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EXHIBIT 10.2
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
STUDY AND EXCLUSIVE OPTION AGREEMENT
entered into on this 5th day of March 2002 (the "Effective Date")
by and between
ASTRAZENECA AB, a company incorporated under the laws of Sweden with its
registered office at S-151 85 Sodertalje, Sweden ("ASTRAZENECA")
and
THE MEDICINES COMPANY, a company incorporated under the laws of Delaware with
its registered office at One Cambridge Center, Cambridge, Massachusetts 02142,
United States ("TMC");
WITNESSETH
WHEREAS, ASTRAZENECA performs research, development and marketing of
pharmaceutical compounds and products inter alia in the cardiovascular therapy
area; and
WHEREAS, ASTRAZENECA has developed the intravenous product Clevidipine for
indications such as the control of blood pressure; and
WHEREAS, TMC performs development of pharmaceutical compounds and marketing of
pharmaceutical products particularly in the cardiovascular therapy area; and
WHEREAS, TMC may be interested in acquiring a license to develop and
commercialise Clevidipine provided that the product fulfils certain clinical
criteria; and
WHEREAS, ASTRAZENECA has expressed its interest to license Clevidipine to TMC
and finds it to be in the mutual interest of the Parties that TMC may perform a
certain clinical study to evaluate whether Clevidipine fulfils the criteria
desired.
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NOW THEREFORE, the Parties hereto agree to the following.
1. DEFINITIONS
In this Agreement the following expressions shall have the following meanings:
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. "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 1.2 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.
1.3. "CDA" shall mean the Confidential Disclosure Agreement entered into
by and between the Parties on 9 April 2001, as subsequently amended
on 21 August 2001.
1.4. "Compound" shall mean ASTRAZENECA's proprietary compound named
Clevidipine with the chemical structure as shown in Schedule 1,
attached hereto.
1.5. "Confidential Information" shall mean any and all information, data
and know-how, whether oral or in writing or software stored relating
to the Compound or the Product and disclosed by or on behalf of
ASTRAZENECA or its Affiliates hereunder.
1.6. "Effective Date" shall have the meaning defined above.
1.7. "FTE Day" shall have the meaning defined in the License Agreement.
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1.8. "Intellectual Property Rights" shall mean know how, patents, trade
marks, service marks, trade names, registered designs, design
rights, copyright (including rights in computer software) and any
rights or property similar to any of the foregoing in any part of
the world whether registered or not registered together with the
right to apply for the registration of any such rights.
1.9. "License Agreement" shall mean the License Agreement providing for
an exclusive license to the Product (as therein defined) by and
between the Parties, attached hereto as a Schedule 2.
1.10. "License Agreement Effective Date" shall have the meaning defined in
Article 9.1.3.
1.11. "License Agreement Notice" shall have the meaning defined in Article
9.1.1.
1.12. "Party" or "Parties" shall mean TMC and/or ASTRAZENECA.
1.13. "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 organisation, including a government or political
subdivision, department or agency of a government.
1.14. "Pilot Study" shall mean the clinical study to be carried out
according to the study outline attached hereto as a Schedule 3.
1.15. "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.
1.16. "Results" shall mean any inventions, formulae, products, processes,
techniques, discoveries, improvements, information, data and
knowledge developed, generated or reduced to practice under or in
connection with the Pilot Study and any Intellectual Property Rights
related thereto.
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1.17. "Samples" shall mean samples of the Product in 100 ml bottles
containing 0.5 mg/ml of Compound in 20 % lipid emulsion for clinical
use.
1.18. "Trigger" shall mean a result of the Pilot Study demonstrating that
the Compound is statistically significantly better (p<=0.05) than
nitroglycerin in preserving creatinine clearance, such statistically
significantly better result measured as change in 24 hours
creatinine clearance before and after on pump CABG in at least 100
patients.
2. THE PILOT STUDY
2.1. ASTRAZENECA shall supply to TMC, or shall cause its
manufacturer of Product to supply to TMC, whichever ASTRAZENECA
elects, within forty-five (45) days from the date of delivery to
ASTRAZENECA from ASTRAZENECA's manufacturer of the complete number
of Samples indicated below in this Article 2.1 ordered from such
manufacturer or the date when such number of Samples is ready for
delivery from such manufacturer, whichever day ASTRAZENECA elects,
Samples in a total quantity of 700 bottles. Any such delivery to
TMC shall be made free of charge to TMC at TMC's designated
facility. ASTRAZENCA shall reimburse TMC any cost for 20%
Intralipid to be used as placebo in the Pilot Study. Such cost
should not exceed New Zealand Dollars [**].
2.2. The Parties acknowledge that TMC has as of the Effective Date
received under the CDA the information it will need to carry out the
Pilot Study. In addition thereto ASTRAZENECA may at its own
discretion, from time to time during the term of this Agreement,
disclose Confidential Information to TMC in such manner as shall be
agreed between the Parties to enable TMC to carry out the Pilot
Study.
2.3. The Pilot Study shall be carried out entirely by TMC. TMC shall be
fully and solely responsible for the reporting of any Adverse Events
emanating from or relating to the Pilot Study. TMC shall perform its
obligations under this Agreement to the best of its abilities in a
manner appropriate to assure that the Results are true, accurate and
correct.
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TMC shall have the right to use CROs and other sub-contractors for
the purposes of carrying out the Pilot Study, provided that TMC
shall notify ASTRAZENECA without unreasonable delay following any
such appointment of a CRO or other sub-contractor. TMC shall ensure
that all of its CROs or other sub-contractors will comply with all
terms and conditions of this Agreement and TMC shall remain fully
responsible for the compliance by such CROs or other sub-contractors
with the terms and conditions of this Agreement as if such CROs or
other sub-contractors were TMC hereunder.
2.4. The Parties shall use their best reasonable efforts to initiate and
complete without unreasonable delay following the Effective Date a
study protocol setting forth a detailed description of the Pilot
Study, to be based in all substantial parts on the study outline set
forth in Schedule 3. Such study protocol shall be attached hereto as
the Schedule 3, thereby replacing and superseding the version of
Schedule 3 attached hereto at the Effective Date, and, for the
avoidance of doubt, the Pilot Study shall be carried out according
to such study protocol. Should the Parties not have been able
despite such best reasonable efforts to agree on a study protocol
within four (4) months of the Effective Date, then upon the request
in writing by either
Party within thirty (30) days of the expiration of such four months
period this Agreement shall immediately terminate.
2.5. Tottie Nordlander at ASTRAZENECA, or whoever ASTRAZENECA assigns and
notifies TMC in writing about, shall be ASTRAZENECA's primary
contact person during the term of this Agreement. TMC shall where
necessary, advisable or useful discuss with Tottie Nordlander any
important aspects of the performance of the Pilot Study.
2.6. TMC shall keep ASTRAZENECA continually updated about the conduct of
the Pilot Study by means of meetings and written reports, whichever
would be suitable for the purpose of keeping ASTRAZENECA
sufficiently informed. No less than once every fourth (4th) week TMC
shall submit to ASTRAZENECA a written report summarising progress on
the Pilot Study during the period concerned. Within sixty (60) days
of completion of clean file
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of the Pilot Study TMC shall submit to ASTRAZENECA a final report,
in a format consistent with the International Committee on
Harmonization guidelines for a clinical study report, summarising
the work performed and the Results achieved during the Pilot Study
("the Final Report").
Any such report contemplated in this Article 2.6 may be submitted to
ASTRAZENECA's contact person as stated in Article 2.5.
2.7. TMC shall carry out the Pilot Study in accordance with any
applicable law or other regulation including but not limited to Good
Laboratory Practice and Good Clinical Practice as from time to time
set forth by the European Union. TMC shall during its performance of
the Pilot Study allow ASTRAZENECA to comment on any aspect of the
Pilot Study and shall take into reasonable account any such comment
made by ASTRAZENECA; provided always, however, that any such comment
is given by ASTRAZENECA without any warranty or guarantee as to the
results. For the avoidance of doubt, such ASTRAZENECA's right to
comment shall not prejudice TMC's right to manage and determine the
conduct of the Pilot Study, subject always to what is stated in this
Agreement and in Schedule 3.
Assistance by ASTRAZENECA to TMC in relation to Fresenius
2.8. At the Effective Date Astra Hassle AB, subsequently merged into
ASTRAZENECA, and Fresenius (as defined in the License Agreement) are
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 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.
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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 for under Article 2.1, any
quantity of Compound or Product to TMC.
