Document:

exv10w34

Exhibit 10.34

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

10 April, 2003

The Medicines Company

8 Campus Drive

Parsippany

New Jersey 07054

United States

Att: Clive Meanwell

Executive Chairman

	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”)

Dear Mr. Meanwell,

(Each term used herein and defined in the Option Agreement shall have the meaning so defined
therein.)

We would hereby like to confirm our mutual decision for the License Agreement to enter into
effect. Hence, despite the fact that the Final Report has yet not been received by
AstraZeneca, and regardless of whether the Trigger has been met or will be met, License
Agreement Notice shall be deemed to have been given by The Medicines Company. As a consequence
hereof the License Agreement shall be deemed to have entered into force. 28 March 2003 shall
constitute the License Agreement Effective Date.

AstraZeneca would appreciate payment of [**] U.S. Dollars (USD [**]) in accordance with Article
6.1.1 of the License Agreement to be made by wire transfer to the following account of AstraZeneca.

	 	 	 

	Bank name:

	 	[**]
	Account No.:

	 	[**]
	Swift:

	 	[**]

 

 

If the above correctly reflects our agreement please sign both originals of this Letter Agreement
where indicated below and return one signed original to Dr. Anders Waas at the following address:
AstraZeneca R&D Mölndal, Global Licensing, SE-431 83 Mölndal Sweden.

	 	 	 	 	 

	Yours sincerely,	 	Agreed and accepted
	 
	 	 	 	 
	AstraZeneca AB (publ)	 	Date:
	 
	 	 	 	 
	[illegible]	 	The Medicines Company

	 	 	 
	Name:

	 	 	 	/s/ Clive Meanwell
	 

	 	 	 	Name: Clive Meanwell
	 
	 	 	 	 
	cc:

	 	Steven D. Singer	 	 
	 

	 	Hale and Dorr	 	 
	 

	 	60 State Street	 	 
	 

	 	Boston, MA 02109	 	 
	 

	 	United States	 	 

 

 

License Agreement

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	Article	 	Page
	1. Definitions
	 	 	ii	 
	2. Grant of License
	 	 	8	 
	3. Development and Commercialisation
	 	 	9	 
	4. Supply Matters
	 	 	15	 
	5. Exchange of Information
	 	 	16	 
	6. Consideration
	 	 	17	 
	7. Intellectual Property — Prosecution and Maintenance
	 	 	22	 
	8. Claims Regarding Infringement and Invalidity
	 	 	23	 
	9. Trademark
	 	 	25	 
	10. Indemnity
	 	 	27	 
	11. Confidentiality
	 	 	29	 
	12. Adverse Events
	 	 	30	 
	13. Representation and Warranty
	 	 	30	 
	14. Term and Termination
	 	 	32	 
	15. Consequences of Termination
	 	 	33	 
	16. Force Majeure
	 	 	36	 
	17. General Provisions
	 	 	36	 
	- Assignment
	 	 	36	 
	- Severance
	 	 	36	 
	- Notices
	 	 	37	 
	- Contact Information
	 	 	37	 
	- Agency, Partnership or Joint Venture Excluded
	 	 	37	 
	- Entire Agreement
	 	 	38	 
	- Agreement to Supersede earlier Agreements
	 	 	38	 
	- Amendments
	 	 	38	 
	- Publicity and Announcements
	 	 	38	 
	- Waiver
	 	 	38	 
	- No Benefit to Third Parties
	 	 	38	 
	18. Governing Law and Arbitration
	 	 	38	 

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LICENSE AGREEMENT

This Agreement is entered into on the License Agreement Effective Date

by and between

ASTRAZENECA AB, a company incorporated under the laws of Sweden with its registered office at S-151
85 Södertälje, Sweden (“ASTRAZENECA”) and

THE MEDICINES COMPANY, a company incorporated under the laws of Delaware with its registered office
at One Cambridge Center, Cambridge, Massachusetts 02142, United States (“TMC”);

WITNESSETH

WHEREAS, ASTRAZENECA performs research, development and marketing of pharmaceutical compounds and
products inter alia in the cardiovascular therapy area; and

WHEREAS, ASTRAZENECA has developed the intravenous product Clevidipine for indications such as the
control of blood pressure; and

WHEREAS, TMC performs development of pharmaceutical compounds and marketing of pharmaceutical
products particularly in the cardiovascular therapy area; and

WHEREAS, ASTRAZENECA has expressed an interest to license Clevidipine to TMC and TMC has expressed
an interest to license said compound; and

WHEREAS, it is a mutual objective of the Parties to maximise the sales of the Product.

NOW THEREFORE, the Parties hereto agree to the following.

1. DEFINITIONS

When used in this Agreement the following expressions shall have the meanings defined herein. The
singular form of the defined expression shall include the plural form thereof and vice versa.

ii

 

1.1. “Adverse Event” shall mean the development of an undesirable medical condition or the
deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical
product whether or not considered causally related to such product.

1.2. “ANDA Act” shall have the meaning defined in Article 8.3.1(a).

1.3. “Affiliate” with respect to a Person shall mean any other Person that directly, or indirectly
through one or more intermediaries, controls, is controlled by or is under common control with such
Person. For the purposes of this Article 1.3 only, “control” and, with correlative meanings, the
terms “controlled by” and “under common control with”, shall mean (a) the possession, directly or
indirectly, of the power to direct the management or policies of a Person, whether through the
ownership of voting securities, by contract or otherwise, and/or (b) the ownership, directly or
indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest
of a Person.

1.4. “Agreement” shall mean this document including any and all schedules, appendices and other
addenda to it as may be changed, added and/or amended from time to time in accordance with the
provisions of this Agreement.

1.5. “ASTRAZENECA IP” shall mean the ASTRAZENECA Patent Rights, the ASTRAZENECA Know-How and,
subject to what is stated in Article 9.1, the ASTRAZENECA Trademark.

1.6. “ASTRAZENECA Indemnified Party” shall have the meaning defined in Article 10.1.1.

1.7. “ASTRAZENECA Know-How” shall mean any Know-How relating to the Compound and/or the Product,
developed, acquired or licensed by ASTRAZENECA prior to the License Agreement Effective Date and in
ASTRAZENECA’s possession at the License Agreement Effective Date.

1.8. “ASTRAZENECA Patent Rights” shall mean the patents and patent applications as set out in
Schedule A and any Patent Rights claiming priority thereto.

1.9. “ASTRAZENECA Trademark” shall mean the trademark CleveloxTM which ASTRAZENECA as of the License
Agreement Effective Date has registered for the Product in the countries set forth in Schedule B.

1.10. “Combination Product” shall mean any pharmaceutical product in a finished dosage form which
comprises the Compound and at least one other active pharmaceutical ingredient.

1.11. “Commercially Reasonable Efforts” shall mean with respect to the efforts to be expended by a
Party with respect to any objective, the use of reasonable, diligent, good faith efforts to
accomplish such objective as such Party would normally use to accomplish a similar objective under
similar circumstances, it being understood and agreed that with respect to the research,
development or commercialisation of Product, such efforts shall be substantially equivalent to
those efforts and resources commonly used by a Party for a product owned by it or to which it has
rights, which product is at a similar stage in its development or product life and is of similar
market potential taking into account efficacy, safety, Regulatory Authority-approved labelling, the
competitiveness of alternative products in the marketplace, the patent and other proprietary
position of the Product, the likelihood of

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regulatory approval given the regulatory structure involved, the profitability of the Product
taking into account the royalties payable to licensors of patent or other intellectual property
rights, alternative products and other relevant commercial factors. Commercially Reasonable
Efforts shall be determined on a country-by-country basis for the Product, and it is anticipated
that the level of effort will change over time (including, to the extent appropriate, the reduction
or cessation of active promotional efforts), reflecting changes in the status of the Product and
the market(s) involved

1.12. “Compound” shall mean ASTRAZENECA’s proprietary compound named Clevidipine with the
chemical structure as shown in Schedule C, attached hereto, including all salts, esters, complexes,
chelates, hydrates, isomers, stereoisomers, crystalline and amorphous forms, prodrugs, solvates,
metabolites and metabolic precursors (whether active or inactive) thereof.

1.13. “Confidential Information” shall mean (i) in the case of TMC being the receiving Party,
ASTRAZENECA IP, and (ii) in the case of ASTRAZENECA being the receiving Party TMC IP, and (iii) in
the case of either Party being the receiving Party, data generated by either or both Parties
hereunder and trade secrets and/or confidential information relating to technology, including but
not limited to compound(s), composition(s), formulation(s) and/or manufacturing information, and/or
relating to the business affairs, including but not limited to commercial forecasts, plans,
programs, customers, assets, financial projections, costs and customer lists and/or finances of the
Disclosing Party, supplied or otherwise made available to the Receiving Party or coming into
Receiving Party’s possession in relation to the performance of this Agreement.

1.14. “Disclosing Party” shall mean the Party which discloses Confidential Information to the other
Party.

1.15. “Documents” shall mean reports, research notes, charts, graphs, comments, computations,
analyses, recordings, photographs, paper, notebooks, books, files, ledgers, records, tapes, discs,
diskettes, CD-ROM, computer programs and documents thereof, computer information storage means,
samples of material, other graphic or written data and any other media on which Know-How can be
permanently or temporarily stored.

1.16. “European Union” shall mean the countries that are, whether at the License Agreement
Effective Date or at any time thereafter, members of the European Union.

1.17. “European Economic Area” shall mean the European Union plus Norway, Iceland and
Liechtenstein.

1.18. “FDA” shall mean the United States Food and Drug Administration or any successor agency
thereto.

1.19. “FTE Day” shall mean the equivalent of one person employed by ASTRAZENECA or TMC, as
applicable, or their respective Affiliates full time for one day.

1.20. “Filing of an NDA” shall mean the date of acceptance for review by the competent registration
body in a given country of an NDA.

1.21. “Force Majeure” shall mean any cause preventing either Party from performing any or all of
its obligations which arises from or is attributable to acts, events, omissions or

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accidents beyond the reasonable control of the Party so prevented, act of God, war, riot, civil
commotion, malicious damage, accident, breakdown of plant or machinery, fire, flood or storm.

1.22. “Fresenius” shall mean Fresenius Kabi Nutrition AB, S-751 74 Uppsala, Sweden.

1.23. “Launch” or “Launched” shall mean the first invoiced commercial sale by TMC, its Affiliates,
sub-licensees or distributors, however not including sales made by one such entity to another such
entity, of the Product in a country following NDA Approval in such country.

1.24. “Know-How” shall mean technical and other information, which is not subject to published
patent rights and which is not in the public domain, including, but not limited to, information
comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions,
methods, models, assays, research plans, procedures, designs for experiments and tests and results
of experimentation and testing, including results of research or development, processes, including
manufacturing processes, specifications and techniques, laboratory records, chemical,
pharmacological, toxicological, clinical, analytical and quality control data, trial data, case
report forms, data analyses, reports, manufacturing data or summaries and information contained in
submissions to and information from ethical committees and regulatory authorities. Know-How
includes Documents containing Know-How, including but not limited to any rights including trade
secrets, copyright, database or design rights protecting such Know-How. The fact that an item is
known to the public shall not be taken to preclude the possibility that a compilation including the
item, and/or a development relating to the item, is not known to the public.

1.25. “License Agreement Effective Date” shall have the meaning defined in the Option Agreement.

1.26. “Major Market” shall mean each of [**] and [**]. Further [**] shall constitute one Major
Market.

1.27. “NDA” shall mean a fully completed marketing license application comparable to a New Drug
Application filed with the FDA, including all supporting documentation and data required for such
application to be accepted for review by the competent health regulatory authorities for any
country requesting approval for commercialisation of the Product for a particular indication in
such country. NDA as herein defined shall for this purpose include applications for pricing or
reimbursement approval where appropriate.

1.28. “NDA Approval” shall mean the approval by the competent registration body for a given country
of an NDA.

1.29. “Net Sales” shall mean the gross sales of Product by a Party or its Affiliates, and,
regarding sales in the United States, its sub-licensees or distributors, to Third Parties after
deduction of:

	 	a)	 	[**] and/or [**];
	 
	 	b)	 	amounts [**] determined in good faith;
	 
	 	c)	 	[**] such sales; and

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	 	d)	 	[**] the Product.

