18 million in expense reimbursement paid upfront and up to
an additional $214 million available for damages in the
event of launch of a generic version of Angiomax in the United
States before June 15, 2015 as a result of the extension of
the 404 patent being held invalid on the basis that the
application for the extension was not timely filed; and
our second product, Cleviprex, was approved for sale in the
United States; we expect it to generate revenue well past the
term of the 404 patent.
since inception, except for 2004, 2006 and 2010, we have
incurred net losses on an annual basis, as of December 31,
2010, we had an accumulated deficit of approximately
$239.5 million;
our primary revenue generating product, Angiomax, could face
generic competition before June 15, 2015 if the extension
of the 404 patent is held invalid and we are not
successful in defending the additional Angiomax patents that
expire in July 2028; and
we are currently involved in patent infringement litigation
relating to the additional U.S. Angiomax patents with a number
of companies that, if unfavorably resolved, would adversely
affect future operations and profit levels.
Item 7A.
Quantitative
and Qualitative Disclosure About Market Risk
83
Table of Contents
Item 8.
Financial
Statements and Supplementary Data
Item 9.
Changes
in and Disagreements with Accountants on Accounting and
Financial Disclosure
Item 9A.
Controls
and Procedures
84
Table of Contents
Item 10.
Directors,
Executive Officers and Corporate Governance
Item 11.
Executive
Compensation
Item 12.
Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
Item 13.
Certain
Relationships and Related Transactions, and Director
Independence
Item 14.
Principal
Accountant Fees and Services
85
Table of Contents
Item 15.
Exhibits
and Financial Statement Schedules
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-8
F-9
86
Table of Contents
By:
Signature
Title(s)
Chief Executive Officer, President and Chairman of the Board of
Directors (Principal Executive Officer)
March 15, 2011
Executive Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
March 15, 2011
Director
March 15, 2011
Director
March 15, 2011
Director
March 15, 2011
Director
March 15, 2011
Director
March 15, 2011
Director
March 15, 2011
Director
March 15, 2011
87
Table of Contents
THE MEDICINES COMPANY
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-8
F-9
F-1
Table of Contents
Internal Control over Financial Reporting
pertain to the maintenance of records that in reasonable detail
accurately and fairly reflect the transactions and dispositions
of the assets of The Medicines Company;
provide reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and
that receipts and expenditures of The Medicines Company are
being made only in accordance with authorizations of management
and directors of The Medicines Company; and
provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use or disposition of The
Medicines Companys assets that could have a material
effect on the financial statements.
Chief Executive Officer
Chief Financial Officer
F-2
Table of Contents
F-3
Table of Contents
on Internal Control over Financial Reporting
F-4
Table of Contents
F-5
Table of Contents
Year Ended
December 31,
2010
2009
2008
(In thousands, except per share
amounts)
$
437,645
$
404,241
$
348,157
129,299
118,148
88,355
85,241
117,610
105,720
158,690
193,832
164,903
373,230
429,590
358,978
64,415
(25,349
)
(10,821
)
(267
)
(2,818
)
5,235
64,148
(28,167
)
(5,586
)
40,487
(48,062
)
(2,918
)
$
104,635
$
(76,229
)
$
(8,504
)
$
1.98
$
(1.46
)
$
(0.16
)
$
1.97
$
(1.46
)
$
(0.16
)
52,842
52,269
51,904
53,184
52,269
51,904
F-6
Table of Contents
Accumulated
Additional
Comprehensive
Total
Common Stock
Paid-in
Accumulated
(Loss)
Stockholders
Shares
Amount
Capital
Deficit
Income
Equity
(In thousands)
51,866
52
537,027
(259,444
)
261
277,896
321
5,541
5,541
93
22,798
22,798
(283
)
(283
)
(8,504
)
(8,504
)
(52
)
(52
)
629
629
(7,927
)
52,280
$
52
$
565,083
$
(267,948
)
$
838
$
298,025
231
1,803
1,803
319
1
1
19,437
19,437
(1,645
)
(1,645
)
(76,229
)
(76,229
)
(297
)
(297
)
(706
)
(706
)
(77,232
)
52,830
$
53
$
584,678
$
(344,177
)
$
(165
)
$
240,389
558
3,361
3,361
76
8,336
8,336
292
292
104,635
104,635
611
611
(26
)
(26
)
105,220
53,464
$
53
$
596,667
$
(239,542
)
$
420
$
357,598
F-7
Table of Contents
Year Ended
December 31,
2010
2009
2008
(In thousands)
$
104,635
$
(76,229
)
$
(8,504
)
6,124
5,767
2,932
21,373
5,000
3,260
2,118
113
(1,217
)
580
8,336
19,437
22,798
293
33
33
33
(43,592
)
47,737
1,520
292
1,720
486
(364
)
414
262
(16,627
)
3,182
(7,614
)
701
2,774
6,890
5,031
(1,713
)
(1,236
)
165
(7,851
)
3,315
(736
)
8,343
(18,945
)
(616
)
(8,519
)
9,588
62
(28
)
4,939
67,467
951
38,077
(128,240
)
(133,700
)
(161,822
)
108,640
161,646
161,505
(340
)
(342
)
(19,395
)
(2,000
)
(5,000
)
263
(37,168
)
(23,534
)
1,278
(1,652
)
(18,399
)
(11,216
)
(50,246
)
3,361
1,804
5,542
3,361
1,804
5,542
1,710
(332
)
(482
)
54,139
(8,793
)
(7,109
)
72,225
81,018
88,127
$
126,364
$
72,225
$
81,018
$
1,699
$
358
$
2,518
$
$
$
6,327
F-8
Table of Contents
1.
Nature of
Business
2.
Significant
Accounting Policies
F-9
Table of Contents
As of December 31,
2010
As of December 31,
2009
Carrying
Unrealized
Carrying
Unrealized
Cost
Fair Value
Value
Gain
Cost
Fair Value
Value
Gain
(In thousands)
$
55,222
$
55,222
$
55,222
$
$
103,936
$
103,965
$
103,965
$
29
$
65,055
$
65,058
$
65,058
$
3
$
$
$
$
$
120,277
$
120,280
$
120,280
$
3
$
103,936
$
103,965
$
103,965
$
29
F-10
Table of Contents
F-11
Table of Contents
Product returns.
The Companys customers
have the right to return any unopened product during the
18-month
period beginning six months prior to the labeled expiration date
and ending 12 months after the labeled expiration date. As
a result, in calculating the accrual for product returns, the
Company must estimate the likelihood that product sold might not
be used within six months of expiration and analyze the
likelihood that such product will be returned within
12 months after expiration. The Company considers all of
these factors and adjusts the accrual periodically throughout
each quarter to reflect actual experience. When customers return
product, they are generally given credit against amounts owed.
The amount credited is charged to the Companys product
returns accrual.
Chargebacks and rebates.
Although the Company
primarily sells products to ICS in the United States, the
Company typically enters into agreements with hospitals, either
directly or through group purchasing organizations acting on
behalf of their hospital members, in connection with the
hospitals purchases of products.
F-12
Table of Contents
Fees-for-service.
The
Company offers discounts to certain wholesalers and ICS based on
contractually determined rates for certain services. The Company
estimates its
fee-for-service
accruals and allowances based on historical sales, wholesaler
and distributor inventory levels and the applicable discount
rate. The Companys discounts are accrued at the time of
the sale and are typically settled with the wholesalers or ICS
within 60 days after the end of each respective quarter.
The Companys
fee-for-service
accruals and allowances were $2.6 million and
$3.1 million at December 31, 2010 and
December 31, 2009, respectively.
F-13
Table of Contents
Cash
Fees-for-
Discounts
Returns
Chargebacks
Rebates
Service
$
507
$
3,060
$
597
$
1,662
$
1,657
7,510
138
5,628
1,413
6,562
159
123
(506
)
(261
)
(720
)
(1,397
)
(721
)
(2,121
)
(6,829
)
(4,442
)
(1,247
)
(5,542
)
682
975
1,186
431
1,956
8,291
3,764
13,439
212
9,582
274
(648
)
(1,249
)
(1,174
)
(275
)
(1,670
)
(7,661
)
(8,787
)
(357
)
(6,743
)
664
3,764
4,664
11
3,125
9,817
3,420
53,756
10,976
1,163
(688
)
(3,811
)
(4,041
)
(3,051
)
(8,674
)
(3,909
)
(40,516
)
(8,416
)
$
1,119
$
627
$
13,863
$
11
$
2,634
F-14
Table of Contents
F-15
Table of Contents
F-16
Table of Contents
3.
Inventory
Inventory
2010
2009
(In thousands)
$
9,801
$
13,609
7,183
8,646
8,359
3,581
$
25,343
$
25,836
4.
Fixed
Assets
Estimated
December 31,
Life (Years)
2010
2009
(In thousands)
3-7
$
12,376
$
12,680
3
1,924
2,622
3
2,204
3,549
5-15
19,170
20,485
35,674
39,336
(15,012
)
(14,264
)
$
20,662
$
25,072
F-17
Table of Contents
5.
Acquisitions
Upon approval from the European Medicines Agency (EMA) of a
Marketing Authorization Application (MAA) for oritavancin for
the treatment of serious gram-positive bacterial infections,
including acute bacterial skin and skin structure infections
(ABSSSI) (which were formerly referred to as complicated skin
and skin structure infections, or cSSSI) on or before
December 31, 2013, approximately $10.5 million.
Upon final approval from the FDA of a new drug application (NDA)
for oritavancin for the treatment of ABSSSI on or before
December 31, 2013, approximately $10.5 million.
Upon final approval from the FDA of an NDA for the use of
oritavancin for the treatment of ABSSSI administered by a single
dose intravenous infusion on or before December 31, 2013,
approximately $14.7 million. This payment may become
payable simultaneously with the payment described in the
previous bullet above.
If aggregate net sales of oritavancin in four consecutive
calendar quarters ending on or before December 31, 2021
reach or exceed $400 million, approximately
$49.4 million.
F-18
Table of Contents
(In thousands)
$
4,815
397
2,440
1,960
69,500
14,671
70
93,853
3,280
6,976
23,181
17,877
556
51,870
$
41,983
F-19
Table of Contents
Project
(In thousands)
$
54,000
5,900
6,400
3,200
$
69,500
Years Ended
December 31,
2009
2008
(In thousands, except per share
amounts)
$
404,241
$
348,157
(36,020
)
(70,219
)
(87,346
)
(67,317
)
$
(1.67
)
$
(1.30
)
$
(1.67
)
$
(1.30
)
52,269
51,904
52,269
51,904
Table of Contents
6.
Intangible
Assets and Goodwill
As of December 31,
2010
As of December 31,
2009
Weighted
Gross
Net
Gross
Net
Average
Carrying
Accumulated
Carrying
Carrying
Accumulated
Carrying
Useful Life
Amount
Amortization
Amount
Amount
Amortization
Amount
(In thousands)
8 years
$
7,457
$
(1,715
)
$
5,742
$
7,457
$
(861
)
$
6,596
8 years
4,448
(1,023
)
3,425
4,448
(514
)
3,934
8 years
3,024
(695
)
2,329
3,024
(349
)
2,675
13 years
2,000
(71
)
1,929
2,000
(27
)
1,973
9 years
$
16,929
$
(3,504
)
$
13,425
$
16,929
$
(1,751
)
$
15,178
(1)
The Company amortizes intangible assets related to Angiox based
on the ratio of annual forecasted revenue compared to total
forecasted revenue from the sale of Angiox through the end of
its patent life.
(2)
The Company amortizes intangible assets related to the Cleviprex
approval over the remaining life of the patent.
F-21
Table of Contents
As of December 31,
2010
As of December 31,
2009
Gross
Net
Gross
Net
Carrying
Accumulated
Carrying
Carrying
Accumulated
Carrying
Amount
Amortization
Amount
Amount
Amortization
Amount
(In thousands)
$
69,500
$
$
69,500
$
69,500
$
$
69,500
$
69,500
$
$
69,500
$
69,500
$
$
69,500
December 31,
December 31,
2010
2009
(In thousands)
$
14,934
$
14,934
(263
)
$
14,671
$
14,934
7.
Accrued
Expenses
2010
2009
(In thousands)
$
$
71
24,739
20,523
16,873
15,208
18,780
14,638
3,300
5,992
7,450
7,598
2,534
10,332
2,566
2,726
$
76,242
$
77,088
F-22
Table of Contents
8.
Stockholders
Equity
9.
Stock-Based
Compensation
the 2009 Equity Inducement Plan (the 2009 Plan),
the 2007 Equity Inducement Plan (the 2007 Plan),
the 2004 Stock Incentive Plan (the 2004 Plan),
the 2001 Non-Officer,
Non-Director
Stock Incentive Plan (the 2001 Plan),
the 2000 Outside Director Stock Option Plan (the
2000 Director Plan), and
the 1998 Stock Incentive Plan (the 1998 Plan).
F-23
Table of Contents
F-24
Table of Contents
20,000 shares of common stock on the date of his or her
initial election to the Board of Directors (the Initial
Options); and
7,500 shares of the common stock on the date of each annual
meeting of the Companys stockholders (the Annual Options),
except if such non-employee director was initially elected to
the Board of Directors at such annual meeting. The lead director
will be granted an additional option to purchase
5,000 shares of the common stock on the date of each annual
meeting of the Companys stockholders.
F-25
Table of Contents
Weighted-
Average
Weighted-Average
Remaining
Exercise Price
Contractual
Aggregate
Number of Shares
Per Share
Term
Intrinsic Value
7,923,154
21.83
3,588,990
19.25
(217,160
)
18.36
(529,463
)
24.19
10,765,521
20.92
1,533,850
10.92
(18,505
)
5.85
(1,286,459
)
20.23
10,994,407
$
19.63
1,079,700
9.01
(357,225
)
5.77
(3,691,471
)
20.31
8,025,411
$
18.51
6.23
$
9,639,530
5,821,879
$
20.62
5.41
$
2,976,829
5,851,947
F-26
Table of Contents
Years Ended
December 31,
2010
2009
2008
0
%
0
%
0
%
52
%
47
%
45
%
2.13
%
2.05
%
2.78
%
5.17
5.12
4.89
Years Ended
December 31,
2010
2009
2008
0
%
0
%
0
%
65
%
79
%
39
%
0.19
%
0.32
%
2.04
%
0.5
0.5
0.5
F-27
Table of Contents
Options Outstanding
Options Vested
Weighted Average
Number
Remaining
Weighted Average
Number
Weighted Average
Range of Exercise
Outstanding
Contractual Life
Exercise Price
Exercisable
Exercise Price
Prices Per Share
at 12/31/10
(Years)
Per Share
at 12/31/10
Per Share
916,001
8.85
$
7.46
236,010
$
7.41
925,728
7.66
10.43
363,095
10.42
992,353
6.11
15.85
640,221
16.17
928,105
5.89
18.27
814,991
18.29
231,562
5.81
18.91
205,520
18.90
1,007,773
6.89
19.34
732,658
19.34
906,077
5.58
20.35
790,060
20.39
897,191
4.73
24.38
839,176
24.43
1,220,621
4.63
28.82
1,200,148
28.82
8,025,411
6.23
$
18.51
5,821,879
$
20.62
Weighted Average
Number of
Grant-Date
Shares
Fair Value
159,950
24.46
92,970
18.93
(64,050
)
22.65
188,870
22.35
408,184
12.42
(77,938
)
21.56
(88,836
)
15.67
430,280
14.45
172,874
8.82
(128,196
)
14.76
(96,830
)
12.85
378,128
$
12.18
F-28
Table of Contents
10.
