EXECUTION COPY
LICENSE AGREEMENT
BETWEEN
LIPHA, S.A.
AND
▇▇▇, ▇.▇.
September 1, 1998
TABLE OF CONTENTS
Page
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1. Definitions.............................................................. 1
2. Grant of License to Patent Rights........................................ 3
3. Licensee's Obligations................................................... 3
4. Grant-back of Licensee Improvements...................................... 3
5. Confidentiality.......................................................... 4
6. Term..................................................................... 5
7. Royalties................................................................ 5
8. Representations of Licensor.............................................. 6
9. Limitations on Licensee's Rights......................................... 6
10. Cooperation; Payment of Fees and Charges................................. 7
11. Infringement............................................................. 7
12. Books and Records........................................................ 8
13. Licensor's Right to Monitor Product Quality; Insurance................... 8
14. Patent Notices........................................................... 9
15. Regulatory Compliance.................................................... 9
16. Product Complaints....................................................... 9
17. Indemnification.......................................................... 9
18. Governmental Laws and Regulations........................................ 10
19. No Partnership or Agency................................................. 11
20. Assignment and Sublicense................................................ 11
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Page
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21. Licensee's Rights Outside Scope of the Licenses.......................... 11
22. Termination.............................................................. 11
23. Effect of Termination or Expiration...................................... 12
24. No Waiver................................................................ 13
25. Notices.................................................................. 13
26. Section Headings......................................................... 14
27. Entire Agreement......................................................... 14
28. Counterparts............................................................. 14
29. Binding Effect........................................................... 14
30. Governing Law............................................................ 14
31. Injunctive Relief........................................................ 14
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LICENSE AGREEMENT
AGREEMENT dated as of September 1, 1998 between LIPHA, S.A., a French
Societe Anonyme, having offices at ▇▇ ▇▇▇ ▇▇. ▇▇▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇▇ (the
"Licensor") and ▇▇▇, ▇.▇., a Delaware Limited Partnership, having offices at
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ (the "Licensee") (the
Licensor and the Licensee hereinafter to be collectively referred to as "the
Parties" and singly as a "Party").
WHEREAS, the Licensor holds certain Patent Rights (as such term is
hereinafter defined) relating to a dry powder inhaler which may be used to
deliver drugs to the bronchial tubes and lungs of humans;
WHEREAS, the Licensee desires to acquire an exclusive license to use
the Patent Rights in connection with the delivery of respiratory and-or
broncho-pulmonary prescription drugs in humans; and
WHEREAS, the Licensor is willing to license the Patent Rights to the
Licensee for such use on the terms and conditions set forth herein;
NOW, THEREFORE, the parties agree as follows:
1. Definitions. For purposes of this Agreement, the following terms
shall have the meanings indicated:
(a) "Affiliates" of a party shall mean any corporation or
other business entity which is controlled by a Party. For purposes of this
Section 1(a), control shall mean direct or indirect ownership of more than 50%
of the voting interest or income interest in a corporation or entity, or such
other relationship as, in fact, constitutes actual control.
(b) "Approvals" shall mean any and all government approvals
required by any government or regulatory authority necessary to permit the
development, manufacture, marketing, promotion, distribution and/or sale of the
Licensed Product in any country.
(c) "FDA" shall mean the United States Food and Drug
Administration and any successor thereto.
(d) "Field" shall mean the use of the Licensed Product for the
delivery of respiratory and/or broncho-pulmonary prescription drugs in humans.
(e) "Improvements" shall mean modifications, whether patented
or unpatented, to the Licensed Product (as the term is hereinafter defined).
Improvements to the Licensed Product made, developed or acquired by the Licensor
shall be included within the definition of Licensed Product.
(f) "including" shall mean including without limitation.
(g) "Licensed Product" shall mean a device, including any
variations of such device, known as a dry powder inhaler, the manufacture, use
or sale of which is covered by the Patent Rights, which is used for dispensing
doses of finely divided solid medicament to the bronchial tubes and lungs of
humans for the treatment of disease (but does not include any substance that may
be delivered by such device).
(h) "Licensed Technology" shall mean any and all proprietary
information owned, developed or acquired by or licensed to the Licensor, or to
which the Licensor has the right to grant licenses or sublicenses before or
during the term of this Agreement and which may contribute to, or has
contributed to, the development, manufacture, registration, marketing, sale or
use of Licensed Product in the Field.
(i) "Licensee Improvements" shall mean Improvements made,
developed or acquired by the Licensee during the term of this Agreement.
(j) "Licenses" shall mean the rights granted by the Licensor
to the Licensee in Section 2 hereof.