In the event the Product is sold as part of a Combination Product, the Net Sales
from the Combination Product, for the purposes of determining royalty payments,
shall be determined by multiplying the Net Sales of the Combination Product (as
defined in the standard Net Sales definition), during the applicable royalty
reporting period, by the fraction, A/A+B, where A is the average sale price of the
Product when sold separately in finished form and B is the average sale price of the
other product(s) included in the Combination Product when sold separately in
finished form, in each case during the applicable royalty reporting period or, if
sales of both the Product and the other product(s) did not occur in such period,
then in the most recent royalty reporting period in which sales of both occurred, as
adjusted, as necessary, for inflation from the date when both the Product and all
other product(s) last were sold and the date of determination of Net Sales under
this Article 1.29. In the event that such average sale price cannot be determined
for both the Product and all other products(s) included in the Combination Product,
Net Sales for the purposes of determining royalty payments shall be calculated by
multiplying the Net Sales of the Combination Product by the fraction of C/C+D where
C is the fair market value of the Product and D is the fair market value of all
other pharmaceutical product(s) included in the Combination Product. In such event,
the selling Party shall in good faith make a determination of the respective fair
market values of the Product and all other pharmaceutical products included in the
Combination Product, and shall notify the other Party of such determination and
provide the other Party with data to support such determination. The other Party
shall have the right to review such determination and supporting data, and to notify
the selling Party if it disagrees with such determination. If the other Party does
not agree with such determination and if the Parties are unable to agree in good
faith as to such respective fair market values, then such matter shall be referred
to arbitration pursuant to Article 18.1.

Net Sales shall exclude (i) the transfer of a commercially reasonable quantity of
free samples of Product to be given out to customers for promotional purposes; (ii)
the transfer of Product for use in clinical trials; and (iii) the sales or transfers
of Product among a Party and its Affiliates, and, in the United States, its
sub-licensees or distributors, unless the receiver is the consumer or user of the
Product; however, the resale or transfer of such Product to a Third Party shall be
included in Net Sales.

Product sold or otherwise transferred (x) in other than an arms length transaction
or for other property (e.g. barter); or (y) where no separate price has been decided
for the Product but a price is decided jointly for the Product plus at least one
other product, shall be deemed invoiced at its fair market price in the country of
sale or transfer.

It is acknowledged that sub-licensees of a Party or its Affiliates and conventional
distributors whose function is to purchase and resell Product, will be considered
Third Parties when referring to Product sold outside the United States. The Parties
agree further that for the purpose of the first

5

 

paragraph of this Article 1.29 the Net Sales of the Product outside the United
States by TMC or its Affiliates to such sub-licensees and distributors shall be the
Net Sales received by TMC or its Affiliates from such sub-licensee or distributor
for the Product or [**] percent ([**]%) of the actual gross sales, less deductions
under subsections (a) through (d) above, of the Product by such sublicensee or
distributor, whichever amount is the higher.

6

 

1.30. “Option Agreement” shall mean the Study and Exclusive Option Agreement entered into by and
between the Parties on 5 March 2002.

1.31. “Party” or “Parties” shall mean TMC and/or ASTRAZENECA.

1.32. “Patent Rights” shall mean patent applications and patents, utility models, utility
certificates, certificates of addition and all foreign counterparts of them in all countries,
including any divisional applications and patents, refilings, renewals, continuations,
continuations-in-part, patents of addition, extensions (including patent term extensions),
reissues, substitutions, confirmations, registrations, revalidations, pipeline and administrative
protections and additions, and any equivalents of the foregoing in any and all countries of or to
any of them, as well as any supplementary protection certificates and equivalent protection rights
in respect of any of them.

1.33. “Person” shall mean an individual, sole proprietorship, partnership, limited partnership,
limited liability partnership, corporation, limited liability company, business trust, joint stock
company, trust, unincorporated association, joint venture or other similar entity or organization,
including a government or political subdivision, department or agency of a government.

1.34. “Procedure” shall have the meaning defined in Article 3.5.1.

1.35. “Product” shall mean any pharmaceutical formulation or product for intravenous application
containing the Compound as the sole active ingredient in a finished dosage form suitable for
administration to patients. Apart from in this Article 1.35, and unless the context clearly
requires otherwise in this Agreement, when mentioned in this Agreement Product shall be deemed to
include Combination Product.

1.36. “Phase III Clinical Trial” shall mean a large scale, pivotal multicentre, human clinical
trial to be conducted in a number of patients estimated to be sufficient to establish safety or
efficacy in the particular claim and indication and at a standard suitable to obtain NDA Approval.

1.37. “Receiving Party” shall mean the Party which receives Confidential Information from the other
Party.

1.38. “Results” shall have the meaning defined in Article 7.8.

1.39. “Supply Agreement” shall have the meaning described in Article 4.3.1.

1.40. “TMC IP” shall mean TMC Know-How and TMC Patent Rights.

1.41. “TMC Indemnified Party” shall have the meaning defined in Article 10.2.1.

1.42. “TMC Know-How” shall mean any Know-How relating directly to the Compound and/or the Product
developed, acquired or licensed by TMC during the term of this Agreement.

1.43. “TMC Patent Rights” shall mean any Patent Rights directly relating to the Compound and/or the
Product developed, acquired or licensed by TMC during the term of this Agreement.

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1.44. “TMC Trademark” shall have the meaning defined in Article 9.1.

1.45. “Territory” shall mean any country in the world except Japan.

1.46. “Third Party” shall mean any Person not including the Parties or the Parties’ respective
Affiliates.

2. GRANT OF LICENSE

2.1. License Grant. ASTRAZENECA hereby grants to TMC an exclusive license in the Territory
under the ASTRAZENECA IP to perform research on, have research performed on, develop, have
developed, use, have used, make, have made, import, have imported, market, have marketed, sell and
have sold the Compound and the Product for all indications. Notwithstanding the foregoing, TMC’s
license to the ASTRAZENECA Trademark included in the license now granted shall be subject to what
is stated in Article 9.1.

2.2. Grant to TMC’s Affiliates. TMC’s Affiliates shall have the benefit and burden of the
licenses and rights set out in Article 2.1 for the same purposes and under the same conditions as
set forth herein, provided that TMC shall remain fully responsible for the compliance by such
Affiliates with the terms and conditions of this Agreement as if such Affiliates were TMC
hereunder.

2.3. Right to Sublicense. TMC shall have the right to grant sub-licenses to the rights
granted under Article 2.1, provided that TMC shall notify ASTRAZENECA of each such sublicense
without unreasonable delay following any such grant of sub-license. TMC shall ensure that all of
its sub-licensees will comply with all terms and conditions of this Agreement and TMC shall remain
fully responsible for the compliance by such sub-licensees with the terms and conditions of this
Agreement as if such sub-licensees were TMC hereunder.

2.4. Right to Appoint Distributors. TMC shall also have the right to appoint distributors
in the Territory for the sale of the Product. TMC shall at all times ensure that its distributors
act fully in compliance with the terms and conditions of this Agreement.

2.5. Duration of License Grant. The licenses set out in Article 2.1 shall continue in
accordance with what is stated therein on a country-by-country basis until royalty payment is no
longer due in the country concerned in accordance with what is stated in Article 6.4, except for
the license to the ASTRAZENECA Trademark which shall be governed by what is stated in Article 6.5.
The licenses set out in Article 2.1 shall, subject again to what is stated in Article 6.5 regarding
the license to the ASTRAZENECA Trademark, thereafter continue on a non-exclusive basis and become
fully paid up and royalty-free in the country concerned.

2.6. First Right of Refusal of TMC regarding Japan. Should ASTRAZENECA within its sole
discretion at any time determine that ASTRAZENECA will not Launch the Product in Japan and/or that
ASTRAZENECA will not license, transfer or otherwise dispose of its interest in the ASTRAZENECA IP
regarding Japan, then ASTRAZENECA shall offer to TMC, by providing written notice, the first right
to negotiate a license on exclusive rights to commercially exploit the Compound and the Product
under the ASTRAZENECA IP in Japan on terms similar to those under this Agreement. Should TMC wish
to exercise such right, then TMC shall notify ASTRAZENECA hereof in writing no later than ninety
(90) days upon receipt of ASTRAZENECA’s notice. In reasonable connection with such notice the
Parties

8

 

shall enter into good faith negotiations using their reasonable endeavours to reach a mutually
acceptable agreement providing for such TMC’s commercial exploitation as mentioned in this Article
2.6.

2.7. TMC Grant of Rights to ASTRAZENECA Regarding Japan.

2.7.1. In consideration of the rights granted by ASTRAZENECA hereunder, TMC hereby grants to
ASTRAZENECA, at no cost or remuneration, a sub-licensable non-exclusive license under the TMC IP to
perform research on, have research performed on, develop, have developed, use, have used, make,
have made, import, have imported, market, have marketed, sell and have sold the Compound and the
Product for all indications in Japan.

2.7.2. TMC shall for the purpose of the license granted in Article 2.7.1 make available to
ASTRAZENECA, upon ASTRAZENECA’s request, any Filings of an NDA in the Territory, any NDA Approvals
obtained in the Territory and any related documents and any TMC’s correspondence with any
regulatory authorities in the Territory regarding any such Filing of an NDA, NDA Approval or
related issues, and shall allow ASTRAZENECA to make cross-references to any such Filing of an NDA
or NDA Approval in the Territory. For any services or assistance performed by TMC pursuant to this
Article 2.7.2, ASTRAZENECA shall reimburse TMC for TMC’s out-of-pocket costs for such activities
plus [**] U.S. Dollars ($[**]) per FTE Day.

2.7.3. Should TMC have selected the TMC Trademark in the Territory, then the license under Article
2.7.1 shall include an exclusive right and license for ASTRAZENECA to utilize the TMC Trademark in
Japan. Should ASTRAZENECA use the TMC Trademark in connection with the sales and marketing of
Product in Japan, then ASTRAZENECA shall pay to TMC a running royalty of [**] percent ([**]%) on
the annual Net Sales of the Product in Japan.

2.8. Section 365(n) of Title 11. All rights and licenses granted under or pursuant to any
section of this Agreement, including amendments hereto, are, for all purposes of Section 365(n) of
Title 11 of the United States Bankruptcy Code (“Title 11”), licenses of rights to “intellectual
property” as defined in Title 11. The Parties shall retain and may fully exercise all of their
respective rights under this Agreement pursuant to Title 11. Rejection of this Agreement pursuant
to Section 365 of Title 11 constitutes a material breach of this Agreement and entitles the
aggrieved Party to terminate this Agreement for material breach upon written notice. Upon
bankruptcy of either Party, the non-bankrupt Party shall further be entitled to a complete
duplicate of (or complete access to, as appropriate) any such intellectual property, and such, if
not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the
bankrupt Party elects to continue, and continues, to perform all of its obligations under this
Agreement.

3. DEVELOPMENT AND COMMERCIALIZATION

3.1. Transfer of ASTRAZENECA Know-How. Without unreasonable delay following the License
Agreement Effective Date, ASTRAZENECA shall make available and transfer to TMC the following
ASTRAZENECA Know-How.

     a) a description of the process used by ASTRAZENECA for the
manufacturing of the Compound intended for Phase III

9

 

Clinical Trials and a summary report of the development of such process;

     b) a description of the process, available to AstraZeneca at the
License Agreement Effective Date, for the manufacture of the [**] to be
used for the manufacturing of the Compound;

     c) a description of the analytical methods and validation reports for
the starting materials and intermediates to be used in the manufacturing
of the Compound.

It is acknowledged that at the License Agreement Effective Date some of
those analytical methods are not fully developed and validated, and such
development and validation will not be continued or completed by
ASTRAZENECA. ASTRAZENECA will, however, provide a summary report of the
status of these methods at the License Agreement Effective Date;

     d) the description of the tentative test-methods used by ASTRAZENECA
for validating the bulk Compound manufactured, and a brief summary of the
validation done thereon by ASTRAZENECA;

     e) to the extent available to ASTRAZENECA at the License Agreement
Effective Date, reference and analytical standard compounds to be used as
reference material in the conduct of comparative analyses in relation to
the manufacturing process with the Compound. It is explicitly understood
that no such compound may be used for any other purpose than the purpose
now stated;

     f) a description of all ASTRAZENECA Know-How relating to clinical
trials conducted by ASTRAZENECA using the Product prior to the License
Agreement Effective Date.

     g) reports, the names of which are set forth in Schedule D,
containing ASTRAZENECA Know-How relating to the manufacturing of the
Compound.

Any documents contemplated by this Article 3.1 shall be in English when transferred
to TMC.