2.9. ASTRAZENECA undertakes, upon having received written notice from
TMC, for a period of three (3) months starting sixty (60) days upon
ASTRAZENECA's receipt of such TMC's notice, to assist TMC, by
telephone, e-mail or other appropriate means as agreed by the
Parties, in TMC's discussions with Fresenius (as defined in the
License Agreement) in connection with Fresenius' restart of the
formulation program regarding the Product. Such ASTRAZENECA's
assistance shall be given to an extent necessary and reasonable and
shall not, together with any such assistance provided for under
Article 3.1, 3.2 and 3.5.1 under the License Agreement, exceed in
total [**]. 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.
For any services or assistance performed by ASTRAZENECA pursuant to
this Article 2.9, 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.
ASTRAZENECA shall invoice TMC for all assistance during each
relevant time period within thirty (30) days of the expiration of
each calendar half-year.
Submission of first draft of the Supply Agreement
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2.10. Due to the fact that the Supply Agreement (as defined in the License
Agreement) has not been entered into on the Effective Date,
ASTRAZENECA shall no later than three (3) months of the Effective
Date provide to TMC a first draft on the Supply Agreement. Should
ASTRAZENECA fail to do so, then TMC's sole remedy therefor shall be
ASTRAZENECA's loss of right, as stated in Article 4.3.3, second
paragraph, of the License Agreement, to terminate the License
Agreement.
3. REMUNERATION
As the sole consideration for TMC's right to carry out the Pilot
Study hereunder TMC shall carry itself any costs and shall be solely
responsible for any cost for, connected to or arising from the
performance of the Pilot Study.
4. UNDERTAKINGS OF TMC
In consideration of ASTRAZENECA supplying the Samples and disclosing
the Confidential Information to TMC, TMC hereby undertakes:
4.1. to use the Samples and the Confidential Information solely and
exclusively for the Pilot Study, and not to use the Samples, the
Confidential Information or the Results for any other purpose
whatsoever; and
4.2. to maintain confidential the Results, the Confidential Information
and the Samples and not to disclose directly or indirectly the
Results, nor the Confidential Information or give any part of the
Samples to any other Person, save as permitted by Article 5.
5. PERMITTED DISCLOSURES
5.1. Notwithstanding Article 4:
5.1.1. TMC may supply Samples and/or disclose Confidential Information to
any of its Affiliates who need to receive the Samples and/or know
the Confidential Information in order to fulfil the Pilot Study,
provided that TMC shall procure that, prior to such supply of
Samples and/or disclosure of Confidential Information, each
Affiliate to which Samples are to be supplied and/or
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Confidential Information is to be disclosed is made aware of the
obligations contained in this Agreement and undertakes, in a manner
legally enforceable by ASTRAZENECA, to adhere to such terms of this
Agreement as if it were a party to it; and
5.1.2. TMC may supply Samples and/or disclose Confidential Information to
its directors and employees (and those of its Affiliates to whom
disclosure may be made in accordance with Article 5.1.1) and
professional advisers, and to such CROs or other sub-contractors
provided for under Article 2.3, who need to receive such Samples
and/or know the Confidential Information in order to fulfil the
Pilot Study, provided that TMC shall procure that prior to such
disclosure each of those directors, employees, professional advisers
and sub-contractors to whom Samples are to be supplied and/or
Confidential Information is to be disclosed is made aware of the
obligations of confidentiality and non-use herein contained and
undertakes, in a manner legally enforceable by ASTRAZENECA, to
adhere to such terms of this Agreement as if he or she were a party
to it.
5.2. Nothing in Article 4 shall preclude the supply of Samples or the
disclosure of any Confidential Information required by any
government or regulatory authority or court entitled by law to
receipt and/or disclosure of the same, or which are required by law
to be so supplied and/or disclosed, provided that TMC promptly
notifies ASTRAZENECA when such requirement to supply and/or disclose
has arisen, to enable ASTRAZENECA to seek an appropriate protective
order or other secrecy order and to make known to the said
governmental or regulatory authority or court the proprietary nature
of the Samples and/or the Confidential Information and to make any
applicable claim of confidentiality in respect thereof. TMC agrees
to co-operate in any appropriate action, which ASTRAZENECA may
decide to take. If TMC is advised to make a supply and/or disclosure
in accordance with this Article 5 it shall only make such supply
and/or disclosure to the extent to which it is obliged.
6. EXCEPTIONS
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The provisions of Article 4 shall not apply to any Samples or
Confidential Information which TMC can demonstrate to the reasonable
satisfaction of ASTRAZENECA:
6.1. was already in the possession of TMC and at TMC's free use and
disposal or in the public domain prior to its disclosure by
ASTRAZENECA hereunder; or
6.2. is purchased or otherwise legally acquired by TMC at any time from a
third party having good title thereto and the right to disclose the
same; or
6.3. comes into the public domain, otherwise than through the fault of
TMC; or
6.4. is independently generated by TMC without any recourse or reference
to the Samples or the Confidential Information.
7. PUBLICATION
7.1. ASTRAZENECA recognises that TMC may wish to publish or disclose the
Results, or part thereof, in a lecture, paper in a scientific
journal, thesis or by other means. It is expressly agreed, however,
that without ASTRAZENECA's approval in writing TMC may not make any
publications or disclosure of the Results unless and until TMC has
provided License Agreement Notice to ASTRAZENECA.
Should TMC have given License Agreement Notice to ASTRAZENECA, then
TMC may make publication or disclosure of the Results according to
the following. In order to avoid loss of patent or other
Intellectual Property Rights as a result of premature disclosure of
patentable or other information, TMC shall before any publication or
disclosure submit to ASTRAZENECA for review at least sixty (60) days
prior to submission for publication or disclosure any manuscript,
pre-publications and other pre-disclosure material in its form
intended for publication or disclosure which contains, or does
possibly contain, any part of the Results. If ASTRAZENECA within its
sole discretion determines anything in the received material
patentable or subject to any other Intellectual Property Rights, TMC
shall upon ASTRAZENECA's request
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delay publication or disclosure for an additional period of ninety
(90) days from the day of such ASTRAZENECA's request.
Should ASTRAZENECA by the reasons mentioned above in this paragraph
reasonably determine that it would need a further period of delay of
the publication or disclosure concerned, then upon ASTRAZENECA's
notice in writing to TMC, to be provided prior to the expiration of
the last 90-days period mentioned in the first paragraph of this
Article 7.1, TMC shall delay such publication or disclosure for a
period specified in ASTRAZENECA's notice but not to exceed ninety
(90) days from the date of such notice.
7.2. For the avoidance of doubt, such publications contemplated under
this Article 7 may never, unless exempted from obligations of
confidentiality according to Article 6, contain Confidential
Information.
8. INTELLECTUAL PROPERTY RIGHTS
8.1. In consideration of ASTRAZENECA supplying the Samples and disclosing
the Confidential Information to TMC, TMC hereby agrees that any
Results shall be the exclusive property of ASTRAZENECA, and TMC
hereby assigns any right and title to any Results to ASTRAZENECA.
8.2. If any further document or action is necessary, advisable or useful
for the purpose of confirming, effecting or perfecting ASTRAZENECA's
rights according to Article 8.1 or for ASTRAZENECA's applications
for patents or any other Intellectual Property Rights, TMC agrees to
execute, at ASTRAZENECA's expense, any and all such further
documents and actions as now mentioned. TMC further undertakes to
execute any documents and take such actions as provided in this
Article 8.2 also in relation to any of ASTRAZENECA's Affiliates.
8.3. Notwithstanding TMC's general reporting obligations under Article
2.6, TMC warrants that it will promptly disclose to ASTRAZENECA in
writing any Results.
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9. EXCLUSIVE OPTION
9.1. Entering into effect of the License Agreement
9.1.1. Should the Final Report, or other report compiled upon completion of
the Pilot Study containing information sufficient to make the
appropriate determinations whether the Trigger has been reached,
whichever is communicated earlier to ASTRAZENECA, show that the
result of the Pilot Study meets the Trigger, then either Party may
require that the License Agreement shall enter into force by
providing written notice thereon ("License Agreement Notice") to the
other Party.
9.1.2. Should the Final Report or such other report mentioned in Article
9.1.1 show that the result of the Pilot Study does not meet the
Trigger, then TMC may anyhow, at its discretion, require that the
License Agreement shall enter into force by providing License
Agreement Notice to ASTRAZENECA.
9.1.3. Upon the first Party, or, in the situation contemplated by Article
9.1.2, ASTRAZENECA, receiving License Agreement Notice by the other
Party ("License Agreement Effective Date") the License Agreement
shall enter into force in accordance with its terms and conditions.