(k) "Net Sales" shall mean the gross amount invoiced for all
arm's length sales to third parties of any Licensed Product, including any
substance to be delivered thereby, in the Territory by the Licensee and its
Affiliates and sublicensees, less deductions for (i) trade, quantity, and cash
discounts or rebates, credits, allowances, refunds and retroactive price
reductions, including chargebacks; (ii) any tax or government charge (other than
income tax) levied on the sale, transportation or delivery of the Product and
borne by the seller thereof; (iii) any charges for freight, postage, shipping,
import or export taxes, insurance or charges for returnable containers borne by
the seller; and (iv) Medicare, Medicaid and other private or governmental
sponsored rebates and administration fees.
(l) "Patent Rights" shall mean any and all rights under
certificates of invention, patents, certificates of protection and all decrees,
grants, concessions, licenses and contracts (and applications therefor) whereby
any governmental authority confers any of the foregoing the exclusive right
within any country in the Territory for any period of time to manufacture, sell
or use a process, apparatus or article which relates to the sale or use of any
Licensed Product. The Patent Rights owned by or licensed to the Licensor that
are applicable to this Agreement shall include those identified in Exhibit "A"
attached hereto and such other Patent Rights as the Licensor shall from time to
time designate in writing to the Licensee in its sole discretion.
(m) "Term" is defined in Section 6 hereof.
(n) "Territory" shall mean the United States, Canada and
Mexico and their respective territories and possessions.
(o) "Third Party" or "Third Parties" shall mean any party
other than the Licensor or the Licensee or any affiliate of either the Licensor
or the Licensee.
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2. Grant of License to Patent Rights. The Licensor hereby grants to the
Licensee, and the Licensee hereby accepts, during the term of this Agreement and
subject to the terms and conditions set forth below an exclusive right and
license (with the right to sublicense others, subject to Section 20) to use the
Patent Rights and Licensed Technology in the Territory to develop, manufacture,
market, sell and have sold Licensed Product, with or without any substance to be
delivered thereby, in the Field.
3. Licensee's Obligations. It shall be the Licensee's obligation at its
expense to develop Licensed Product, design and implement the production
processes therefor, obtain and maintain all Approvals, including the conduct of
all clinical trials, required for the manufacture, marketing and/or sale thereof
in the Field in the Territory and to use reasonable commercial efforts to market
and sell Licensed Product in the Field throughout the Territory during the Term.
The Licensee shall not adopt, use or apply for registration of any trade name or
▇▇▇▇ with respect to Licensed Product, unless such name or ▇▇▇▇ has been
approved by the Licensor, such approval not to be unreasonably withheld, and the
Licensor agrees that the Licensee shall own such name or ▇▇▇▇ and the Licensor
shall not object to the Licensee registering such name or ▇▇▇▇ in its own name,
provided that such name or ▇▇▇▇ does not comprise, in whole or in part, any name
or ▇▇▇▇ owned or used by the Licensor or that is confusingly similar to any name
or ▇▇▇▇ owned or used by the Licensor prior to its use or the application for
registration thereof by the Licensee.
4. Grant-back of Licensee Improvements. (a) The Licensee shall promptly
disclose in writing to the Licensor full details of any Licensee Improvements.
Without limiting the generality of the foregoing, each Licensee Improvement
shall be disclosed to the Licensor in writing no later than sixty (60) days
prior to its being placed in public use or on sale or described in any printed
publication or otherwise made public in any country by the Licensee. In
furtherance of its disclosure obligations hereunder, the Licensee will from time
to time forward to the Licensor and, at the Licensor's or such other licensee's
cost, to such other licensees as the Licensor may designate, copies of such
materials as the Licensee may prepare in the conduct of its business relating to
the Licensed Product, including technical information in the form of drawings,
program code, material lists and instructions. In consideration of the Licensor
licensing the Patent Rights and the Licensed Technology hereunder, the Licensee
hereby sells and assigns all its rights in any Licensee Improvements to the
Licensor, which rights shall, however, be included within the Patent Rights and
the Licensed Technology licensed hereunder.
(b) The Licensee shall use its best efforts to obtain the
assignment to the Licensee from its employees, contractors, or other persons
under its control of all rights in Licensee Improvements.
(c) Within 45 days after any disclosure by the Licensee to the
Licensor given in writing pursuant to subsection (a) above, the Licensor shall
notify the Licensee in writing whether or not the Licensor intends to file for
patent protection on the Licensee Improvements which are disclosed, and shall
specify the countries in which patent applications are to be filed. If and when
requested by the Licensor, the Licensee shall use its best efforts to obtain for
the
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Licensor the right to file and prosecute applications for patent protection for
such Licensee Improvements in such country or countries, at the expense of the
Licensor and by an attorney selected by the Licensor. At the expense and request
of the Licensor, the Licensee shall execute, acknowledge, and verify any and all
such applications for patent protection, including divisional, continuation,
continuation-in-part, and reissue applications, as applicable and to any and all
things which may be necessary or useful to aid the Licensor in filing such
application and procuring the issuance of patent protection on such applications
to the Licensee and/or the Licensor. The Licensee shall assign or cause to be
assigned to the Licensor any patent right owned or controlled by the Licensee
which may be issued for any Licensee Improvements on applications filed and
prosecuted at the expense of the Licensor.