3.2. Third Party Manufacturers.

3.2.1. It is acknowledged that TMC may present the ASTRAZENECA Know-How described under Article 3.1
to Third Party manufacturers for the purposes permitted under Article 11.2.4. TMC shall notify
ASTRAZENECA in writing regarding the date of submission of such information to any such Third Party
manufacturer(s). ASTRAZENECA shall in this connection assist TMC to address questions raised about
such ASTRAZENECA Know-How by no more than three (3) of such Third Party manufacturer(s) selected by
TMC, during a period of three (3) months from the date of presentation of such ASTRAZENECA

10

 

Know-How to the Third Party manufacturer concerned. ASTRAZENECA shall also provide TMC with advice
on the technical merits of proposals regarding manufacturing of the Compound brought forward by
such Third Party manufacturer(s). Any assistance provided under this Article 3.2.1 may be given by
telephone or e-mail or by other appropriate means as agreed by the Parties.

3.2.2. ASTRAZENECA undertakes to participate in no more than one (1) meeting in person with one
Third Party manufacturer, selected by TMC, to outline details of the manufacturing synthesis
regarding the Compound, provided that such meeting shall take place at ASTRAZENECA’s manufacturing
site in Södertälje, Sweden.

3.2.3. ASTRAZENECA further undertakes, should TMC not have exercised its right under Article 2.9 of
the Option Agreement, upon having received written notice from TMC, for a period of three (3)
months starting sixty (60) days upon ASTRAZENECA’s receipt of such notice, to assist TMC, by
telephone, e-mail or other appropriate means as agreed by the Parties, in TMC’s discussions with
Fresenius in connection with Fresenius’ restart of the formulation program regarding the Product.
The Parties agree, however, that TMC may not give such notice contemplated above in this Article
3.2.3 later than eight (8) months of the License Agreement Effective Date.

3.2.4. ASTRAZENECA agrees to provide reasonable assistance to the Third Party manufacturer selected
by TMC, by telephone, e-mail or other appropriate means as agreed by the Parties, in connection
with the start-up of manufacturing operations for the Product for a period of twelve (12) months
following commencement of process development by such contract manufacturer or fifteen (15) months
of the License Agreement Effective Date, whichever is the earliest to occur.

3.3. Duration of and Compensation for Assistance by ASTRAZENECA.

3.3.1. The Parties agree that any assistance to be provided by ASTRAZENECA under Articles 3.1, 3.2
and 3.5.1 shall be given to an extent necessary and reasonable and shall be given only within the
first four (4) years of the License Agreement Effective Date and shall not in total exceed sixty
(60) FTE Days. It is acknowledged that ASTRAZENECA may at its discretion carry out any such
assistance for up to fifty percent (50%) of such sixty FTE Days by using Third Party consultants.

3.3.2. For any services or assistance performed by ASTRAZENECA pursuant to Article 3.3.1, TMC shall
reimburse ASTRAZENECA for ASTRAZENECA’s out-of-pocket costs for such activities plus two thousand
U.S. Dollars ($2,000) per FTE Day. Should ASTRAZENECA use a Third Party consultant(s) for carrying
out assistance for a certain FTE Day, or part thereof, then, for the avoidance of doubt, the FTE
Day rate now stated shall apply thereon, and the out-of-pocket costs for consultants, if any, as
indicated above in this paragraph, shall apply only to costs for consultants which would typically
have been incurred should the assistance have been actually carried out by an employee(s) of
ASTRAZENECA or its Affiliates.

3.3.3. ASTRAZENECA shall invoice TMC for all assistance during each relevant time period within
thirty (30) days of the expiration of each calendar half-year.

11

 

3.4. Development of Product. 

3.4.1. TMC shall, subject to the obligations stated in this Article 3 and in Article 5, carry out
the development work permitted hereunder within its sole discretion and at its own cost and
expense.

3.4.2. TMC shall use Commercially Reasonable Efforts to develop Product up until the stage of
Filing of an NDA in each country of the Territory.

3.5. Regulatory Filings.

3.5.1. TMC shall be responsible for the preparation, submission and prosecution of all Filings of
an NDA in each country in which TMC, its Affiliates, sub-licensees or distributors will sell
Product. TMC, its Affiliates, sub-licensees or distributors shall be the owner and party of record
for all such filings, applications and approvals. ASTRAZENECA agrees to provide assistance
requested by TMC as reasonably necessary for preparation and prosecution of such filings and
applications in the European Union (it being contemplated that such filings and applications will
be done by using the then most efficient centralised procedure for applying for and obtaining
multi-country NDAs in the European Union (the “Procedure”)), and in the United States. TMC shall
reimburse ASTRAZENECA for any costs and expenses incurred in such assistance. TMC shall be
responsible for any costs associated with preparation, submission and prosecution of all such
Filing of an NDA and NDA Approvals required.

3.5.2. TMC shall, at its own expense, use Commercially Reasonable Efforts in Filing of an NDA and
prosecution thereof and in obtaining NDA Approvals in its own name or in the name of its
Affiliate(s) in each Major Market and other country of the Territory.

3.5.3. Regarding any country in the European Union where TMC makes a Filing of an NDA, TMC shall
for such purpose use the Procedure, unless TMC can clearly establish that Filing of an NDA
regarding one or more separate countries within the European Union would be more advantageous to
the Product from a regulatory or commercial perspective.

3.5.4. TMC shall promptly inform ASTRAZENECA in writing of any Filing of an NDA and of any NDA
Approval, and shall in immediate connection therewith provide ASTRAZENECA with a written summary of
any such Filing of an NDA and NDA Approval, or with a copy thereof, whichever ASTRAZENECA may
elect.

3.5.5. Following NDA Approval in a certain Major Market or other country of the Territory TMC shall
use its Commercially Reasonable Efforts to Launch the Product in such Major Market or other country

3.6. Marketing and Sales of Product.

3.6.1. Regarding any country of the Territory where the Product is Launched, TMC shall promptly
inform ASTRAZENECA writing of the occurrence of such Launch.

3.6.2. TMC shall, in each Major Market or other country of the Territory where the Product has been
Launched, at its own expense, or the expense of its Affiliates, sub-licensees or distributors, use
Commercially Reasonable Efforts to market and sell the Product.

12

 

3.6.3. For the avoidance of doubt, what is stated regarding the obligations of TMC in this Article
3 or elsewhere in this Agreement shall always be subject to what is stated in Articles 2.2 and 2.3,
such that any of TMC’s obligations may be performed by one or more of TMC’s Affiliates or
sublicensees. Further, in accordance with what is stated in Article 2.4, any of TMC’s obligations
under this Article 3.6 and under Article 3.7 may be performed by one or more of TMC’s distributors.

3.7. Specific Time Limits for Performance. Notwithstanding what is stated in Articles
3.4.2, 3.5.2, 3.5.5 and 3.6.2, and without limiting the general performance criteria stated
therein, the following performance criteria stated in this Article 3.7 shall apply to the
situations herein described.

3.7.1. Time Limit for entering into Phase III Clinical Trials. TMC shall no later than 30 June
2004 have made the first dosing of a patient in a Phase III Clinical Trial regarding the Compound.

3.7.2. Time Limit for Filing of an NDA.

(a) TMC shall no later than 30 June 2006 have made a Filing of an NDA in the
United States.

(b) TMC shall no later than 30 June 2007 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 such one (1) Major Market shall be sufficient.

(c) TMC shall no later than 30 June 2008 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.

3.7.3. Time Limit for Launch of the Product

TMC shall no later than six (6) months following NDA
Approval in any Major Market Launch the Product in the country(ies)
concerned.

3.8. Remedy for Failure.

3.8.1. Non-Compliance.

     Should TMC at any time not comply with the applicable criteria of performance as set forth in
Articles 3.4.2, 3.5.2, 3.5.5, 3.6.2, 3.7.1, 3.7.2 or 3.7.3, then TMC shall promptly so notify
ASTRAZENECA in writing.

	 	(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.

3.8.2. Non-compliance regarding the European Union

      Should TMC have failed to comply with any such criteria of performance referred to
under Article 3.8.1, and should such non-compliance relate to the European Union, then TMC shall
anyway be considered to have fulfilled such performance criteria provided always that the countries
within the European Union to which such non-compliance relate are less than five (5).
Notwithstanding what is stated in Article 1.16, European Union for the purpose of this Article
3.8.2 shall constitute only those countries being members of European Union at the License
Agreement Effective Date.

3.8.3. Reasonable Delay or Other Non-Compliance.

     a) Should TMC upon receipt of notice from ASTRAZENECA according to Article 3.8.1 (i) through
(iii) be able to show that the delay or other non-compliance in the country(ies) concerned is
justifiable from a clinical, scientific or regulatory perspective, then the Parties shall meet and
consult whether the situation so occurred could be reasonably solved. Should the Parties, despite
such consultations, not be able to find a mutually acceptable solution within three (3) months upon
having entered into such consultations, then ASTRAZENECA may terminate the license regarding the
country(ies) concerned by giving TMC a notice of same in writing, whereupon the license regarding
such country(ies) shall immediately terminate and what is stated in Article 15.1 shall apply
regarding such country(ies).

14

 

     b) Should, following the initiation of the consultations pursuant to the first paragraph of
this Article 3.8.3, either Party reasonably believe that a solution to the situation arisen may be
solved through such consultations, but not within the initial three-month timeframe, then such
Party may notify the other Party hereof; and the three-months period provided for in Article 3.8.3
a) shall be extended with a time-period as requested by such Party in such notice but with no more
than three (3) months from the date of the notice.

3.9. The remedies stated in Article 3.8 shall be ASTRAZENECA’s sole remedy in case of any failure
by TMC to comply with what is stated in this Article 3.

4. SUPPLY MATTERS

4.1. Transfer of Bulk Compound to TMC. ASTRAZENECA undertakes to supply to TMC free of
charge approximately ten (10) kilograms of bulk Compound no later than ninety (90) days after the
License Agreement Effective Date. The transport of such entire quantity of bulk Compound shall be
entirely at TMC’s risk and expense. It is explicitly understood that this quantity of Compound was
manufactured by ASTRAZENECA at an earlier date, and was not made for the purpose of the supply now
stated, and that ASTRAZENECA gives no guarantee whatsoever as to the characteristics of the
Compound or the Compound’s fitness for any particular purpose.

4.2. Assignment of Agreement with Fresenius. Unless such Contract has been assigned or
terminated in accordance with what is stated in Article 2.8 of the Option Agreement, Astra Hässle
AB, subsequently merged into ASTRAZENECA, and Fresenius are at the License Agreement Effective Date
parties to a Development and Commercial Supply Contract of 28 December 1995 providing for the
supply by Fresenius to ASTRAZENECA of Product. Should Fresenius agree with TMC on the supply of
Product to TMC and with ASTRAZENECA to release ASTRAZENECA from any obligation under said Contract,
then ASTRAZENECA will, provided always that the release or termination of such Contract or TMC’s
entering into any such arrangement will not incur any expenses or liability on ASTRAZENECA, agree
to assign its rights under the Contract to TMC, or to terminate the Contract with Fresenius,
whichever TMC desires and notifies ASTRAZENECA in writing of.

It is explicitly understood and agreed by the Parties that ASTRAZENECA shall have no obligations
whatsoever to transfer or supply, other than as explicitly provided under Article 4.1, any quantity
of Compound or Product to TMC.

4.3. Supply of Compound and Product by TMC.

4.3.1. TMC undertakes to supply ASTRAZENECA’s Affiliate in Japan, AstraZeneca KK, at TMC’s [**],
AstraZeneca KK’s entire need of Product for clinical trials, sale, promotion and marketing in
Japan, pursuant to the Supply Agreement between TMC and AstraZeneca KK, attached hereto, subject to
what is stated in Article 4.3.3, as a Schedule E.

4.3.2. TMC further undertakes to supply ASTRAZENECA, subject to Article 15.1 (i), at TMC’s [**] and
otherwise under terms to be as consistent as possible with those under the Supply Agreement,
ASTRAZENECA’s 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;
provided always that such TMC’s obligation shall not become effective unless and until TMC has
Launched the Product in at least with one (1) country of the Territory.

15

 

4.3.3. The Supply Agreement may not have been entered into on the License Agreement Effective Date
due to the Parties’ desire to expeditiously enter into the Option Agreement, not delaying such
procedure by awaiting the completion of the Supply Agreement. The parties acknowledge the
substantial need for ASTRAZENECA to rely on TMC for its supply of the Product for the countries
mentioned in Articles 4.3.1 and 4.3.2 and that entering into the Supply Agreement is a substantial
prerequisite to ASTRAZENECA for entering into the Option Agreement. Should regardless hereof the
Supply Agreement not have been concluded within six (6) months of the License Agreement Effective
Date for other reasons than ASTRAZENECA’s lack of good faith in conducting such negotiations or
unnecessary delays caused by ASTRAZENECA, then ASTRAZENECA shall have the right to terminate this
Agreement forthwith by giving written notice to TMC.

