Exibit 99.1
TECHNOLOGY LICENSE AGREEMENT
This TECHNOLOGY LICENSE AGREEMENT (the "Agreement") is made as of
December 22, 1997, by and among DURA PHARMACEUTICALS, INC., a Delaware
corporation ("DURA"), DURA DELIVERY SYSTEMS, INC., a Delaware corporation
("DDSI"), SPIROS DEVELOPMENT CORPORATION, a Delaware corporation ("Spiros
Corp."), and SPIROS DEVELOPMENT CORPORATION II, INC., a Delaware corporation
("Spiros Corp. II").
RECITALS
WHEREAS, DURA and Spiros Corp. II are parties to the Development Agreement,
the Manufacturing and Marketing Agreement, and the Albuterol and Product Option
Agreement (all capitalized terms shall have the respective meanings set forth in
Section 1 hereof).
WHEREAS, DURA has the Purchase Option to acquire all of the Spiros Corp. II
Common Stock.
WHEREAS, DURA, DDSI and/or Spiros Corp. are the owners or licensees of the
Core Technology and of certain rights relating to the Spiros Products and
certain intellectual property rights relating thereto.
WHEREAS, DURA, DDSI and Spiros Corp. are willing to grant to Spiros Corp.
II and Spiros Corp. II desires to acquire from DURA, DDSI and Spiros Corp., a
license to the Core Technology and the Spiros Products for the purpose of
allowing Spiros Corp. II to perform research, develop and commercialize the
Spiros Products.
WHEREAS, pursuant to the Development Agreement, Spiros Corp. II has engaged
DURA to employ the intellectual property rights and technology licensed
hereunder in conducting the Development and commercialization of Spiros
Products.
WHEREAS, in the course of researching and developing the Program
Technology, DURA or Spiros Corp. II may develop certain inventions, processes or
know-how, or DURA may obtain on behalf of Spiros Corp. II rights to certain
additional technology or patents or other proprietary rights useful to other
than just the Spiros Products.
WHEREAS, DURA desires to acquire, and Spiros Corp. II is willing to grant
to DURA, an exclusive worldwide license or sublicense to make, use, market and
sell such developments, technology or rights other than with respect to Spiros
Products.
NOW, THEREFORE, in consideration of the mutual covenants set forth herein
and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and in order to induce
DURA to enter into the Agreements, DURA, DDSI, Spiros Corp. and Spiros Corp. II
hereby agree as follows:
1. DEFINITIONS.
1.1 DEFINITIONS. All capitalized terms used herein and not otherwise
defined shall have the respective meanings, to the extent such terms are used
herein, set forth in SCHEDULE 1.1 attached hereto, which is incorporated by this
reference as though fully set forth herein.
1.2 SINGULAR AND PLURAL. Singular and plural forms, as the case may be,
of terms defined herein shall have correlative meanings.
2. GRANT OF LICENSES.
2.1 GRANT OF EXCLUSIVE LICENSES TO SPIROS CORP. II; RIGHT TO SUBLICENSE.
2.1.1 DURA GRANT. Subject to the terms and conditions of this
Agreement, DURA hereby grants to Spiros Corp. II an exclusive (against DURA and
all other Persons) perpetual, worldwide right and license, terminable only as
set forth herein, to employ the DURA Core Technology to research, develop, make,
have made, use, sell, have sold and import the Spiros Products (except with
respect to beclomethasone in Japan, Hong Kong, Singapore, the Republic of China,
Taiwan, the Republic of Korea and the People's Republic of China).
2.1.2 DDSI GRANT. Subject to the terms and conditions of this
Agreement, DDSI hereby grants to Spiros Corp. II an exclusive (against DDSI and
all other Persons) perpetual, worldwide right and license, terminable only as
set forth herein, to employ the DDSI Core Technology to research, develop, make,
have made, use, sell, have sold and import the Spiros Products (except with
respect to beclomethasone in Japan, Hong Kong, Singapore, the Republic of China,
Taiwan, the Republic of Korea and the People's Republic of China).