9.2. License Agreement not entering into effect
Should, in the situation contemplated by Article 9.1.1, neither
Party, or, in the situation contemplated by Article 9.1.2, should
not TMC, have given License Agreement Notice within ninety (90) days
of ASTRAZENECA's receipt of the Final Report or such other report
mentioned in Article 9.1.1, then the License Agreement shall not
enter into force.
10. CONFIDENTIALITY MEASURES
10.1. As part of TMC's undertaking set out in Article 4 to secure the
confidentiality attaching to the Confidential Information, the
Samples and the Results, TMC agrees:
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10.2. to keep separate all Samples, Confidential Information and Results
from all other documents and records held by TMC; and
10.3. to keep all documents and any other material bearing or
incorporating any of the Confidential Information, the Samples or
the Results at TMC's usual place of business, namely 5 Sylvan Way,
Parsippany, New Jersey 07054, United States.
10.4. not to use, reproduce, transform or store any of the Confidential
Information, Samples or Results in any externally accessible
computer or electronic information retrieval system or transmit it
in any form or by any means whatsoever outside of TMC's usual place
of business; and
10.5. to make copies of the Confidential Information, Samples or Results
only to the extent that the same are strictly required for the
Purpose; and
10.6. to notify ASTRAZENECA promptly of the date of, and the circumstances
involved in, the loss or unauthorised disclosure, if any, of the
Samples or the Results or any documents, drawings, descriptions,
writings or formulae comprised in, containing or relating to the
Confidential Information.
10.7. Notwithstanding what is stated in Articles 10.3 and 10.4, should TMC
let, to the extent necessary for the conduct of the Pilot Study,
such keeping of documents or materials as mentioned in Article 10.3
or such storage in computer or electronic information retrieval
systems mentioned in Article 10.4 be made at the premises, or within
the computer or other such systems, of a CRO or other sub-contractor
as permitted under Article 2.3, then such keeping or storage shall
not be considered a violation of such Articles 10.3 or 10.4 provided
that TMC shall procure that prior to such keeping or storage such
CRO or other sub-contractor is made aware of the obligations of
confidentiality and non-use herein contained and undertakes, in a
manner legally enforceable by ASTRAZENECA, to adhere to such terms
of this Agreement as if it was a party to it.
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11. PUBLICITY AND ANNOUNCEMENTS.
11.1. Subject to Article 11.2 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. Notwithstanding the above, TMC may make the press
announcement set forth in Schedule 4 at the Effective Date or in
immediate connection therewith.
11.2. Either Party may make an announcement concerning the transaction
contemplated by this Agreement or any ancillary matter if required
by law, existing contractual obligations or any securities exchange
or Regulatory Authority or governmental body to which either Party
is subject or submits, wherever situated, provided that the Party
required to make such announcement notifies the other Party of the
details of the announcement prior to making such announcement and in
sufficient time for the other Party to consider and comment on the
announcement, and takes advantage of all provisions to keep
confidential as many terms of the Agreement as possible.
12. NO GRANT OF RIGHTS
Nothing in this Agreement shall be interpreted expressly or implied
as granting either Party any licence or other rights, except as
expressly set out in this Agreement.
13. DISCLAIMER
13.1. Any Samples so furnished by ASTRAZENECA to TMC hereunder are to be
treated by TMC as potentially hazardous in handling and use and
ASTRAZENECA gives no warranty or representation regarding the safety
or efficacy of the Compound.
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ASTRAZENECA represents to TMC that to the best of its knowledge it
has disclosed to TMC all its knowledge at the Effective Date
regarding the characteristics of the Compound. Except for the
representation given in the preceding sentence, ASTRAZENECA
disclaims any representation or warranty with respect to the
Compound and ASTRAZENECA shall have no responsibility or liability
for the use of the Compound by TMC, Principal Investigator, or by
other TMC's employees or students.
13.2. ASTRAZENECA makes no representation that the Compound will not
infringe any patent or other proprietary rights of any third party.
14. INDEMNITY
14.1. TMC shall be responsible for and shall indemnify ASTRAZENECA and its
directors, officers, other employees, agents and consultants
(collectively the "Indemnified Party") against any and all
liability, loss, damage, cost and expense (including legal costs)
incurred or suffered by the Indemnified Party arising out of the
Pilot Study or arising out of any other activities to be carried out
by TMC, its Affiliates or sub-contractors pursuant to this Agreement
except where such liability, loss, damage, cost and expense has been
incurred or suffered as a result of gross negligence or misconduct
on the part of ASTRAZENECA.
14.2. An Indemnified Party that intends to claim indemnification under
Article 14.1 shall notify TMC promptly of any such liability, loss,
damage, cost and expense and permit TMC to control the defence and
disposition thereof and further agrees to reasonably cooperate at
TMC's expense with TMC in the handling thereof. The Indemnified
Party shall not compromise or settle the 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.
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15. TERM AND TERMINATION
15.1. This Agreement shall enter into force on the Effective Date and
shall expire (i) in accordance with what is stated in Article 2.4;
or (ii) at the License Agreement Effective Date; or (iii) at the
date when it can be determined, pursuant to Article 9.2, that the
License Agreement will not enter into effect, whichever of (i)
through (iii) that is the earliest to occur.
Should, however, TMC not have provided to ASTRAZENECA the Final
Report within fifteen (15) months of the date of delivery to TMC of
such number of Samples indicated in Article 2.1, then ASTRAZENECA
shall have the right to terminate this Agreement forthwith by giving
written notice to TMC.
15.2. If either party is in material default hereunder, the other party
may terminate this Agreement at any time upon thirty (30) days'
prior written notice to the defaulting party, whereupon this
Agreement shall so terminate unless the fault is rectified by the
defaulting party within said notice period.
15.3. To the extent permitted by law, if either Party shall become
insolvent or shall make assignment for the benefit of creditors, or
proceedings in bankruptcy shall be instituted against a Party, or
proceedings in voluntary bankruptcy of a Party shall be instituted
by that Party, or a receiver or trustee of all, or substantially
all, of the property of a Party shall be appointed, the other Party
shall be entitled to terminate this Agreement by giving written
notice to this effect to the first Party whereupon this Agreement
shall immediately terminate.
Upon termination
15.4. Upon termination or expiration of this Agreement, or at the request
of ASTRAZENECA, TMC shall
(i) return to ASTRAZENECA any tangible Confidential Information,
including any reproduction thereof furnished by or on behalf
of ASTRAZENECA or its Affiliates; and
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(ii) return to ASTRAZENECA any Samples delivered by or on behalf of
ASTRAZENECA or its Affiliates, unless, and to the extent, such
Samples have been used in the course of TMC's performance of
the Pilot Study; and
(iii) deliver to ASTRAZENECA any Results not already reported or
delivered to ASTRAZENECA including, without limitation, any
draft reports developed by such time should the Final Report
not have been delivered to ASTRAZENECA.
15.5. Survival
15.5.1. What is stated in Articles 1, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15,
20 and 21 shall survive termination or expiration of this Agreement.
15.5.2. What is stated in Article 2.9 shall survive until the expiration of
the three-months period therein stated, provided that TMC has given
notice as contemplated therein prior to the date of termination or
expiration of this Agreement.
15.5.3. What is stated in Articles 4 and 10 shall survive termination or
expiration of this Agreement and shall continue to be in force for a
period of five (5) years following such termination or expiration.
16. ASSIGNMENT
16.1. Save as provided in Articles 16.2 and 16.3, a party may not assign,
transfer, charge or deal in any other manner with this Agreement or
any of its rights under it, nor purport to do any of the same, nor
sub-contract any or all of its obligations under this Agreement
without having obtained the prior written consent of the other
party.
16.2. ASTRAZENECA shall be entitled to assign its rights under this
Agreement to an Affiliate. Any assignment made pursuant to this
Article 16.2 shall be on the condition that no such assignment shall
relieve ASTRAZENECA of any of its obligations under this Agreement.
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16.3. Each Party shall be entitled to assign its rights under this
Agreement to an acquiror of all or substantially all of its capital
or stock assets related to the pharmaceutical business described in
this Agreement, whether through purchase, merger, consolidation or
otherwise.
17. AGREEMENT TO PREVAIL
This Agreement shall not affect the validity of the CDA, provided,
however, that in case of any inconsistency between this Agreement
and the CDA what is stated in this Agreement shall prevail.
18. SEVERANCE
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 affect
the other provisions of this Agreement which shall remain in full
force and effect.