Earnings
(Loss) per Share
Years Ended
December 31,
2010
2009
2008
(In thousands, except per share
amounts)
$
104,635
$
(76,229
)
$
(8,504
)
53,209
52,722
52,090
367
453
186
52,842
52,269
51,904
342
53,184
52,269
51,904
$
1.98
$
(1.46
)
$
(0.16
)
$
1.97
$
(1.46
)
$
(0.16
)
F-29
Table of Contents
11.
Income
Taxes
2010
2009
2008
(In thousands)
$
(1,380
)
$
(237
)
$
(377
)
(1,433
)
(238
)
(1,021
)
150
(2,813
)
(325
)
(1,398
)
43,582
(43,740
)
(1,910
)
(282
)
(3,997
)
390
43,300
(47,737
)
(1,520
)
$
40,487
$
(48,062
)
$
(2,918
)
2010
2009
2008
(In thousands)
$
80,765
$
(15,744
)
$
30,375
(16,617
)
(12,423
)
(35,961
)
$
64,148
$
(28,167
)
$
(5,586
)
F-30
Table of Contents
Year Ended
December 31,
2010
2009
2008
(In thousands)
$
22,452
$
(9,858
)
$
(1,955
)
1,115
2,753
430
1,551
168
4,576
(1,408
)
(1,456
)
1,324
1,701
219
1,398
558
390
272
191
510
167
783
326
188
(23,438
)
(5,783
)
(45,174
)
58,493
$
(40,487
)
$
48,062
$
2,918
December 31,
2010
2009
(In thousands)
$
74,314
$
95,800
24,931
23,460
22,922
25,137
14,894
18,507
13,002
9,500
150,063
172,404
(104,334
)
(171,386
)
45,729
1,018
$
(1,065
)
$
(1,018
)
(19,467
)
(18,395
)
(20,532
)
(19,413
)
$
25,197
$
(18,395
)
F-31
Table of Contents
F-32
Table of Contents
Federal Research
Federal Net
and Development
Operating Loss
Tax Credit
Year of Expiration
Carryforwards
Carryforwards
(In thousands)
$
$
95
923
1,083
477
29,711
1,856
19,693
2,031
11
1,795
12,858
3,436
9,628
1,971
30,804
1,028
43,710
1,186
899
$
146,415
$
16,780
F-33
Table of Contents
Gross
Unrecognized
Tax Benefits
(In thousands)
$
1,381
1,381
510
$
1,891
12.
Fair
Value Measurements
Quoted prices in active markets for identical assets or
liabilities. The Companys Level 1 assets and
liabilities consist of money market investments.
Observable inputs other than Level 1 prices, such as quoted
prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable
or can be corroborated by observable market data for
substantially the full term of the assets or liabilities. The
Companys Level 2 assets and liabilities consist of
U.S. government agency and corporate debt securities.
Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the
assets or liabilities. The Companys Level 3 assets
and liabilities consist of the contingent purchase price
associated with the Targanta acquisition (note 6). The fair
value of the contingent purchase price was determined utilizing
a probability weighted discounted financial model.
F-34
Table of Contents
Significant
Quoted Prices in
Other
Significant
Active Markets for
Observable
Unobservable
Balance at
Identical Assets
Inputs
Inputs
December 31,
Assets and Liabilities
(Level 1)
(Level 2)
(Level 3)
2010
(In thousands)
$
9,360
$
$
$
9,360
55,222
55,222
65,058
65,058
$
9,360
$
120,280
$
$
129,640
$
$
$
25,387
$
25,387
$
$
$
25,387
$
25,387
Level 3
(In thousands)
$
23,667
1,720
$
25,387
13.
Restructuring
Costs and Other, Net
F-35
Table of Contents
Balance as
Balance as of
of January 1,
Expenses,
December 31,
2009
Net
Cash
Noncash
2010
(In thousands)
$
$
5,703
$
5,569
$
$
134
1,105
150
945
10
$
$
6,808
$
5,719
$
945
$
144
14.
License
Agreements
F-36
Table of Contents
F-37
Table of Contents
15.
Manufacturing
Agreements
F-38
Table of Contents
16.
Commitments
and Contingencies
Contractual
Obligations
2011
2012
2013
2014
2015
Later Years
Total
(In thousands)
$
30,316
$
14,669
$
$
$
$
$
44,985
26,419
19,234
320
119
65
46,157
8,870
8,035
6,346
5,006
4,623
34,021
66,901
3,092
1,826
216
5,134
1,891
1,891
$
70,588
$
43,764
$
6,882
$
5,125
$
4,688
$
34,021
$
165,068
F-39
Table of Contents
F-40
Table of Contents
F-41
Table of Contents
17.
Employee
Benefit Plan
F-42
Table of Contents
18.
Selected
Quarterly Financial Data
(Unaudited)
Three Months Ended
Mar. 31,
June 30,
Sept. 30,
Dec. 31,
Mar. 31,
June 30,
Sept. 30,
Dec. 31,
2010
2010
2010
2010
2009
2009
2009
2009
(In thousands, except per share
data)
$
102,088
$
110,135
$
105,743
$
119,679
$
99,217
$
104,175
$
98,789
$
102,060
28,769
33,568
31,568
35,394
28,297
30,353
28,308
31,190
62,998
59,984
52,464
68,485
78,031
67,694
69,822
95,894
9,432
15,426
21,205
58,572
(3,348
)
3,811
(3,197
)
(73,494
)
$
0.18
$
0.29
$
0.40
$
1.10
$
(0.06
)
$
0.07
$
(0.06
)
$
(1.40
)
$
0.18
$
0.29
$
0.40
$
1.09
$
(0.06
)
$
0.07
$
(0.06
)
$
(1.40
)
19.
Segment
and Geographic Information
Years Ended
December 31,
2010
2009
2008
(In thousands)
$
413,044
94.4
%
$
385,939
95.5
%
$
334,582
96.1
%
20,126
4.6
%
13,908
3.4
%
9,051
2.6
%
4,475
1.0
%
4,394
1.1
%
4,524
1.3
%
437,645
404,241
348,157
Years Ended
December 31,
2010
2009
(In thousands)
$
117,095
98.8
%
$
122,968
98.4
%
1,213
1.0
%
1,684
1.3
%
220
0.2
%
353
0.3
%
$
118,528
$
125,005
20.
Subsequent
Events
F-43
Table of Contents
F-44
Table of Contents
Number
Description
2
.1
Sale and Purchase Agreement, dated August 4, 2008, between
The Medicines Company (Leipzig) GmbH and Curacyte AG (filed as
Exhibit 2.1 of the registrants current report on
Form 8-K/A,
filed on November 10, 2008)
2
.2
Agreement and Plan of Merger among the registrant, Boxford
Subsidiary Corporation, and Targanta Therapeutics Corporation,
dated as of January 12, 2009 (filed as Exhibit 2.1 of
the registrants current report on
Form 8-K,
filed on January 14, 2009)
2
.3
Amendment to Sale and Purchase Agreement dated December 14,
2009 between The Medicines Company (Leipzig) GmbH and Curacyte
AG (filed as Exhibit 2.3 to the registrants annual
report on
Form 10-K
for the year ended December 31, 2009)
3
.1
Third Amended and Restated Certificate of Incorporation of the
registrant, as amended (filed as Exhibit 4.1 to the
Amendment No. 1 to the registrants registration
statement on
Form 8-A/A,
filed July 14, 2005)
3
.2
Amended and Restated By-laws of the registrant, as amended
(filed as Exhibit 3.2 to the registrants annual
report on
Form 10-K
for the year ended December 31, 2007)
10
.1
Amended and Restated Registration Rights Agreement, dated as of
August 12, 1998, as amended, by and among the registrant
and the other parties thereto (filed as Exhibit 10.1 to the
registrants quarterly report on
Form 10-Q
for the quarter ended June 30, 2002)
10
.2
Lease for 8 Campus Drive dated September 30, 2002 by and
between Sylvan/Campus Realty L.L.C. and the registrant, as
amended by the First Amendment and Second Amendment, (filed as
Exhibit 10.15 to the registrants annual report on
Form 10-K
for the year ended December 31, 2003)
10
.3
Third Amendment to Lease for 8 Campus Drive dated
December 30, 2004 by and between Sylvan/Campus Realty
L.L.C. and the registrant (filed as Exhibit 10.18 to the
registrants annual report on
Form 10-K
for the year ended December 31, 2004)
10
.4
Lease for 8 Sylvan Way, Parsippany, NJ dated October 11,
2007 by and between 8 Sylvan Way, LLC and the registrant (filed
as Exhibit 10.32 to the registrants annual report on
Form 10-K
for the year ended December 31, 2007)
10
.5
Amendment to Lease for 8 Sylvan Way, Parsippany, NJ dated
October 11, 2007 by and between 8 Sylvan Way, LLC and the
registrant (filed as Exhibit 10.40 to the registrants
annual report on
Form 10-K
for the year ended December 31, 2008)
10
.6*
Employment agreement dated September 5, 1996 by and between
the registrant and Clive Meanwell (filed as Exhibit 10.12
to the registration statement on
Form S-1
filed on May 19, 2000 (registration
no. 333-37404))
10
.7*
Letter Agreement dated December 1, 2004 by and between the
registrant and John Kelley (filed as Exhibit 10.25 to the
registrants annual report on
Form 10-K
for the year ended December 31, 2004)
10
.8*
Letter Agreement dated March 2, 2006 by and between the
registrant and Glenn P. Sblendorio, (filed as Exhibit 10.23
to the registrants annual report on
Form 10-K
for the year ended December 31, 2005)
10
.9*
Severance Agreement, dated February 17, 2009 by and between
Catharine Newberry and the registrant (filed as
Exhibit 10.42 to the registrants annual report on
Form 10-K
for the year ended December 31, 2008)
10
.10*
Severance Agreement, dated October 22, 2009 by and between
John Kelley and the registrant (filed as Exhibit 10.1 to
the registrants quarterly report on
Form 10-Q
for the quarter ended September 30, 2009)
10
.11*
Form of Amended and Restated Management Severance Agreement by
and between the registrant and each of Clive Meanwell and Glenn
Sblendorio (filed as Exhibit 10.24 to the registrants
annual report on
Form 10-K
for the year ended December 31, 2008)
10
.12*
Form of Amended and Restated Management Severance Agreement by
and between the registrant and each of Paul Antinori, William
OConnor and Leslie Rohrbacker (filed as Exhibit 10.25
to the registrants annual report on
Form 10-K
for the year ended December 31, 2008)
Table of Contents
Number
Description
10
.13*
Form of
Lock-Up
Agreement dated as of December 23, 2005 by and between the
registrant and each of its executive officers and directors
(filed as Exhibit 10.27 to the registrants annual
report on
Form 10-K
for the year ended December 31, 2005)
10
.14*
Summary of Board of Director Compensation (filed as
Exhibit 10.1 to the registrants quarterly report on
Form 10-Q
for the quarter ended March 31, 2007)
10
.15*
1998 Stock Incentive Plan, as amended (filed as
Exhibit 10.1 to the registration statement on
Form S-1
filed on May 19, 2000 (registration
no. 333-37404))
10
.16*
Form of stock option agreement under 1998 Stock Incentive Plan
(filed as Exhibit 10.3 to the registrants quarterly
report on
Form 10-Q
for the quarter ended June 30, 2004)
10
.17*
2000 Employee Stock Purchase Plan, as amended (filed as
Exhibit 10.1 of the registrants registration
statement on
Form S-8,
filed on September 1, 2009)
10
.18*
2000 Outside Director Stock Option Plan, as amended (filed as
Exhibit 10.1 to the registrants quarterly report on
Form 10-Q
for the quarter ended March 31, 2003)
10
.19
2001 Non-Officer,
Non-Director
Employee Stock Incentive Plan (filed as Exhibit 99.1 to the
registration statement on
Form S-8
filed December 5, 2001 (registration
no. 333-74612))
10
.20*
Amended and Restated 2004 Stock Incentive Plan (filed as
Exhibit 99.1 to the registrants registration
statement on
Form S-8,
dated July 3, 2008)
10
.21*
Form of stock option agreement under 2004 Stock Incentive Plan
(filed as Exhibit 10.22 to the registrants annual
report on
Form 10-K
for the year ended December 31, 2004)
10
.22*
Form of restricted stock agreement under 2004 Stock Incentive
Plan (filed as Exhibit 10.1 to the registrants
quarterly report on
Form 10-Q
for the quarter ended March 31, 2006)
10
.23*
2007 Equity Inducement Plan (filed as Exhibit 10.1 to the
registration statement on
Form S-8
filed January 11, 2008 (registration
no. 333-148602))
10
.24*
Form of stock option agreement under 2007 Equity Inducement Plan
(filed as Exhibit 10.34 to the registrants annual
report on
Form 10-K
for the year ended December 31, 2007)
10
.25*
Form of restricted stock agreement under 2007 Equity Inducement
Plan (filed as Exhibit 10.35 to the registrants
annual report on
Form 10-K
for the year ended December 31, 2007)
10
.26*
2009 Equity Inducement Plan (filed as Exhibit 10.1 to the
registration statement on
Form S-8
filed February 24, 2009 (registration number
333-157499))
10
.27*
Form of stock option agreement under 2009 Equity Inducement Plan
(filed as Exhibit 10.2 to the registrants quarterly
report on
Form 10-Q
for the quarter ended March 31, 2009)
10
.28*
Form of stock option agreement for employees in Italy under 2009
Equity Inducement Plan (filed as Exhibit 10.3 to the
registrants quarterly report on
Form 10-Q
for the quarter ended March 31, 2009)
10
.29*
Form of restricted stock agreement under 2009 Equity Inducement
Plan (filed as Exhibit 10.4 to the registrants
quarterly report on
Form 10-Q
for the quarter ended March 31, 2009)
10
.30*
Summary of Annual Cash Bonus Plan (filed as Exhibit 10.2 to
the registrants quarterly report on
Form 10-Q
for the quarter ended June 30, 2008)
10
.31*
Summary of Performance Measures under the registrants
Annual Cash Bonus Plan (filed in Item 5.02 of the
registrants current report on Form 8-K, filed on
February 22, 2011)
10
.32
License Agreement, dated as of June 6, 1990, by and between
Biogen, Inc. and Health Research, Inc., as assigned to the
registrant (filed as Exhibit 10.6 to the registration
statement on
Form S-1
filed on May 19, 2000 (registration
no. 333-37404))
10
.33
License Agreement dated March 21, 1997, by and between the
registrant and Biogen, Inc. (filed as Exhibit 10.7 to the
registration statement on
Form S-1
filed on May 19, 2000 (registration
no. 333-37404))
10
.34
License Agreement effective as of March 28, 2003 by and
between AstraZeneca AB and the registrant
10
.35
Amendment No. 1 to License Agreement dated April 25,
2006 by and between AstraZeneca AB
10
.36
Amendment No. 2 to License Agreement, dated
October 22, 2008 by and between the registrant and
AstraZeneca AB (filed as Exhibit 10.38 to the
registrants annual report on
Form 10-K
for the year ended December 31, 2008)
Table of Contents
Number
Description
10
.37
License Agreement dated as of December 18, 2003 by and
between AstraZeneca AB and the registrant (filed as
Exhibit 10.18 to the registrants annual report on
Form 10-K
for the year ended December 31, 2003)
10
.38
Amendment to License Agreement dated July 6, 2007 between
AstraZeneca AB and the registrant (filed as Exhibit 10.4 to
the registrants quarterly report on
Form 10-Q
for the quarter ended September 30, 2007)
10
.39
License Agreement, dated December 23, 2005 by and between
Targanta Therapeutics Corporation (as successor to InterMune,
Inc.) and Eli Lilly and Company (filed as Exhibit 10.11 to
Targantas registration statement on
Form S-1
(registration
no. 333-142842),
as amended, originally filed with the SEC on May 11, 2007)
10
.40
Contingent Payment Rights Agreement dated February 25, 2009
between the registrant and American Stock Transfer &
Trust Company (filed as Exhibit 99.1 of the
registrants current report on
Form 8-K,
filed on March 2, 2009)
10
.41
License Agreement dated as of December 18, 2009 between the
registrant and Pfizer Inc. (filed as Exhibit 10.41 to the
registrants annual report on
Form 10-K
for the year ended December 31, 2009)
10
.42
Consent and Release Agreement dated as of December 18, 2009
between the registrant and Washington Cardiovascular Associates,
LLC, HDLT LLC, H. Bryan Brewer, Silvia Santamarina-Fojo and
Michael Matin (filed as Exhibit 10.42 to the
registrants annual report on
Form 10-K
for the year ended December 31, 2009)
10
.43
Chemilog Development and Supply Agreement, dated as of
December 20, 1999, by and between the registrant and UCB
Bioproducts S.A. (filed as Exhibit 10.5 to the registration
statement on
Form S-1
filed on May 19, 2000 (registration
no. 333-37404))
10
.44
Amended and Restated Distribution Agreement dated
February 28, 2007 between the registrant and Integrated
Commercialization Solutions, Inc. (filed as Exhibit 10.2 to
the registrants quarterly report on
Form 10-Q
for the quarter ended June 30, 2009)
10
.45
Amendment No. 1 to Amended and Restated Distribution
Agreement dated November 7, 2007 between the registrant and
Integrated Commercialization Solutions, Inc. (filed as
Exhibit 10.3 to the registrants quarterly report on
Form 10-Q
for the quarter ended June 30, 2009)
10
.46
Amendment No. 2 to Amended and Restated Distribution
Agreement dated October 1, 2008 between the registrant and
Integrated Commercialization Solutions, Inc. (filed as
Exhibit 10.4 to the registrants quarterly report on
Form 10-Q
for the quarter ended June 30, 2009)
10
.47
Amendment No 3 to the Amended and Restated Distribution
Agreement dated August 12, 2009 between the registrant and
Integrated Commercialization Solutions, Inc. (filed as
Exhibit 10.2 to the registrants quarterly report on
Form 10-Q
for the quarter ended September 30, 2009)
10
.48
Second Amendment to License Agreement dated as of June 1,