2.1.3 SPIROS CORP. GRANT. Subject to the terms and conditions of
this Agreement, Spiros Corp. hereby grants to Spiros Corp. II an exclusive
(against Spiros Corp. and all other Persons) perpetual, worldwide right and
license, terminable only as set forth herein, to employ the Spiros Core
Technology to research, develop, make, have made, use, sell, have sold and
import the Spiros Products (except with respect to beclomethasone in Japan, Hong
Kong, Singapore, the Republic of China, Taiwan, the Republic of Korea and the
People's Republic of China).
2.2 THIRD PARTY LICENSES TO DURA OR ANY OF ITS AFFILIATES. With respect
to the rights of third parties that may be obtained by DURA after the date
hereof, and which are necessary or useful to the Development under the
Development Agreement or the
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commercialization of the Spiros Products under the Manufacturing and
Marketing Agreement, DURA shall use commercially reasonable efforts to secure
such rights and the right to sublicense such rights to Spiros Corp. II and
shall sublicense such rights to Spiros Corp. II whenever possible; PROVIDED
that Spiros Corp. II shall not be obligated to accept any grant of rights or
assume any obligations hereunder without its prior written consent. If
Spiros Corp. II desires to obtain any such rights licensed to DURA or any of
its Affiliates pursuant to an agreement with any Person other than Spiros
Corp. II (a "Third Party Agreement"), the existence of which DURA shall
promptly inform Spiros Corp. II, Spiros Corp. II and DURA agree to negotiate
in good faith regarding the allocation between DURA or any of its Affiliates
and Spiros Corp. II of the royalty, license fee, milestone fee or other
payments payable to the third party and the assumption of any obligations
applicable to such license, if any. Spiros Corp. II shall bear the cost of
obtaining any such rights and shall assume such obligations only in
proportion to its and its sublicensees' (other than DURA's and/or any of its
Affiliates) use of such rights. Any sublicense granted to Spiros Corp. II
hereunder shall be limited to the rights that DURA and/or any of its
Affiliates has a right to grant under any such Third Party Agreement and to
any obligations under any such Third Party Agreement, and to any obligations
assumed by DURA and/or any of its Affiliates in consideration of the grant or
assignment of such rights to DURA which are to be sublicensed to Spiros Corp.
II. No party shall take any action, or fail to take any action within its
control, that would constitute or give rise to a breach or other violation by
DURA or any of its Affiliates of any such Third Party Agreement. The parties
agree that no future licensing fees are required to be paid by Spiros Corp.
II during the term of this Agreement as consideration for the licenses and
sublicenses granted to Spiros Corp. II hereunder, except as set forth in this
Section 2.2.
2.3 SPIROS CORP. II SUBLICENSES AND LICENSES TO DURA.
2.3.1 DEVELOPMENT LICENSE. Spiros Corp. II hereby grants DURA an
exclusive, even as to Spiros Corp. II and all other Persons, royalty-free
license to employ and engage in any and all uses of the Program Technology to
conduct Development, subject to the terms and conditions of and to the extent
necessary to perform its obligations under the Development Agreement. The
rights granted under this Section 2.3.1 may be further sublicensed by DURA only
to its Affiliates or as permitted under of the Development Agreement (and, in
such a case, solely to the extent necessary to perform any subcontracting
services thereunder) or as otherwise agreed to in writing by Spiros Corp. II.
2.3.2 COMMERCIALIZATION LICENSE. Spiros Corp. II hereby grants
DURA an exclusive, even as to Spiros Corp. II and all other Persons, worldwide
license to use the Program Technology to make, have made, use, sell, supply and
import Spiros Products subject to the terms and conditions of and to the extent
necessary to perform its obligations under the
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Manufacturing and Marketing Agreement. The rights granted under this
Section 2.3.2 may be further sublicensed by DURA only to its Affiliates or as
permitted under the Manufacturing and Marketing Agreement (and, in such a case,
solely to the extent necessary to perform any subcontracting services
thereunder) or as otherwise agreed to in writing by Spiros Corp. II.