Should ASTRAZENECA have failed, however, to provide to TMC in accordance with what is stated in
Article 2.10 of the Option Agreement a first draft of the Supply Agreement, then, notwithstanding
what is stated in the first paragraph of this Article 4.3.3, ASTRAZENECA shall not have the right
to terminate this License Agreement.

5. EXCHANGE OF INFORMATION

5.1. Obligation of TMC to Share Information. In addition to the obligations specifically
requiring TMC to inform ASTRAZENECA regarding particular events, TMC undertakes to keep ASTRAZENECA
informed about the progress of the development work regarding the Compound hereunder. For this
purpose:

5.1.1. the Parties will, up until the date when Filing of an NDA has been made in the last Major
Market, meet at least once a year to review TMC’s progress and efforts in the development work
contemplated herein. Such meeting will take place on a location to be agreed by the Parties, or,
should the Parties not be able to agree, alternately with each Party at a site to be determined by
the Party hosting the meeting. In advance of such meeting, TMC will provide ASTRAZENECA a
reasonable written summary of such development work, including, without limitation, summaries of
protocol designs of any clinical trials conducted or to be conducted, any changes to same and any
Results developed during the period concerned;

5.1.2. TMC shall further in advance of such meeting provide ASTRAZENECA in writing a timetable for
the expected Filings of an NDA, expected NDA Approvals and expected Launches during the one-year
period, or other shorter applicable period, to come. In connection therewith TMC shall provide to
ASTRAZENECA in writing, for the same period of time, a non-binding marketing plan and sales
forecast for the Product in any Major Market where the Product by that time has been Launched or is
expected to be Launched during the applicable period immediately to come;

5.1.3. TMC shall notify ASTRAZENECA forthwith and provide particulars of any halt or substantial
delay in any development program or clinical trial, any obstacles in the Product reaching the
market and any substantial changes anticipated in the sales potential of the Product;

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

16

 

any NDA Approval by ASTRAZENECA in Japan or which may otherwise relate to such Filing of an NDA or
NDA Approval.

5.2. Obligation of AstraZeneca to Share Information. ASTRAZENECA shall keep TMC informed
about the progress of the clinical trials, sale, promotion and marketing of Product in any country
in which ASTRAZENECA has rights to sell Product. For this purpose:

5.2.1. ASTRAZENECA shall at least once each year provide TMC in writing a timetable for the
expected Filings of an NDA, expected NDA Approvals and expected Launches during the one-year period
to come.

5.2.2. ASTRAZENECA shall notify TMC forthwith regarding, and provide copies of, any correspondence
with the regulatory authorities in any Major Market that could reasonably be of any significance
regarding the possibility, time frame or scope of any Filing of an NDA or any NDA Approval by TMC
in any country for which TMC has yet to file an NDA or receive NDA Approval.

6. CONSIDERATION

In consideration of the rights granted hereunder TMC shall pay to ASTRAZENECA the remuneration
stated in this Article 6.

6.1. Milestone Payments.

6.1.1. Within thirty (30) days of the License Agreement Effective Date TMC shall pay to ASTRAZENECA
the amount of One Million U.S. Dollars (U.S. $1,000,000).

6.1.2. Within thirty (30) days of the date of TMC’s Filing of an NDA in the first Major Market, TMC
shall pay to ASTRAZENECA the amount of One Million Five Hundred Thousand U.S. Dollars (U.S.
$1,500,000).

6.1.3. Within thirty (30) days of TMC’s receipt of NDA Approval in the first Major Market TMC shall
pay to ASTRAZENECA the amount of One Million Five Hundred Thousand U.S. Dollars (U.S. $1,500,000).

6.1.4. Within thirty (30) days of the TMC’s receipt of NDA Approval in the second Major Market, TMC
shall pay to ASTRAZENECA the amount of [**] U.S. Dollars (U.S. $[**]).

6.1.5. Within thirty (30) days of the TMC’s receipt of NDA Approval in the third Major Market, TMC
shall pay to ASTRAZENECA a final milestone payment in the amount of [**] U.S. Dollars (U.S. $[**]).

6.2. Royalty Rate.

6.2.1. Following Launch of the Product, on a country-by-country basis for the period set out in
Article 6.4 TMC shall pay to ASTRAZENECA, subject to what is stated in Article 6.2.2, a running
royalty on the annual Net Sales of the Product as follows:

17

 

	 	 	 
	Annual Net Sales	 	Royalty Rate
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]
	[**]
	 	[**]

The relevant royalty rate so stated shall apply to the amount of annual Net Sales
within the applicable layer only.

For convenience of example only and without limiting the above, the royalty rate of
[**]% shall apply to the amount of annual Net Sales under $[**] and should the
annual Net Sales exceed $[**] then the royalty rate of [**]% shall apply only to the
amount of annual Net Sales exceeding $[**] (and up to $[**]).

6.2.2. Notwithstanding the royalty rates set forth in Article 6.2.1, on the Net Sales of the
Product during the time period starting on the License Agreement Effective Date and ending on
December 31, 2007, the running royalty rate shall be reduced to [**] percent ([**]%) of the rate
otherwise stated in Article 6.2.1.

6.2.3. For the purpose of Article 6.2.1 the term “annual” shall refer to calendar years, provided,
however, that for the purpose of determining what royalty rates to apply during the first or last
calendar year of the royalty payment period pursuant to Article 6.4, which parts may not constitute
a full calendar year, the following shall apply.

a) The applicable royalty rate under each of items (a) through (i) of Article
6.1.1, subject to what is stated in Article 6.2.2, shall apply to the Net Sales
exceeding the amount “A” in the following formula.

NM

TA x — = A          
         
           

12

18

 

where “NM” is the “number of full months” of sales attracting royalty
hereunder, regardless of the number of countries in which sales are being made,
during the calendar year concerned; and where “TA” is the applicable “threshold
amount” under the respective items (a) through (i) of Article 6.2.1.

b) For convenience of example only and without limiting the above standing, the
following calculation shows the application of the provision stated.

If Launch occurs in the first country three months before the end of the
calendar year, the formula will read, regarding the royalty rate of [**]% under
6.2.1(a): $[**] x 3/12 = $[**]. The royalty rate of [**]% under 6.2.1(b) will
then become applicable on any Net Sales exceeding $[**] (and up to $[**]) and a
royalty rate of [**]% will be applicable on any Net Sales up to and including
$[**]. Notwithstanding the foregoing, as this example is with respect to sales
in the first country in which Launch occurs, the above stated royalty rates may
be reduced by [**] percent ([**]%) pursuant to Article 6.2.2.

6.3. Minimum Royalty. Notwithstanding what is stated in Article 6.2, during the second
through fourth full calendar years following Launch in the first Major Market the aggregate annual
royalty amount due by TMC to ASTRAZENECA for sales of the Product shall, regardless of the actual
Net Sales amount accrued during such calendar year, not go below the following amounts during the
years specified.

6.3.1. Second full calendar year following Launch: [**] U.S. Dollars ($[**]);

6.3.2. Third full calendar year following Launch: [**] U.S. Dollars ($[**])

6.3.3. Fourth full calendar year following Launch: [**] U.S. Dollars ($[**])

6.3.4. Should the Net Sales by TMC for any calendar year not generate the relevant royalty amount
indicated under this Article 6.3, then TMC shall pay the difference between the minimum royalty
amount stated and the amount actually generated within thirty (30) days after the date when the
royalty payment for the last full quarter of the calendar year concerned is due according to
Article 6.6.1.

6.4. Duration of Royalty Payments. Royalties under Article 6.2 shall be payable on a
country by country basis for the longer of :

a) the life of ASTRAZENECA Patent Rights which are necessary to continue to
manufacture, use or sell the Product in such country; or

b) a period of ten (10) years from Launch in that country (provided always that
in the case of a country within the European Economic Area such ten (10) years
period shall run from the date of Launch anywhere in the European Economic
Area);

6.5. ASTRAZENECA Trademark Royalty. Unless the license to the ASTRAZENECA Trademark has
been reverted pursuant to Article 9.1, TMC shall, following expiration of the

19

 

period indicated under Article 6.4 on a country-by-country basis, and for as long as TMC sells the
Product in any country in the Territory, in consideration of the exclusive license in the Territory
to use the ASTRAZENECA Trademark in connection with the sales and marketing of the Product pay to
ASTRAZENECA an annual running royalty on the Net Sales of the Product of [**] percent ([**]%).

6.6. Reports.

6.6.1. TMC shall deliver to ASTRAZENECA within sixty (60) days after the end of each calendar
quarter ending March 31, June 30, September 30 and December 31, a written report showing its
computation of the remuneration due to ASTRAZENECA under this Agreement during such calendar
quarter including (i) the quantity of the Product sold by or on behalf of TMC during such calendar
quarter; and (ii) the total remuneration due in respect thereof and at the same time make the
payment of the remuneration due. Any payment to be made hereunder shall be made in U.S. Dollars.
Each such report mentioned in this Article 6.6.1 shall include the rates of exchange used for
conversion to U.S. Dollars from the currency in which such sales were made.

6.6.2. In the event that ASTRAZENECA, its Affiliates or sublicenses sells Product pursuant to
Article 2.7.3, then ASTRAZENECA shall deliver to TMC within sixty (60) days after the end of each
calendar quarter ending March 31, June 30, September 30 and December 31, a written report showing
its computation of the remuneration due to TMC under this Agreement during such calendar quarter
including (i) the quantity of the Product sold by or on behalf of ASTRAZENECA during such calendar
quarter; and (ii) the total remuneration due in respect thereof and at the same time make the
payment of the remuneration due. Any payment to be made hereunder shall be made in U.S. Dollars.
Each such report mentioned in this Article 6.6.2 shall include the rates of exchange used for
conversion to U.S. Dollars from the currency in which such sales were made.

6.7. Taxes.

6.7.1. The payments to be made hereunder by either Party shall be net payments i.e. without
deduction of any bank or transfer charges.

6.7.2. ASTRAZENECA shall pay any and all taxes levied on account of, or measured exclusively by,
all payments it receives under this Agreement, including without limitation Swedish Value Added Tax
(“mervärdesskatt”). Amounts payable from TMC to ASTRAZENECA under this Agreement shall be paid by
TMC without deduction for any tax, provided however that TMC may withhold income tax as required by
internal laws of any applicable jurisdiction. In the case of such withholding being applicable,
ASTRAZENECA may apply for the reduction of rate of withholding tax (including under the U.S./Sweden
tax treaty) with the assistance of TMC and provided evidence of acceptance of this claim is
submitted to TMC, TMC shall apply this rate accordingly. If applicable laws require that taxes be
withheld, TMC will deduct those taxes from the remittable payments, make timely payment of the
taxes to the proper taxing authority and send proof of such payment to ASTRAZENECA within sixty
(60) days following that payment.

6.7.3. TMC shall pay any and all taxes levied on account of, or measured exclusively by, all
payments it receives under this Agreement. Amounts payable from ASTRAZENECA to TMC under this
Agreement shall be paid by ASTRAZENECA without deduction for any tax, provided however that
ASTRAZENECA may withhold income tax as required by internal

20

 

laws of any applicable jurisdiction. In the case of such withholding being applicable, TMC may
apply for the reduction of rate of withholding tax (including under the U.S./Sweden tax treaty)
with the assistance of ASTRAZENECA and provided evidence of acceptance of this claim is submitted
to ASTRAZENECA, ASTRAZENECA shall apply this rate accordingly. If applicable laws require that
taxes be withheld, ASTRAZENECA will deduct those taxes from the remittable payments, make timely
payment of the taxes to the proper taxing authority and send proof of such payment to TMC within
sixty (60) days following that payment.

6.8. Exchange Rates. For the purpose hereof, the rate of exchange to be used for
conversion hereunder to U.S. Dollars shall be the average rate of exchange for the period to which
the payment relates, as published by the Wall Street Journal.

6.9. Books and Audit. Each Party shall keep complete and accurate books and records with
respect to its sale of the Product and remuneration payable hereunder. Each Party shall have the
right to have such pertinent books and records of the other Party inspected and examined once each
calendar year for the purpose of determining the accuracy of payments made hereunder. Such
inspection and examination shall be conducted by an independent, certified, public accountant
selected by the Party requesting such examination. Such accountant shall not disclose to such Party
any information except for information necessary to verify the accuracy of the records and payments
made pursuant to this Agreement. The charges of the independent, certified, public accountant shall
be paid by the Party requesting examination except if the payments pursuant to this Agreement have
been understated by more than five percent (5%) in which case the Party who has underpaid will bear
the cost and pay the shortfall in payment pursuant to this Agreement with interest to the other
Party. Should instead the payments have been overstated the Party who has overpaid may deduct any
such amount from the royalty payments due hereunder until such amount has been recovered by such
Party.