19. DAMAGES
Each of the Parties agrees that damages may not be an adequate
remedy for breach of this Agreement and accordingly ASTRAZENECA
shall be entitled to injunctive or other equitable relief and no
proof of special damages shall be necessary for the enforcement of
this Agreement.
20. GOVERNING LAW AND ARBITRATION
20.1. 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.
20.2. 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.
19
21. NOTICES
Any notice permitted or required under this Agreement shall be in
writing and directed to the following respective addresses and shall
be deemed given, in case of lack of proof of earlier receipt, four
(4) days upon dispatch if sent by prepaid registered mail.
If to ASTRAZENECA:
Address: AstraZeneca AB, S-151 85 Sodertalje, Sweden
Facsimile: +46-8 553 290 00
For the attention of: President & CEO
If to TMC:
Address: The Medicines Company, 5 Sylvan Way, Parsippany,
New Jersey 07054, United States
Facsimile: +1-973-656-9898
For the attention of: Clive Meanwell, Executive Chairman
with a copy to
Steven D. Singer
Hale and Dorr, LLP
60 State Street
Boston MA 02109
United States
22. AGENCY, PARTNERSHIP OR JOINT VENTURE EXCLUDED
22.1. Nothing in this Agreement shall be construed so as to constitute
either Party to be the agent of the other.
20
22.2. 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.
23. 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 or entity (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.
24. VARIATION
No variation of this Agreement or any of the documents referred to
in it shall be valid unless it is in writing and signed by or on
behalf of each of the Parties.
25. 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.
IN WITNESS WHEREOF, the Parties have executed this Agreement on the Effective
Date.
ASTRAZENECA AB (publ) THE MEDICINES COMPANY
/s/ Hamish Cameron /s/ Clive Meanwell
- --------------------------------- ----------------------------------
Name: Dr. Hamish Cameron Name: Clive Meanwell
Title: Vice President, Head Title: Executive Chairman
Cardiovascular Therapy Area
SCHEDULE 1
Compound
SCHEDULE 1, COMPOUND
CHEMICAL STRUCTURE, CHEMICAL NAME AND MOLECULAR FORMULA
Chemical structure
[BOX]
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(21)H(23)Cl(2)NO(6)
SCHEDULE 2
License Agreement
Schedule 2
LICENSE AGREEMENT
Entered into by and between AstraZeneca AB and
The Medicines Company on the License Agreement Effective Date
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 Termination 53
15. Consequences of Termination 55
16. Force Majeure 58
17. 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
- i -
1
Schedule 2
LICENSE AGREEMENT
This Agreement is entered into on the License Agreement Effective Date
by and between
ASTRAZENECA AB, a company incorporated under the laws of Sweden with its
registered office at S-151 85 Sodertalje, Sweden ("ASTRAZENECA") and
THE MEDICINES COMPANY, a company incorporated under the laws of Delaware with
its registered office at One Cambridge Center, Cambridge, Massachusetts 02142,
United States ("TMC");
WITNESSETH
WHEREAS, ASTRAZENECA performs research, development and marketing of
pharmaceutical compounds and products inter alia in the cardiovascular therapy
area; and
WHEREAS, ASTRAZENECA has developed the intravenous product Clevidipine for
indications such as the control of blood pressure; and
WHEREAS, TMC performs development of pharmaceutical compounds and marketing of
pharmaceutical products particularly in the cardiovascular therapy area; and
WHEREAS, ASTRAZENECA has expressed an interest to license Clevidipine to TMC and
TMC has expressed an interest to license said compound; and
WHEREAS, it is a mutual objective of the Parties to maximise the sales of the
Product.
NOW THEREFORE, the Parties hereto agree to the following.
2
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.
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.
3
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 regulatory
approval given the regulatory structure involved,
4
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
5
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 accidents beyond the
reasonable control of the Party so prevented, act of God, war, riot,
civil commotion, malicious damage, accident, breakdown of plant or
machinery, fire, flood or storm.
1.22. "Fresenius" shall mean Fresenius Kabi Nutrition AB, S-751 74
Uppsala, Sweden.
1.23. "Launch" or "Launched" shall mean the first invoiced commercial sale
by TMC, its Affiliates, sub-licensees or distributors, however not
including sales made by one such entity to another such entity, of
the Product in a country following NDA Approval in such country.
6
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.
7
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
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
8
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,
9
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 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.
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.
10
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.
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.
11
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
12
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 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,
13
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
14
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 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
15
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
16
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 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.
17
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.
18
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.
19
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.
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.
20
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.
21
(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 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.
22
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-
23
period as requested by such Party in such notice but with no more
than three (3) months from the date of the notice.
3.9. The remedies stated in Article 3.8 shall be ASTRAZENECA's sole
remedy in case of any failure by TMC to comply with what is stated
in this Article 3.
4. SUPPLY MATTERS
4.1. Transfer of Bulk Compound to TMC. ASTRAZENECA undertakes to supply
to TMC [**] 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
24
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
25
entering into the Supply Agreement is a substantial prerequisite to
ASTRAZENECA for entering into the Option Agreement. Should
regardless hereof the Supply Agreement not have been concluded
within six (6) months of the License Agreement Effective Date for
other reasons than ASTRAZENECA's lack of good faith in conducting
such negotiations or unnecessary delays caused by ASTRAZENECA, then
ASTRAZENECA shall have the right to terminate this Agreement
forthwith by giving written notice to TMC.
Should ASTRAZENECA have failed, however, to provide to TMC in
accordance with what is stated in Article 2.10 of the Option
Agreement a first draft of the Supply Agreement, then,
notwithstanding what is stated in the first paragraph of this
Article 4.3.3, ASTRAZENECA shall not have the right to terminate
this License Agreement.
5. EXCHANGE OF INFORMATION
5.1. Obligation of TMC to Share Information. In addition to the
obligations specifically requiring TMC to inform ASTRAZENECA
regarding particular events, TMC undertakes to keep ASTRAZENECA
informed about the progress of the development work regarding the
Compound hereunder. For this purpose:
5.1.1. the Parties will, up until the date when Filing of an NDA has been
made in the last Major Market, meet at least once a year to review
TMC's progress and efforts in the development work contemplated
herein. Such meeting will take place on a location to be agreed by
the Parties, or, should the Parties not be able to agree,
alternately with each Party at a site to be determined by the Party
hosting the meeting. In advance of such meeting, TMC will provide
ASTRAZENECA a reasonable written summary of such development work,
including, without limitation, summaries of protocol
26
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.
27
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. $[**]).
28
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
---------------- ------------
[**] [**]
29
The relevant royalty rate so stated shall apply to the amount of
annual Net Sales within the applicable layer only.
For convenience of example only and without limiting the above, the
royalty rate of [**]% shall apply to the amount of annual Net Sales
under $[**] and should the annual Net Sales exceed $[**] then the
royalty rate of [**]% shall apply only to the amount of annual Net
Sales exceeding $[**] (and up to $[**]).
6.2.2. Notwithstanding the royalty rates set forth in Article 6.2.1, on the
Net Sales of the Product during the time period starting on the
License Agreement Effective Date and ending on December 31, 2007,
the running royalty rate shall be reduced to [**] percent ([**]%) of
the rate otherwise stated in Article 6.2.1.
6.2.3. For the purpose of Article 6.2.1 the term "annual" shall refer to
calendar years, provided, however, that for the purpose of
determining what royalty rates to apply during the first or last
calendar year of the royalty payment period pursuant to Article 6.4,
which parts may not constitute a full calendar year, the following
shall apply.
a) The applicable royalty rate under each of items (a) through
(i) of Article 6.1.1, subject to what is stated in Article
6.2.2, shall apply to the Net Sales exceeding the amount "A"
in the following formula.
NM
TA x ---- = A
12
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.
30
b) For convenience of example only and without limiting the above
standing, the following calculation shows the application of
the provision stated. If Launch occurs in the first country
three months before the end of the calendar year, the formula
will read, regarding the royalty rate of [**]% under 6.2.1(a):
$[**] x 3/12 = $[**]. The royalty rate of [**]% under 6.2.1(b)
will then become applicable on any Net Sales exceeding $[**]
(and up to $[**]) and a royalty rate of [**]% will be
applicable on any Net Sales up to and including $[**].
Notwithstanding the foregoing, as this example is with respect
to sales in the first country in which Launch occurs, the
above stated royalty rates may be reduced by [**] percent
([**]%) pursuant to Article 6.2.2.