2.3.3 ALBUTEROL PRODUCT LICENSE. Spiros Corp. II hereby grants
DURA effective upon the exercise of the Albuterol Option, an exclusive, royalty-
free, irrevocable, perpetual, worldwide license to use the Program Technology to
develop, make, have made, use, sell, have sold, supply and import the Albuterol
Product. The license granted hereunder shall include the right to grant
sublicenses with respect to the Program Technology licensed under this Section
2.3.3 for use with the Albuterol Product.
2.3.4 PRODUCT OPTION LICENSE. Spiros Corp. II hereby grants DURA
effective upon the exercise of the Product Option, an exclusive, royalty-free,
irrevocable, perpetual, worldwide license to use the Program Technology to
develop, have developed, make, have made, use, sell, have sold, supply and
import the Option Product. The license granted hereunder shall include the
right to grant sublicenses with respect to the Program Technology licensed under
this Section 2.3.4 for use with the Option Product.
2.3.5 ADDITIONAL LICENSE. Spiros Corp. II hereby grants DURA an
exclusive, royalty-free, irrevocable, perpetual, worldwide license to use the
Program Technology, including technology relating to enhancements to Spiros
technology or any next generation inhaler system in which Spiros Corp. II has
rights, to develop, have developed, make, have made, use, sell, have sold,
supply and import any products other than the Spiros Products.
2.3.6 OTHER LICENSES. The foregoing licenses are granted in
addition to, and not in substitution for, any other license granted to DURA,
whether pursuant to this Agreement or otherwise.
2.4 RESTRICTIONS UPON USE OF PROGRAM TECHNOLOGY. Except as provided in
the Agreements or by the prior written consent of DURA, Spiros Corp. II shall
not, directly or indirectly, prior to the expiration or termination (other than
by exercise) of the Purchase Option, (a) license, sublicense, encumber, pledge,
sell, assign or otherwise transfer to any Person any rights under the Program
Technology, (b) make, have made, use or sell any of the Program Technology for
any purpose whatsoever, or (c) authorize, cause or assist in any way any other
Person to do any of the foregoing. Following the expiration or termination
(other than by exercise) of the Purchase Option, the foregoing limitations shall
cease to be applicable and Spiros Corp. II shall have, without limitation, the
right to sublicense the Program Technology for use with the Spiros Products.
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2.5 ADJUSTMENT OF LICENSES. The licenses granted in Sections 2.1 and 2.3
hereunder shall be subject to adjustment (a) upon the Albuterol Option Closing
Date, so as to exclude any rights to the Albuterol Program Assets from the
licenses granted therein, and (b) upon the Product Option Closing Date, so as to
exclude any rights to Spiros Product Program Assets from the license granted
therein.
3. REPRESENTATIONS, WARRANTIES AND COVENANTS.
3.1 REPRESENTATIONS, WARRANTIES AND COVENANTS OF DURA. DURA represents,
warrants and covenants to Spiros Corp. II as follows:
3.1.1 ORGANIZATION OF DURA. DURA is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware
with full corporate power and authority adequate for executing and delivering
and performing its obligations under this Agreement;
3.1.2 ORGANIZATION OF DDSI. DDSI is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware
with full corporate power and authority adequate for executing and delivering
and performing its obligations under this Agreement;
3.1.3 ORGANIZATION OF SPIROS CORP.. Spiros Corp. is a corporation
duly organized, validly existing and in good standing under the laws of the
State of Delaware with full corporate power and authority adequate for executing
and delivering and performing its obligations under this Agreement.
3.1.4 AUTHORIZATION. The execution, delivery and performance of
this Agreement have been duly authorized by all necessary corporate action on
the part of DURA, DDSI and Spiros Corp. and this Agreement shall constitute a
legal, valid and binding obligation of each of DURA, DDSI and Spiros Corp.,
enforceable against DURA, DDSI and Spiros Corp. in accordance with its terms,
subject to laws of general application relating to bankruptcy, insolvency and
the relief of debtors;
3.1.5 COMPLIANCE WITH OTHER INSTRUMENTS. The execution, delivery
and performance of this Agreement do not and will not conflict with or
contravene any provision of the charter documents or by-laws of each of DURA,
DDSI and Spiros Corp. or any material agreement, document, instrument, indenture
or other obligation of DURA, DDSI or Spiros Corp.;
3.1.6 OTHER AGREEMENTS. None of DURA, DDSI or Spiros Corp. shall
enter into any agreement, make any commitment, take any action or fail to take
any action that would contravene any material provision of, or materially
derogate or restrict any of the rights and licenses granted or assigned to
Spiros Corp. II under, this Agreement and each of DURA, DDSI and Spiros Corp.