6.10. Wire Transfer Instructions.

6.10.1. Unless otherwise instructed by ASTRAZENECA, all payments by TMC hereunder shall be made
from the United States by wire transfer in the requisite amount to the following account of
ASTRAZENECA.

Bank Name: [**]

Account No: [**]

Swift: [**]

6.10.2. Unless otherwise instructed by TMC, all payments by ASTRAZENECA hereunder shall be made
from Sweden by wire transfer in the requisite amount to the following account of TMC.

Bank Name: [**]

Account No: [**]

Bank Code: [**]

6.10.2.1. Interest. If any sum payable pursuant to this Agreement shall not have been paid
to a Party by the due date then (without prejudice to any other claim or remedy of such Party) the
Party owing such sum shall pay interest thereon to the other Party at an annual rate

21

 

of LIBOR + three percent (3%) from time to time published in respect of the period starting on the
due date of payment and ending on the actual date of payment.

“LIBOR” shall mean the thirty (30) days US dollar BBA London Interbank Offered Rate as
published by Reuter.

7. INTELLECTUAL PROPERTY — PROSECUTION AND MAINTENANCE

7.1. Any and all ASTRAZENECA IP vested in ASTRAZENECA shall as between ASTRAZENECA and TMC remain
vested in ASTRAZENECA.

7.2. Any and all TMC IP vested in TMC shall as between TMC and ASTRAZENECA remain vested in TMC.

7.3. ASTRAZENECA shall, during the term of this Agreement be responsible for the filing,
prosecution and maintenance of the ASTRAZENECA Patent Rights and the ASTRAZENECA Trademark in the
Territory. Should registration of the ASTRAZENECA Trademark be necessary or appropriate in any
country, then ASTRAZENECA shall be responsible for obtaining such registration.

TMC shall reimburse ASTRAZENECA for any out-of-pocket expenses (including fees to outside counsel
and consultants) incurred by ASTRAZENECA in relation to any action taken by ASTRAZENECA pursuant to
this Article 7.3.

7.4. TMC shall have the right to give comments and recommendations as to the overall strategy
regarding the filing, prosecution and maintenance of the ASTRAZENECA Patent Rights and the
ASTRAZENECA Trademark; and before taking any significant step in the filing, prosecution or
maintenance of the ASTRAZENECA Patent Rights or the ASTRAZENECA Trademark, ASTRAZENECA shall allow
TMC to comment on the action proposed to be taken and ASTRAZENECA shall consider any such comments.

7.5. In the event that ASTRAZENECA should decide to permit any pending patent application or any
patent included in the ASTRAZENECA Patent Rights to lapse by any action, inaction or failure to
take any action or to pay any fee when due, ASTRAZENECA shall promptly inform TMC of such decision,
but no later than fifteen (15) days prior to such action, inaction or failure to pay, provided that
such period is available to ASTRAZENECA, so that TMC might, for the avoidance of doubt at TMC’s
expense, seek such patent protection or prevent any such lapse.

7.6. ASTRAZENECA shall not be liable to TMC in contract, tort, negligence, breach of statutory duty
or otherwise for any economic loss or other loss of turnover, profits, savings, business or
goodwill or any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by
TMC because of ASTRAZENECA’s actions pursuant to or as a consequence of this Article 7.

     Patent term extensions

7.7. Should ASTRAZENECA not be able to lawfully apply for patent term extensions, including, but
not limited to, Supplementary Protection Certificates, relating to the

22

 

ASTRAZENECA Patent Rights in the Territory in its own name, or should ASTRAZENECA otherwise
require, TMC shall co-operate with ASTRAZENECA in any issue regarding the gaining of such patent
term extension by assisting ASTRAZENECA with any actions or documents needed for such purpose.

Should in any country in the Territory any decision have to be made as to what product, claim or
otherwise to apply for such patent term extension regarding, then ASTRAZENECA shall have the right
to make such decision at its own discretion.

7.8. Rights to the Results. Any patents and other intellectual property rights,
information, ideas, knowledge, data or know-how relating solely to the Compound, and/or the Product
developed during the term of this Agreement (hereinafter referred to as “Result(s)”) shall as
between TMC and ASTRAZENECA be TMC IP and the sole property of TMC. TMC shall have the sole
management of, and shall bear the cost of, any Results. ASTRAZENECA shall be given the reasonable
opportunity to comment on important aspects of the prosecution of any patent applications, and
shall use its reasonable endeavours to assist TMC in the prosecution of any patent applications.

8. CLAIMS REGARDING INFRINGEMENT AND INVALIDITY

8.1. Notification of Claim. If a Third Party notifies ASTRAZENECA or TMC, or their
respective Affiliates or sub-licensees, that any act by TMC, or its Affiliates or sub-licensees,
utilizing the ASTRAZENECA IP allegedly infringes in the Territory any Patent Rights or other
intellectual property rights owned by or licensed to the Third Party, ASTRAZENECA or TMC shall
promptly notify the other in writing.

8.2. Defence of Claimed Infringement.

8.2.1. ASTRAZENECA shall have no obligation to defend or settle any claim by a Third Party that the
manufacture, sale or other use of the Product by TMC resulting from the use or exercise of the
license granted hereunder under the ASTRAZENECA IP infringes any Patent Rights or other
intellectual property rights owned by or licensed to a Third Party, subject to the provisions of
Article 10.

8.2.2. If a Third Party makes an infringement claim or files an infringement action against
ASTRAZENECA, its Affiliates or sub-licensees, or TMC, its Affiliates or sub-licensees, arising out
of TMC’s, its Affiliates’ or sub-licensees’ manufacture, sale or other use of the Product in the
Territory, or if a Third Party challenges any of the ASTRAZENECA IP, then TMC shall defend or
settle the claim or action at its expense, subject to the provisions of Article 10.

8.2.3. ASTRAZENECA may join such proceedings mentioned under sub-section 8.2.2 voluntarily, subject
always to TMC’s, its Affiliates’ or sub-licensees’, right to decide the conduct over such
litigation. Any such joining of the proceedings shall be at ASTRAZENECA’s cost and expense.
ASTRAZENECA shall for such purpose have the right to independently retain legal counsel and
consultants, at its sole cost and expense.

8.2.4. It is understood between the Parties that any proposed settlement will be subject to
ASTRAZENECA’s prior written approval, which approval shall not be unreasonably withheld. Such
approval might be withheld primarily on the grounds that ASTRAZENECA reasonably determines that the
settlement proposed is overly burdensome, financially or

23

 

strategically, that ASTRAZENECA determines that TMC’s conduct of the defence has a reasonable
chance of succeeding or that ASTRAZENECA intends to continue such defence itself.

Should ASTRAZENECA withhold such approval, then ASTRAZENECA shall have the right, but not the
obligation (other than in the case that ASTRAZENECA has announced to TMC its intention to continue
such defence itself), to continue the defence of the claim or action at its own expense. In such
case TMC, its Affiliates or sub-licensees shall, at ASTRAZENECA’s request and at ASTRAZENECA’s
expense for TMC’s, its Affiliates’ or sub-licensees’ costs and expenses, assist in the prosecution
of such action, including, but not limited to, consenting to being joined in such action as a
voluntary plaintiff.

8.2.5. Should TMC reasonably believe that the Third Party rights contemplated by Article 8.2.1 are
valid in a certain country(ies) and that infringement is likely to be occurring in such
country(ies), TMC may seek and enter into a licence thereto from such Third Party on appropriate
commercial terms, whereby any remuneration and any costs and expenses (including but not limited to
reasonable external legal costs) for such license shall be shared equally between TMC and
ASTRAZENECA according to the following.

TMC may deduct an amount equivalent to [**] percent ([**]%) of TMC’s payments to such Third Party
pursuant to such arrangement as indicated in the first paragraph of this Article 8.2.5 from the
royalty payments to be made by TMC to ASTRAZENECA on the Net Sales in the country concerned
pursuant to Article 6.2 to cover ASTRAZENECA’s obligation to carry [**] percent ([**]%) of such
payments and costs. This deduction shall be subject to the proviso that the royalty payments due to
ASTRAZENECA shall not be reduced in total by more than [**] percent ([**]%) in any calendar year,
and any residue not offset may be carried forward by TMC until such time as it has recovered
ASTRAZENECA’s [**] per cent ([**]%) share of such costs and expenses, or until the royalty payment
obligations of TMC hereunder expire, whichever is the earlier.

8.3. Third Party Infringement. If a Third Party shall, in the reasonable opinion of either
Party, infringe any ASTRAZENECA Patent Rights or ASTRAZENECA Trademark in the Territory, then the
Party having such opinion shall promptly notify the other Party.

8.3.1. Further, each Party shall within five (5) working days or as soon as reasonably possible
thereafter advise the other Party of receipt of any notice of:

a) any certification filed under the U.S. “Drug Price Competition and Patent
Term Restoration Act of 1984” (“ANDA Act”), claiming that any ASTRAZENECA Patent
Rights are invalid or claiming that the ASTRAZENECA Patent Rights will not be
infringed by the manufacture, use or sale of a product for which an application
under the ANDA Act is filed or;

b) any equivalent or similar certification or notice in any other jurisdiction.

8.3.2. TMC, its Affiliates or sub-licensees shall have the initial sole right to commence an action
for infringement in the Territory against the Third Party, in its own name, together with the right
to enforce and collect any judgement thereon. ASTRAZENECA may join such proceedings voluntarily,
subject always to TMC’s, its Affiliates’ or sub-licensees’ right to

24

 

decide the conduct over such litigation. Any such joining of the proceedings shall be at
ASTRAZENECA’s cost and expense. ASTRAZENECA shall for such purpose have the right to independently
retain legal counsel and consultants, at its sole cost and expense.

8.3.3. Any monetary recovery (whether by settlement or judgement) in connection with an
infringement action commenced by TMC, its Affiliates or sub-licensees shall be applied first to
reimburse TMC, its Affiliates or sub-licensees for their out-of-pocket expenses (including
reasonable attorneys fees) incurred in prosecuting such action and the expenses of ASTRAZENECA
borne by TMC hereunder. Any balance remaining shall be allocated among ASTRAZENECA and TMC in a
manner reasonably calculated to correspond to the distribution of profits, in accordance with what
would normally be provided for under this Agreement, on the sales of Product to which such recovery
pertains.

8.3.4. Should neither TMC, nor its Affiliates or sub-licensees, take appropriate and diligent
action with respect to any such infringement or challenge as contemplated in this Article 8.3
within forty-five (45) days, or, in the case of a certification filed under the ANDA Act or similar
certification or notice as contemplated under Article 8.3.1, within twenty (20) days, after
receiving notice of any infringement or possible infringement or challenge, then ASTRAZENECA shall
have the right, but not the obligation, to take such action, at its own expense, in its own name,
and the right to enforce and collect any judgement thereon.

a) Should ASTRAZENECA elect to take such action then TMC, its Affiliates or
sub-licensees, shall, at ASTRAZENECA’s request and at ASTRAZENECA’s expense for
TMC’s, its Affiliates’ or sub-licensees’, costs and expenses, assist in the
prosecution of such action, including, but not limited to, consenting to being
joined in such action as a voluntary plaintiff.

b) If the recovery of such action as contemplated in this Article 8.3.4 exceeds
ASTRAZENECA’s out-of-pocket expenses (including reasonable attorneys fees) for
prosecuting the action, then such excess recovery shall be shared by the
Parties on a [**] basis.

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 Japan or in any other 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 ASTRAZENECA’s, its Affiliates’ or
sub-licensees’ right to decide the conduct over such litigation. Any such joining of the
proceedings shall be at TMC’s 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 shall be retained by ASTRAZENECA.

9. TRADEMARK

9.1. Should TMC not within twelve (12) months of the License Agreement Effective Date notify
ASTRAZENECA that TMC wishes to maintain its exclusive license to the ASTRAZENECA Trademark as
granted under Article 2.1, or should TMC within such twelve-months period notify ASTRAZENECA in
writing that TMC does not wish to

25

 

maintain such exclusive license to the ASTRAZENECA Trademark, then upon the expiration of such
twelve-months period or the date of such written notice, whichever is the earlier,

	 	(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.

Should the rights have been so reverted, then TMC shall select a trademark of its own, not being
confusingly similar to the ASTRAZENECA Trademark, to use in connection with the sales, marketing
and distribution of the Product and shall be the owner and party of record of such trademark (the
“TMC Trademark”). TMC shall have sole responsibility for clearance and registration of said TMC
Trademark. TMC shall be responsible for all decisions and costs relating to selection, clearance,
registration, defence and maintenance of the TMC Trademark.