2010 between AstraZeneca AB and the registrant (filed as
Exhibit 10.1 to the registrants quarterly report on
Form 10-Q
for the quarter ended June 30, 2010)
10
.49*
The Medicines Companys 2010 Employee Stock Purchase Plan
(incorporated by reference to Appendix I to the
registrants definitive proxy statement, dated and filed
with the Securities and Exchange Commission on April 30,
2010, for the registrants 2010 Annual Meeting of
Stockholders)
10
.50*
The Medicines Companys 2004 Amended and Restated Stock
Incentive Plan, as amended (incorporated by reference to
Appendix II to the registrants definitive proxy
statement, dated and filed with the Securities and Exchange
Commission on April 30, 2010, for the registrants
2010 Annual Meeting of Stockholders)
10
.51
First Amendment to lease for 400 Fifth Avenue, Waltham, MA,
dated as of June 30, 2010 by and between ATC Realty Sixteen
Inc. and the registrant (filed as Exhibit 10.1 to the
registrants quarterly report on
Form 10-Q
for the quarter ended September 30, 2010)
10
.52*
Form of restricted stock agreement under the registrants
Amended and Restated 2004 Stock Incentive Plan (filed as
Exhibit 10.2 to the registrants quarterly report on
Form 10-Q
for the quarter ended September 30, 2010)
10
.53*
Restricted stock agreement of Clive Meanwell under the
registrants Amended and Restated 2004 Stock Incentive Plan
Table of Contents
Number
Description
10
.54
Second Amended and Restated Distribution Agreement effective as
of October 1, 2010 between the registrant and Integrated
Commercialization Solutions, Inc.
21
Subsidiaries of the registrant
23
Consent of Ernst & Young LLP, Independent Registered
Accounting Firm
31
.1
Chief Executive Officer Certification pursuant to
Rule 13a-14(a)
of the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
31
.2
Chief Financial Officer Certification pursuant to
Rule 13a-14(a)
of the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32
.1
Chief Executive Officer Certification pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
32
.2
Chief Financial Officer Certification pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
101
.INS
The following materials from The Medicines Company Annual Report
on
Form 10-K
for the year ended December 31, 2010, formatted in XBRL
(Extensible Business Reporting Language): (i) the
Consolidated Balance Sheet, (ii) the Consolidated Statement
of Operations, (iii) the Consolidated Statement of Cash
Flow, and (iv) Notes to Consolidated Financial Statements,
tagged as blocks of text.
*
Management contract or compensatory plan or arrangement filed as
an exhibit to this form pursuant to Items 15(a) and 15(c)
of
Form 10-K
Confidential treatment requested as to certain portions, which
portions have been omitted and filed separately with the
Securities and Exchange Commission Unless otherwise indicated,
the exhibits incorporated herein by reference were filed under
Commission file number
000-31191.
Re: | Option Agreement regarding Clevidipine entered into by and between AstraZeneca AB (AstraZeneca) and The Medicines Company, on 5 March 2002, with subsequent amendments dated 31 July 2002 and 20 November 2002, (the Option Agreement) |
Bank name:
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[**] | |
Account No.:
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[**] | |
Swift:
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[**] |
Yours sincerely, | Agreed and accepted | |||
|
||||
AstraZeneca AB (publ) | Date: | |||
|
||||
[illegible] |
The Medicines Company
|
|||
Name:
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/s/ Clive Meanwell | |||
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Name: Clive Meanwell | |||
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||||
cc:
|
Steven D. Singer | |||
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Hale and Dorr | |||
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60 State Street | |||
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Boston, MA 02109 | |||
|
United States |
Article | Page | |||
1. Definitions
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ii | |||
2. Grant of License
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8 | |||
3. Development and Commercialisation
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9 | |||
4. Supply Matters
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15 | |||
5. Exchange of Information
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16 | |||
6. Consideration
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17 | |||
7. Intellectual Property Prosecution and Maintenance
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22 | |||
8. Claims Regarding Infringement and Invalidity
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23 | |||
9. Trademark
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25 | |||
10. Indemnity
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27 | |||
11. Confidentiality
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29 | |||
12. Adverse Events
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30 | |||
13. Representation and Warranty
|
30 | |||
14. Term and Termination
|
32 | |||
15. Consequences of Termination
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33 | |||
16. Force Majeure
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36 | |||
17. General Provisions
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36 | |||
- Assignment
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36 | |||
- Severance
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36 | |||
- Notices
|
37 | |||
- Contact Information
|
37 | |||
- Agency, Partnership or Joint Venture Excluded
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37 | |||
- Entire Agreement
|
38 | |||
- Agreement to Supersede earlier Agreements
|
38 | |||
- Amendments
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38 | |||
- Publicity and Announcements
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38 | |||
- Waiver
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38 | |||
- No Benefit to Third Parties
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38 | |||
18. Governing Law and Arbitration
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38 |
i
ii
2
3
a) | [**] and/or [**]; | ||
b) | amounts [**] determined in good faith; | ||
c) | [**] such sales; and |
4
d) | [**] the Product. |
5
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7
8
9
10
11
12
(i) | In case of non-compliance with the performance criteria set forth in Articles 3.4.2 or 3.7.1 ASTRAZENECA shall have the right, by giving ninety (90) days written notice to TMC, to require the license granted hereunder to terminate regarding the Compound and the Product, subject to Article 3.8.3. |
13
(ii) | In case of non-compliance with the performance criteria set forth in Articles 3.5.2, 3.5.5, 3.6.2, 3.7.2 (a) or 3.7.3, ASTRAZENECA shall have the right, by giving ninety (90) days written notice to TMC, to require the license granted hereunder to terminate regarding the Compound and the Product in the Major Market or other country concerned, subject to Article 3.8.3. | ||
(iii) | In case of non-compliance with the performance criteria set forth in Article or 3.7.2 (b) or (c), ASTRAZENECA shall have the right, by giving ninety (90) days written notice to TMC, to require the license granted hereunder to terminate regarding the Compound and the Product in any Major Market(s) other than the Major Market(s) regarding which the performance criteria concerned was fulfilled (and, in the case of non-compliance with Article 3.7.2 (c), the Major Market(s) regarding which such criteria had been fulfilled under Article 3.7.2 (b)), subject to Article 3.8.3. | ||
(iv) | If ASTRAZENECA makes a request under (i), (ii) or (iii) above, and provided that TMC has not remedied the default concerned within the ninety-days period stated, then, provided that ASTRAZENECA notifies TMC in writing hereof within thirty (30) days upon the expiration of such ninety-days period, the license regarding the Major Market or other country contemplated by such notice for the Compound and the Product shall terminate and what is stated in Article 15.1 shall apply regarding such Major Market or other country subject to Article 3.8.3. |
14
15
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17
Annual Net Sales | Royalty Rate | |
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[**] | |
[**]
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[**] | |
[**]
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[**] | |
[**]
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[**] | |
[**]
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[**] | |
[**]
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[**] | |
[**]
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[**] |
18
19
20
21
22
23
24
25
(a) | the exclusive license insofar as it relates to the ASTRAZENECA Trademark under Article 2.1 shall immediately cease and the ASTRAZENECA Trademark shall cease to be a part of the ASTRAZENECA IP for all purposes of this Agreement; | ||
(b) | all rights so granted in the ASTRAZENECA Trademark to TMC shall revert to ASTRAZENECA; | ||
(c) | TMC shall immediately return to ASTRAZENECA any ASTRAZENECA Know-How relating to the ASTRAZENECA Trademark and grant to ASTRAZENECA a non-exclusive, perpetual, remuneration-free and world-wide license to use any Know-How developed by TMC relating to the ASTRAZENECA Trademark for the purpose of commercialising the Product. |
26
27
28
29
30
31
32
(a) | at the option of ASTRAZENECA, grant to ASTRAZENECA a non-exclusive, world-wide or for the country concerned, whichever is applicable, sub-licensable licence under the TMC IP to develop, have developed, make, have made, use, have used, import, have imported, market, have marketed, sell and have sold the Compound and the Product for any indications. The term of such non-exclusive licence shall continue on a country by country basis for the longer of the life of the TMC Patent Rights, or for ten (10) years from first commercial sale of any resultant product in such country by ASTRAZENECA, its Affiliates, sub-licensees or nominees, whichever is the longer. TMC shall do all such acts and things as may reasonably be necessary to fulfil this obligation. The licence set out in this Article 15.1 (a) shall be royalty-free and free from any other remuneration. | ||
(b) | return to ASTRAZENECA any ASTRAZENECA Know-How and deliver to ASTRAZENECA a copy of any TMC Know-How; | ||
(c) | deliver to ASTRAZENECA any and all quantities of Product in its possession, power, custody or control subject always to TMCs right to dispose of Product which is the subject of pre-termination date orders pursuant to Article 15.1 (h). For the avoidance of doubt, should this Article 15.1 (c) become applicable because of termination regarding a certain country or countries pursuant to Article 3.8, then the quantities of Product referred to herein shall mean only those quantities clearly designated, by marking, labelling or similar, for the country or countries concerned and which could only be used for the country or countries concerned; |
33
(d) | ensure that its patent attorneys transfer to ASTRAZENECA a copy of the patent files relating to the TMC Patent Rights which TMC has been prosecuting and maintaining and ASTRAZENECA shall be entitled to prosecute and shall maintain such TMC Patent Rights at its own cost and expense on terms similar to those set out in Article 7.3 and to deal with infringers on terms similar to those set out in Article 8.2 and 8.3. TMC further undertakes to take any action and produce any documents so as to enable ASTRAZENECA to apply for patent term extensions, including, but not limited to, Supplementary Protection Certificates, relating to the TMC Patent Rights in ASTRAZENECAs name. | ||
(e) | Should this Article 15.1 become applicable because of the termination of the license regarding a certain country or countries pursuant to Article 3.8, then TMC shall, notwithstanding the license granted under Article 15.1 (a), on the request by ASTRAZENECA continue to prosecute, maintain and defend the TMC Patent Rights. | ||
(f) | commensurate with legislative and regulatory requirements, transfer to ASTRAZENECA or its nominee all NDA Approvals, and regulatory filings for the Compound or Product (including, without limitation, all information and documentation used in the Filings of an NDA and NDA approvals referred to in Article 3.5.2 and 3.5.4). In the event that in any country such a transfer is not possible, TMC shall use reasonable endeavours to ensure that ASTRAZENECA has the benefit of the relevant NDA Approvals, NDAs and other related regulatory filings and approvals and, to this end, consents to any regulatory authority cross-referencing to the data and information on file with any regulatory authority as may be necessary to facilitate the granting of second NDA Approvals to and permit Filings of an NDA by ASTRAZENECA, and TMC agrees to complete whatever other procedures that are reasonably necessary in relation to the same to enable ASTRAZENECA (either itself or in conjunction with a Third |
34
Party) freely to develop and sell the Product in substitution for TMC; |
(g) | if applicable, assign the TMC Trademark or grant a royalty-free exclusive licence to ASTRAZENECA to use the TMC Trademark for the marketing, sales and distribution of the Product; | ||
(h) | not after the date of termination itself take any further action to develop, manufacture, have manufactured, use, market, distribute or sell the Compound or Product during the life of the TMC Patent Rights or the ASTRAZENECA Patent Rights, whichever is the longer, except that TMC has the right to dispose of that part of its inventory of Product on hand as of the effective date of termination which is the subject of orders for Product accepted prior to the date of notice of termination for a period of three (3) months after the effective date of termination, and, within thirty (30) days after disposition of such inventory pursuant to the fulfilment of such orders, TMC will forward to ASTRAZENECA a final report and pay all royalties due on the Net Sales of Product during such period; and | ||
(i) | provide ASTRAZENECA, should ASTRAZENECA so require, with reasonable assistance in relation to ASTRAZENECAs appointment of a Third Party manufacturer of Product. |
35
36
For ASTRAZENECA | ||
Address: AstraZeneca AB, S151 85 Södertälje, Sweden
Facsimile: +46-8 553 290 00 For the attention of: President & CEO |
||
For TMC | ||
Address: The Medicines Company, 5 Sylvan Way, Parsippany,
New Jersey 07054, United States Facsimile: +1-973-656-9898 For the attention of: Clive Meanwell, Executive Chairman |
||
with a copy to | ||
Steven D. Singer
Hale and Dorr, LLP 60 State Street Boston MA 02109 United States |
37
38
ASTRAZENECA AB
|
THE MEDICINES COMPANY | |
|
||
(publ)
|
39
Family
|
: | A1262 | ||
App./Propr
|
: | Astra AB | ||
Title
|
: | Short acting dihydropyridines | ||
Inventors
|
: | ANDERSSON, Kjell | ||
|
NORDLANDER, Margareta | |||
|
WESTERLUND, Christer |
Country | SN | F | App No | App Date | Pat No. | Grant Dt. | Exp. Dt | Status | ||||||||
Argentina
|
1 | 329878 | 24.10.1994 | 253845 | 13.12.1999 | 13.12.2014 | Granted | |||||||||
Argentina
|
2 | 980104360 | 01.09.1998 | Filed | ||||||||||||
Austria
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Australia
|
1 | P | 81196/94 | 03.11.1994 | 685532 | 07.05.1998 | 03.11.2014 | Granted | ||||||||
Belgium
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Brazil
|
2 | PI110048-7 | 06.05.1997 | Filed | ||||||||||||
Canada
|
1 | P | 2174969 | 03.11.1994 | Filed | |||||||||||
Switzerland
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
China P.R.