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agree to abide and be bound by the terms of any license agreement to which they
are a party, any of the rights to which have been or will be sublicensed or
assigned to Spiros Corp. II;
3.1.7 INTELLECTUAL PROPERTY RIGHTS. To the best of its
knowledge, each of DURA, DDSI and Spiros Corp. has sufficient legal and/or
beneficial title and ownership to grant the licenses to the DURA Core
Technology, the DDSI Core Technology and the Spiros Corp. Core Technology,
respectively, and the other intellectual property rights provided in Section
2 above. None of DURA, DDSI or Spiros Corp. is aware of and has not received
any communications alleging that it has violated, or that Spiros Corp. II by
practicing the Core Technology as contemplated in the Agreements would
violate, any intellectual property rights of any third party. Except for the
1933 Royalty Agreement, there are no outstanding options, licenses or
agreements of any kind between DURA, DDSI or Spiros Corp. and any third party
relating to the research, development, manufacture, use or sale of the Spiros
Products. To the best of its knowledge, there is no material unauthorized
use, infringement or misappropriation of any of the Core Technology. DURA,
DDSI and Spiros Corp. are not aware of, nor have they received any
communications challenging the ownership, validity or effectiveness of the
Core Technology.
3.1.8 VALIDITY. None of DURA, DDSI or Spiros Corp. is aware of any
action, suit or inquiry or investigation instituted by any federal, state, local
or foreign governmental agency or instrumentality which questions or threatens
the validity of the Agreements.
3.2 REPRESENTATIONS, WARRANTIES AND COVENANTS OF SPIROS CORP. II. Spiros
Corp. II represents, warrants and covenants to DURA, DDSI and Spiros Corp. as
follows:
3.2.1 ORGANIZATION. Spiros Corp. II is a corporation duly
organized, validly existing and in good standing under the laws of State of
Delaware with full corporate power and authority adequate for executing and
delivering and performing its obligations under this Agreement;
3.2.2 AUTHORIZATION. The execution, delivery and performance of
this Agreement have been duly authorized by all necessary corporate action on
the part of Spiros Corp. II, and this Agreement shall constitute a legal, valid
and binding obligation of Spiros Corp. II, enforceable against Spiros Corp. II
in accordance with its terms, subject to laws of general application relating to
bankruptcy, insolvency and the relief of debtors;
3.2.3 COMPLIANCE WITH OTHER INSTRUMENTS. The execution, delivery
and performance of this Agreement do not and will not conflict with or
contravene any provision of the charter documents or by-laws of Spiros Corp. II
or any material agreement, document, instrument, indenture or other obligation
of Spiros Corp. II;
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3.2.4 OTHER AGREEMENTS. Spiros Corp. II shall not enter into any
agreement, make any commitment, take any action or fail to take any action that
would contravene any material provisions of, or materially derogate or restrict
any of the rights or licenses granted to DURA under, this Agreement;
3.2.5 SUBLICENSES. Spiros Corp. II agrees to abide and be bound by
the terms of the sublicenses granted to it in accordance with the terms of this
Agreement by DURA, DDSI and/or Spiros Corp. under any Third Party Agreement or
under any agreement with a third party;
3.2.6 NON-COMPETITION. Spiros Corp. II shall not, during the
term of this Agreement, without the prior written consent of DURA, solicit
the employment of any person, in any capacity, who, at any time during the
term of this Agreement, shall have been an officer, director, employee or
agent of DURA or any of its Affiliates, except for the officers of Spiros
Corp. II on the date hereof; and
3.2.7 VALIDITY. Spiros Corp. II is aware of no action, suit or
inquiry or investigation instituted by any federal, state, local or foreign
governmental agency or instrumentality which questions or threatens the validity
of the Agreements.