(d) In any instance where the Licensee is a proprietor but not
the sole beneficial owner of any Licensee Improvement or related patent rights
to which subsections (a) or (b) above are applicable, it shall use reasonable
efforts to obtain the consent of all Third Parties interested in such Licensee
Improvements or related patent rights to enable the Licensee to implement its
obligations as stipulated herein, but shall not be obligated to pay any
consideration to obtain such consent.
(e) With respect to any Licensee Improvement that is
patentable within the Territory, Licensee may demand in writing that Licensor
make a patent application in a country within the Territory covering such
Licensee Improvement. If the Licensor does not make such an application within
one hundred eighty (180) days of receipt of such demand, Licensee shall be
entitled to make a patent application in a country in the Territory in its own
name, at its own cost, with respect to such Licensee Improvement.
(f) The Parties' obligations under this Section 4 shall
terminate upon the end of the Term of this Agreement in every country in the
Territory.
5. Confidentiality. (a) The Licensee shall treat and maintain as
confidential all Patent Rights and Licensed Technology licensed pursuant to this
Agreement. The Licensee shall not disclose any aspect of such Patent Rights or
Licensed Technology, whether evidenced by the Licensed Product, documents made
available by the Licensor or generated by the Licensee, or otherwise, to any
Third Party without the prior written consent of the Licensor; provided, that
the Licensee shall have the right to disclose such Patent Rights and Licensed
Technology to its officers, employees, sublicensees, customers, sales
representatives, remarketers, suppliers, and other contractors, but only to the
extent necessary for the conduct of its business and consistent with applicable
laws and regulations.
(b) The Licensee shall instruct each of its officers,
employees, customers, sales representatives, remarketers, suppliers and other
contractors to whom Patent Rights or Licensed Technology may be disclosed
hereunder not to divulge to any Third Party or use at any time or for any reason
whatsoever any such Patent Rights or Licensed Technology except as authorized
under this Agreement.
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(c) The Licensee shall be fully liable for any disclosure,
directly or indirectly, of any aspects of the Patent Rights or the Licensed
Technology by the Licensee or any of its officers, employees, sublicensees,
customers, sales representatives, remarketers, suppliers or other contractors
hereunder to any Third Party which is not authorized under this Agreement, it
being no defense that the Licensee has exercised due care in hiring,
supervising, or contracting with its officers, employees, customers, sales
representatives, remarketers, suppliers and other contractors, as relevant.
(d) The undertaking in this Section 5 shall not apply to
information that (i) is in the public domain at the time of its acquisition by
the Licensee; (ii) through no fault of the Licensee, becomes generally available
as information in the public domain; (iii) the Licensor makes publicly available
as part of the process of obtaining a patent; or (iv) either Party is required
to disclose by order or regulation of a governmental agency or court of
competent jurisdiction, provided that the Party shall not make any such
disclosure (other than a filing of information or materials with the U.S.
Securities and Exchange Commission made with a request for confidential
treatment for portions thereof for which such treatment may reasonably be
expected to be granted, a similar filing of information or materials or with the
National Association of Securities Dealers or a filing of information or
materials pursuant to the ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Anti-Trust Improvements Act of 1976,
or amended, and the rules and regulations thereunder, as amended) without first
notifying the other Party and allowing the other Party a reasonable opportunity
to seek injunctive relief from (or protective order with respect to) the
obligation to make such disclosure. The Licensee's obligations under this
Section 5 shall survive the termination or expiration of this Agreement for a
period of five (5) years.
6. Term. The term of this Agreement (the "Term") shall begin on the
date hereof and (subject to Section 22 hereof) shall end as to each country in
the Territory on the date of the last to expire of the Patent Rights necessary
for the manufacture, use or sale of the Licensed Products in such country or on
the date all of such Patent Rights are found by a final judgment of a court of
competent jurisdiction not subject to appeal to be invalid. Following the
expiration of the term of this Agreement in each such country, the Licensee
shall have the royalty-free non-exclusive right and license to make, use and
sell Licensed Product in the Field in such country.
7. Royalties. (a) In consideration for the license of the Patent Rights
and the Licensed Technology under this Agreement, the Licensee hereby agrees to
pay the Licensor as follows:
(i) Five million U.S. dollars ($5,000,000.00) within thirty
(30) days following the execution; and delivery hereof; and
(ii) A royalty during the term of this Agreement calculated as
follows:
(A) on Net Sales by the Licensee or its Affiliates or
sublicensees during the Term up to a cumulative total of
$75,000,000, one percent (1%) of Net Sales;
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(B) on Net Sales by the Licensee or its Affiliates or
sublicensees during the Term in excess of a cumulative total
of $75,000,000 and up to a cumulative total of $125,000,000,
two percent (2%) of Net Sales;
(C) on Net Sales by the Licensee or its Affiliates
or sublicensees during the Term in excess of a cumulative
total of $125,000,000, three percent (3%) of Net Sales.