|
1 | P | 94194500.6 | 03.11.1994 | 94194500.6 | 20.11.1999 | 03.11.2014 | Granted | ||||||||
Czech Republ
|
1 | P | PV1273/96 | 03.11.1994 | 285691 | 17.08.1999 | 03.11.2014 | Granted | ||||||||
Germany
|
1 | X | 95900347.6 | 03.11.1994 | 6942515.2 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Denmark
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Estonia
|
1 | P | P9600051 | 03.11.1994 | 03230 | 20.10.1999 | 03.11.2014 | Granted | ||||||||
Egypt
|
1 | 689/94 | 02.11.1994 | 20539 | 31.07.1999 | 03.11.2004 | Granted | |||||||||
European Pat
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Spain
|
1 | X | 95900347.6 | 03.11.1994 | ES2150544 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Finland
|
1 | P | 961914 | 03.11.1994 | Filed | |||||||||||
France
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Great Britain
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Greece
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Hong Kong
|
1 | 98114638.2 | 02.12.1998 | 1013292 | 08.12.2000 | 03.11.2014 | Granted | |||||||||
Hungary
|
1 | P | P9601187 | 03.11.1994 | 215591 | 04.12.1998 | 03.11.2014 | Granted | ||||||||
Indonesia
|
1 | P-941873 | 02.11.1994 | ID0004550 | 06.12.1999 | 02.11.2014 | Granted | |||||||||
Ireland
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Israel
|
1 | 111127 | 03.10.1994 | 111127 | 22.02.2001 | 03.10.2014 | Granted | |||||||||
Iceland
|
1 | 4218 | 30.09.1994 | 1674 | 31.12.1997 | 30.09.2014 | Granted | |||||||||
Italy
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Korea South
|
1 | P | 96/702346 | 03.11.1994 | Filed | |||||||||||
Lithuania
|
1 | X | 95900347.6 | Docketed | ||||||||||||
Luxembourg
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Latvia
|
1 | E | Docketed | |||||||||||||
Monaco
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Mexico
|
1 | 948392 | 28.10.1994 | 196540 | 22.05.2000 | 28.10.2014 | Granted | |||||||||
Malaysia
|
1 | PI94002934 | 04.11.1994 | MY111770A | 30.12.2000 | 30.12.2015 | Granted | |||||||||
Netherlands
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Norway
|
1 | P | 961776 | 03.11.1994 | 305656 | 05.07.1999 | 03.11.2014 | Granted |
1
Country | SN | F | App No | App Date | Pat No. | Grant Dt. | Exp. Dt | Status | ||||||||
New Zealand
|
1 | P | 275915 | 03.11.1994 | 275915 | 29.09.1997 | 03.11.2014 | Granted | ||||||||
Philippines
|
1 | 49112 | 04.10.1994 | 1-1994-49112 | 28.04.2000 | 28.04.2017 | Granted | |||||||||
Poland
|
1 | P | P314128 | 03.11.1994 | Filed | |||||||||||
Portugal
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Russian Fed
|
1 | P | 96112152 | 03.11.1994 | 2139278 | 10.10.1999 | 03.11.2014 | Granted | ||||||||
Saudi Arabia
|
1 | 94150250 | 19.10.1994 | Filed | ||||||||||||
Sweden
|
1 | 9303657-2 | 05.11.1993 | Inactive | ||||||||||||
Sweden
|
1 | X | 95900347.6 | 03.11.1994 | 0726894 | 05.07.2000 | 03.11.2014 | Granted | ||||||||
Slovak Repub
|
1 | P | PV0559/96 | 03.11.1994 | 281467 | 10.01.2001 | 03.11.2014 | Granted | ||||||||
Thailand
|
1 | 024372 | 04.11.1994 | Filed | ||||||||||||
Taiwan
|
1 | 83108995 | 29.09.1994 | NI-078831 | 15.10.1996 | 29.09.2014 | Granted | |||||||||
Ukraine
|
1 | P | 96041753 | 03.11.1994 | Filed | |||||||||||
United States
|
1 | P | 356224 | 03.11.1994 | 5856346 | 05.01.1999 | 05.01.2016 | Granted | ||||||||
South Africa
|
1 | 94/7570 | 28.09.1994 | 94/7570 | 26.07.1995 | 28.09.2014 | Granted |
2
Family
|
: | A1279 | ||
App./Propr
|
: | Astra AB | ||
Title
|
: | Pharmaceutical emulsion | ||
Inventors
|
: | ANDERSSON, Kjell | ||
|
BYRÖD, Eva | |||
|
NORDLANDER, Margareta | |||
|
WESTERLUND, Christer | |||
|
HANSSON, Anna-Carin |
Country | SN | F | App No | App Date | Pat No. | Grant Dt. | Exp. Dt | Status | ||||||||
Argentina
|
1 | 330005 | 04.111994 | 255314 | 01.11.2001 | 01.11.2016 | Granted | |||||||||
Argentina
|
2 | 990105741 | 11.11.1999 | Filed | ||||||||||||
Austria
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Australia
|
1 | P | 10371/95 | 03.11.1994 | 678650 | 25.09.1997 | 03.11.2014 | Granted | ||||||||
Belgium
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Brazil
|
1 | P | Inactive | |||||||||||||
Canada
|
1 | P | 2176360 | 03.11.1994 | Filed | |||||||||||
Switzerland
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
China P.R.
|
1 | P | 94194111.6 | 03.11.1994 | 94194111.6 | 11.08.2001 | 03.11.2014 | Granted | ||||||||
Czech Republ
|
1 | P | PV1338/96 | 03.11.1994 | Filed | |||||||||||
Germany
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Denmark
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Estonia
|
1 | P | P9600052 | 03.11.1994 | 03223 | 20.10.1999 | 03.11.2014 | Granted | ||||||||
Egypt
|
1 | 710/94 | 09.11.1994 | 20764 | 31.01.2000 | 09.11.2014 | Granted | |||||||||
European Pat
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Spain
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Finland
|
1 | P | 961999 | 03.11.1994 | Filed | |||||||||||
France
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Great Britain
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Greece
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Hong Kong
|
1 | 98114639.1 | 22.12.1998 | Filed | ||||||||||||
Hungary
|
1 | P | P9601268 | 03.11.1994 | Filed | |||||||||||
Indonesia
|
1 | P-941957 | 11.11.1994 | ID0004476 | 01.11.1999 | 11.11.2014 | Granted | |||||||||
Ireland
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Israel
|
1 | 111345 | 20.10.1994 | 111345 | 03.12.2000 | 20.10.2014 | Granted | |||||||||
Iceland
|
1 | 4224 | 21.10.1994 | Filed | ||||||||||||
Italy
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Korea South
|
1 | P | 96/702485 | 03.11.1994 | Filed | |||||||||||
Liechtenstei
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Lithuania
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Luxembourg
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Latvia
|
1 | E | Docketed | |||||||||||||
Monaco
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Mexico
|
1 | 948732 | 10.11.1994 | Filed |
3
Country | SN | F | App No | App Date | Pat No. | Grant Dt. | Exp. Dt | Status | ||||||||
Malaysia
|
1 | PI94003029 | 14.11.1994 | Filed | ||||||||||||
Netherlands
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Norway
|
1 | P | 961898 | 03.11.1994 | Filed | |||||||||||
New Zealand
|
1 | P | 276197 | 03.11.1994 | 276197 | 18.09.1997 | 03.11.2014 | Granted | ||||||||
Philippines
|
1 | 49235 | 25.10.1994 | Filed | ||||||||||||
Poland
|
1 | P | P314263 | 03.11.1994 | 181462 | 31.07.2001 | 03.11.2014 | Granted | ||||||||
Portugal
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Russian Fed
|
1 | P | 96112112 | 03.11.1994 | 2144358 | 20.01.2000 | 03.11.2014 | Granted | ||||||||
Saudi Arabia
|
1 | 94150314 | 13.11.1994 | Filed | ||||||||||||
Sweden
|
1 | X | 95900965.5 | 03.11.1994 | 0727997 | 13.02.2002 | 03.11.2014 | Granted | ||||||||
Slovak Repub
|
1 | P | PV0597/96 | 03.11.1994 | Filed | |||||||||||
Thailand
|
1 | 024457 | 11.11.1994 | Filed | ||||||||||||
Ukraine
|
1 | P | 96051803 | 03.11.1994 | 40633 | 15.08.2001 | 03.11.2014 | Granted | ||||||||
United States
|
1 | P | 08/364953 | 03.11.1994 | 5739152 | 14.04.1998 | 14.04.2015 | Granted | ||||||||
South Africa
|
1 | 94/8180 | 18.10.1994 | 94/8180 | 26.07.1995 | 18.10.2014 | Granted |
4
Family
|
: | A2004 | ||
Appl./Propr
|
: | AstraZeneca AB | ||
Title
|
: | NEW MANUFACTURING PROCESS |
Country | SN | F | App No | App Date | Pat No. | Grant Dt. | Exp. Dt | Status | ||||||||
Australia
|
1 | P | 20105/00 | 22.11.1999 | Filed | |||||||||||
Canada
|
1 | P | 2349195 | 22.11.1999 | Filed | |||||||||||
European Pat
|
1 | X | 99963732.5 | 22.11.1999 | Filed | |||||||||||
Hong Kong
|
1 | [**] | [**] | Filed | ||||||||||||
New Zealand
|
1 | P | 511503 | 22.11.1999 | Filed | |||||||||||
United States
|
1 | P | 09/508260 | 22.11.1999 | Filed | |||||||||||
South Africa
|
1 | P | 2001/3434 | 22.11.1999 | Filed |
5
1
2
3
1
2
1
2
- i -
- ii -
:
CLEVELOX
:
A02243
:
MST
:
MST
:
Clevidipine
:
20298
:
20298
:
Cardio vascular
:
Country
SN
Appl De
Reg. Dt
Reg No
Expir. Dt
Status
1
Inactive
1
05.12.1997
Inactive
1
24.11.1997
06.02.1998
173947
29.02.2008
Registered
1
26.11.1997
26.11.1997
749529
26.11.2007
Registered
1
Inactive
1
21.11.1997
21.11.1997
622377
21.11.2007
Registered
1
16.12.1997
Filed
1
21.11.1997
02.04.1998
450528
21.11.2007
Registered
1
28.11.1997
14.02.1999
1246211
14.02.2009
Registered
1
03.12.1997
Filed
1
03.12.1997
27.05.1999
217843
03.12.2007
Registered
1
22.11.1997
30.01.1998
39756082
30.11.2007
Registered
1
21.11.1997
15.09.1998
199802513
15.09.2008
Registered
1
01.12.1997
Filed
1
26.11.1997
20.05.1998
2128403
26.11.2007
Registered
1
21.11.1997
13.11.1998
211790
13.11.2008
Registered
1
24.11.1997
24.11.1997
97705657
24.11.2007
Registered
1
21.11.1997
21.11.1997
2151563
21.11.2007
Registered
1
17.11.1997
17.11.1999
135252
17.11.2007
Registered
1
08.12.1997
08.12.1997
3239/99
08.12.2004
Registered
1
27.11.1997
08.02.1999
155530
27.11.2007
Registered
1
12.12.1997
12.12.1997
427623
12.12.2007
Registered
1
30.10.1997
21.11.1997
208749
21.11.2007
Registered
1
24.11.1997
07.02.1999
116095
24.11.2004
Registered
1
26.11.1997
Filed
1
24.11.1997
28.01.1998
210/1998
28.01.2008
Registered
1
25.11.1997
18.05.2000
813581
25.11.2007
Registered
1
09.01.1998
02.04.1999
4257306
02.04.2009
Registered
2
17.04.2000
07.09.2001
4504229
07.09.2011
Registered
1
27.11.1997
27.11.1998
431337
27.11.2008
Registered
1
04.12.1997
04.12.1997
568689
04.12.2007
Registered
1
28.11.1997
Filed
1
21.11.1997
18.06.1998
190954
18.06.2008
Registered
1
25.11.1997
25.11.1997
285223
25.11.2004
Registered
Country
SN
Appl De
Reg. Dt
Reg No
Expir. Dt
Status
1
25.11.1997
Filed
1
25.11.1997
06.03.2001
123629
25.11.2007
Registered
1
25.11.1997
15.05.1998
327385
15.05.2008
Registered
1
05.12.1997
05.12.1997
33325
05.12.2007
Registered
1
03.12.1997
24.02.1999
172676
03.12.2007
Registered
1
12.01.1998
12.01.1998
474/30
22.09.2007
Registered
1
21.11.1997
06.08.1999
332270
06.08.2009
Registered
1
15.12.1997
Filed
1
25.11.1997
14.12.1999
188597
25.11.2007
Registered
1
09.12.1997
09.12.1997
80071
09.12.2007
Registered
1
26.12.1997
26.12.1997
195964
26.12.2007
Registered
1
04.12.1997
16.10.1998
820735
16.10.2008
Registered
1
21.11.1997
Inactive
2
19.04.2001
Filed
1
05.01.1998
07.05.1999
30808
05.01.2008
Registered
1
01.12.1997
01.12.1997
97/18422
01.12.2007
Registered
Report
Pages
Comment
7
10+6
12
15
21
9
2
2
2
24
15
Written in English
7
17
15
6
33
6
17
Written in English
5
Written in English
22
Clevidipine, delivered batch 401/97
26
28
23
10-20
AstraZeneca AB
S-151 85 Sodertalje
Sweden
Facsimile No.: 46 8 553 233 00
Re:
License Agreement regarding Clevidipine, effective as of March 28, 2003
Executive Chairman
cc:
Dr. Margareta Nordlander
Dr. Anders Waas
THE MEDICINES COMPANY
/s/ Clive Meanwell
Name: Clive Meanwell
Title: Executive Chairman
1. | Capitalized terms used herein but not otherwise defined herein, shall have the meanings provided in the Agreement. | |
2. | Article 1.26 is amended and restated as follows: |
1.26. | Major Market shall mean each of [**]. |
3. | Article 1.45 is amended and restated as follows: |
1.45. | Territory shall mean every country in the world. |
4. | Article 2.6 is deleted in its entirety. | |
5. | Article 2.7 is deleted in its entirety. | |
6. | Article 3.7.2 is amended and restated as follows: |
(a) | TMC shall no later than 30 September 2007 have made a Filing of an NDA in the United States. | ||
(b) | TMC shall no later than 30 September 2008 or twelve (12) months after having made a Filing of an NDA in the United States, whichever is the earlier, have made a filing of an NDA in at least three (3) additional Major Markets, provided, however, that if such Filing of an NDA has been made in the European Union then one (1) Major Market shall be sufficient. | ||
(c) | TMC shall, subject to what is stated in the second paragraph hereof, no later than 30 September 2009 or twelve (12) months after having made the last Filing of an NDA under Article 3.7.2(b), whichever is the earlier, have made a Filing of an NDA in all Major Markets. | ||
Notwithstanding what is now stated, TMC shall no later than 31 December 2010 have made a Filing of an NDA in Japan. |
7. | Article 4.3.1 is amended and restated as follows: |
4.3.1. | Subject to Article 15.1(i), TMC undertakes to supply ASTRAZENECA, ASTRAZENECAs entire need of Product for clinical trials, sale, promotion and marketing in any country where the license granted under Article 2 has been terminated pursuant to Article 3.8 as more fully set forth in that certain Supply Agreement dated June 24, 2004 as amended from time to time (the Supply Agreement). |
8. | Article 4.3.2 is deleted in its entirety | |
9. | Article 5.1.4 is amended and restated as follows: |
5.1.4. | TMC shall notify ASTRAZENECA forthwith regarding, and provide copies of, any correspondence with the regulatory authorities in the Territory that could reasonably be of any significance regarding the possibility, time frame or scope of any Filing of an NDA or any NDA Approval or which may otherwise relate to such Filing of an NDA or NDA Approval. |
10. | Article 6 is amended by removal of the words a final milestone payment in in Article 6.1.5 and the addition of the following Article 6.1.6.: |
6.1.6. | Within thirty (30) days of TMCs receipt of NDA Approval in the fourth Major Market, TMC shall pay to ASTRAZENECA the amount of USD [**] ($[**]). |
11. | Article 6.6.2 is deleted in its entirety. | |
12. | Article 8.3.5 is amended and restated as follows: |
8.3.5. | ASTRAZENECA, its Affiliates or sub-licensees shall have the sole right to commence an action for infringement of the |
ASTRAZENECA IP in any country in which the license granted to TMC hereunder has reverted to ASTRAZENECA pursuant to Article 3.8 against the Third Party, in its own name, together with the right to enforce and collect any judgement thereon. TMC may join such proceedings voluntarily, subject always to ASTRAZENECAs, its Affiliates or sub-licensees right to decide the conduct of such litigation. Any such joining of the proceedings shall be at TMCs cost and expense. TMC shall for such purpose have the right to independently retain legal counsel and consultants, at its sole cost and expense. Any monetary recovery (whether by settlement or judgement) in connection with an infringement action commenced by ASTRAZENECA under this Article 8.3.5 shall be retained by ASTRAZENECA. |
13. | Where an Article is deleted pursuant to this Amendment no other provision will take the number of such former Article, and the number of the deleted Article will remain in the Agreement with no wording attached to it. | |
14. | Upon execution of this Amendment No. 1, TMC shall pay to ASTRAZENECA the amount of USD [**] ($[**]). | |
15. | This Amendment No. 1 shall be deemed to be part of the Agreement and, as modified in accordance herewith, the Agreement is hereby ratified and declared in full force and effect. This Amendment No. 1 shall be effective as of the date first written above. |
ASTRAZENECA AB (publ)
|
THE MEDICINES COMPANY | |||
|
||||
Signature: /s/ Gunnar Olsson
|
Signature: /s/ John Kelley | |||
Name: Gunnar Olsson
|
Name: John Kelley | |||
Title: Vice President, Head of CVGI Therapy
|
Title: President, C.O.O. | |||
Area
|
THE MEDICINES COMPANY | ||||||
|
||||||
|
By: | /s/ Glenn P. Sblendorio | ||||
|
||||||
|
Name: | Glenn P. Sblendorio | ||||
|
Title: |
Executive Vice President and
Chief Financial Officer |
||||
|
||||||
PARTICIPANT | ||||||
|