4. DISCLOSURE AND USE OF TECHNOLOGY AND RIGHTS.
4.1 TECHNOLOGY TRANSFER.
4.1.1 PRIOR TO EXPIRATION OR TERMINATION OF PURCHASE OPTION. At any
time prior to the expiration or termination (other than by exercise) of the
Purchase Option and upon request by Spiros Corp. II, each of DURA, DDSI and
Spiros Corp. shall, within a reasonable time thereafter, provide access to
Spiros Corp. II to all physical manifestations of the Program Technology which
they control.
4.1.2 AFTER EXPIRATION OR TERMINATION OF OPTION. After expiration
or termination (other than by exercise) of the Purchase Option, DURA shall,
except as provided otherwise in any of the Agreements, within thirty (30) days
of a written request by Spiros Corp. II, provide to Spiros Corp. II or a
sublicensee designated by Spiros Corp. II, reasonably sufficient quantities of
previously manufactured quantities of Spiros Products and all physical
manifestations of the Program Technology, including, without limitation, copies
of all laboratory notebooks, designs, specifications, formulas, procedures,
clinical and pre-clinical data and other information, all to the extent that
such Spiros Products, or Program Technology were developed prior to the time of
such required delivery. Spiros Corp. II shall pay all costs of shipping,
packaging, copying and similar or related costs in connection therewith,
provided such costs have not been previously paid by Spiros Corp. II hereunder
or under the
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Development Agreement.
4.1.3 TECHNICAL ASSISTANCE AFTER EXPIRATION OR TERMINATION OF
PURCHASE OPTION. For a period of one (1) year after expiration or termination
(other than by exercise) of the Purchase Option, each of DURA, DDSI and Spiros
Corp. shall provide to Spiros Corp. II, or a sublicensee designated by Spiros
Corp. II, at Spiros Corp. II's or such permitted sublicensee's sole option and
expense, reasonable technical assistance and instruction in understanding,
interpreting and applying the Program Technology solely for the purposes of
further developing the Program Technology and developing and commercializing
Spiros Products. Each of DURA, DDSI and Spiros Corp. shall make their
respective employees directly involved in the Development of the Program
Technology prior to the expiration or termination (other than by exercise) of
the Purchase Option, reasonably available for consultation by telephone, or in
person at their respective offices at reasonable cost, in connection with such
assistance and instruction, all at the sole expense of Spiros Corp. II or such
sublicensee. The obligations set forth in this Section 4.1.3 shall not include
any obligation to disclose matters unrelated to the application of the Program
Technology to the Spiros Products, matters with respect to the Albuterol Product
(following the exercise of the Albuterol Option) or matters with respect to the
Option Product (following the exercise of the Product Option).
4.2 PATENTS.
4.2.1 RIGHTS PRIOR TO EXPIRATION OR TERMINATION OF PURCHASE
OPTION. Except as set forth below, until the expiration or termination (other
than by exercise) of the Purchase Option, DURA shall, at Spiros Corp. II's
sole expense, direct and cause appropriate patent applications to be
prepared, filed and prosecuted in all relevant territories, in a timely
fashion, with respect to any inventions included in the Program Technology
whether arising out of inventions made solely by DURA employees or
consultants, inventions made solely by DDSI employees or consultants,
inventions made solely by Spiros Corp. employees or consultants, inventions
made solely by Spiros Corp. II employees or consultants or inventions made
jointly by any of the parties' employees or consultants. DURA and Spiros
Corp. II shall discuss and evaluate with each other such discoveries and
inventions and shall confer regarding the advisability of filing patent
applications to cover those discoveries and inventions, including the
countries in which such patent applications should be filed. DURA shall
cause any patents issuing thereon to be maintained and enforced that DURA and
Spiros Corp. II believe, in their commercially reasonable judgment, are
patentable and commercially and technically significant to Spiros Corp. II.
With respect to the Developed Technology that has substantial application to
Spiros Products, as well as to products other than the Spiros Products, the
expenses of preparing, prosecuting and maintaining such patents shall be
reasonably allocated between DURA and Spiros Corp. II by their mutual
agreement.