(b) All payments to be made to the Licensor pursuant to this
Agreement shall be made via bank wire transfer to the bank account(s) and
bank(s) as directed by the Licensor.
(c) All royalty payments due under Section 7(a) hereof with
respect to Net Sales during each calendar quarter during the Term shall be paid
no later than thirty (30) days following the close of such calendar quarter.
Each such payment shall be accompanied by a statement showing the computation of
the amount of Net Sales during such calendar quarter and the amount of royalties
due on such Net Sales.
(d) The Licensee shall make all payments required under this
Agreement in United States Dollars. The royalty payments due on the sale of
Products outside the United States shall be translated at the rate of exchange
at which United States Dollars are listed in The Wall Street Journal for the
currency of the country in which the royalty is accrued for the last business
day of the period in which such sales were made.
(e) If part or the entire amount of any payment payable by the
Licensee to the Licensor pursuant to this Agreement shall be overdue for any
reason, the Licensee shall pay to the Licensor interest on the overdue amount,
accruing on a daily basis and payable immediately upon demand, at Citibank N.A.
New York, New York's "base" rate.
8. Representations of Licensor. The Licensor represents and warrants
that: (i) ownership and title in and to the Patent Rights set forth at Exhibit A
is either vested solely in the Licensor or licensed to the Licensor pursuant to
valid licenses; (ii) the Licensor has all necessary right, power and authority
to enter into this Agreement and to grant the Licenses; (iii) the Licensor has
not entered into any agreement or commitment with any Third Party which would
impair, interfere with or infringe upon the rights granted hereunder; (iv) to
the best of the Licensor's knowledge, the use of the Patent Rights will not
result in the infringement of any Third Party's patents; and (v) to the best of
the Licensor's knowledge there are no claims or actions pending or threatened
relating to the Patent Right or the rights granted hereunder. Except as
expressly provided in this Section 8, the Licensor makes no representation or
warranty with respect to the Patent Rights or the Licensed Technology or any
application or use thereof made by the Licensee.
9. Limitations on Licensee's Rights. The Licensee recognizes and
acknowledges the ownership or other rights and validity of such rights which the
Licensor may, now or in the future, have in the Patent Rights and shall, under
no circumstance, use, except as contemplated by this Agreement, or infringe upon
any Patent Rights owned by the Licensor in the Territory
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or in any other place in the world, nor induce anyone else to do so. Except to
the extent specifically provided in Section 4 above, the Licensee shall not
apply for the registration, either in its own name or in the name of the
Licensor, of any rights as to any of the Patent Rights, either during the term
of this Agreement or after its expiration or termination. The Licensee shall
not, at any time whatsoever, raise or cause to be raised any objection to the
validity of the Licensor's rights in or to the Patent Rights.
10. Cooperation; Payment of Fees and Charges. (a) The Licensee agrees
that both during the term of this Agreement and thereafter it will cooperate
fully and in good faith with the Licensor and execute such documents as the
Licensor may reasonably request for the purpose of securing and preserving the
rights of the Licensor in and to the Licensor's Patent Rights.
(b) The Licensor agrees that during the term of this Agreement
it shall directly pay or reimburse the Licensee for any and all filing fees,
annuities, maintenance fees or equivalent governmental charges that may be due
in the Territory with respect to the Patent Rights licensed hereunder, for the
purpose of securing and preserving the rights of the Licensor thereto.
11. Infringement. (a) The Licensee shall promptly notify the Licensor
in writing of any infringement by any Third Party of the Patent Rights in the
Territory which comes to the Licensee's attention. The Licensee's notification
to the Licensor shall contain, if known by the Licensee, the name of the alleged
infringer, identification of the subject Patent Right and the dates, places and
circumstances of the alleged infringement. In the event that the Licensor
determines that action should be taken against any such Third Party, the
Licensor may take such action in its own name (or that of any licensor to the
Licensor of rights which are the subject of the proposed action) and at its own
expense or, where required by law, in the Licensee's name in which event the
Licensor shall bear the cost of such action and shall be entitled to control the
prosecution thereof. The Licensee agrees to cooperate fully with the Licensor to
whatever extent is necessary to prosecute any such action.
