Exhibit 10.17
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
10 April, 2003
The Medicines Company
0 Xxxxxx Xxxxx
Xxxxxxxxxx
Xxx Xxxxxx 00000
Xxxxxx Xxxxxx
Att: Xxxxx Xxxxxxxx
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 Xx. Xxxxxxxx,
(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 Xx.
Xxxxxx Waas at the following address: AstraZeneca R&D Molndal, Global Licensing,
XX-000 00 Xxxxxxx Xxxxxx.
Yours sincerely, Agreed and accepted
ASTRAZENECA AB (publ) Date:
[illegible] THE MEDICINES COMPANY
---------------------------- /s/ Xxxxx Xxxxxxxx
Name: -----------------------------------
Name: Xxxxx Xxxxxxxx
cc: Xxxxxx X. Xxxxxx
Xxxx and Xxxx
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Xxxxxx Xxxxxx
LICENSE AGREEMENT
TABLE OF CONTENTS
ARTICLE
Page
----
1. Definitions 2
2. Grant of License 11
3. Development and Commercialisation 14
4. Supply Matters 23
5. Exchange of Information 25
6. Consideration 28
7. Intellectual Property - Prosecution and Maintenance 35
8. Claims Regarding Infringement and Invalidity 37
9. Trademark 42
10. Indemnity 45
11. Confidentiality 47
12. Adverse Events 49
13. Representation and Warranty 50
14. Term and Xxxxxxxxxxx 00
00. Consequences of Xxxxxxxxxxx 00
00. Xxxxx Xxxxxxx 00
00. General Provisions 59
- Assignment 59
- Severance 60
- Notices 60
- Contact Information 61
- Agency, Partnership or Joint Venture Excluded 62
- Entire Agreement 62
- Agreement to Supersede earlier Agreements 62
- Amendments 62
- Publicity and Announcements 62
- Waiver 63
- No Benefit to Third Parties 63
18. Governing Law and Arbitration 63
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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 X-000 00 Xxxxxxxxxx, Xxxxxx ("ASTRAZENECA") and
THE MEDICINES COMPANY, a company incorporated under the laws of Delaware with
its registered office at Xxx Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000,
Xxxxxx Xxxxxx ("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 Clevelox(TM) 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
2
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
3
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, X-000 00 Xxxxxxx,
Xxxxxx.
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.
7
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 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
10
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 Sodertalje,
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 [**]. It is
acknowledged that ASTRAZENECA may at its discretion carry out any such
assistance for up to [**] percent ([**]%) of such [**] 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 [**]U.S. Dollars ($[**]) [**]. 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.
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.
11
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.
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.
12
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 [**] 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 [**] have made a Filing of an
NDA in the United States.
(b) TMC shall no later than [**] or [**] 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 [**] or [**] 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 [**] 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.
(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
13
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).
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.
14
4. SUPPLY MATTERS
4.1. TRANSFER OF BULK COMPOUND TO TMC. ASTRAZENECA undertakes to supply to
TMC [**] 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 Hassle 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.
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
15
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 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.
16
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 [**] U.S. Dollars
(U.S. $[**]).
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 [**] U.S. Dollars (U.S.
$[**]).
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:
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.
17
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
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 $[**]. Notwithstanding the foregoing, as this example
is with respect to sales in the first country in which Launch
occurs, the above stated royalty rates may be reduced by [**]
percent ([**]%) pursuant to Article 6.2.2.
6.3. MINIMUM ROYALTY. Notwithstanding what is stated in Article 6.2, during
the second through fourth full calendar years following Launch in the first
Major Market the aggregate annual royalty amount due by TMC to ASTRAZENECA for
sales of the Product shall, regardless of the actual Net Sales amount accrued
during such calendar year, not go below the following amounts during the years
specified.
6.3.1. Second full calendar year following Launch: [**] U.S. Dollars ($[**]);
18
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 [**] years from Launch in that country
(provided always that in the case of a country within the
European Economic Area such [**] 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 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.
19
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 ("mervardesskatt"). 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 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.
20
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 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 Xxxxxx.
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.
21
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 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
22
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 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.
23
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 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.
24
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 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
25
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.
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
26
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 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
27
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.
10.2.3. ASTRAZENECA will either maintain appropriate liability insurance or be
self insured against such liability as contemplated under Article 10.2.1.
28
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;
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;
29
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
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
30
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 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
31
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.
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
32
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;
(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.
33
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 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.
34
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.
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.
35
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.