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4.2.2 RIGHTS AFTER EXPIRATION OR TERMINATION OF PURCHASE OPTION.
After the expiration or termination of the Purchase Option (other than by
exercise), Spiros Corp. II shall have the exclusive right, at its sole expense,
to prepare and prosecute, in its name, patent applications, and to maintain
patents issued with respect to the Program Technology. In the event that Spiros
Corp. II declines to prepare, prosecute or maintain any such patent application
or patent, Spiros Corp. II shall give DURA no less than sixty (60) days' prior
written notice of such decision but in all events at least as much time so as to
allow DURA to take action to forestall a loss of novelty or a statutory bar to
patentability. Following such written notice, and in order to protect its
rights, DURA shall have the right in its sole discretion and at its sole
expense, to undertake the preparation, prosecution or maintenance of any such
patent application or patent issued thereon with respect to the DURA Core
Technology, the DDSI Core Technology and the Spiros Core Technology.
Enforcement rights upon the expiration or termination (other than by exercise)
of the Purchase Option are governed by Section 5.2.2 hereunder.
4.2.3 COOPERATION. Each party agrees to cause each of its employees
and agents to take all actions and to execute, acknowledge and deliver all
instruments or agreements reasonably requested by the other party, and necessary
for the perfection, maintenance, enforcement or defense of that party's rights
as set forth above.
4.3 CONFIDENTIAL INFORMATION. Any party receiving Confidential
Information shall maintain the confidential and proprietary status of such
Confidential Information, keep such Confidential Information and each part
thereof within its possession or under its control sufficient to prevent any
activity with respect to the Confidential Information that is not specifically
authorized by this Agreement, use all commercially reasonable efforts to prevent
the disclosure of any Confidential Information to any other Person, and use
commercially reasonable efforts to ensure that such Confidential Information is
used only for those purposes specifically authorized herein; PROVIDED, HOWEVER,
that such restriction shall not apply to any Confidential Information that is
(a) independently developed by the receiving party outside the scope of this
Agreement or the Development Agreement (PROVIDED, HOWEVER, that such restriction
shall apply to any technology licensed by DURA, DDSI or Spiros Corp. to Spiros
Corp. II under this Agreement), (b) in the public domain at the time of its
receipt or thereafter becomes part of the public domain through no fault of the
receiving party, (c) received without an obligation of confidentiality from a
third party having the right to disclose such information, (d) released from the
restrictions of this Section 4.3 by the express written consent of the
disclosing party, (e) disclosed to any permitted assignee, permitted sublicensee
or permitted subcontractor of DURA, DDSI, Spiros Corp. or Spiros Corp. II under
the Agreements (if such assignee, sublicensee or
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subcontractor is subject to the provisions of this Section 4.3 or
substantially similar provisions) or (f) required by law, statute, rule or
court order to be disclosed (the disclosing party shall, however, use
commercially reasonable efforts to obtain confidential treatment of any such
disclosure). The obligations set forth in this Section 4.3 shall survive for
a period of ten (10) years from the expiration or termination (other than by
exercise) of the Purchase Option. Without limiting the generality of the
foregoing, DURA, DDSI, Spiros Corp. and Spiros Corp. II each shall use
commercially reasonable efforts to obtain, if not already in place,
confidentiality agreements from their respective employees and agents,
similar in scope to this Section 4.3, to protect the Confidential Information.
4.4 PERMITTED DISCLOSURES. Notwithstanding the provisions of Section 4.3
hereof, DURA, DDSI, Spiros Corp. and Spiros Corp. II (and their permitted
sublicensees) may, to the extent necessary, disclose and use Confidential
Information, consistent with the rights of DURA, DDSI, Spiros Corp. and Spiros
Corp. II otherwise granted hereunder (a) for the purpose of securing
institutional or government approval to clinically test or market any Spiros
Product, (b) for the purpose of securing patent protection for an invention
within the scope of the Program Technology, (c) in the case of Spiros Corp. II,
following expiration or termination (other than by exercise) of the Purchase
Option, to the extent necessary or useful in the development or
commercialization of any Spiros Products or (d) in the case of DURA, following
exercise of the Albuterol Option or the Product Option, to the extent necessary
or useful in the development or commercialization of the Albuterol Product or
the Option Product, respectively; PROVIDED, that the disclosing party obtains an
agreement from any Person to whom such Confidential Information is disclosed to
preserve the confidentiality thereof upon terms reasonably equivalent to those
set forth herein and to use such Confidential Information only for those
purposes consistent with the respective rights granted to Spiros Corp., DURA,
DDSI and Spiros Corp. II hereunder or under any of the Agreements.