(b) If the Licensor decides not to bring any such action,
after having been requested in writing by the Licensee to do so, upon notice of
at least thirty (30) days to the Licensor, then the Licensee will be entitled,
at its own expense, to bring such action in its own name or, where required by
law, in the Licensor's name (or the name of any licensor to the Licensor of
rights which are the subject of the proposed action) and, where necessary, to
defend, in the name of the party involved, any counterclaim brought by the
opponent in such action. The Licensee will at all times keep the Licensor
informed of all details arising in connection with any such action and the
Licensor will at all times have the right to participate in any such action, at
its own expense. Notwithstanding the foregoing, the Licensee will not be
entitled to bring or continue any such action if, for valid reasons of policy,
to be indicated by the Licensor to the Licensee in writing, the Licensor opposes
the bringing or continuing of such action, provided that if the failure to bring
or continue such action results, or is reasonably expected to result, in
substantial damage to the business of the Licensee, the Parties shall negotiate
in good faith a reasonable adjustment to the royalties set forth in Section 7 of
this Agreement.
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(c) In the event that any action brought under this Section 11
results in any monetary recovery, such recovery shall belong to the party that
brought such action and, if both parties have brought such action, any such
recovery shall be shared equally or as the parties may otherwise agree.
12. Books and Records. The Licensee agrees to keep accurate books of
account and records covering all transactions relating to the licenses hereby
granted, and the Licensor or its duly authorized representatives shall have the
right during normal business hours to examine said books of account and records
and all other documents and materials in the possession or under the control of
the Licensee with respect to the subject matter and terms of this Agreement, and
shall have free and full access thereto for such purpose and for the purpose of
making photocopies therefrom. All books of account and records shall be kept
available by the Licensee for at least three (3) years after the calendar
quarter or part thereof to which they relate.
13. Licensor's Right to Monitor Product Quality; Insurance. In order to
maintain the quality and safety of Licensed Product manufactured by the Licensee
pursuant to this Agreement, the Licensee agrees as follows:
(a) The Licensee agrees that at all reasonable times during the term of
this Agreement the Licensor and its authorized representatives shall have access
to and shall be entitled to visit for periods of reasonable duration and without
charge to the Licensee all offices and facilities of the Licensee concerned or
connected with the engineering, design, manufacture, assembly, and/or testing of
Licensed Product for the purpose of consulting with the personnel at such
facilities and inspecting the activities (including but not limited to sales,
research, engineering, assembly, testing, design and manufacturing activities)
related to Licensed Product. At such times, the Licensee shall provide the
Licensor at Licensee's cost representative product samples of any Licensed
Product being produced by the Licensee, including samples of the cartons and
containers (including packing and wrapping material), in reasonable quantities.
(b) The Licensee shall use its best efforts to develop, and to maintain
and adhere to, satisfactory manufacturing quality control, and testing and
safety testing and inspection capabilities, or cause such controls and
capabilities to be maintained and adhered to by its contractors. The Licensee
will assume all financial, service, warranty and other sales obligations and
liabilities with respect to any Licensed Product manufactured by it.
(c) The Licensee shall maintain with an issuer, on terms and in amounts
acceptable to the Licensor all risks insurance, including property damage, and
manufacturers' and product liability insurance, including personal injury,
against defects or failure in design, production, installation, use or otherwise
of any Licensed Product manufactured by it. The Licensee shall use its best
efforts to name the Licensor and any licensor of the rights licensed hereunder
to the Licensor as additional insureds in its insurance policies and to cause a
certificate from an insurance company or a licensed insurance broker attesting
to said coverage to be delivered to the Licensor and any such licensor of the
Licensor before the sale of the first Licensed Product by the Licensee. Any
policy with respect to the insurance referred to in this paragraph shall:
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(i) waive any right of the insurance carrier to claim any
premium or commission or assert any counterclaim or set-off against the
Licensor and any such licensor of the Licensor;
(ii) waive any right of subrogation of the insurance carrier
against the Licensor and any such licensor of the Licensor; and
(iii) provide for at least thirty (30) days prior written
notice by the insurer to the Licensor and any such licensor of the
Licensor in the event of non-renewal, cancellation, expiration or
material modification.
14. Patent Notices. At the request of the Licensor, the statement that
the Licensed Product is "manufactured under Patent Nos.________ under license
from Lipha, S.A." showing the applicable patent numbers shall be affixed by the
Licensee in clear and legible letters on each Licensed Product or on the
container therefor or shall appear on an insert placed in the container
therefor.
15. Regulatory Compliance. The Licensee shall comply with all
applicable legal and regulatory requirements, including those of the FDA and
counterpart agencies within the Territory, in connection with the manufacture,
marketing and/or sale of Licensed Product in the Territory by the Licensee or
its Affiliates or sublicensees during the Term.
16. Product Complaints. Each Party shall immediately inform the other
of product, quality, health or safety related concerns or inquiries that raise
potentially serious and unexpected quality, health or safety concerns; however,
the Licensee shall, or shall require any sublicensees of any of its rights
hereunder, to administer any inquiries or complaints relating to sales of
Licensed Product in the Territory in accordance with applicable laws and
regulations.