9.2. Utilisation of the ASTRAZENECA Trademark

9.2.1. Unless the license to the ASTRAZENECA Trademark has been reverted pursuant to Article 9.1,
TMC shall, as soon as reasonably possible upon completion of the item concerned, but no later than
one (1) year prior to the estimated Launch in each country, notify ASTRAZENECA in a clearly visible
manner how TMC intends to utilise the ASTRAZENECA Trademark in connection with the marketing, sales
and distribution of the Product in the country concerned, including but not limited to showing the
shape, size and colour of the intended logo containing the ASTRAZENECA Trademark, the intended
packages of the Product and the intended promotional materials regarding the Product in such
country. TMC may not utilise the ASTRAZENECA Trademark in any context without ASTRAZENECA’s prior
written approval, such approval not to be unreasonably withheld.

9.2.2. Should ASTRAZENECA not approve such TMC’s proposal, or part thereof, under Article 9.2.1,
then ASTRAZENECA shall submit to TMC a proposal, within sixty (60) days of having received TMC’s
proposal, on how to utilise the ASTRAZENECA Trademark in this regard.

9.2.3. Should TMC not accept ASTRAZENECA’s proposal, or part thereof, provided under Article 9.2.2,
then TMC may notify ASTRAZENECA of a new proposal on the utilisation of the ASTRAZENECA Trademark,
or such part thereof, in such way as set forth in Article 9.2.1; such proposal to be noticeably
different from all previous proposals. Should ASTRAZENECA not approve such proposal, then what is
stated in Article 9.2.2. shall apply.

26

 

9.2.4. Should ASTRAZENECA not within forty-five (45) days of such notice as stated in Article 9.2.1
have notified TMC that it objects all or in part to such TMC’s proposal, or should ASTRAZENECA
after having not approved a proposal, or part thereof, fail to present a proposal as stated under
Article 9.2.2, then the proposal presented by TMC shall be considered to have been approved by
ASTRAZENECA.

9.3. TMC shall use the ASTRAZENECA Trademark in accordance with applicable laws in any country
where TMC markets, sells or distributes the Product utilising the ASTRAZENECA Trademark. Unless the
rights to the ASTRAZENECA Trademark have been reverted pursuant to Article 9.1, TMC undertakes to
use the ASTRAZENECA Trademark at any time when the Product is sold, marketed or distributed in the
Territory and not to use any trademark other than the ASTRAZENECA Trademark in connection with the
sales, marketing and distribution of the Product. TMC further undertakes not to use any trademark
being confusingly similar to the ASTRAZENECA Trademark in connection with marketing, sales and
distribution of any other product.

9.4. Should in any country of the Territory TMC by legal, regulatory or similar reasons be
prevented from using the ASTRAZENECA Trademark or should usage of the ASTRAZENECA Trademark in
connection with the sales, marketing and distribution of the Product prove to be commercially
unreasonable in such country because of such legal, regulatory or similar reasons, then TMC shall
immediately notify ASTRAZENECA hereof in writing and TMC shall not have the obligation to use the
ASTRAZENECA Trademark for the marketing, sales and distribution of the Product in the country
concerned. The Parties shall in such case meet and in good faith endeavour to find a new trademark
as similar to the ASTRAZENECA Trademark as possible. Such new trademark selected for the country
concerned shall for all purposes of this Agreement be considered an ASTRAZENECA Trademark.

TMC shall carry all costs and expenses for the development and creation of such new trademark,
provided always that should such costs be disproportionately high in relation primarily to the
estimated value of the Product then TMC may offer ASTRAZENECA to carry all or part of such costs,
or, should ASTRAZENECA notify TMC in writing that it declines to do so, notify ASTRAZENECA that it
does not wish to maintain the license to the ASTRAZENECA Trademark for the country concerned;
whereupon what is stated in Articles 9.1. (a) through (c) shall apply regarding such country.

9.5. TMC undertakes, should ASTRAZENECA so require in writing, to mention on all packages, package
inserts and promotional and advertising materials for the Product “Licensed from AstraZeneca AB” or
the equivalent wording in the major language(s) of the country in which the Product is sold, or,
should legal, regulatory or similar reasons prevent the use of that wording, such other wording as
close as possible to the wording herein stated.

10. INDEMNITY

10.1. Indemnity by TMC.

10.1.1. TMC shall be responsible for and shall indemnify ASTRAZENECA, its Affiliates and its and
its Affiliates’ directors, officers, other employees, agents and consultants (collectively the
“ASTRAZENECA Indemnified Party”) against any and all liability, loss, damage, cost and expense
(including legal costs) incurred or suffered by the ASTRAZENECA Indemnified

27

 

Party as a result of any claim brought against an ASTRAZENECA Indemnified Party by a Third Party
(i) arising out of the testing, manufacture, sale, use or promotion by TMC, its Affiliates or
sub-licensees of any Compound or Product hereunder; (ii) arising out of any theory of product
liability (including, but not limited to, actions in the form of tort, warranty or strict
liability) based on Compounds or Products developed by TMC hereunder; or (iii) arising out of any
other activities to be carried out by TMC, its Affiliates or sub-licensees pursuant to this
Agreement to the extent not included in (i) and (ii) above, except where such liability, loss,
damage, cost and expense has been incurred or suffered as a result of a material breach of warranty
or representation of ASTRAZENECA set out in Article 13 or by gross negligence or misconduct on the
part of ASTRAZENECA.

10.1.2. An ASTRAZENECA Indemnified Party that intends to claim indemnification under Article 10.1.1
shall notify TMC promptly of any such liability, loss, damage, cost and expense and permit TMC to
control the defence and disposition thereof and further agrees to reasonably cooperate at TMC’s
expense with TMC in the handling thereof. The ASTRAZENECA Indemnified Party shall not compromise or
settle such claim. TMC agrees to keep ASTRAZENECA informed of the progress in the defence and
disputation of such claims and to consult with ASTRAZENECA with regard to any settlement thereof
which TMC proposes to enter into and will provide ASTRAZENECA with suitable information regarding
the same.

10.1.3. TMC will maintain appropriate liability insurance against such product and other liability
as contemplated under Article 10.1.1 at levels appropriate for products and activities of the
relevant type.

10.2. Indemnity by ASTRAZENECA.

10.2.1. ASTRAZENECA shall be responsible for and shall indemnify TMC, its Affiliates and its and
its Affiliates’ directors, officers, other employees, agents and consultants (collectively the “TMC
Indemnified Party”) against any and all liability, loss, damage, cost and expense (including legal
costs) incurred or suffered by the TMC Indemnified Party as a result of any claim brought against
the TMC Indemnified Party by a Third Party (i) arising out of the testing, manufacture, sale, use
or promotion by ASTRAZENECA, its Affiliates or sub-licensees, of any Compound or Product hereunder;
(ii) arising out of any theory of product liability (including, but not limited to, actions in the
form of tort, warranty or strict liability) based on Compounds or Products sold by ASTRAZENECA
hereunder; or (iii) which arises as a result of a breach of a warranty or representation of
ASTRAZENECA set out in Article 13, except where such liability, loss, damage, cost and expense has
been incurred or suffered as a result of a material breach of TMC’s obligations under this
Agreement or by gross negligence or misconduct on the part of TMC.

10.2.2. A TMC Indemnified Party that intends to claim indemnification under Article 10.2.1 shall
notify ASTRAZENECA promptly of any such liability, loss, damage, cost and expense and permit
ASTRAZENECA to control the defence and disposition thereof and further agrees to reasonably
cooperate at ASTRAZENECA’s expense with ASTRAZENECA in the handling thereof. The TMC Indemnified
Party shall not compromise or settle such claim. ASTRAZENECA agrees to keep TMC informed of the
progress in the defence and disputation of such claims and to consult with TMC with regard to any
settlement thereof which ASTRAZENECA proposes to enter into and will provide TMC with suitable
information regarding the same.

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10.2.3. ASTRAZENECA will either maintain appropriate liability insurance or be self insured against
such liability as contemplated under Article 10.2.1.

11. CONFIDENTIALITY

11.1. Confidential Information. At all times during the term of this Agreement and
for a period of five (5) years following termination or expiration hereof, each Party shall, and
shall cause its officers, directors, employees and agents to, keep confidential and not publish or
otherwise disclose and not use, directly or indirectly, for any purpose, any Confidential
Information provided to it by the other Party, provided, that, each Party may disclose and
use the Confidential Information of the other Party to the extent such disclosure or use is
expressly permitted by the terms of this Agreement, including without limitation those purposes set
forth in Article 11.2, or is otherwise reasonably necessary for the performance of this Agreement.

11.2. Permitted Use and Disclosure. The Receiving Party may use and/or disclose
Confidential Information to the extent that such disclosure is:

11.2.1. made in response to a valid order of a court of competent jurisdiction or other competent
authority provided however that the Receiving Party shall first have given notice to the Disclosing
Party and given the Disclosing Party a reasonable opportunity to obtain a protective order
requiring that the Confidential Information and documents that are the subject of such order be
held in confidence by such court or authority or, if disclosed, be used only for the purpose for
which the order was issued; and provided further that if a protective order is not obtained, the
Confidential Information disclosed in response to such court or governmental order shall be limited
to that information which is legally required to be disclosed in response to such court or
governmental order;

11.2.2. made by the Receiving Party to a regulatory authority as required in connection with any
Filing of an NDA; provided, however, that reasonable measures will be taken to assure confidential
treatment of such information;

11.2.3. made by the Receiving Party to a patent authority as required in connection with any filing
or application for Patent Rights; or

11.2.4. made by the Receiving Party to Third Parties as may be necessary or useful in connection
with the development, manufacturing, marketing, use and sale of the Compound or the Product as
contemplated by this Agreement, including subcontracting, sublicensing and distribution
transactions in connection therewith, provided that any such Third Party has undertaken
confidentiality obligation with respect to the Confidential Information disclosed by the Receiving
Party to it and the results of any such activities. Regardless hereof, TMC may not disclose to such
Third Party which compound(s), other than the Compound, that [**] may be used as a manufacturing
starting material, or intermediate, for.

11.3. Release from Restrictions. Notwithstanding the foregoing, Confidential Information
shall not include any information that, as determined by competent written proof:

11.3.1. is or hereafter becomes part of the public domain by public use, publication, general
knowledge or the like through no wrongful act, fault or negligence on the part of the Receiving
Party;

29

 

11.3.2. can be demonstrated by documentation or other competent proof to have been in the Receiving
Party’s possession prior to disclosure by the Disclosing Party;

11.3.3. is subsequently received by the Receiving Party from a Third Party who is not bound by any
obligation of confidentiality with respect to the said information;

11.3.4. is generally made available to Third Parties by the Disclosing Party without restriction on
disclosure; or

11.3.5. is independently developed by or for the Receiving Party without reference to the
Disclosing Party’s Confidential Information.

12. ADVERSE EVENTS

12.1. Reporting of Adverse Events.

12.1.1. TMC shall be fully responsible for reporting to the relevant regulatory or other competent
authorities in the Territory any Adverse Event(s) which are or might be attributed to the use or
application of the Compound or the Product. At ASTRAZENECA’s request in writing TMC shall inform
ASTRAZENECA of any Adverse Event in the country(ies) contemplated, and during the time period
contemplated, by such notice.

12.1.2. ASTRAZENECA shall be fully responsible for reporting to the relevant regulatory or other
competent authorities in any country outside the Territory or for which the license to TMC
hereunder has been terminated any Adverse Event(s) which are or might be attributed to the use or
application of the Compound or the Product. At TMC’s request in writing ASTRAZENECA shall inform
TMC of any Adverse Event in the country(ies) contemplated, and during the time period contemplated,
by such notice. For the avoidance of doubt ASTRAZENECA may appoint any Affiliate(s) or
sub-licensee(s) carrying out the marketing of the Product in the country concerned to fulfil any
such obligation as stated hereunder.

12.1.3. Without limiting what is stated in Article 12.1, the Parties shall at an appropriate point
of time during development of the Product jointly establish any such Adverse Event reporting
procedures, including, but not limited to, any agreement regarding safety data exchange, as may be
required or useful.