5. PATENT INFRINGEMENT.
5.1 NOTIFICATION OF INFRINGEMENT. Each party shall notify all other
parties of any infringement known to such party by any Person of any Patent
Rights and shall provide all other parties with the available evidence, if any,
of such infringement.
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5.2 ENFORCEMENT OF PATENT RIGHTS. If any party has actual notice of
infringement by any Person of Patent Rights, the respective officers of DURA and
Spiros Corp. II shall confer to determine in good faith an appropriate course of
action to enforce such Patent Rights or otherwise abate the infringement
thereof, subject to the provisions of this Section 5.2. DURA and Spiros Corp.
II shall consult with each other in the planning and execution of any action to
enforce Patent Rights.
5.2.1 RIGHTS PRIOR TO EXPIRATION OR TERMINATION OF OPTION. Until
the expiration or termination (other than by exercise) of the Purchase Option,
if DURA determines that enforcement of Patent Rights is appropriate, DURA shall
have the right, but not the obligation, to take appropriate action to enforce
such Patent Rights. Any enforcement with respect to the Patent Rights shall be
at DURA's expense; PROVIDED, HOWEVER, that if DURA elects to so act with respect
to the Patent Rights, Spiros Corp. II shall have the right to participate in the
enforcement of such Patent Rights by agreeing to bear a percentage of the costs
of such enforcement in such amount as the parties shall determine. If, within
six (6) months after notice of infringement, DURA has not commenced an action to
enforce such Patent Rights or thereafter ceases to diligently pursue such
action, Spiros Corp. II shall have the right, at its expense, to take
appropriate action to enforce such Patent Rights as its sole remedy hereunder.
All amounts recovered in any action to enforce Patent Rights undertaken by DURA
and Spiros Corp. II, whether by judgment or settlement, shall be retained by
DURA and Spiros Corp. II pro rata according to the respective percentages of
expenses borne by them in enforcing such Patent Rights. Neither DURA nor Spiros
Corp. II shall enter into any settlement that includes the grant of a license
under, agreement not to enforce, or any statement prejudicial to the validity or
enforceability of any Patent Rights without the consent of the other, which
consent shall not be unreasonably withheld. Any amounts retained by Spiros
Corp. II shall not be considered Available Funds.
5.2.2 RIGHTS AFTER EXPIRATION OR TERMINATION OF OPTION. After the
expiration or termination (other than by exercise) of the Purchase Option, if
Spiros Corp. II determines that enforcement of Patent Rights is appropriate,
Spiros Corp. II shall have the right, but not the obligation, to take
appropriate action to enforce such Patent Rights. Any enforcement with respect
to the Patent Rights shall be at Spiros Corp. II's expense; PROVIDED, HOWEVER,
that if Spiros Corp. II elects to so act with respect to the Patent Rights, DURA
shall have the right to participate in the enforcement of such Patent Rights by
agreeing to bear a percentage of the costs of such enforcement in such amount as
the parties shall determine. If, within six (6) months after notice of
infringement, Spiros Corp. II has not commenced an action to enforce such Patent
Rights or thereafter ceases to diligently pursue such action, DURA shall have
the right, at its expense, to take appropriate action to enforce such Patent
Rights as its sole remedy hereunder. All amounts recovered in any action to
enforce Patent Rights undertaken by
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Spiros Corp. II and DURA, whether by judgment or settlement, shall be
retained by Spiros Corp. II or DURA pro rata according to the respective
percentages of expenses borne by them in enforcing such Patent Rights.
Neither DURA nor Spiros Corp. II shall enter into any settlement that
includes the grant of a license under, agreement not to enforce, or any
statement prejudicial to the validity or enforceability of any Patent Rights
without the consent of the other, which consent shall not be unreasonably
withheld.