17. Indemnification. (a) The Licensee agrees to indemnify and hold
harmless the Licensor and each of its Affiliates and any corporation or other
business entity with controls or is under common control with the Licensor to
the extent permitted by applicable law against all actions, claims, costs,
damages and expenses arising out of or based upon the breach of this Agreement
by the Licensee or the manufacture, assembly, design, development, engineering,
production, distribution, marketing, sale, use or export by the Licensee of
Licensed Product or any derivatives thereof (including all actions, claims,
costs, damages and expenses relating to any claim for product liability).
(b) The Licensor agrees to indemnify the Licensee and its
Affiliates to the extent permitted by applicable law against all actions,
claims, costs, demands and expenses to the extent such actions, claims, costs,
demands or expenses arise out of, or are based upon a breach of the
representations and warranties of the Licensor set forth in Section 8 hereof.
Except as provided in the preceding sentence, in no event shall the Licensor be
liable to the Licensee or to any Third Party, whether under contract, tort
(including negligence), strict liability or any other theory of law, for loss of
anticipated profits, loss by reason of plant shutdown, non-operation or
increased expense of operation, claims of customers, cost of money,
9
loss of use of capital or revenue, or for any special, incidental, direct,
indirect or consequential loss or damage of any nature arising at any time or
from any cause whatsoever.
(c) In the event of the occurrence of an event which either
Party asserts constitutes an indemnifiable claim hereunder, such Party shall
provide the indemnifying Party with prompt notice of such event and shall
otherwise make available to the indemnifying Party all relevant information
which is material to the claim and which is in the possession of or available to
the indemnified Party. The indemnifying Party shall have the right to elect to
join in the defense, settlement, adjustment or compromise of such claim, and to
employ counsel to assist such indemnifying Party in connection with the handling
of such claim, at the sole expense of the indemnifying Party, and no such claim
shall be settled, adjusted or compromised, or the defense thereof terminated,
without the prior written consent of the indemnifying Party (which shall not be
unreasonably withheld or delayed) unless and until the indemnifying Party shall
have failed, after the lapse of a reasonable period of time, but in no event
more than 30 days, to join in the defense, settlement, adjustment or compromise
of the same. An indemnified Party's failure to give timely notice or to furnish
the indemnifying Party with any relevant data and documents in connection with
any claim for indemnification shall not constitute a defense (in part or in
whole) to such claim, except and only to the extent that such failure shall
result in any material prejudice to the indemnifying Party. If so desired by any
indemnifying Party, such party may elect, at such Party's sole expense, to
assume control of the defense, settlement, adjustment or compromise of any such
claim for indemnification, provided that such indemnifying Party shall obtain
the prior written consent of the indemnified Party, which shall not be
unreasonably withheld or delayed, before entering into any settlement,
adjustment or compromise of such claim, or ceasing to defend against such claim,
if as a result thereof, or pursuant thereto, there would be imposed on the
indemnified Party any liability or obligation not covered by the indemnification
obligations of the indemnifying Party under this Agreement (including any
injunctive relief or other remedy).
18. Governmental Laws and Regulations. (a) The obligations of each
party hereunder shall be subject to and in accordance with all applicable laws
or governmental regulations of any applicable jurisdictions, including those of
the FDA.
(b) In the event of any present or future governmental law,
regulation or action forbidding performance of any of the obligations of either
of the parties hereunder, or in the event of either Party's inability to obtain
any present or future governmental action required for the performance of its
obligations hereunder, such Party shall be excused from the performance of such
obligations except for the obligations of confidentiality under Section 5, of
cooperation under Section 10 and of indemnification under Section 17, and the
Licensee's obligation to make payments under this Agreement, which obligations
shall be unconditional.
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19. No Partnership or Agency. This Agreement does not constitute a
partnership and nothing herein is intended to constitute, nor shall anything
herein be construed to constitute, the parties hereto as partners of each other.
Nothing contained herein shall constitute either Party an agent of the other
party, and neither Party shall have the power, authority or right to act on
behalf of or bind the other Party or negotiate or conclude contracts on behalf
of or in the name of the other Party or impose any liability or obligation to
Third Parties upon the other Party.
20. Assignment and Sublicense. (a) The Licensee shall not assign this
Agreement without the prior written consent of the Licensor. The Licensor may
assign Licensor's Patent Rights and any and all rights of the Licensor under
this Agreement in whole or in part to anyone at any time, subject to the
Licensee's rights hereunder.
(b) The Licensee shall not have the right to sublicense its
rights hereunder without obtaining the Licensor's prior written consent, such
consent not to be unreasonably withheld.
21. Licensee's Rights Outside Scope of the Licenses. (a) If the
Licensor proposes to use or license a third party to use the Patent Rights or
Licensed Technology to manufacture or sell the Licensed Product or any
derivation thereof in the Territory, but outside of the Field, Lipha shall offer
to negotiate in good faith with the Licensee for the Licensee to manufacture all
of the Licensor's or such licensee's requirements for such products for sale in
the Territory. If the Licensee accepts such offer to negotiate with thirty (30)
days of receipt thereof, the Parties shall negotiate such an agreement in good
faith, provided that the Licensor shall not be obliged to consummate such an
agreement if the terms and conditions of such an agreement are commercially
materially worse for the Licensor or the third party licensee than if such
product were to be manufactured by the Licensor or by such third party under
license from the Licensor.