||||||
|
||||||
|
/s/ Clive A. Meanwell | |||||
|
Clive A. Meanwell |
1.0 | DEFINITIONS |
1.1 | Applicable Law means all applicable ordinances, rules, regulations, laws, requirements and court orders of any kind whatsoever of any United States or state government regulatory authority as may be amended from time to time. | ||
1.2 | Authorized Distributor of Record means a licensed pharmaceutical distributor or wholesaler formally authorized in writing by MDCO to purchase, market, promote, sell, and distribute Products. | ||
1.3 | Bill-To Customer(s) means (i) under the Drop Ship Channel, the Wholesalers, and (ii) under the Direct Channel, the End-User. | ||
1.4 | Continuing Guaranty means the Continuing Guaranty and Indemnification Agreement dated October 8, 2002, executed and delivered by MDCO in favor of Distributors parent corporation, AmerisourceBergen Corporation, a copy of which is attached hereto as Schedule B . | ||
1.5 | Direct Channel shall be the method of distribution of the Products under which the End-User orders the Products directly from the Distributor and the Distributor ships and sells the Products to, and invoices, the End-User directly. | ||
1.6 | Distributor Indemnitees has the meaning set forth in Section 11.1. |
1.7 | Drop Ship Channel shall be the method of distribution of the Products under which the End-User orders the Products from a Wholesaler and the Distributor sells the Products to, and invoices, the Wholesaler and ships the Products to the End-User. | ||
1.8 | Parties means MDCO and Distributor together, and Party means either of them as the context requires. | ||
1.9 | Product(s) means the pharmaceutical products described in the Commercial Price List attached hereto as Exhibit B , which may be amended from time to time by MDCO. | ||
1.10 | Records has the meaning set forth in Section 7. | ||
1.11 | End-Users means the hospitals or other acute care facilities which purchase Product from Distributor and are the end users of the Products. | ||
1.12 | Territory means the United States; the Commonwealth of Puerto Rico; and the territories of Guam, American Samoa, and the Virgin Islands. | ||
1.13 | MDCO Contracts means those contracts between MDCO and certain End-Users, group purchasing organizations that contract on behalf of their members to purchase the Products, and MDCOs government-managed or regulated pricing arrangements. | ||
1.14 | MDCO Indemnitees has the meaning set forth in Section 10.2. | ||
1.15 | Wholesaler means those customers identified in Section 8 in the Operating Guidelines attached hereto as Exhibit A , which may be amended by mutual written agreement signed by the Parties. | ||
1.16 | Term has the meaning set forth in Section 12.2. |
2.0 | APPOINTMENT AS AUTHORIZED DISTRIBUTOR OF RECORD |
2.1 | Primary Distributor . MDCO hereby appoints Distributor, and Distributor hereby accepts appointment, as the primary Authorized Distributor of Record for the Products in the Territory during the Term. During the Term, so long as Distributor is not in default under this Agreement, MDCO shall not sell Products to any person or entity in the Territory, other than Distributor. | ||
2.2 | Other ADRs . Notwithstanding anything to the contrary in Section 2.1, MDCO may appoint other distributors or wholesalers as Authorized Distributors of Record for the purpose of acknowledging a business relationship with such named distributors or wholesalers, purchasing the Products from the Distributor and selling the Products to End-Users within the Territory. |
3.0 | DISTRIBUTION SERVICES AND OBLIGATIONS OF DISTRIBUTOR |
3.1 | Product Ordering . Distributor will place orders for Products with MDCO or its designee by EDI or by faxing (866) 860-3566 or such other number as MDCO may designate. Distributor will place such orders on Monday of each week or the following business day if Monday is a holiday. Distributor will place orders for such quantities of Product as are necessary to maintain an appropriate level of inventory based on End Users historical |
2
purchase volumes. Any purchase order not rejected in whole or in part by MDCO within two (2) business days after receipt will be deemed accepted. | |||
3.2 | Inspection, Storage, and Handling of Products . |
3.2.1 | Distributor shall examine Product shipments upon delivery and shall notify MDCO (a) no later than fifteen (15) days following receipt of Product with defects reasonably discoverable upon visual inspection without unloading individual shipping units; or (b) for defects not reasonably discoverable by visual inspection, no later than fifteen (15) days after Distributor learns or is notified of such defect. Along with notice of any defects, Distributor shall furnish to MDCO a written description of the nature of the defect. Upon receipt of notice of any defect in accordance with this Section 3.2.1, MDCO, at its option, shall issue a return authorization and replace any defective Product unit or issue Distributor a credit in the full amount of the purchase price of the Product. Distributor will, at MDCOs request and expense, follow MDCOs instructions to return to MDCO or MDCOs third party disposal company any Product unit delivered to Distributor that contains a defect. Distributor shall reasonably cooperate with MDCO in investigating the cause of any defect in a Product unit. | ||
3.2.2 | Distributor agrees to store the Products, at all times, in accordance with Exhibit A and with the storage requirements set forth in the current approved product labeling for the Products. Distributor will store the Products at its distributor centers located at 345 International Boulevard, Brooks, KY 40109 and/or 5360 Capital Court, Reno, NV 89502. Distributor will not store Products at any other facility without notifying MDCO and obtaining MDCOs prior written approval. |
3.3 | Product Distribution . |
3.3.1 | Distributor will use commercially reasonable efforts to promote and to distribute the Product in the Territory, in accordance with the standards and procedures set forth in Exhibit A . Such efforts will include: |
(a) | maintaining, promoting and distributing current price list | ||
(b) | providing a dedicated customer service team; | ||
(c) | setting up accounts for all Bill-To Customers; | ||
(d) | approving or denying business applications for potential customers; | ||
(e) | taking and processing orders on a daily basis (Monday Friday only); | ||
(f) | validating active DEA licenses for End-Users to whom Products are being shipped; and | ||
(g) | picking, packing and arranging for delivery of Products on the next business day via Next Day Saver for orders placed prior to Distributors normal order cut-off time. MDCO to reimburse Distributor the cost difference for upgrading from Ground to Next Day Saver Freight in compliance with Exhibit D, Fee Schedule. |
3.3.2 | Distributor will comply with Exhibit A , Operating Guidelines, in all respects in its performance of the distribution services. | ||
3.3.3 | Distributor will sell Products to Bill-To Customers upon approval of Distributors then-current business application. |
3
3.3.4 | Distributor acknowledges that it has current commercial agreements with the Wholesalers identified in Exhibit A, Section 8.2 and will not sell or ship Product to pharmaceutical distributors or wholesalers not designated as ADR by MDCO, or to retail (non-acute care) pharmacies. | ||
3.3.5 | End-Users may purchase the Products through the Direct Channel or the Drop Ship Channel. Under the Direct Channel, the End-User will order and purchase Products directly from Distributor and will be both the Bill-To Customer and the End-User. Under the Drop Ship Channel, the End-User will order and purchase Products from a Wholesaler and the Distributor will ship Products only to the End-User that purchased such Products and will sell Products to and invoice the Wholesaler Bill-To Customer. Distributor will be responsible for ensuring that each End-User to whom the Products are shipped by Distributor will be, at the time of shipment, eligible under Applicable Law to receive such shipments, and that the Drop-Ship order originated with the Wholesaler. End-Users shall not be allowed to place Drop-Ship orders except through their respective Wholesaler mechanism. | ||
3.3.6 | Distributor will have sole responsibility for determining the prices at which it sells the Products to its customers; provided, however, that such prices will not exceed MDCOs wholesale acquisition cost (WAC), as determined at the time of sale to Bill-To Customer. Distributor will maintain, publish and promote current price list. | ||
3.3.7 | In the event of a shortage of the Products, Distributor will allocate available supplies of Products among its End-Users in a commercially-reasonable manner in accordance with such End-Users utilization of the Products during the preceding twelve-month period. |
3.4 | Distributor Personnel . Distributor will provide a dedicated team of representatives to deal with customers. Distributor will be responsible for ensuring that all personnel dealing with customers are properly trained to perform their duties in accordance with Applicable Law. MDCO and Distributor will work together to develop an orientation program and training materials for Distributor personnel to use upon request from Distributor. | ||
3.5 | Maintenance and Transfer of Data . Distributor will maintain current and accurate records for the sale and distribution of Products. Distributor will make available to MDCO detailed Products activity (inventory), Product transfer (sales/returns), order and shipment data (Data) as described in Exhibit C . MDCO will compensate Distributor according to the fee schedule set forth in Exhibit D for additional Data not described in Exhibit A or Exhibit C . Distributor will not provide Data to any third party without MDCOs prior written approval, except that Distributor may provide Data in accordance with Applicable Law to First DataBank, Wolters Kluwer, IMS Health, Inc., NDCHealth Corporation or other third party data aggregators without the approval of MDCO. | ||
3.6 | MDCO Contracts . Distributor will recognize and administer MDCO Contracts, under which MDCO and certain End-Users and/or group purchasing organizations have established prices and may purchase the Product, as well as MDCOs government-managed or regulated pricing arrangements, subject to the continued validity of MDCO Contracts in accordance with Applicable Law, including without limitation the Federal Anti-kickback Statute, 42 U.S.§ 1320a-7b. Distributor will administer MDCO Contracts |
4
under this Agreement in accordance with the chargeback procedures set forth in Exhibits A and E. | |||
3.7 | Disaster Recovery . Distributor will maintain a disaster recovery plan for its warehouse premises, which will include, at a minimum, a back-up warehouse facility, and plans for maintaining customer services, Product ordering, Data maintenance and transfer, and other systems capabilities. | ||
3.8 | Returns . |
a) | Product not in the original packaging, product whose contents have been adulterated, or which shows signs of tampering. | ||
b) | Product obtained in violation of applicable regulations. | ||
c) | Product damaged or made unsalable due to improper storage, handling or shipping by customer and/or distributor. | ||
d) | Product involved in a fire sale, sacrifice or bankruptcy sale, or which has been acquired in other than normal channels of trade distribution. | ||
e) | Product sold on a non-returnable basis. | ||
f) | Product damaged by fire or water and/or other insurable hazards. | ||
g) | Product more than 12 months beyond expiration. |
4.0 | MDCO RESPONSIBILITIES |
4.1 | Shipments; Title and Risk of Loss . Once Distributor establishes third-party logistics services in accordance with the 3PL agreement between the Parties in Reno, NV, there shall be no charge to MDCO for Distributor transferring Products from its 3PL facility to its distribution centers. Title to and risk of loss to each order of Product shipped to Distributor under this Agreement shall pass to Distributor upon receipt of Product at the distribution center. | ||
4.2 | Invoicing . MDCO will invoice Distributor for Products on the same day that Product orders are shipped to Distributor and will use its commercially reasonable efforts to fill Distributors Product orders within two (2) business days of order receipt. Distributor shall be permitted to cancel any order of Product that has not been delivered within two (2) business days of a purchase order accepted by MDCO. |
5.0 | PAYMENT |
5.1 | Payment by Distributor for Product Orders . Distributor agrees to pay for each Product unit based on the purchase price schedule in Exhibit B, which may be amended from time |
5
to time at MDCOs sole discretion. Distributors terms of payment shall be (a) [**]. Distributor shall be entitled to four (4) float days for all remit payments by electronic fund transfers to the MDCO lockbox account. |
Account Name: | The Medicines Company | |
Bank Name:
|
JP Morgan Chase Bank
New York, NY 01004 |
|
Account No.:
|
[**] | |
FED ABA No.:
|
[**] |
5.2 | Penalties . Distributor will be liable for late fees equal to [**]% per month (or any portion thereof) on all amounts not paid within forty-five (45) days of the date of billing, except for any portion of any bill that is the subject of any dispute raised by Distributor in good faith. If any dispute is resolved in favor of MDCO, Distributor will pay the applicable late fee on such amount from the original due date. | ||
5.3 | Payment by MDCO for Distribution Services . Distributor will submit on a monthly basis an invoice for its distribution services in accordance with the fee schedule attached as Exhibit D . This amount represents fair market value for the services performed by Distributor under this Agreement and was negotiated in an arms-length transaction. Terms of payment are net 45 days. MDCO will be liable for late fees equal to [**]% per month (or any portion thereof) on all amounts not paid within forty-five (45) days of the date of billing, except for any portion of any bill that is the subject of any dispute raised by MDCO in good faith. If any dispute is resolved in favor of Distributor, MDCO will pay the applicable late fee on such amount from the original due date. | ||
5.4 | Chargeback Reconciliation Payment . Distributor will submit chargeback data in accordance with Exhibits A and C for reconciliation and reimbursement by MDCO. Distributor will submit invoices for chargebacks on a monthly basis, and MDCO will pay such invoices in full within 45 days of the date an invoice is received. With respect to sales of Product under MDCO Contracts, Distributor shall submit invoices to MDCO, and MDCO shall pay such invoices, equal to the difference between (a) the current WAC at the time of the sale under the applicable MDCO Contract, and (b) the sale price under the applicable MDCO Contract. Similarly, MDCO may request Distributor, from time to time, to issue credits related to certain patient discounts, in which case Distributor shall submit invoices to MDCO for payment of the discounted amount, and MDCO shall pay such invoices, in the same manner as invoices are submitted and paid with respect to MDCO Contracts. Terms of payment for chargeback obligations are net 45 days. MDCO will be liable for late fees equal to [**]% per month (or any portion thereof) on all amounts not paid within 45 days of the date of billing, except for any portion of any bill that is the subject of any dispute raised by MDCO in good faith. If any dispute is resolved in favor of Distributor, MDCO will pay the applicable late fee on such amount from the original due date. |