6.3. Minimum Royalty. Notwithstanding what is stated in Article 6.2,
during the second through fourth full calendar years following
Launch in the first Major Market the aggregate annual royalty amount
due by TMC to ASTRAZENECA for sales of the Product shall, regardless
of the actual Net Sales amount accrued during such calendar year,
not go below the following amounts during the years specified.
6.3.1. Second full calendar year following Launch: [**] U.S. Dollars
($[**]);
6.3.2. Third full calendar year following Launch: [**] U.S. Dollars ($[**])
6.3.3. Fourth full calendar year following Launch: [**] U.S. Dollars
($[**])
6.3.4. Should the Net Sales by TMC for any calendar year not generate the
relevant royalty amount indicated under this Article 6.3, then TMC
shall pay
31
the difference between the minimum royalty amount stated and the
amount actually generated within thirty (30) days after the date
when the royalty payment for the last full quarter of the calendar
year concerned is due according to Article 6.6.1.
6.4. Duration of Royalty Payments. Royalties under Article 6.2 shall be
payable on a country by country basis for the longer of :
a) the life of ASTRAZENECA Patent Rights which are necessary to
continue to manufacture, use or sell the Product in such
country; or
b) a period of ten (10) years from Launch in that country
(provided always that in the case of a country within the
European Economic Area such ten (10) years period shall run
from the date of Launch anywhere in the European Economic
Area);
6.5. ASTRAZENECA Trademark Royalty. Unless the license to the ASTRAZENECA
Trademark has been reverted pursuant to Article 9.1, TMC shall,
following expiration of the 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
32
payment to be made hereunder shall be made in U.S. Dollars. Each
such report mentioned in this Article 6.6.1 shall include the rates
of exchange used for conversion to U.S. Dollars from the currency in
which such sales were made.
6.6.2. In the event that ASTRAZENECA, its Affiliates or sublicenses sells
Product pursuant to Article 2.7.3, then ASTRAZENECA shall deliver to
TMC within sixty (60) days after the end of each calendar quarter
ending March 31, June 30, September 30 and December 31, a written
report showing its computation of the remuneration due to TMC under
this Agreement during such calendar quarter including (i) the
quantity of the Product sold by or on behalf of ASTRAZENECA during
such calendar quarter; and (ii) the total remuneration due in
respect thereof and at the same time make the payment of the
remuneration due. Any payment to be made hereunder shall be made in
U.S. Dollars. Each such report mentioned in this Article 6.6.2 shall
include the rates of exchange used for conversion to U.S. Dollars
from the currency in which such sales were made.
6.7. Taxes.
6.7.1. The payments to be made hereunder by either Party shall be net
payments i.e. without deduction of any bank or transfer charges.
6.7.2. ASTRAZENECA shall pay any and all taxes levied on account of, or
measured exclusively by, all payments it receives under this
Agreement, including without limitation Swedish Value Added Tax
("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,
33
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.
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,
34
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: [**]
35
6.11. 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 Reuter.
7. INTELLECTUAL PROPERTY - PROSECUTION AND MAINTENANCE
7.1. Any and all ASTRAZENECA IP vested in ASTRAZENECA shall as between
ASTRAZENECA and TMC remain vested in ASTRAZENECA.
7.2. Any and all TMC IP vested in TMC shall as between TMC and
ASTRAZENECA remain vested in TMC.
7.3. ASTRAZENECA shall, during the term of this Agreement be responsible
for the filing, prosecution and maintenance of the ASTRAZENECA
Patent Rights and the ASTRAZENECA Trademark in the Territory. Should
registration of the ASTRAZENECA Trademark be necessary or
appropriate in any country, then ASTRAZENECA shall be responsible
for obtaining such registration.
TMC shall reimburse ASTRAZENECA for any out-of-pocket expenses
(including fees to outside counsel and consultants) incurred by
ASTRAZENECA in relation to any action taken by ASTRAZENECA pursuant
to this Article 7.3.
7.4. TMC shall have the right to give comments and recommendations as to
the overall strategy regarding the filing, prosecution and
maintenance of the
36
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.
37
Should in any country in the Territory any decision have to be made
as to what product, claim or otherwise to apply for such patent term
extension regarding, then ASTRAZENECA shall have the right to make
such decision at its own discretion.
7.8. Rights to the Results. Any patents and other intellectual property
rights, information, ideas, knowledge, data or know-how relating
solely to the Compound, and/or the Product developed during the term
of this Agreement (hereinafter referred to as "Result(s)") shall as
between TMC and ASTRAZENECA be TMC IP and the sole property of TMC.
TMC shall have the sole management of, and shall bear the cost of,
any Results. ASTRAZENECA shall be given the reasonable opportunity
to comment on important aspects of the prosecution of any patent
applications, and shall use its reasonable endeavours to assist TMC
in the prosecution of any patent applications.
8. CLAIMS REGARDING INFRINGEMENT AND INVALIDITY
8.1. Notification of Claim. If a Third Party notifies ASTRAZENECA or TMC,
or their respective Affiliates or sub-licensees, that any act by
TMC, or its Affiliates or sub-licensees, utilizing the ASTRAZENECA
IP allegedly infringes in the Territory any Patent Rights or other
intellectual property rights owned by or licensed to the Third
Party, ASTRAZENECA or TMC shall promptly notify the other in
writing.
8.2. Defence of Claimed Infringement.
8.2.1. ASTRAZENECA shall have no obligation to defend or settle any claim
by a Third Party that the manufacture, sale or other use of the
Product by TMC resulting from the use or exercise of the license
granted hereunder under the ASTRAZENECA IP infringes any Patent
Rights or other intellectual
38
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,
39
its Affiliates' or sub-licensees' costs and expenses, assist in the
prosecution of such action, including, but not limited to,
consenting to being joined in such action as a voluntary plaintiff.
8.2.5. Should TMC reasonably believe that the Third Party rights
contemplated by Article 8.2.1 are valid in a certain country(ies)
and that infringement is likely to be occurring in such
country(ies), TMC may seek and enter into a licence thereto from
such Third Party on appropriate commercial terms, whereby any
remuneration and any costs and expenses (including but not limited
to reasonable external legal costs) for such license shall be shared
equally between TMC and ASTRAZENECA according to the following.
TMC may deduct an amount equivalent to [**] percent ([**]%) of TMC's
payments to such Third Party pursuant to such arrangement as
indicated in the first paragraph of this Article 8.2.5 from the
royalty payments to be made by TMC to ASTRAZENECA on the Net Sales
in the country concerned pursuant to Article 6.2 to cover
ASTRAZENECA's obligation to carry [**] percent ([**]%) of such
payments and costs. This deduction shall be subject to the proviso
that the royalty payments due to ASTRAZENECA shall not be reduced in
total by more than [**] percent ([**]%) in any calendar year, and
any residue not offset may be carried forward by TMC until such time
as it has recovered ASTRAZENECA's [**] per cent ([**]%) share of
such costs and expenses, or until the royalty payment obligations of
TMC hereunder expire, whichever is the earlier.
8.3. Third Party Infringement. If a Third Party shall, in the reasonable
opinion of either Party, infringe any ASTRAZENECA Patent Rights or
ASTRAZENECA Trademark in the Territory, then the Party having such
opinion shall promptly notify the other Party.
8.3.1. Further, each Party shall within five (5) working days or as soon as
reasonably possible thereafter advise the other Party of receipt of
any notice of:
40
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.
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
41
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.
42
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
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
43
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
44
TMC's proposal, or should ASTRAZENECA after having not approved a
proposal, or part thereof, fail to present a proposal as stated
under Article 9.2.2, then the proposal presented by TMC shall be
considered to have been approved by ASTRAZENECA.
9.3. TMC shall use the ASTRAZENECA Trademark in accordance with
applicable laws in any country where TMC markets, sells or
distributes the Product utilising the ASTRAZENECA Trademark. Unless
the rights to the ASTRAZENECA Trademark have been reverted pursuant
to Article 9.1, TMC undertakes to use the ASTRAZENECA Trademark at
any time when the Product is sold, marketed or distributed in the
Territory and not to use any trademark other than the ASTRAZENECA
Trademark in connection with the sales, marketing and distribution
of the Product. TMC further undertakes not to use any trademark
being confusingly similar to the ASTRAZENECA Trademark in connection
with marketing, sales and distribution of any other product.