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, X-000 00 Xxxxxxxxxx, Xxxxxx
Facsimile: x00-0 000 000 00
For the attention of: President & CEO
For TMC
Address: The Medicines Company, 0 Xxxxxx Xxx, Xxxxxxxxxx,
00
Xxx Xxxxxx 00000, Xxxxxx Xxxxxx
Facsimile: x0-000-000-0000
For the attention of: Xxxxx Xxxxxxxx, Executive Chairman
with a copy to
Xxxxxx X. Xxxxxx
Xxxx and Xxxx, LLP
00 Xxxxx Xxxxxx
Xxxxxx XX 00000
Xxxxxx Xxxxxx
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.
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
37
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) Xxx 0000 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 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)
38
Schedule A
ASTRAZENECA Patent Rights
0
PATENT FAMILY LIST
Family : A1262
App./Propr : Astra AB
Title : Short acting dihydropyridines
Inventors : ANDERSSON, Xxxxx
XXXXXXXXXX, Xxxxxxxxx
XXXXXXXXXX, Xxxxxxxx
Country SN F App No App Date Xxx No. Xxxxx Xx. 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
Xxxxx Xxxxxx 0 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 Xxx 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
Xxxxxxx 0 X 000000 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
Xxxxxx 0 000000 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
Xxxxxx 0 X 000000 03.11.1994 305656 05.07.1999 03.11.2014 Xxxxxxx
0
Xxx Xxxxxxx 0 X 000000 03.11.1994 275915 29.09.1997 03.11.2014 Granted
Philippines 1 49112 04.10.1994 0-0000-00000 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
Xxxxxx Xxxxx 0 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
Xxxxxxx 0 X 00000000 00.00.0000 Xxxxx
Xxxxxx Xxxxxx 0 X 000000 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, Xxxxx
XXXXX, Xxx
XXXXXXXXXX, Xxxxxxxxx
XXXXXXXXXX, Xxxxxxxx
XXXXXXX, Xxxx-Xxxxx
Country SN F App No App Date Xxx No. Xxxxx Xx. 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
Xxxxxx 0 X Xxxxxxxx
Xxxxxx 0 X 0000000 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
Xxxxx Xxxxxx 0 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 Xxx 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
Xxxxxxx 0 X 000000 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 XX0000000 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
Xxxxxx 0 000000 10.11.1994 Filed
3
Malaysia 1 PI94003029 14.11.1994 Filed
Netherlands 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Xxxxxx 0 X 000000 03.11.1994 Filed
Xxx Xxxxxxx 0 X 000000 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
Xxxxxx Xxxxx 0 P PV0597/96 03.11.1994 Filed
Thailand 1 024457 11.11.1994 Filed
Xxxxxxx 0 X 00000000 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 Xxx No. Xxxxx Xx. Exp. Dt Status
----------------- ---- -- ---------------- -------------- ---------------- -------------- ------------- ----------
Australia 1 P 20105/00 22.11.1999 Filed
Canada 1 P 2349195 22.11.1999 Filed
European Xxx 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
Xxxxxxxx 0 00.00.0000 Xxxxx
Xxxxx Xxxxx 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
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
Xxxxxx Xxxxxxxx 0 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
Xxxxxx Xxxxxx 0 00.00.0000 Xxxxxxxx
Xxxxxx Xxxxxx 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
C SUB(21)H SUB(23)Cl SUB(2)NO SUB(6)
2
Schedule D
Reports
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
1
Schedule E
Supply Agreement
- i -
THE MEDICINES COMPANY
February 13, 0000
Xxxxxx Xxxxx
XxxxxXxxxxx XX
X-000 00 Xxxxxxxxxx
Xxxxxx
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/ Xxxxx X. Xxxxxxxx
Xxxxx X. Xxxxxxxx, M.D.
Executive Chairman
cc: Xx. Xxxxxxxxx Xxxxxxxxxx
Xx. Xxxxxx 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 XX-000 00 Xxxxxxxxxx, Xxxxxx ("ASTRAZENECA"), and
The Medicines Company, with its registered office at 0 Xxxxxx Xxxxx, Xxxxxxxxxx,
Xxx Xxxxxx 00000, Xxxxxx Xxxxxx ("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/ Xxxxxx Xxxxxx /s/ Xxxxx Xxxxxxxx
---------------------------------------- ----------------------------------
Name: Xxxxxx Xxxxxx Name: Xxxxx Xxxxxxxx
Title: VP & Head of CV TA Title: Executive Chairman
December 19, 2003
0 Xxxxxx Xxxxx Xxxxxxxxxx, Xxx Xxxxxx 00000 Tel: (000) 000-0000
Fax (000) 000-0000