(b) If Licensor uses or licenses a third party to use the
Patent Rights or Licensed Technology outside of the Territory or to develop,
manufacture, market, sell or have sold products within the Territory, but
outside of the Field, the Licensee shall not be obligated to provide assistance,
know-how or any proprietary information owned, developed or acquired by or
licensed to the Licensee in relation to such products or the manufacture thereof
to the Licensor or such licensee, except as provided under Section 4 hereof and
except as provided in any separate agreement with the Licensee for valuable
consideration.
22. Termination. (a) If the Licensee makes any assignment of its assets
or business for the benefit of creditors, or if a trustee or receiver is
appointed to administer or conduct its business, or if it is adjudged in any
legal proceeding to be a voluntary or involuntary bankrupt, then the licenses
hereby granted shall automatically cease and terminate, without any notice or
action by the Licensor.
(b) If the Licensee shall violate its obligation to render
royalty reports and pay the amounts due under Section 7 hereof, the Licensor
shall have the right to terminate the licenses hereby granted upon thirty (30)
days' notice in writing, and such notice of termination
11
shall become effective unless the Licensee shall completely remedy the violation
within thirty (30) days after such notice is duly given.
(c) If the Licensee shall violate any of its obligations under
the terms of this Agreement, other than its obligation to render royalty reports
and pay the amounts due under Section 7 hereof, the Licensor shall have the
right to terminate the licenses hereby granted upon sixty (60) days' notice in
writing, and such notice of termination shall become effective unless the
Licensee shall completely remedy the violation within sixty (60) days after such
notice is duly given and satisfy the Licensor that such violation has been
remedied; provided, however, that in the event the violation giving rise to the
Licensor's notice of termination is of such character that it cannot be
completely remedied within such sixty (60) day period, then the Licensee shall
have such reasonable further period to remedy the violation completely provided
that the Licensee shall have commenced action within such initial sixty (60) day
period to remedy such violation and shall diligently and continuously pursue
thereafter its efforts to remedy the violation completely.
(d) If the Board of Directors of the Licensee determines in
its reasonable business judgment that the manufacture and sale of Licensed
Product in the Field is no longer profitable, the Licensee shall have the right
on one hundred eighty (180) days notice to the Licensor to terminate the
licenses granted hereby.
(e) If the Licensor shall violate any of its obligations under
the terms of this Agreement, the Licensee shall have the right to terminate the
licenses hereby granted upon sixty (60) days' notice in writing, and such notice
of termination shall become effective unless the Licensor shall completely
remedy the violation within sixty (60) days after such notice is duly given and
satisfy the Licensee that such violation has been remedied; provided, however,
that in the event the violation giving rise to the Licensee's notice of
termination is of such character that it cannot be completely remedied within
such sixty (60) day period, then the Licensor shall have such reasonable further
period to remedy the violation completely provided that the Licensor shall have
commenced action within such initial sixty (60) day period to remedy such
violation and shall diligently and continuously pursue thereafter its efforts to
remedy the violation completely.
23. Effect of Termination or Expiration. (a) Termination of the
licenses granted hereby under the provisions of Section 22 hereof shall be
without prejudice to any rights which the parties may otherwise have against
each other. Without limiting the generality of the foregoing, the provisions of
Sections 5, 10, 17, 30, and 31 hereof shall survive termination of this
Agreement. Upon any termination or expiration of the licenses granted hereby,
notwithstanding anything to the contrary herein, all royalties in respect of
sales theretofore made (or thereafter made pursuant to subsection (b) of this
Section 23) shall continue to be due and payable.
(b) After termination, or expiration of the licenses granted
hereunder, the Licensee may, within the Territory, dispose of Licensed Product
and any other items manufactured using the Licensor's Patent Rights that are on
hand or in process for a period of
12
one hundred eighty (180) days after the effective date of termination or
expiration, provided that royalties are paid and a royalty report furnished with
respect to such 180-day period within thirty (30) days following the last day
thereof. Notwithstanding the foregoing, in no event shall the Licensee continue
to dispose of or distribute any materials manufactured using the Licensor's
Patent Rights in the event of termination of this Agreement pursuant to Section
22(b) hereof.
24. No Waiver. Any failure of any Party to comply with any of the
obligations or agreements set forth in this Agreement or to fulfill any
condition set forth herein may be waived only by a written instrument signed by
the other party. No failure by any party to exercise, and no delay in
exercising, any right hereunder shall operate as a waiver of such right, nor
shall any single or partial exercise of any right hereunder by any party
preclude any other or future exercise of that right or any other right hereunder
by that party.