6.0 | REGULATORY MATTERS |
6.1 | Food and Drug Administration Clearance. MDCO represents and warrants that during the Term (a) the Products have been approved by the United States Food and Drug Administration (FDA) to be marketed in the Territory; (b) all federal and state approvals and permits for the manufacture, importation, design, testing, inspection, labeling, and instructions for use, sale and distribution of the Products in the Territory have been obtained; and (c) the Products will be the subject of a duly approved NDA or ANDA (New Drug Application or Abbreviated NDA) and may be legally transported or |
6
sold under Applicable Law. MDCO will be solely responsible for, and shall comply with, all applicable federal and state laws governing the regulation of the manufacture, importation, design, testing, inspection, labeling, sale, and instructions for use of the Products in the Territory. Distributor represents that it has obtained all federal and state approvals and permits to perform its obligations under this Agreement. | |||
6.2 | Inspections. |
6.2.1 | Distributor agrees to cooperate with any inspection of Product shipments conducted by a governmental agency. | ||
6.2.2 | Distributor shall notify MDCO promptly of any inspection by any federal, state or local regulatory or governmental representative concerning the Product and shall provide MDCO with a summary of the results of such inspection and such actions, if any, taken to remedy conditions cited in such inspections. |
6.3 | Complaints, Adverse Reactions, Recalls. |
6.3.1 | Distributor will inform MDCO promptly of any information concerning complaints involving the Products or adverse drug experiences (as defined in 21 CFR § 314.80), injury, toxicity, sensitivity reaction associated with the clinical use of the Products by any End-User or other third party . If Distributor receives such information, Distributor shall immediately transfer the call to the locations and numbers provided by MDCO; and report the adverse experience to MDCO within 24 hours. Before making the call, Distributor shall record the name and contact details of the reporter, the name of the physician and contact information, the patient identifier, a description of the adverse experience, and the name of the product at issue. | ||
6.3.2 | If there is a recall, withdrawal or replacement of the Products imposed by MDCO or the FDA (Recall), Distributor will stop shipping recalled Product lots after Distributor receives written notification of such Recall. MDCO will notify Distributor of any proposed Recall as soon as possible and, in any event, will do so within forty-eight (48) hours of initiating a Recall. Distributor shall cooperate fully in any such Recall. | ||
6.3.3 | MDCO will reimburse Distributor for any documented reasonable costs or expenses that Distributor actually may incur due to a Recall. For all Products held by Distributor, such Recall costs and expenses include MDCOs reimbursement to Distributor of its original acquisition cost. Each Party will use best efforts to minimize Recall costs and expenses. Distributor shall prepare a detailed invoice of such costs or expenses, which invoice shall be paid by MDCO within thirty (30) days of its receipt of such invoice. MDCO will be liable for late fees equal to [**]% per month (or any portion thereof) on all amounts not paid within thirty (30) days of the date of billing, except for any portion of any bill that is the subject of any dispute raised by MDCO in good faith. If any dispute is resolved in favor of Distributor, MDCO will pay the applicable late fee on such amount from the original due date. |
6.4 | Compliance with Law. Each Party shall at all times during the term of this Agreement comply with all Applicable Laws, including, without limitation, the Federal Anti-kickback Statute, 42 U.S.C. § 1320(a)-7b and the corresponding regulations, the Federal |
7
Self-Referral Law, 42 U.S.C. § 1395nn, and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. | |||
6.5 | Compliance with Fee, Rebate and Discount Laws. Distributor shall disclose all fees and/or discounts required to be disclosed under any state or federal program that provides cost or charge based reimbursement to Distributor for the Products provided under this Agreement as may be required by Applicable Laws. Distributor further represents and warrants that it, and any of its affiliates who perform services under this Agreement, are in compliance with, and during the Term covenants that it and its affiliates shall remain in compliance with, any federal or state laws applicable to the fees, rebates or discounts paid by MDCO pursuant to this Agreement, including any laws requiring the proper disclosure and/or reporting of fees, rebates or discounts. | ||
6.6 | [**]. The Parties agree that a modification of Exhibit B under this Section 6.6 will be commercially equivalent to Exhibit B as of the Effective Date of this Agreement. If the Parties are unable to agree to a modification of the terms of Exhibit B , the Agreement will terminate pursuant to Section 12.2.2(d). |
7.0 | RECORDS AND ACCOUNTING | |
During the Term of this Agreement and for seven 10 years thereafter, or such longer period as may be required by Applicable Law, Distributor shall maintain accurate records as required to meet Applicable Law, as well as all records, data and documentation required to verify the accuracy of the information underlying any Data described in Section 3.5 (Records). The Records shall be maintained in a secure area reasonably protected from fire, theft, alteration, and destruction. For the same period, except as otherwise required by any such laws or regulations, Distributor shall provide MDCO, upon reasonable advance notice and during reasonable business hours, access to any requested documentation related to the performance of this Agreement or to verify the accuracy of Data. Any access to Records shall be conducted at MDCOs expense and in a manner that does not unreasonably interfere with Distributors normal business operations. | ||
8.0 | CONFIDENTIALITY | |
The parties have previously executed a written Confidential Disclosure Agreement (Confidentiality Agreement) dated March 27, 2000, attached as Schedule A . The parties will abide by its provisions during the Term and for at least five (5) years thereafter, regardless of any shorter term in the Confidentiality Agreement. | ||
9.0 | GENERAL WARRANTIES |
9.1 | MDCO . In addition to and not in lieu of the Continuing Guaranty, MDCO warrants that upon delivery to Distributor: (a) the Products will be in compliance with Applicable Laws and all regulatory requirements of the FDA; (b) no Products will be adulterated, misbranded or otherwise prohibited within the meaning of Sections 501 and 502 of the Food Drug and Cosmetics Act (FDCA), or within the meaning of other Applicable Law; (c) the Products will not be merchandise which may not be introduced into interstate commerce pursuant to the requirements of Sections 404, 505, 514, 515, 516 or 520 of the FDCA; (d) the Products will be manufactured in accordance with current FDA Good Manufacturing Practices as required by 21 C.F.R. §§ 210 and 820; (e) the Products will be free from material defects in materials and workmanship; and (f) the Products will not violate or infringe upon the intellectual property rights of any third parties. |
8
9.2 | Distributor . Distributor warrants that (a) it possesses and will maintain all federal, state and territory licenses and permits necessary to its performance of this Agreement and agrees to comply, in all material respects, with all Applicable Laws; and (b) it has not been debarred, nor is it subject to a pending debarment proceeding, and that it shall not use in any capacity in connection with performance of this Agreement any person who has been debarred pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, or who is subject to a pending debarment proceeding. Distributor agrees to inform MDCO promptly if Distributor or any of its employees or agents engaged in the performance of this Agreement is debarred or is the subject of a pending debarment proceeding. Notwithstanding anything in this Agreement to the contrary, if Distributor fails to discover that an employee or agent used in connection with the performance of this Agreement is the subject of a pending debarment proceeding, despite its good faith efforts to do so, MDCOs sole and exclusive remedy will be to terminate the Agreement. |
10.0 | INDEMNIFICATION |
10.1 | MDCO . In addition to the indemnification obligations set forth in the Continuing Guaranty, MDCO will indemnify, defend, and hold harmless Distributor, its affiliates, parents, subsidiaries, directors, officers, agents and employees (collectively, Distributor Indemnitees) from and against, and reimburse Distributor Indemnitees for, any and all claims, demands, actions, causes of action, losses, judgments, damages, costs and expenses (including, but not limited to, reasonable attorneys fees, court costs and costs of settlement) (Claims) against Distributor Indemnitees to the extent arising out of: (a) MDCOs manufacture of the Products; (b) the death of, or bodily injury to, any person, or property damage resulting from the use of the Products or any defect in its design, workmanship or manufacture; (c) any recall or withdrawal of the Product, other than as a result of Distributors negligence or willful misconduct; (d) MDCOs violation of any Applicable Law; (e) any breach by MDCO of any of its representations, warranties, covenants or agreements in this Agreement; or (f) any negligent act or omission of MDCO. The foregoing indemnification will not apply to the extent any Claims result from the negligence or willful misconduct of Distributor. | ||
10.2 | Distributor . Distributor will indemnify, defend, and hold harmless MDCO, its affiliates, parents, subsidiaries, directors, officers, agents and employees (collectively MDCO Indemnitees) from and against, and reimburse MDCO Indemnitees for, any and all Claims against MDCO Indemnitees to the extent arising out of: (a) the death of, or bodily injury to, any person or property damage resulting from the use of the Products that is caused by Distributors negligence or willful misconduct; (b) any recall or withdrawal of the Products as a result of Distributors negligence or willful misconduct; (c) Distributors violation of any Applicable Law; (d) any breach by Distributor of any of its representations, warranties, covenants or agreements in this Agreement or (e) any negligent act or omission of Distributor. The foregoing indemnification will not apply to the extent any Claims result from the negligence or willful misconduct of MDCO. | ||
10.3 | Notice . Each Party agrees to notify the other Party within thirty (30) days of receipt of any Claims made for which the other Party might be liable under Section 10.1 or 10.2, as the case may be; provided, however, any failure to do so will not relieve an indemnifying Party of any liability it may have to an indemnified Party except to the extent such liability was caused by such failure. The indemnifying Party shall have the right, but not |
9
the obligation to defend, negotiate and settle such Claims; provided; however, that the indemnified Party shall be entitled to participate in the defense of such matter and to employ counsel at its expense to assist therein. The Party seeking indemnification shall provide the indemnifying Party with such information and assistance as the indemnifying Party may reasonably request at the expense of the indemnifying Party. | |||
10.4 | Settlement . Neither Party shall be responsible or bound by any settlement of any Claim or suit made without its prior written consent; provided , however , that the indemnified Party may not unreasonably withhold or delay such consent. An indemnified Party may not reasonably withhold its consent if a settlement admits no wrongdoing on its behalf and contains an absolute waiver of liability in its favor and each Party has acted in compliance with the requirements of Section 10.3. | ||
10.5 | LIMITATION . NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL OR PUNITIVE DAMAGES OF ANY KIND OR NATURE WHATSOEVER, ARISING OUT OF OR IN CONNECTION WITH A BREACH OF THIS AGREEMENT, HOWEVER CAUSED. |
11.0 | INSURANCE |
11.1 | Requirements . Distributor will maintain in effect during the Term a commercial general liability occurrence-based policy covering all obligations under or related to this Agreement in a minimum annual amount of [**] dollars ($[**]) per occurrence, except for fire which shall only be [**] dollars ($[**]) per occurrence, and [**] dollars ($[**]) in the aggregate.MDCO will maintain in effect during the Term of this Agreement insurance as set forth in the Continuing Guaranty. | ||
11.2 | Evidence of Insurance . Upon either Partys request, but no more frequently than once every twelve (12) months, the other Party shall provide satisfactory evidence of insurance coverage satisfying the requirements of Section 11.1 above. | ||
11.3 | Notice of Changes . Each Party will endeavor to provide the other party with thirty (30) days advance notice of any cancellations or material changes to its insurance coverage. |
12.0 | TERM AND TERMINATION |
12.1 | Term . This Agreement shall commence upon the Effective Date and will continue until September 30, 2013, unless sooner terminated in accordance with the terms of this Agreement. Thereafter, this Agreement shall automatically renew for subsequent terms of one additional year, unless either Party provides the other Party with written notice of its intent not to renew this Agreement at least 90 days before expiration of the current Term. The initial term and all renewal terms are collectively referred to as the Term. | ||
12.2 | Termination . Either Party may terminate during the Term the entire Agreement or on an individual Product basis if more than one Product is being distributed under this Agreement, only as follows: |
12.2.1 | Without Cause . This Agreement may be terminated by either Party without cause provided that (i) MDCO provides one hundred eighty (180)days written notice to Distributor or (ii) the Distributor provides one hundred eighty (180) days written notice to MDCO terminate. |
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12.2.2 | With Cause . This Agreement may be terminated by either Party upon thirty (30) days prior written notice to the other Party for the following for-cause events: |
(a) | If the other Party defaults in the performance of any of its material obligations under this Agreement and does not cure that default within the thirty (30) day notice period; | ||
(b) | If any existing federal or state law or regulation is changed, if any new law or regulation is promulgated or if there is made any new or changed interpretation of any law or regulation such that the effect thereof in connection with this Agreement would materially affect either Partys business, pricing policies or the manner in which it does business (including among such effects a requirement that MDCO give to others any benefit given to Distributor under this Agreement) and the Parties are, after good faith efforts, unable to negotiate a modification to this Agreement that will be commercially equivalent to the terms of this Agreement as of the Effective Date; | ||