13. REPRESENTATION AND WARRANTY

13.1. Representations and Warranties of ASTRAZENECA. ASTRAZENECA represents and warrants
to TMC as follows:

a) as of the License Agreement Effective Date it is the sole and exclusive
owner of the ASTRAZENECA Patent Rights and ASTRAZENECA Trademark; all of which
is free and clear of any liens, charges and encumbrances; and

b) as of the License Agreement Effective Date ASTRAZENECA has not previously
assigned, transferred, licensed, conveyed or otherwise encumbered its right,
title and interest in the ASTRAZENECA Patent Rights or the ASTRAZENECA
Trademark; and

30

 

c) as of the License Agreement Effective Date and to the best of ASTRAZENECA’s
knowledge, no Person other than ASTRAZENECA or any of its Affiliates, has or
shall have any claim of ownership with respect to ASTRAZENECA Patent Rights or
the ASTRAZENECA Trademark; and

d) as of the License Agreement Effective Date and to the best of ASTRAZENECA’s
knowledge, the manufacture, use and sale of the Compound does not infringe upon
any intellectual property rights of any Third Party, although it is expressly
acknowledged by TMC that ASTRAZENECA has made no particular searches or
investigations to determinate whether such infringement occurs; and

e) as of the License Agreement Effective Date there are no claims, judgements
or settlements against or owed by ASTRAZENECA or pending or threatened claims
or litigation relating to the ASTRAZENECA Patent Rights or the ASTRAZENECA
Trademark; and

f) except as insofar relating to any kind of formulation, or work or
development related thereto, of the Product, there are no other Patent Rights
or Know-How owned or licensed by ASTRAZENECA required to develop and/or
commercialise the Product, and ASTRAZENECA shall not assert against TMC any
Patent Rights or other intellectual property owned or licensed by ASTRAZENECA
as of the License Agreement Effective Date or at any time thereafter which are
or may be infringed by the Compound or the Product; and

g) as of the License Agreement Effective Date ASTRAZENECA has disclosed to TMC
any known interference with the ASTRAZENECA Patent Rights or re-examination or
reissue proceeding concerning such ASTRAZENECA Patent Rights; and

h) as of the License Agreement Effective Date ASTRAZENECA has no knowledge
from which it can reasonably be inferred that the granted ASTRAZENECA Patent
Rights or the ASTRAZENECA Trademark are invalid or that the applications for
ASTRAZENECA Patent Rights or ASTRAZENECA Trademark will not proceed to grant.

13.2. Acknowledgement of TMC. TMC is aware that the ASTRAZENECA Patent Rights or the
ASTRAZENECA Know-How may not sufficiently enable TMC to manufacture or conduct any other
operational or manufacturing-related activities with respect to the formulation of the Product, and
it is explicitly understood by TMC that TMC will have to independently conduct any analysis,
evaluation and investigation regarding what intellectual property, techniques, routes, equipment or
other help or assistance that will be required for such purpose and it will be entirely at TMC’s
risk to find such intellectual property, techniques, routes, equipment or other help or assistance
in order to conduct such activities.

13.3. Representations and Warranties of the Parties. Each Party represents and warrants to
the other Party that it is a duly organized and validly existing corporation under the laws of its
jurisdiction of incorporation, and has taken all required corporate action to authorize the
execution, delivery and performance of this Agreement; it has the full right, power and

31

 

authority to enter into this Agreement and perform all of its obligations hereunder; the execution
and delivery of this Agreement and the transactions contemplated herein do not violate, conflict
with, or constitute a default under its Articles of Association or similar organization document,
its by-laws or the terms or provisions of any material agreement or other instrument to which it is
a party or by which it is bound, or any order, award, judgement or decree to which it is a party or
by which it is bound; and upon execution and delivery, this Agreement will constitute the legal,
valid and binding obligation of it.

13.4. Limitations. EXCEPT AS OTHERWISE SET FORTH IN THIS AGREEMENT ASTRAZENECA EXPRESSLY
DISCLAIMS ANY AND ALL IMPLIED OR EXPRESS WARRANTIES AND MAKES NO EXPRESS OR IMPLIED WARRANTY,
STATUTORY OR OTHERWISE, OF ANY KIND, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE REGARDING THE COMPOUND, ASTRAZENECA’S CONFIDENTIAL INFORMATION, DOCUMENTS,
ASTRAZENECA KNOW-HOW, ASTRAZENECA PATENT RIGHTS, OR PRODUCTS.

14. TERM AND TERMINATION

14.1. Term. This Agreement shall become effective on the License Agreement Effective Date
and shall expire when TMC ceases to sell the Product in the last country of the Territory or
otherwise terminates this Agreement as set forth in Article 14.2.

14.2. Termination by TMC. Should TMC determine that it does no longer consider it viable
to continue to exercise the rights under this Agreement, then TMC may give written notice to
ASTRAZENECA, whereupon this Agreement shall terminate thirty (30) days of such notice, unless
ASTRAZENECA, within twenty (20) days of having received such notice, requests TMC in writing to
enter into good faith discussions to see whether TMC’s concerns could be reasonably overcome.
However, upon TMC having given such notice TMC shall not be liable for any payments under Articles
6.1.2 through 6.1.5 or for any payments under Articles 6.3.1 unless corresponding to the royalty
amounts actually due, which become due after the expiration of the 30-days period mentioned above
in this Article 14.2.

Should the Parties not within three (3) months of the date of commencement of such good faith
discussions mentioned above in this Article 14.2 have managed to reach a mutually acceptable
solution to TMC’s concerns, then TMC may terminate this Agreement by giving ninety (90) days
written notice.

14.3. Termination for Breach. In the event that either Party (the “Breaching Party”) shall
be in significant default in the performance of any of its material obligations under this
Agreement, in addition to any other right and remedy the other Party (the “Complaining Party”) may
have, the Complaining Party may terminate this Agreement by sixty (60) days prior written notice
(the “Notice Period”) to the Breaching Party, specifying the breach and its claim of right to
terminate, provided always that the termination shall not become effective at the end of the Notice
Period if the Breaching Party cures the breach complained about during the Notice Period.

14.4. Survival of Obligations. Termination or expiration of this Agreement shall not
relieve either Party from any obligation incurred hereunder prior thereto.

32

 

14.5. Survival of Provisions upon Termination and/or Expiration. Subject to what is stated
in Article 15, the provisions of Articles 1, 7.1, 7.2, 10, 11, 12, 13, 14.5, 15, 17 and 18 shall
survive termination or expiration of this Agreement. The provisions of Article 2.5 shall survive
only upon expiration of this Agreement. The provisions of Article 11 shall survive termination or
expiration of this Agreement and shall continue to be in force for a period of five (5) years after
termination or expiration of this Agreement.

15. CONSEQUENCES OF TERMINATION

15.1. Termination and handback of license

In addition to any remedy either Party may have in law, tort or in contract, subject to what is
stated in Article 3.9, upon termination of the Agreement or the license in a certain country, the
following shall apply.

Upon termination of this Agreement by TMC pursuant to Article 14.2 or by ASTRAZENECA pursuant to
Article 14.3, or by ASTRAZENECA in a certain country pursuant to Article 3.8, the license granted
under Article 2.1 regarding the country(ies) contemplated by the termination concerned shall cease,
and TMC shall, regarding the Territory or the country concerned, whichever is applicable:

	 	(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 TMC’s 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 ASTRAZENECA’s 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 ASTRAZENECA’s appointment of a Third Party
manufacturer of Product.

Upon such termination as stated in this Article 15.1, ASTRAZENECA shall have the right to disclose
Confidential Information, to Third Parties for the purpose only of, and only to the extent
necessary for, enabling such Third Party to evaluate the financial and scientific status of the
Compound or Product for the purpose of making a financial offer to ASTRAZENECA on the licensing or
acquisition of the rights returned to ASTRAZENECA and the rights licensed to ASTRAZENECA under this
Article 15.1, and, if such licensing or acquisition occurs, as necessary to exploit or enforce such
rights.

15.2. Termination followed by continued license

Upon the termination of this Agreement by TMC pursuant to Article 14.3, ASTRAZENECA’s licences
granted to TMC under Article 2 shall continue, provided that TMC continues to make payments
pursuant to Article 6 as if the Agreement was still in effect.

35

 

16. FORCE MAJEURE

16.1. If either Party is prevented or delayed in the performance of any of its obligations
under this Agreement by Force Majeure, that Party shall forthwith serve notice in writing on the
other Party specifying the nature and extent of the circumstances giving rise to Force Majeure, and
shall subject to service of such notice and to Article 16.3 have no liability in respect of the
performance of such of its obligations as are prevented by the Force Majeure event during the
continuation of such events, and for such time after they cease as is necessary for that Party,
using all reasonable endeavours, to recommence its affected operations in order for it to perform
its obligations.

16.2. If either Party is prevented from performance of its obligations, due to Force Majeure, for a
continuous period in excess of six (6) months, the other Party may terminate this Agreement
forthwith on service of written notice upon the Party so prevented. In the event of termination
under this Article 16.2 the provisions of Article 15 shall not apply immediately and the Parties
shall meet to discuss the ASTRAZENECA IP and TMC IP and agree on a process for arrangements upon
termination.

16.3. The Party claiming to be prevented or delayed in the performance of any of its obligations
under this Agreement by reason of Force Majeure shall use its reasonable endeavours to bring the
Force Majeure event to a close or to find a solution by which the Agreement may be performed
despite the continuation of the Force Majeure event.

17. GENERAL PROVISIONS

17.1. Assignment.

17.1.1. Subject to Articles 17.1.2 and 17.1.3, neither Party shall without the prior written
consent of the other Party assign, transfer, charge or deal in any other manner with this Agreement
or any of its rights under it.

17.1.2. Each Party shall be entitled to assign its rights under this Agreement to an acquiror of
all or substantially all of its capital stock or assets related to the pharmaceutical business
described in this Agreement, whether through purchase, merger, consolidation or otherwise.

17.1.3. Each Party shall be entitled to assign its rights under this Agreement to an Affiliate
provided that such Party shall require that any such Affiliate to whom it assigns any of its rights
under this Agreement shall assign such rights back to the assigning Party immediately prior to it
ceasing to be an Affiliate of the assigning Party.

17.2. Severance.

17.2.1. If any provision of this Agreement shall be found by any court or administrative body of
competent jurisdiction to be invalid or unenforceable, such invalidity or unenforceability shall
not, provided that the general content of the Agreement remains substantially the same as prior to
such invalidity or unenforceability, affect the other provisions of this Agreement which shall
remain in full force and effect.

17.2.2. The Parties agree, in the circumstances referred to in Article 17.2.1, to attempt to
substitute for any invalid or unenforceable provision a valid or enforceable provision which
achieves to the greatest extent possible the same effect as would have been achieved by the invalid
or unenforceable provision.

36

 

17.3. Notices.

17.3.1. All notices and other communications given or made in relation to this Agreement;

17.3.2. shall be in English and in writing;

17.3.3. shall be delivered by hand or sent by first class registered post or facsimile;

17.3.4. shall be delivered or sent to the Party concerned at the relevant address or facsimile
number, shown in Article 17.4 subject to such amendments as may be notified from time to time in
accordance with this Article by the relevant Party to the other Party by no less than three
business days notice; and

17.3.5. shall be deemed to have been duly given or made if addressed in the aforesaid manner;

17.3.6. if delivered by hand, upon delivery;

17.3.7. if posted by first class registered post, four (4) business days after posting;

17.3.8. if sent by facsimile, when a complete and legible copy of the communication has been
received at the appropriate address

17.4. Contact Information. Initial details for the purposes of Article 17.3 are:

	 	 	For ASTRAZENECA
	 
	 	 	Address: AstraZeneca AB, S–151 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

17.5. Agency, Partnership or Joint Venture Excluded.

17.5.1. Nothing in this Agreement shall be construed so as to constitute either Party to be the
agent of the other.

37

 

17.5.2. Nothing in this Agreement and no action taken by the Parties pursuant to this Agreement
shall constitute a partnership or joint venture of any kind between the Parties.

17.6. Entire Agreement. Each of the Parties acknowledges and agrees that in entering into
this Agreement, and the documents referred to in it, it does not rely on, and shall have no remedy
in respect of, any statement, representation, warranty or understanding (whether negligently or
innocently made) of any Person (whether party to this Agreement or not) other than as expressly set
out in this Agreement as a warranty. Nothing in this Article shall either operate to limit or
exclude any liability for fraud.

17.7. Agreement to Supersede earlier Agreements. The Confidential Disclosure Agreement
entered into by and between the Parties on 9 April 2001 ceases to have effect from the date of this
Agreement, except such termination does not affect a Party’s accrued rights and obligations at the
date of termination.

17.8. Amendments. No amendment to or variation of this Agreement shall be valid unless it
is in writing and signed by or on behalf of each of the Parties.

17.9. Publicity and Announcements.

17.9.1. Subject to Article 17.9.2 no press release, announcement or any other communication to any
Third Party concerning the transaction contemplated by this Agreement, the financial terms of this
Agreement, the subject matter of this Agreement or any ancillary matters shall be made or permitted
or authorized to be made by either Party without the prior written approval of the other, such
approval not to be unreasonably withheld or delayed and such approval to be given by an authorized
representative of the Party in question.