25. Notices. All notices, requests or other communications required or
permitted hereunder shall be deemed to have been duly given if in writing and
delivered: by hand, when received, as evidenced by signed acknowledgment of
receipt by the person to whom such notice shall have been addressed; by telefax,
upon confirmed transmission; ten (10) days after mailing if mailed by registered
or certified air mail with postage prepaid, as evidenced by the acknowledgment
of receipt issued with respect thereto by the applicable postal authorities; or
two business days after proper dispatching, if sent by an internationally
recognized overnight courier service; in each case addressed to the party to
receive the same at such party's respective address set forth below, or at such
other address as may from time to time be notified by such party to the other in
accordance with this Section 25:
If to the Licensor:
LIPHA, S.A.
▇▇ ▇▇▇ ▇▇. ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇
Attention: The President
Fax: ▇▇▇ ▇▇ ▇ ▇▇ ▇▇ ▇▇ 05
If to the Licensee:
▇▇▇, ▇.▇.
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
U.S.A.
Attention: The President
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
In either case, a copy to:
Coudert Brothers
13
1114 Avenue of the Americas
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇., Esq.
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
26. Section Headings. Section headings used herein are for convenience
only and are not a part of this Agreement and shall not be used in construing
it.
27. Entire Agreement. This Agreement embodies the entire understanding
of the parties with respect to the subject matter hereof, and there are no other
prior or contemporaneous agreements or understandings, written or oral, in
effect between parties with respect to the subject matter hereof. This Agreement
may be amended or modified only by an instrument of equal formality signed by
the parties or their duly authorized representatives.
28. Counterparts. This Agreement may be executed in any number of
duplicate counterparts, each of which shall be deemed an original and all of
which together shall constitute one and the same instrument.
29. Binding Effect. This Agreement and the provisions thereof shall be
binding upon and inure to the benefit of the respective successors and assigns
of the parties.
30. Governing Law. The parties agree that the validity, construction,
operation and effect of this Agreement shall be determined and enforced in
accordance with the laws of the State of New York, without giving effect to
principles of conflicts of law thereunder.
31. Injunctive Relief. It is acknowledged that it will be impossible to
measure in money the damages that would be suffered if the Parties fail to
comply with the obligations imposed pursuant to Sections 5, 10(a) and 23 of this
Agreement and that in the event of any such failure, the non-defaulting Party
may be irreparably damaged and will not have an adequate remedy at law. The
Parties shall, therefore, be entitled to injunctive relief and/or specific
performance to enforce such obligations and, if any action should be brought in
equity to enforce any such provision, the other Party shall not raise the
defense that there is an adequate remedy at law.
14
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
WITNESS: LIPHA, S.A.
/s/ ▇▇▇▇ ▇▇▇▇ Julliard By: /s/ ▇▇▇▇-▇▇▇▇ Treilles
--------------------------- --------------------------
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇-▇▇▇▇ Treilles
Director, Business and President
Economic Affairs
WITNESS: ▇▇▇, ▇.▇.
By ▇▇▇, INC., General Partner
/s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇
--------------------------- --------------------------
▇▇▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇
Executive Vice President Chief Executive Officer
and CFO
15
EXHIBIT A TO LICENSE AGREEMENT BETWEEN
LIPHA, S.A. AND ▇▇▇., L.P.
DATED SEPTEMBER 1, 1998
PATENT RIGHTS
9506 -- Device for administering single doses of a particulate material
Filing number Date of filing Publication number Granted Expiration
------------- ---------------- ------------------ ------------- -------------
US 96-663245 December 9, ▇▇▇▇ ▇▇▇▇▇▇▇ June 23, 1998 June 23, 2015
Canada 2179202 December 9, ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ December 14, 1994
9507 -- Improvements in and relating to containers of particulate material
Filing number Date of filing Publication number Granted Expiration
------------- ---------------- ------------------ ------------- -------------
US 95-442676 May 17, 1995
Canada 2190497 May 16, 1995
▇▇▇▇▇▇ ▇▇▇▇▇▇ May 16, 1995
9508 -- Device for administering single doses of a medicament
Filing number Date of filing Publication number Granted Expiration
------------- ---------------- ------------------ ------------- -------------
US 95-442674 May 17, ▇▇▇▇ ▇▇▇▇▇▇▇ April 8, ▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇
▇▇▇▇▇▇ 2190496 May 16, 1995
▇▇▇▇▇▇ ▇▇▇▇▇▇ May 16, 1995
9509 -- Charging dispenser with reduced volume doses of a powdered medicament
Filing number Date of filing Publication number Granted Expiration
------------- ---------------- ------------------ ------------- -------------
US 98-068645 November 14, 1996
Canada 2237990 ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
▇▇▇▇▇▇ 96-02794 November 14, ▇▇▇▇ ▇▇-▇▇▇▇▇
----------
* No specific Mexican filing. Reference to PCT world filing.