(c) | If any performance under this Agreement by the other Party fails, after notice and a reasonable opportunity to cure, to comply in all material respects with any Applicable Law, including the laws governing the testing, approval, sale, storage, packaging or distribution of the Product or the Anti-kickback Law as may be amended, supplemented or modified; or | ||
(d) | If the Parties are unable to negotiate in good faith a modification of this Agreement resulting from the establishment of a new best price or Average Sales Price for a Product, in accordance with Section 6.6. |
12.3 | Termination upon Certain Events . The Term may be terminated immediately by a Party, upon written notice to the other Party, if the other Party (a) makes a general assignment for the benefit of creditors; (b) files a petition in bankruptcy; (c) has a receiver, custodian or trustee appointed with respect to a substantial part of its property unless the proceeding and the person appointed are dismissed within thirty (30) days; (d) is insolvent within the meaning of Uniform Commercial Code Section 1-201 or fails generally to pay its debts as they become due within the meaning of Section 303 of the Bankruptcy Code, as amended; (e) has an order for relief entered against it in a Bankruptcy Code proceeding; (f) has a proceeding commenced against it which will substantially impair its ability to perform hereunder; (g) certifies in writing its inability to pay its debts as they become due (and either Party may periodically require the other to certify its ability to pay its debts as they become due); or (h) except as provided in Section 15.6, undergoes a change of ownership or control, or is merged with or into another entity. | ||
12.4 | Remedies. Each of the Parties to this Agreement shall be entitled to enforce its rights under this Agreement to recover damages and costs (including reasonable attorneys fees) caused by any breach of any provision of this Agreement and to exercise all other rights existing in its favor, regardless of any termination of this Agreement by such breaching Party. |
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13.0 | JOINT PUBLICITY | |
If either Party wishes to make a public announcement concerning this Agreement or the relationship established hereunder and such disclosure mentions the other Party by name or description or incorporates that Partys trademarks, service marks, logos or other similar marks, the Party seeking to make the public announcement will provide other Party \ with an advance copy of the disclosure and the other Party shall have five (5) business days within which to approve or disapprove such use of its name or description (including mention of the name of a Product). Approval shall not be unreasonably withheld by either Party. Absent approval, no public disclosure shall use the name or marks of or otherwise describe such Party except to the extent required by Applicable Law, or to the extent that the description of the other Party is limited to public information about the availability of the Product. The foregoing shall not prohibit Distributors use of MDCOs names or marks in connection with the performance of the services in a manner consistent with this Agreement. All pricing and payment terms in this Agreement are confidential. Except as set forth in Section 9.0 of this Agreement, a Party will remove such information (or request confidential treatment) if it discloses this Agreement for any reason, including in a Securities Exchange Commission filing. Notwithstanding the foregoing, Distributor may publicly disclose that it is an authorized distributor of record for the Product, and MDCO shall comply with all Applicable Laws requiring it to publicly disclose that Distributor is an authorized distributor of record for the Product. | ||
14.0 | ASSIGNMENT | |
This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed, except that Distributor may assign this Agreement or its rights and obligations under this Agreement to any of its corporate affiliates with notice to MDCO and provided that the assignee assumes and agrees to be bound by the terms of this Agreement and is capable of performing its obligations under this Agreement. The foregoing notwithstanding, MDCO may, without such consent, but upon written notice to Distributor, assign this Agreement or its rights and obligations hereunder in connection with the transfer or sale of all or substantially all of its business, or in the event of a merger, consolidation, change in control or similar transaction, provided that (i) the assignee is financially capable of performing its obligations under this Agreement, (ii) the assignee is not a competitor of Distributor or any of its affiliates, (iii) the assignee executes and delivers to Distributor a Continuing Guaranty and Indemnification Agreement in form and substance reasonably satisfactory to Distributor, and (iv) MDCO remains subject to the Continuing Guaranty with respect to Product sold before the assignment. Any permitted assignee shall assume the rights and obligations of its assignor under this Agreement. | ||
15.0 | MISCELLANEOUS |
15.1 | Choice of Law. This Agreement shall be governed by, interpreted and construed under the laws of the State of New York, without regard to any choice of law principle that would dictate the application of the law of another jurisdiction. | ||
15.2 | Waiver. No waiver of any default under this Agreement by either Party or any failure to enforce any rights under this Agreement shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other provision of this Agreement. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver. |
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15.3 | Notice . Any notice, request or other document to be given under this Agreement to a Party shall be effective when received and shall be given in writing and delivered in person or sent by overnight courier or registered or certified mail, return receipt requested, as follows: |
If to MDCO:
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The Medicines Company | |
|
8 Sylvan Way | |
|
Parsippany, NJ 07054 | |
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ATTN: Sr. Director, Global Distribution & Customer Servoce | |
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With a copy to:
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The Medicines Company | |
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8 Sylvan Way | |
|
Parsippany, NJ 07054 | |
|
ATTN: General Counsel | |
|
||
If to Distributor:
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Integrated Commercialization Solutions, Inc. | |
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3101 Gaylord Parkway | |
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Frisco, TX 75034 | |
|
ATTN: General Manager | |
|
||
With a copy to:
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AmerisourceBergen Specialty Group, Inc. | |
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3101 Gaylord Parkway | |
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Frisco, TX 75034 | |
|
ATTN: Group Counsel |
15.4 | Amendment. Neither this Agreement nor any of its terms may be terminated, amended, supplemented, waived or modified, except by an instrument in writing signed by each Party. | ||
15.5 | Survival of Provisions. Sections 7, 8, 9, 10, 11, 13, and any other provision which, by its terms or context, the Parties intended to survive, shall survive the expiration or other termination of this Agreement. | ||
15.6 | Relationship of Parties. Distributors relationship with MDCO under this Agreement shall be that of independent contractor, and neither Party shall be considered the agent, partner or employee of or a joint venture with the other Party, in its performance of all duties under this Agreement. | ||
15.7 | Rights; Cumulative Remedies. Nothing contained in this Agreement shall be construed as prohibiting either Party from exercising any rights that may be available to it under law, equity or contract. Except as expressly provided in this Agreement, and to the extent permitted by law, any remedies described in this Agreement are cumulative and not alternative to any other remedies available at law or in equity. | ||
15.8 | Severability. In the event that any one or more of the provisions contained in this Agreement are for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision or provisions had never been included. Provided, however, that any such modification is consistent with the purposes and objectives of this Agreement and does not impose upon either party any obligation that is greater or less than the obligation that would have been imposed by the invalidated or modified provision. The Parties shall, in good faith, attempt to amend this Agreement to provide, to the extent |
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possible, each Party with the benefits provided by such invalid or unenforceable provision. | |||
15.9 | Headings; Interpretation. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. The Parties jointly negotiated this Agreement and, thus, neither this Agreement nor any provision will be interpreted for or against any Party on the basis that it or its attorney drafted the Agreement or the provision at issue. Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender specifically used, will be construed to include any other gender, masculine, feminine, or neuter, as the context requires. And includes or. Or is a disjunctive but not necessarily exclusive. Including means including, but not limited to. | ||
15.10 | Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which, when taken together, shall constitute one and the same instrument. | ||
15.11 | Entire Agreement; No Reliance . Each of the Parties agrees and acknowledges that this Agreement, together with all exhibits attached hereto, including the Confidentiality Agreement and Continuing Guaranty (i) constitutes the entire agreement and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions, whether oral or written, between the Parties with respect to the subject matter of this Agreement, and (ii) amends, restates and supersedes the Existing Agreement in its entirety ab initio, and (iii) is not intended to confer any rights or remedies, or impose any obligations, on any person other than the Parties. Each of the Parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement. Nothing in this Agreement shall affect the obligations of the Parties under the 3PL Agreement. | ||
15.12 | Coordination. In the event of any conflict between the terms of this Agreement and any exhibit attached hereto, invoice, or any purchase order or other form issued by either Party to the other, the terms of this Agreement shall apply. |
INTEGRATED COMMERCIALIZATION SOLUTIONS, INC. | THE MEDICINES COMPANY | |||||||||
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||||||||||
By:
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/s/ Doug Cook
|
By: |
/s/ Tanya Quinn
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|||||||
|
||||||||||
Name:
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Doug Cook | Name: | Tanya Quinn | |||||||
|
||||||||||
Title:
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VP, General Manager | Title: | Sr. Director, Global Distribution and Customer Service | |||||||
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||||||||||
Dated:
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12-22-10 | Dated: | 12/23/10 |
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Schedule A
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Copy of Executed Confidentiality Agreement | |
Schedule B
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Copy of Executed Continuing Guaranty and Indemnification Agreement | |
Exhibit A
|
Operating Guidelines | |
Exhibit B
|
Commercial Price List | |
Exhibit C
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Data Transfer and Reporting | |
Exhibit D
|
Fee Schedule | |
Exhibit E
|
Chargeback Procedures |
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1.0 | WAREHOUSING | |
1.1 | Distributor will maintain its warehouse facilities in accordance with and will comply with all Applicable Laws. | |
1.2 | Distributor will maintain SOPs in accordance with generally-accepted industry standards for a pharmaceutical distribution center operating environment. | |
1.3 | Distributor will comply with all storage, handling and shipping conditions designated by MDCO for the Product. | |
1.4 | The Product will be stored by Distributor in a temperature-controlled environment in conjunction with defined Product label requirements. MDCO will ensure that the storage requirements are identified on the package label. MDCO will ensure that the storage requirements, lot number and expiry date will be in human readable format and the Product NDC number will be in an acceptable barcode format on the unit carton. Distributor will store all Productsin areas that are continuously monitored and periodically validated for the temperature range specified for the Product. Distributor will maintain continuous warehouse environmental monitoring. Distributor will provide such records to MDCO upon written request. | |
1.5 | Product will be stored in an area with secured access, accessible only to authorized Distributor personnel. | |
2.0 | RECEIVING | |
2.1 | MDCO will arrange transportation services to transfer the Product to Distributor. MDCO will notify Distributor of the specific delivery schedule. | |
2.2 | Each individual unit of MDCOs Product will be labeled with a barcode representing the Products NDC number, lot number, and expiration date. This information will also be in human readable format. | |
2.3 | MDCO will ship in increments of one case pack size as described and provided in Exhibit B. | |
2.4 | Shipping terms from MDCO to Distributor will be FOB Destination. Distributors signature on the carriers bill of lading is an acknowledgment only of Distributors receipt of Product and transfer of ownership. | |
2.5 | Distributor will receive each shipment into a secure receiving area and perform all requirements as detailed in Distributors receiving SOP. | |
2.6 | Distributor will count and inspect the exterior packaging of the Product. | |
2.7 | Distributor will move Product from the receiving area to storage following Distributor SOPs. |
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3.0 | INVENTORY | |
3.1 | Inventory will be received, tracked and controlled on Distributors warehouse management system by item number, lot number, expiration date, and quantity of individual units. An individual unit consists of a sellable package size of Product as outlined in Exhibit B. | |
3.2 | Distributor will use its commercially reasonable efforts to maintain accurate and timely inventory records. Inventory data will be made available to MDCO as described in Exhibit C of the Agreement. | |
3.3 | MDCO or its designee may conduct a complete physical inventory once per calendar year, upon reasonable notice. | |
3.4 | Distributor will receive returned Product according to Distributors SOP and MDCOs Returned Goods Policy. | |
4.0 | PRODUCT DISTRIBUTION | |
4.1 | Orders will only be shipped from the Distributor to Wholesalers and End-Users. | |