9.4. Should in any country of the Territory TMC by legal, regulatory or
similar reasons be prevented from using the ASTRAZENECA Trademark or
should usage of the ASTRAZENECA Trademark in connection with the
sales, marketing and distribution of the Product prove to be
commercially unreasonable in such country because of such legal,
regulatory or similar reasons, then TMC shall immediately notify
ASTRAZENECA hereof in writing and TMC shall not have the obligation
to use the ASTRAZENECA Trademark for the marketing, sales and
distribution of the Product in the country concerned. The Parties
shall in such case meet and in good faith endeavour to find a new
trademark as similar to the ASTRAZENECA Trademark as possible. Such
new trademark selected for the country concerned shall for all
purposes of this Agreement be considered an ASTRAZENECA Trademark.
TMC shall carry all costs and expenses for the development and
creation of such new trademark, provided always that should such
costs be
45
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
46
Agreement to the extent not included in (i) and (ii) above, except
where such liability, loss, damage, cost and expense has been
incurred or suffered as a result of a material breach of warranty or
representation of ASTRAZENECA set out in Article 13 or by gross
negligence or misconduct on the part of ASTRAZENECA.
10.1.2. An ASTRAZENECA Indemnified Party that intends to claim
indemnification under Article 10.1.1 shall notify TMC promptly of
any such liability, loss, damage, cost and expense and permit TMC to
control the defence and disposition thereof and further agrees to
reasonably cooperate at TMC's expense with TMC in the handling
thereof. The ASTRAZENECA Indemnified Party shall not compromise or
settle such claim. TMC agrees to keep ASTRAZENECA informed of the
progress in the defence and disputation of such claims and to
consult with ASTRAZENECA with regard to any settlement thereof which
TMC proposes to enter into and will provide ASTRAZENECA with
suitable information regarding the same.
10.1.3. TMC will maintain appropriate liability insurance against such
product and other liability as contemplated under Article 10.1.1 at
levels appropriate for products and activities of the relevant type.
10.2. Indemnity by ASTRAZENECA.
10.2.1. ASTRAZENECA shall be responsible for and shall indemnify TMC, its
Affiliates and its and its Affiliates' directors, officers, other
employees, agents and consultants (collectively the "TMC Indemnified
Party") against any and all liability, loss, damage, cost and
expense (including legal costs) incurred or suffered by the TMC
Indemnified Party as a result of any claim brought against the TMC
Indemnified Party by a Third Party (i) arising out of the testing,
manufacture, sale, use or promotion by ASTRAZENECA, its Affiliates
or sub-licensees, of any Compound or Product hereunder; (ii) arising
out of any theory of product liability (including, but not limited
to, actions in the form of tort, warranty or strict liability) based
on Compounds
47
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.
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,
48
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
49
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;
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
50
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
51
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 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
52
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 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
53
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.
54
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
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.
55
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;
56
(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. 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,
57
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
58
(i) provide ASTRAZENECA, should ASTRAZENECA so require, with
reasonable assistance in relation to ASTRAZENECA's appointment
of a Third Party manufacturer of Product.
Upon such termination as stated in this Article 15.1, ASTRAZENECA
shall have the right to disclose Confidential Information, to Third
Parties for the purpose only of, and only to the extent necessary
for, enabling such Third Party to evaluate the financial and
scientific status of the Compound or Product for the purpose of
making a financial offer to ASTRAZENECA on the licensing or
acquisition of the rights returned to ASTRAZENECA and the rights
licensed to ASTRAZENECA under this Article 15.1, and, if such
licensing or acquisition occurs, as necessary to exploit or enforce
such rights.
15.2. Termination followed by continued license Upon the termination of
this Agreement by TMC pursuant to Article 14.3, ASTRAZENECA's
licences granted to TMC under Article 2 shall continue, provided
that TMC continues to make payments pursuant to Article 6 as if the
Agreement was still in effect.
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
59
endeavours, to recommence its affected operations in order for it to
perform its obligations.
16.2. If either Party is prevented from performance of its obligations,
due to Force Majeure, for a continuous period in excess of six (6)
months, the other Party may terminate this Agreement forthwith on
service of written notice upon the Party so prevented. In the event
of termination under this Article 16.2 the provisions of Article 15
shall not apply immediately and the Parties shall meet to discuss
the ASTRAZENECA IP and TMC IP and agree on a process for
arrangements upon termination.
16.3. The Party claiming to be prevented or delayed in the performance of
any of its obligations under this Agreement by reason of Force
Majeure shall use its reasonable endeavours to bring the Force
Majeure event to a close or to find a solution by which the
Agreement may be performed despite the continuation of the Force
Majeure event.
17. GENERAL PROVISIONS
17.1. Assignment.
17.1.1. Subject to Articles 17.1.2 and 17.1.3, neither Party shall without
the prior written consent of the other Party assign, transfer,
charge or deal in any other manner with this Agreement or any of its
rights under it.
17.1.2. Each Party shall be entitled to assign its rights under this
Agreement to an acquiror of all or substantially all of its capital
stock or assets related to the pharmaceutical business described in
this Agreement, whether through purchase, merger, consolidation or
otherwise.
17.1.3. Each Party shall be entitled to assign its rights under this
Agreement to an Affiliate provided that such Party shall require
that any such Affiliate to whom it assigns any of its rights under
this Agreement shall assign such
60
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;
61
17.3.6. if delivered by hand, upon delivery;
17.3.7. if posted by first class registered post, four (4) business days
after posting;
17.3.8. if sent by facsimile, when a complete and legible copy of the
communication has been received at the appropriate address
17.4. Contact Information. Initial details for the purposes of Article
17.3 are:
For ASTRAZENECA
Address: AstraZeneca AB, S-151 85 Sodertalje, Sweden
Facsimile: +46-8 553 290 00
For the attention of: President & CEO
For TMC
Address: The Medicines Company, 5 Sylvan Way, Parsippany,
New Jersey 07054, United States
Facsimile: +1-973-656-9898
For the attention of: Clive Meanwell, Executive Chairman
with a copy to
Steven D. Singer
Hale and Dorr, LLP
60 State Street
Boston MA 02109
United States
62
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
63
such approval to be given by an authorized representative of the
Party in question.
17.9.2. Either Party may make an announcement concerning the transaction
contemplated by this Agreement or any ancillary matter if required
by law, existing contractual obligations or any securities exchange
or Regulatory Authority or governmental body to which either Party
is subject or submits, wherever situated, provided that the Party
required to make such announcement notifies the other Party of the
details of the announcement prior to making such announcement and in
sufficient time for the other Party to consider and comment on the
announcement, and takes advantage of all provisions to keep
confidential as many terms of the Agreement as possible.
17.10. Waiver. Failure or delay by either Party to exercise any right or
remedy under this Agreement shall not be deemed to be a waiver of
that right or remedy, or prevent it from exercising that or any
other right or remedy on that occasion or on any other occasion.
17.11. No Benefit to Third Parties. No Third Party shall be deemed a third
party beneficiary under this Agreement for any purpose. Without
limiting the foregoing, the Contracts (Rights of Third Parties) Act
1999 and any legislation amending or replacing such Act shall not
apply in relation to this Agreement or any agreement, arrangement,
understanding, liability or obligation arising under or in
connection with this Agreement.