17.9.2. Either Party may make an announcement concerning the transaction contemplated by this
Agreement or any ancillary matter if required by law, existing contractual obligations or any
securities exchange or Regulatory Authority or governmental body to which either Party is subject
or submits, wherever situated, provided that the Party required to make such announcement notifies
the other Party of the details of the announcement prior to making such announcement and in
sufficient time for the other Party to consider and comment on the announcement, and takes
advantage of all provisions to keep confidential as many terms of the Agreement as possible.

17.10. Waiver. Failure or delay by either Party to exercise any right or remedy under this
Agreement shall not be deemed to be a waiver of that right or remedy, or prevent it from exercising
that or any other right or remedy on that occasion or on any other occasion.

17.11. No Benefit to Third Parties. No Third Party shall be deemed a third party
beneficiary under this Agreement for any purpose. Without limiting the foregoing, the Contracts
(Rights of Third Parties) Act 1999 and any legislation amending or replacing such Act shall not
apply in relation to this Agreement or any agreement, arrangement, understanding, liability or
obligation arising under or in connection with this Agreement.

18. GOVERNING LAW AND ARBITRATION

18.1. Arbitration. The Parties shall use their reasonable efforts to settle amicably any
dispute arising out of or in connection with this Agreement. In case the Parties are not able to
settle such dispute between themselves, such dispute shall be finally resolved by arbitration in

38

 

accordance with the Rules of the International Chamber of Commerce. The arbitration proceedings
shall be held in London. Any proceedings shall be held in the English language.

18.2. Governing Law. The validity, construction and interpretation of this Agreement and
any determination of the performance which it requires shall be governed by the laws of England.

IN WITNESS WHEREOF this License Agreement has entered into force on the License Agreement Effective
Date.

	 	 	 

	ASTRAZENECA AB

	 	THE MEDICINES COMPANY
	 
	 	 
	(publ)
	 	 

39

 

Schedule A

ASTRAZENECA Patent Rights

 

 

PATENT FAMILY LIST

	 	 	 	 	 

	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

 

PATENT FAMILY LIST

	 	 	 	 	 

	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

 

PATENT FAMILY LIST

	 	 	 	 	 

	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

 

Schedule B

Trademark Registrations

1

 

Trademark Family Report

	 	 	 	 	 

	TRADEMARK
	 	:	 	CLEVELOX
	 
	 	 	 	 
	TM Family Number
	 	:	 	A02243
	TM Attorney
	 	:	 	MST
	Project Resp. RPT
	 	:	 	MST
	Project Description
	 	:	 	Clevidipine
	Project Number
	 	:	 	20298
	Project Cost Centre
	 	:	 	20298
	Therapeutic Area
	 	:	 	Cardio vascular
	Owner
	 	:	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Country	 	SN	 	Appl De	 	Reg. Dt	 	Reg No	 	Expir. Dt	 	Status
	United Arab Emi
	 	1	 	 	 	 	 	 	 	 	 	Inactive
	Argentina
	 	1	 	05.12.1997	 	 	 	 	 	 	 	Inactive
	Austria
	 	1	 	24.11.1997	 	06.02.1998	 	173947	 	29.02.2008	 	Registered
	Australia
	 	1	 	26.11.1997	 	26.11.1997	 	749529	 	26.11.2007	 	Registered
	Brazil
	 	1	 	 	 	 	 	 	 	 	 	Inactive
	Benelux
	 	1	 	21.11.1997	 	21.11.1997	 	622377	 	21.11.2007	 	Registered
	Canada
	 	1	 	16.12.1997	 	 	 	 	 	 	 	Filed
	Switzerland
	 	1	 	21.11.1997	 	02.04.1998	 	450528	 	21.11.2007	 	Registered
	China P.R.
	 	1	 	28.11.1997	 	14.02.1999	 	1246211	 	14.02.2009	 	Registered
	Colombia
	 	1	 	03.12.1997	 	 	 	 	 	 	 	Filed
	Czech Repub
	 	1	 	03.12.1997	 	27.05.1999	 	217843	 	03.12.2007	 	Registered
	Germany
	 	1	 	22.11.1997	 	30.01.1998	 	39756082	 	30.11.2007	 	Registered
	Denmark
	 	1	 	21.11.1997	 	15.09.1998	 	199802513	 	15.09.2008	 	Registered
	Egypt
	 	1	 	01.12.1997	 	 	 	 	 	 	 	Filed
	Spain
	 	1	 	26.11.1997	 	20.05.1998	 	2128403	 	26.11.2007	 	Registered
	Finland
	 	1	 	21.11.1997	 	13.11.1998	 	211790	 	13.11.2008	 	Registered
	France
	 	1	 	24.11.1997	 	24.11.1997	 	97705657	 	24.11.2007	 	Registered
	Great Britian
	 	1	 	21.11.1997	 	21.11.1997	 	2151563	 	21.11.2007	 	Registered
	Greece
	 	1	 	17.11.1997	 	17.11.1999	 	135252	 	17.11.2007	 	Registered
	Hong Kong
	 	1	 	08.12.1997	 	08.12.1997	 	3239/99	 	08.12.2004	 	Registered
	Hungary
	 	1	 	27.11.1997	 	08.02.1999	 	155530	 	27.11.2007	 	Registered
	Indonesia
	 	1	 	12.12.1997	 	12.12.1997	 	427623	 	12.12.2007	 	Registered
	Ireland
	 	1	 	30.10.1997	 	21.11.1997	 	208749	 	21.11.2007	 	Registered
	Israel
	 	1	 	24.11.1997	 	07.02.1999	 	116095	 	24.11.2004	 	Registered
	India
	 	1	 	26.11.1997	 	 	 	 	 	 	 	Filed
	Iceland
	 	1	 	24.11.1997	 	28.01.1998	 	210/1998	 	28.01.2008	 	Registered
	Italy
	 	1	 	25.11.1997	 	18.05.2000	 	813581	 	25.11.2007	 	Registered
	Japan
	 	1	 	09.01.1998	 	02.04.1999	 	4257306	 	02.04.2009	 	Registered
	Japan
	 	2	 	17.04.2000	 	07.09.2001	 	4504229	 	07.09.2011	 	Registered
	South Korea
	 	1	 	27.11.1997	 	27.11.1998	 	431337	 	27.11.2008	 	Registered
	Mexico
	 	1	 	04.12.1997	 	04.12.1997	 	568689	 	04.12.2007	 	Registered
	Malaysia
	 	1	 	28.11.1997	 	 	 	 	 	 	 	Filed
	Norway
	 	1	 	21.11.1997	 	18.06.1998	 	190954	 	18.06.2008	 	Registered
	New Zealand
	 	1	 	25.11.1997	 	25.11.1997	 	285223	 	25.11.2004	 	Registered

2

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Country	 	SN	 	Appl De	 	Reg. Dt	 	Reg No	 	Expir. Dt	 	Status
	Pakistan
	 	1	 	25.11.1997	 	 	 	 	 	 	 	Filed
	Poland
	 	1	 	25.11.1997	 	06.03.2001	 	123629	 	25.11.2007	 	Registered
	Portugal
	 	1	 	25.11.1997	 	15.05.1998	 	327385	 	15.05.2008	 	Registered
	Romania
	 	1	 	05.12.1997	 	05.12.1997	 	33325	 	05.12.2007	 	Registered
	Russian Federat
	 	1	 	03.12.1997	 	24.02.1999	 	172676	 	03.12.2007	 	Registered
	Saudi Arabia
	 	1	 	12.01.1998	 	12.01.1998	 	474/30	 	22.09.2007	 	Registered
	Sweden
	 	1	 	21.11.1997	 	06.08.1999	 	332270	 	06.08.2009	 	Registered
	Singapore
	 	1	 	15.12.1997	 	 	 	 	 	 	 	Filed
	Slovak Republic
	 	1	 	25.11.1997	 	14.12.1999	 	188597	 	25.11.2007	 	Registered
	Thailand
	 	1	 	09.12.1997	 	09.12.1997	 	80071	 	09.12.2007	 	Registered
	Turkey
	 	1	 	26.12.1997	 	26.12.1997	 	195964	 	26.12.2007	 	Registered
	Taiwan
	 	1	 	04.12.1997	 	16.10.1998	 	820735	 	16.10.2008	 	Registered
	United States
	 	1	 	21.11.1997	 	 	 	 	 	 	 	Inactive
	United States
	 	2	 	19.04.2001	 	 	 	 	 	 	 	Filed
	Vietnam
	 	1	 	05.01.1998	 	07.05.1999	 	30808	 	05.01.2008	 	Registered
	South Africa
	 	1	 	01.12.1997	 	01.12.1997	 	97/18422	 	01.12.2007	 	Registered

3

 

Schedule C

Compound

1

 

Schedule C, compound

Chemical structure, chemical name and molecular formula

Chemical structure

	 	 	 

	 

	 	 

Figure 1. Chemical structure of clevidipine

Chemical name

Butyroxymethyl methyl 4-(2’,3’-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate.

Molecular weight

456.3 g/mol.

Molecular formula

 C21H23Cl2NO6

2

 

Schedule D

Reports

1

 

Reports to be translated and sent to TMC

	 	 	 	 	 
	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	 	 

2

 

Schedule E

Supply Agreement

- i -

 

THE MEDICINES COMPANY

February 13, 2004

Anders Buren

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

Dear Anders:

     This is to advise AstraZeneca AB, pursuant to Section 9.1 of the License Agreement, effective
as of March 28, 2003 (the “License Agreement”), between AstraZeneca AB and The Medicines Company
(“TMC”) that TMC wishes to maintain its exclusive license to the ASTRAZENECA Trademark, Clevelox,
granted to TMC under Article 2.1 of the License Agreement.

Sincerely,

/s/ Clive A. Meanwell

Clive A. Meanwell, M.D.

Executive Chairman

	cc:	 	Dr. Margareta Nordlander

Dr. Anders Waas

- ii -

 

CONFIRMATION

This Confirmation sets forth the Parties’ mutual understanding of the interpretation of
Article 6.2.1 of the License Agreement effective as of 28 March 2003 (the “License Agreement”)
entered into by and between AstraZeneca AB, with its registered office at SE-151 85 Södertälje,
Sweden (“ASTRAZENECA”), and The Medicines Company, with its registered office at 8 Campus Drive,
Parsippany, New Jersey 07054, United States (“TMC”).

Any term with capital initial letter and defined in the License Agreement shall when used in this
Confirmation document have the meaning ascribed to it in the License Agreement.

The Parties hereby confirm that it is their mutual understanding that the annual Net Sales
mentioned in Article 6.2.1 refers to the annual Net Sales in the whole Territory.

The Parties confirm that the Agreement shall remain in full force and effect in accordance with its
terms and conditions.

 

IN WITNESS WHEREOF, the Parties have executed this Confirmation document in two (2) original
copies.

	 	 	 

	ASTRAZENECA AB (publ)

	 	THE MEDICINES COMPANY
	 
	 	 
	/s/ Gunner Olsson

	 	/s/ Clive Meanwell
	 

	 	 
	Name: Gunner Olsson

	 	Name: Clive Meanwell
	Title: VP & Head of CV TA

	 	Title: Executive Chairman

December 19, 2003

8 Campus Drive Parsippany, New Jersey 07054 Tel: (973) 656-1616 Fax (973) 656-9898exv10w35

Exhibit 10.35

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

AMENDMENT NO. 1

TO

LICENSE AGREEMENT

          THIS AMENDMENT NO. 1 (“Amendment No. 1”) TO THE AGREEMENT (as defined below) is entered into
as of April 25, 2006 by and between ASTRAZENECA AB, a company incorporated under the laws of Sweden
with its registered office at SE-151 85 Södertälje, Sweden (“ASTRAZENECA”) and THE MEDICINES
COMPANY, a company incorporated under the laws of Delaware with its registered office at 8 Campus
Drive, Parsippany, New Jersey 07054, United States (“TMC”).

WITNESSETH:

          WHEREAS, the parties hereto are parties to that certain License Agreement on clevidipine that
entered into effect as of March 28, 2003 (the “Agreement”); and

          WHEREAS, the parties desire to amend the Agreement as set forth herein.

          NOW, THEREFORE, the parties agree as follows:

	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:

          “3.7.2 Time Limit for Filing an NDA.

	 	(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, ASTRAZENECA’s
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 TMC’s 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 ASTRAZENECA’s, its Affiliates’ or sub-licensees’ right
to decide the conduct of such litigation. Any such joining of the
proceedings shall be at TMC’s 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.

          IN WITNESS WHEREOF, this Amendment No. 1 has entered into force 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

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