4.2 | Orders approved and available for processing (pick & pack) by 6:00 p.m. Central Time Monday through Friday will be shipped to Wholesalers and End-Users via Next Day Saver delivery service. Orders processed on Fridays will be shipped on Sunday for delivery on Monday. The foregoing schedule does not apply to the following holidays: Christmas Day, New Years Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and the day after Thanksgiving. Distributor shall make commercially reasonable provisions for emergency and weekend orders. Additional shipping and handling costs for such orders shall be billed to the Bill-To Customer. | |
4.3 | Distributor will use commercially reasonable efforts to comply with First-to-Expire, First-Out (FEFO) inventory allocation. | |
4.4 | Distributor will perform quality verification on all MDCO shipments by an individual other than the employee who picked the order. Distributor will use best efforts to pick, check, pack and ship accurately all customer orders. | |
4.5 | Distributor will manage shipping supplies, including supplier selection, stock replenishment, inventory record keeping and storage. | |
5.0 | TRANSPORTATION | |
5.1 | Distributor will be responsible for selecting a common carrier(s) to deliver product to Wholesalers and End-Users the next day. | |
5.2 | Distributor will not deliver Product outside the Territory. | |
5.3 | There will be no additional shipping surcharges applied to any shipments delivered within the Territory. | |
5.4 | Distributor, at the request of the MDCO, will provide proof of delivery for specific End-User shipments up to six months after time of delivery. Distributor will require signature at time of Product delivery to End-Users for all shipments. | |
6.0 | MARKETING, SALES and CUSTOMER SERVICE | |
6.1 | Distributor will provide a dedicated inbound phone line (or lines) for Distributors customers, including End Users and Bill-To Customers, to phone in purchase orders, for product inquiries, and for general product information. | |
6.2 | Distributor will establish and maintain a dedicated webpage for customers to place orders, submit inquiries and obtain general product information. | |
6.3 | Distributor will maintain, publish and promotea current price list of the Products. | |
6.4 | Distributor will staff the inbound phone line from 8:00 a.m. 6:00 p.m. Central Time, Monday |
17
through Friday, except for the following holidays: Christmas Day, New Years Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and the day after Thanksgiving. | ||
6.5 | Distributor will train Distributors customer service representative(s) and backup representative(s), and will document the date and nature of such training. MDCO will provide company and Product specific information for training of the customer service representatives assigned to MDCO Products. MDCO will have the right to review all training materials provided to customer service representatives. All customer services representatives of Distributor assigned to MDCO Products will possess the requisite competency and skills necessary to fulfill the responsibilities in accordance with generally-accepted professional standards. | |
6.6 | Distributor will be responsible for initial set up and on-going maintenance of customer master files, including bill-to files for Bill-To Customers and ship-to files for End-Users. | |
6.7 | Distributor will accept customer orders by phone, electronic data interchange (EDI), mail, fax, or internet. Distributor will maintain records of all customer orders. | |
6.8 | Distributor will use commercially reasonable efforts to answer inbound phone calls within the first thirty (30) seconds. | |
6.9 | As a backup to the customer service representatives, a voice mail system will be maintained to collect messages from customers. | |
6.10 | Distributors customer service representatives will re-route all misdirected calls to the appropriate MDCO designate. | |
7.0 | ORDER ENTRY for WHOLESALER or END USER SHIPMENTS | |
7.1 | The minimum order quantity will be: | |
Angiomax NDC 65293-001-01 one carton of 10 vials
Angiomax NovaPlus NDC 65293-004-22 one carton of 10 vials Cleviprex NDC 65293-002-011 50mg vials one carton of 10 vials Cleviprex NDC 65293-002-055 25mg vials one carton of 10 vials |
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7.2 | Distributor will use commercially reasonable efforts to enter orders accurately. | |
8.0 | CUSTOMER LIST AND APPROVAL | |
8.1 | Distributor will require all customers to complete and submit Distributors then-current Business Application. Distributor will refuse to fill orders of Product until the customers Business Application has been approved by Distributor. | |
8.2 | The initial Bill-To Customer list consists of the following: | |
Wholesalers (ADRs)
[**] |
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8.3 | As stated in the Section 3.3.1 of the Agreement, Distributor is responsible for accounts receivable management for the Bill-To Customers. | |
9.0 | RECOGNITION OF MDCO CONTRACTS | |
9.1 | Any End-User having a MDCO Contract may request purchase of Products from a Wholesaler or Distributor at the prices established under the applicable MDCO Contract. | |
9.2 | MDCO will provide a list of customers eligible under MDCO Contracts to Distributor, with periodic updates as required to ensure proper maintenance of Contract pricing; Distributor will request verification fromWholesalers that MDCO Contracts are loaded. |
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9.3 | Distributor will require Wholesalers to continue to recognize and administer MDCO Contracts, provided that they remain valid and enforceable under Applicable Law. | |
9.4 | MDCO will promptly inform Distributor of changes to MDCO Contracts so that Distributor may inform Wholesalers. Such changes will be retroactive to the date agreed upon by MDCO and the End-User. Upon 20 days prior written notification by MDCO that a MDCO Contract has been terminated, Distributor will require Wholesalers to promptly cease selling Product to that End-User under the terms of that MDCO Contract. | |
10.0 | PRODUCT COMPLAINTS | |
Distributor shall notify MDCO of any Product complaints from Bill-To Customers. MDCO shall reimburse Distributor for all costs associated with Product complaints. | ||
11.0 | CHARGEBACKS | |
11.1 | MDCO may enter into arrangements for select contract or government mandated pricing arrangements. | |
11.2 | Distributor, on behalf of MDCO, will process chargebacks with reconciliation of chargeback discrepancies within five (5) working days. Distributors chargeback SOPs will define the parameters available to Distributor to resolve discrepancies between MDCOs contract terms and conditions and the chargeback submitted by the customer. | |
11.3 | All chargebacks will be processed according to the chargeback procedure for MDCO as stated in Exhibit E to the Agreement. | |
11.4 | All validated chargeback submissions will be settled via credit invoice to the appropriate Bill-To Customer. MDCO will not make advance payments or authorize advance deductions of chargebacks. | |
11.5 | MDCO will reconcile and make payment to Distributor for chargebacks credited to Bill-To Customers on a monthly basis. | |
11.6 | Distributor will make best efforts to process chargebacks within three (3) business days for electronic chargebacks and within five (5) business days for hard copy chargebacks. | |
11.7 | Distributor will provide the necessary reports to ensure MDCO can comply with the reporting requirements of Medicare, Medicaid (OBRA), Veterans HealthCare Act, PHS Covered Entities, and state rebate programs. | |
11.8 | MDCO will provide a periodic update of customers eligible under MDCO Contracts to Distributor as required to maintain accurate contract pricing. All notifications will be provided to Distributor by MDCO in writing five (5) business days in advance of contract effective date. |
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Product Name:
|
ANGIOMAX® (bivalirudin) for Injection | |
NDC#:
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65293-001-01 | |
Drug Type:
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RX | |
Sellable Package Size:
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Carton (10 single use vials) | |
Dosage Form:
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250mg vial | |
Current WAC Price*:
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$[**] per Carton, (*which may change from time to time at MDCOs sole discretion) | |
Case Pack Size
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Thirty (30) Cartons | |
Shipping and Storage Requirements: 20 to 25°C | ||
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||
Product Name:
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ANGIOMAX® (bivalirudin) Nova Plus for Injection | |
NDC#:
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65293-004-22 | |
Drug Type:
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RX | |
Sellable Package Size:
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Carton (10 single use vials) | |
Dosage Form:
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250mg vial | |
Current WAC Price*:
|
$[**] per Carton, (*which may change from time to time at MDCOs sole discretion) | |
Case Pack Size
|
Thirty (30) Cartons | |
Shipping and Storage Requirements: 20 to 25°C | ||
|
||
Product Name:
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Cleviprex (clevidipine butyrate) | |
NDC#:
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65293-002-011 | |
Drug Type:
|
RX | |
Sellable Package Size:
|
Carton (10 single use vials) | |
Dosage Form:
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50mg vial | |
Current WAC Price*:
|
$[**] per Carton, (*which may change from time to time at MDCOs sole discretion) | |
Case Pack Size
|
Six (6) Cartons | |
Shipping and Storage Requirements: 2 to 8°C | ||
|
||
Product Name:
|
Cleviprex (clevidipine butyrate) | |
NDC#:
|
65293-002-055 | |
Drug Type:
|
RX | |
Sellable Package Size:
|
Carton (10 single use vials) | |
Dosage Form:
|
25mg vial | |
Current WAC Price*:
|
$[**] per Carton, (*which may change from time to time at MDCOs sole discretion) | |
Case Pack Size
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Twelve (12) Cartons | |
Shipping and Storage Requirements: 2 to 8°C |
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1. | Orders Received | ||
2. | Packages Shipped |
21
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MDCO will reimburse Distributor monthly for any MDCO Contract sales administered as a direct price (anything less than current WAC of the product) at time of sale. Reimbursement amount to Distributor is current WAC at time of contract sale minus contract price. | ||
Any direct pricing will be provided by MDCO to Distributor . | ||
D. | Pricing Actions | |
Distributor shall realize no benefit or penalty from pricing actions. In the event of a price increase on the Products, Distributor shall deduct the difference in value of the Products held in Distributor inventory held on the day prior to the price increase. For example, the day prior to the price increase the value of the products is $1,000,000 and a 6% price increase raises the value of the same inventory to $1,060,000 on the same number of units of Products. Distributor shall deduct the difference, $60,000, from the next Service Fee. | ||
In the event of a price decrease on the Products, Distributor shall add the difference in value of the Products held in Distributor inventory held on the day prior to the price decrease. For example, the day prior to the price decrease the value of the products is $1,000,000 and a 6% price decrease lowers the value of the same inventory to $940,000 on the same number of units of Products. Distributor shall add the difference, $60,000, to the next Service Fee. |
23
a) | Wholesalers submit chargeback claims to Distributor through EDI transactions and/or manually after sale to the Customer. Bill-To Customers submit proof of sales to Customers with the chargeback claims, including the ship-to location name and address, number of units, NDC number, and WAC. | |
b) | Bill-To Customers product purchase price will be deemed to be WAC for purposes of calculating chargeback claims. The chargeback amount will be the difference between WAC and the price offered by MDCO to the Customer under the MDCO Contract. | |
c) | Distributor will deny any Chargeback claims that it determines to be invalid. | |
d) | If a chargeback claim is denied for insufficient information, Distributor will allow Bill-To Customers to resubmit the claim with complete information. In addition, if new information surfaces that requires corrections and adjustments to sales reports, Distributor will allow claims to be reopened and resubmitted. | |
e) | The Parties will promptly resolve chargeback reconciliation issues, with each Party responding to the other within thirty (30) days following receipt of supporting documentation. If a chargeback dispute arises between Distributor and a Bill-To Customer, Distributor will notify MDCO promptly upon identifying the problem so that MDCO may intervene. If MDCO is unable to resolve the dispute within seven (7) business days of notification, Distributor will have no further obligation to sell to such Bill-To Customer until such time that the Parties resolve the reconciliation issue. | |
f) | If a Customer returns a Product that was subject to a chargeback claim, Distributor will report such return to MDCO and reverse the chargeback claim by adjusting any credit memo(s) issued to Bill-To Customer. | |
g) | MDCO will promptly reimburse Distributor for any amounts deducted by Bill-To Customers from amounts owed by them to Distributor relating to Product such Bill-To Customers purchased from MDCO; provided, however, nothing in this Section shall affect MDCOs and the Distributors rights and obligations under the 3PL Agreement. |
24
Name of Subsidiary | Jurisdiction of Incorporation or Organization | |
MDCO Holdings C.V.
|
Netherlands | |
MEDCO Brasil Participações Ltda.
|
Brazil | |
Medicines Company (India) Private Limited
|
India | |
Targanta Therapeutics Corporation
|
Delaware | |
Targanta Therapeutics Inc.
|
Canada | |
The Medicines Company do Brasil Comercio de Medicamentos
e Produtos Medicos Ltda.
|
Brazil | |
The Medicines Company France SAS
|
France | |
The Medicines Company Holdings, Inc.
|
Delaware | |
The Medicines Company (Australia) Pty Limited
|
Australia | |
The Medicines Company (Austria) GmbH
|
Austria | |
The Medicines Company (Belgium) SPRL/BVBA
|
Belgium | |
The Medicines Company (Denmark) ApS
|
Denmark | |
The Medicines Company (Deutschland) GmbH
|
Germany | |
The Medicines Company (Finland) Oy
|
Finland | |
The Medicines Company (Italy) S.r.l.
|
Italy | |
The Medicines Company (Leipzig) GmbH
|
Germany | |
The Medicines Company (Netherlands) BV
|
Netherlands | |
The Medicines Company (New Zealand) Limited
|
New Zealand | |
The Medicines Company (NL) B.V.
|
Netherlands | |
The Medicines Company (Norway) AS
|
Norway | |
The Medicines Company (Poland) Sp.z.o.o.
|
Poland | |
The Medicines Company (Schweiz) GmbH
|
Switzerland | |
The Medicines Company (Spain) S.L.
|
Spain | |
The Medicines Company (Sweden) AB
|
Sweden | |
The Medicines Company UK Limited
|
England and Wales | |
The Medicines Company Ventures, Inc.
|
Delaware | |
Vita Solutions, Inc.
|
Delaware |
/s/ Ernst & Young LLP | ||||
By: |
/s/ Clive
A. Meanwell
|
By: |
/s/ Glenn
P. Sblendorio
|