18. GOVERNING LAW AND ARBITRATION
18.1. Arbitration. The Parties shall use their reasonable efforts to
settle amicably any dispute arising out of or in connection with
this Agreement. In case the Parties are not able to settle such
dispute between themselves, such dispute shall be finally resolved
by arbitration in accordance with the Rules of the
64
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)
65
Schedule A
ASTRAZENECA Patent Rights
66
PATENT FAMILY LIST
Family : A1262
App./Propr : Astra AB
Title : Short acting dihydropyridines
Inventors : ANDERSSON, Kjell
NORDLANDER, Margareta
WESTERLUND, Christer
Country SN F App No App Date Pat No. Grant Dt. Exp. Dt Status
- ------- -- --- ------ -------- ------- --------- ------- ------
Argentina 1 329878 24.10.1994 253845 13.12.1999 13.12.2014 Granted
Argentina 2 980104360 01.09.1998 Filed
Austria 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Australia 1 P 81196/94 03.11.1994 685532 07.05.1998 03.11.2014 Granted
Belgium 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Brazil 2 PI110048-7 06.05.1997 Filed
Canada 1 P 2174969 03.11.1994 Filed
Switzerland 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
China P.R. 1 P 94194500.6 03.11.1994 94194500.6 20.11.1999 03.11.2014 Granted
Czech Republ 1 P PV1273/96 03.11.1994 285691 17.08.1999 03.11.2014 Granted
Germany 1 X 95900347.6 03.11.1994 6942515.2 05.07.2000 03.11.2014 Granted
Denmark 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Estonia 1 P P9600051 03.11.1994 03230 20.10.1999 03.11.2014 Granted
Egypt 1 689/94 02.11.1994 20539 31.07.1999 03.11.2004 Granted
European Pat 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Spain 1 X 95900347.6 03.11.1994 ES2150544 05.07.2000 03.11.2014 Granted
Finland 1 P 961914 03.11.1994 Filed
France 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Great Britain 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Greece 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Hong Kong 1 98114638.2 02.12.1998 1013292 08.12.2000 03.11.2014 Granted
Hungary 1 P P9601187 03.11.1994 215591 04.12.1998 03.11.2014 Granted
Indonesia 1 P-941873 02.11.1994 ID0004550 06.12.1999 02.11.2014 Granted
Ireland 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Israel 1 111127 03.10.1994 111127 22.02.2001 03.10.2014 Granted
Iceland 1 4218 30.09.1994 1674 31.12.1997 30.09.2014 Granted
Italy 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Korea South 1 P 96/702346 03.11.1994 Filed
Lithuania 1 X 95900347.6 Docketed
Luxembourg 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Latvia 1 E Docketed
Monaco 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Mexico 1 948392 28.10.1994 196540 22.05.2000 28.10.2014 Granted
Malaysia 1 PI94002934 04.11.1994 MY111770A 30.12.2000 30.12.2015 Granted
Netherlands 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
67
Norway 1 P 961776 03.11.1994 305656 05.07.1999 03.11.2014 Granted
New Zealand 1 P 275915 03.11.1994 275915 29.09.1997 03.11.2014 Granted
Philippines 1 49112 04.10.1994 1-1994-49112 28.04.2000 28.04.2017 Granted
Poland 1 P P314128 03.11.1994 Filed
Portugal 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Russian Fed 1 P 96112152 03.11.1994 2139278 10.10.1999 03.11.2014 Granted
Saudi Arabia 1 94150250 19.10.1994 Filed
Sweden 1 9303657-2 05.11.1993 Inactive
Sweden 1 X 95900347.6 03.11.1994 0726894 05.07.2000 03.11.2014 Granted
Slovak Repub 1 P PV0559/96 03.11.1994 281467 10.01.2001 03.11.2014 Granted
Thailand 1 024372 04.11.1994 Filed
Taiwan 1 83108995 29.09.1994 NI-078831 15.10.1996 29.09.2014 Granted
Ukraine 1 P 96041753 03.11.1994 Filed
United States 1 P 356224 03.11.1994 5856346 05.01.1999 05.01.2016 Granted
South Africa 1 94/7570 28.09.1994 94/7570 26.07.1995 28.09.2014 Granted
68
PATENT FAMILY LIST
Family : A1279
App./Propr : Astra AB
Title : Pharmaceutical emulsion
Inventors : ANDERSSON, Kjell
BYROD, Eva
NORDLANDER, Margareta
WESTERLUND, Christer
HANSSON, Anna-Carin
Country SN F App No App Date Pat No. Grant Dt. Exp. Dt Status
- ------- -- - ------ -------- ------- --------- ------- ------
Argentina 1 330005 04.111994 255314 01.11.2001 01.11.2016 Granted
Argentina 2 990105741 11.11.1999 Filed
Austria 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Australia 1 P 10371/95 03.11.1994 678650 25.09.1997 03.11.2014 Granted
Belgium 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Brazil 1 P Inactive
Canada 1 P 2176360 03.11.1994 Filed
Switzerland 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
China P.R. 1 P 94194111.6 03.11.1994 94194111.6 11.08.2001 03.11.2014 Granted
Czech Republ 1 P PV1338/96 03.11.1994 Filed
Germany 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Denmark 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Estonia 1 P P9600052 03.11.1994 03223 20.10.1999 03.11.2014 Granted
Egypt 1 710/94 09.11.1994 20764 31.01.2000 09.11.2014 Granted
European Pat 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Spain 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Finland 1 P 961999 03.11.1994 Filed
France 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Great Britain 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Greece 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Hong Kong 1 98114639.1 22.12.1998 Filed
Hungary 1 P P9601268 03.11.1994 Filed
Indonesia 1 P-941957 11.11.1994 ID0004476 01.11.1999 11.11.2014 Granted
Ireland 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Israel 1 111345 20.10.1994 111345 03.12.2000 20.10.2014 Granted
Iceland 1 4224 21.10.1994 Filed
Italy 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Korea South 1 P 96/702485 03.11.1994 Filed
Liechtenstei 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Lithuania 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Luxembourg 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Latvia 1 E Docketed
Monaco 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
69
Mexico 1 948732 10.11.1994 Filed
Malaysia 1 PI94003029 14.11.1994 Filed
Netherlands 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Norway 1 P 961898 03.11.1994 Filed
New Zealand 1 P 276197 03.11.1994 276197 18.09.1997 03.11.2014 Granted
Philippines 1 49235 25.10.1994 Filed
Poland 1 P P314263 03.11.1994 181462 31.07.2001 03.11.2014 Granted
Portugal 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Russian Fed 1 P 96112112 03.11.1994 2144358 20.01.2000 03.11.2014 Granted
Saudi Arabia 1 94150314 13.11.1994 Filed
Sweden 1 X 95900965.5 03.11.1994 0727997 13.02.2002 03.11.2014 Granted
Slovak Repub 1 P PV0597/96 03.11.1994 Filed
Thailand 1 024457 11.11.1994 Filed
Ukraine 1 P 96051803 03.11.1994 40633 15.08.2001 03.11.2014 Granted
United States 1 P 08/364953 03.11.1994 5739152 14.04.1998 14.04.2015 Granted
South Africa 1 94/8180 18.10.1994 94/8180 26.07.1995 18.10.2014 Granted
70
PATENT FAMILY LIST
Family : A2004
Appl./Propr : AstraZeneca AB
Title : NEW MANUFACTURING PROCESS
Country SN F App No App Date Pat No. Grant Dt. Exp. Dt Status
- ------- -- - ------ -------- ------- --------- ------- ------
Australia 1 P 20105/00 22.11.1999 Filed
Canada 1 P 2349195 22.11.1999 Filed
European Pat 1 X 99963732.5 22.11.1999 Filed
Hong Kong 1 [**] [**] Filed
New Zealand 1 P 511503 22.11.1999 Filed
United States 1 P 09/508260 22.11.1999 Filed
South Africa 1 P 2001/3434 22.11.1999 Filed
71
Schedule B
Trademark Registrations
72
Trademark Family Report
TRADEMARK : CLEVELOX
TM Family Number : A02243
TM Attorney : MST
Project Resp. RPT : MST
Project Description : Clevidipine
Project Number : 20298
Project Cost Centre : 20298
Therapeutic Area : Cardio vascular
Owner :
Country SN Appl De Reg. Dt Reg No Expir. Dt Status
- ------- -- ------- ------- ------ --------- ------
United Arab Emi 1 Inactive
Argentina 1 05.12.1997 Inactive
Austria 1 24.11.1997 06.02.1998 173947 29.02.2008 Registered
Australia 1 26.11.1997 26.11.1997 749529 26.11.2007 Registered
Brazil 1 Inactive
Benelux 1 21.11.1997 21.11.1997 622377 21.11.2007 Registered
Canada 1 16.12.1997 Filed
Switzerland 1 21.11.1997 02.04.1998 450528 21.11.2007 Registered
China P.R. 1 28.11.1997 14.02.1999 1246211 14.02.2009 Registered
Colombia 1 03.12.1997 Filed
Czech Repub 1 03.12.1997 27.05.1999 217843 03.12.2007 Registered
Germany 1 22.11.1997 30.01.1998 39756082 30.11.2007 Registered
Denmark 1 21.11.1997 15.09.1998 199802513 15.09.2008 Registered
Egypt 1 01.12.1997 Filed
Spain 1 26.11.1997 20.05.1998 2128403 26.11.2007 Registered
Finland 1 21.11.1997 13.11.1998 211790 13.11.2008 Registered
France 1 24.11.1997 24.11.1997 97705657 24.11.2007 Registered
Great Britian 1 21.11.1997 21.11.1997 2151563 21.11.2007 Registered
Greece 1 17.11.1997 17.11.1999 135252 17.11.2007 Registered
Hong Kong 1 08.12.1997 08.12.1997 3239/99 08.12.2004 Registered
Hungary 1 27.11.1997 08.02.1999 155530 27.11.2007 Registered
Indonesia 1 12.12.1997 12.12.1997 427623 12.12.2007 Registered
Ireland 1 30.10.1997 21.11.1997 208749 21.11.2007 Registered
Israel 1 24.11.1997 07.02.1999 116095 24.11.2004 Registered
India 1 26.11.1997 Filed
Iceland 1 24.11.1997 28.01.1998 210/1998 28.01.2008 Registered
Italy 1 25.11.1997 18.05.2000 813581 25.11.2007 Registered
Japan 1 09.01.1998 02.04.1999 4257306 02.04.2009 Registered
Japan 2 17.04.2000 07.09.2001 4504229 07.09.2011 Registered
South Korea 1 27.11.1997 27.11.1998 431337 27.11.2008 Registered
Mexico 1 04.12.1997 04.12.1997 568689 04.12.2007 Registered
Malaysia 1 28.11.1997 Filed
Norway 1 21.11.1997 18.06.1998 190954 18.06.2008 Registered
73
New Zealand 1 25.11.1997 25.11.1997 285223 25.11.2004 Registered
Pakistan 1 25.11.1997 Filed
Poland 1 25.11.1997 06.03.2001 123629 25.11.2007 Registered
Portugal 1 25.11.1997 15.05.1998 327385 15.05.2008 Registered
Romania 1 05.12.1997 05.12.1997 33325 05.12.2007 Registered
Russian Federat 1 03.12.1997 24.02.1999 172676 03.12.2007 Registered
Saudi Arabia 1 12.01.1998 12.01.1998 474/30 22.09.2007 Registered
Sweden 1 21.11.1997 06.08.1999 332270 06.08.2009 Registered
Singapore 1 15.12.1997 Filed
Slovak Republic 1 25.11.1997 14.12.1999 188597 25.11.2007 Registered
Thailand 1 09.12.1997 09.12.1997 80071 09.12.2007 Registered
Turkey 1 26.12.1997 26.12.1997 195964 26.12.2007 Registered
Taiwan 1 04.12.1997 16.10.1998 820735 16.10.2008 Registered
United States 1 21.11.1997 Inactive
United States 2 19.04.2001 Filed
Vietnam 1 05.01.1998 07.05.1999 30808 05.01.2008 Registered
South Africa 1 01.12.1997 01.12.1997 97/18422 01.12.2007 Registered
74
Schedule C
Compound
75
SCHEDULE C, COMPOUND
CHEMICAL STRUCTURE, CHEMICAL NAME AND MOLECULAR FORMULA
Chemical structure
[CHEMICAL STRUCTURE GRAPH]
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(21)H(23)Cl(2)NO(6)
76
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
77
Schedule E
Supply Agreement
SCHEDULE 3
Study outline
Subsequently the Study protocol
PROTOCOL SYNOPSIS - CLEVIDIPINE CABG
NAME OF SPONSOR: AstraZeneca and The Medicines Company
NAME OF ACTIVE INGREDIENT: Clevidipine
TITLE OF STUDY: [**]
STUDY CENTERS: [**]
PHASE OF DEVELOPMENT: [**]
OBJECTIVES: [**]
METHODOLOGY: [**]
NUMBER OF PATIENTS: [**]
DIAGNOSIS AND MAIN CRITERIA FOR INCLUSION: [**]
TEST PRODUCT(S), DOSE, MODE OF
ADMINISTRATION: [**]
REFERENCE THERAPY, DOSE, MODE OF
ADMINISTRATION: [**]
DURATION OF TREATMENT: [**]
CRITERIA FOR EVALUATION:
Efficacy: [**]
[**]
[**]
[**]
[**]
[**]
[**]
Safety: [**]
SAMPLE SIZE: [**]
SCHEDULE 4
Press announcement
Contact: Peyton Marshall Jill Sawdon
Chief Financial Officer Director of Corporate
The Medicines Company Communications
(617) 225-9099 (ph) The Medicines Company
(617) 225-2397 (fx) (617) 225-9099 (ph)
(617) 225-2397 (fx)
FOR IMMEDIATE RELEASE
THE MEDICINES COMPANY ANNOUNCES ACQUISITION OF RIGHTS TO CLEVIDIPINE
PHASE 3 DRUG CANDIDATE TO BE TESTED FOR USE IN HOSPITAL HYPERTENSION
PATIENTS
PARSIPPANY, NJ, March 6, 2002 - The Medicines Company (NASDAQ: MDCO) announced
today that it has entered into an agreement with AstraZeneca PLC for the
licensing, development and commercialization of clevidipine, an intravenous,
short-acting calcium channel blocker. Clevidipine will be developed in Phase 3
by The Medicines Company for the short-term control of high blood pressure in
the hospital setting. AstraZeneca has completed clinical pharmacology,
dose-finding and efficacy studies that demonstrate that clevidipine has a short
duration of action, a short plasma half life, and a selective effect on blood
pressure.
The agreement covers all worldwide territories except Japan. The Medicines
Company will perform further clinical development and has the right to
commercialize the product in all other territories worldwide including the
United States. Financial terms of the agreement were not disclosed.
"Acquisition of the rights to clevidipine is consistent with our execution of a
strategy to build a franchise in acute hospital care," said Clive Meanwell,
M.D., Ph.D., Executive Chairman of The Medicines Company. He went on to state,
"Commercially, the product's pharmacological and clinical attributes make it an
ideal candidate for Phase 3 testing in a range of hospital indications including
malignant hypertension, and the control of blood pressure during and after
cardiac surgery, percutaneous coronary intervention and other acute
interventions where precise control of blood pressure is clinically important.
An estimated 18.2 million surgical procedures are performed annually on
hypertensive patients in the United States. These patients are often treated
with multiple medications that have been shown to increase the duration of a
patient's stay in the Intensive Care Unit and require a physician's attention.
We believe clevidipine has the potential to demonstrate a substantial
pharmacoeconomic benefit by reducing complex treatment with multiple medications
and patients' time in the ICU."
Dave Stack, President and CEO of The Medicines Company, added, "This is a
perfect fit with our current U.S. sales configuration. We believe that
clevidipine will be of value to many of the same customers who are currently
adopting ANGIOMAX(R) (bivalirudin) into their practice. This leverages many of
our existing commercial relationships in the U.S. We look forward to forging a
strong relationship with Astra Zeneca and bringing this potentially important
new medicine to patients."
Clive Meanwell will host a conference call at 8:30 AM (Eastern Time) on March 7,
2002. To participate in the call, please dial 800.472.8325. If you are calling
from outside the United States please call 1.706.679.0816. There will be a
digital replay of the call available until March 9 at midnight Eastern Time. To
listen to the replay, please dial 800.642.1687 in the United States or
1.706.645.9291 outside the United States and enter conference ID #3425937. A
webcast of the call will also be available on The Medicines Company's website,
www.themedicinescompany.com.
The Medicines Company was founded in 1996 to acquire, develop and commercialize
selected pharmaceutical products in late stages of development and approved
products. In December 2000, the Company received marketing approval from the
U.S. Food and Drug Administration for ANGIOMAX for use as an anticoagulant in
combination with aspirin in patients with unstable angina undergoing coronary
balloon angioplasty. The Company began selling ANGIOMAX in the United States in
January 2001. The Company expects ANGIOMAX to be the cornerstone product of a
planned acute hospital franchise. The Company is also developing a second
product, CTV-05, a proprietary biotherapeutic agent with a potentially broad
range of applications in the treatment of gynecological and reproductive
infections. Additional information about the company and its products can be
found at www.themedicinescompany.com.
This press release contains forward-looking statements that involve a number of
risks and uncertainties. For this purpose, any statements contained herein that
are not statements of historical fact may be deemed to be forward-looking
statements. Without limiting the foregoing, the words, "believes,"
"anticipates," "plans," "expects," "intends," and similar expressions are
intended to identify forward-looking statements. Important factors that could
cause actual results to differ materially from the expectations described in
these forward-looking statements are set forth under the caption "Certain
Factors that May Affect Future Results" in the Company's Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on November 14, 2001
and incorporated herein by reference. These risk factors include risks as to the
commercial success of ANGIOMAX; how long the Company will be able to operate on
its existing capital resources; whether the Company's products (other than
ANGIOMAX for its approved indication and including clevidipine without
limitation) will advance in the clinical trials process, the timing of such
clinical trials, whether the clinical trial results will warrant continued
product development, whether and when, if at all, the Company's products will
receive approval from the U.S. Food and Drug Administration or equivalent
regulatory agencies, and for which indications, and, if such products receive
approval, whether they will be successfully marketed; whether the Company will
be able to develop or acquire additional products; the Company's history of net
losses; and the Company's dependence on third parties, including manufacturers,
suppliers and collaborators. We do not assume any obligation to update any
forward-looking statements.