5.2.3 COOPERATION. Each party agrees to cause each of its employees
and agents to take all actions and to execute, acknowledge and deliver all
instruments or agreements reasonably requested by the other party, and necessary
for the perfection, maintenance, enforcement or defense of the party's rights as
set forth above.
5.3 DISCLAIMER OF WARRANTY; CONSEQUENTIAL DAMAGES.
5.3.1 DISCLAIMER OF WARRANTY. Nothing in this Agreement shall be
construed as a representation made or warranty given by any party hereto that
any patents will issue based on pending applications within the Patent Rights,
or that any such Patent Rights which do issue will be valid, or that the
practice by a party hereto of any license granted hereunder, or that the use of
any Program Technology licensed hereunder, will not infringe the patent or
proprietary rights of any other Person. Spiros Corp. II understands that the
Development shall involve technologies that have not been approved by any
regulatory authority and that none of DURA, DDSI or Spiros Corp. guarantees the
safety or usefulness of any Spiros Product. In addition, except as expressly
set forth in Section 3 of this Agreement, DURA, DDSI, Spiros Corp. and Spiros
Corp. II acknowledge that THE PROGRAM TECHNOLOGY IS LICENSED TO Spiros Corp. II
AND SUBLICENSED TO DURA HEREUNDER AS IS, AND DURA, DDSI, SPIROS CORP. AND SPIROS
CORP. II EXPRESSLY DISCLAIM AND HEREBY WAIVE, RELEASE AND RENOUNCE ANY WARRANTY,
EXPRESS OR IMPLIED, WITH RESPECT TO SUCH PROGRAM TECHNOLOGY, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
NONINFRINGEMENT. Except as expressly set forth in this agreement, DURA, DDSI,
Spiros Corp. and Spiros Corp. II disclaim all warranties of any nature, express
or implied.
5.3.2 CONSEQUENTIAL DAMAGES. NONE OF THE PARTIES TO THIS AGREEMENT
SHALL BE ENTITLED TO RECOVER FROM ANOTHER PARTY HERETO ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES.
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6. INDEMNIFICATION.
6.1 INDEMNIFICATION BY DURA. DURA shall indemnify the Spiros Corp. II
Indemnitees, pay on demand and protect, defend, save and hold harmless each
Spiros Corp. II Indemnitee from and against any and all Claims incurred by or
asserted against any Spiros Corp. II Indemnitee of whatever kind or nature,
including, without limitation, any claim or liability based upon negligence,
warranty, strict liability, violation of government regulation or
infringement of patent or other propriety rights, arising from or occurring
as a result of (a) any use of the Program Technology by DURA or any
Affiliate, agent or sublicensee of DURA (other than Spiros Corp. II in
contravention of the terms of this Agreement), (b) any of the Development or
any other services to be performed by DURA during the term of the Agreements
pursuant to the Agreements, including, without limitation, any workers'
compensation claim by any DURA employee or consultant or other Person or (c)
subject to Section 5.3.2, any breach of the Agreements by DURA, except, with
respect to Spiros Corp. II Indemnitees, in cases in which Claims of Spiros
Corp. II Indemnitees are based upon the gross negligence or willful
misconduct of a Spiros Corp. II Indemnitee. A Spiros Corp. II Indemnitee
shall promptly notify DURA of any Claim with respect to which an Spiros Corp.
II Indemnitee is seeking indemnification hereunder, upon becoming aware
thereof, and permit DURA at DURA's cost to defend against such Claim and
shall cooperate in the defense thereof.
6.2 INDEMNIFICATION BY SPIROS CORP. II. Spiros Corp. II shall indemnify
the DURA Indemnitees, the DDSI Indemnitees and the Spiros Corp. Indemnitees, pay
on demand and protect, defend, save and hold harmless each DURA Indemnitee, DDSI
Indemnitee or Spiros Corp. Indemnitee from and against any and all Claims
incurred by or asserted against any DURA Indemnitee, DDSI Indemnitee or Spiros
Corp. Indemnitee of whatever kind or nature, including, without limitation, any
claim or liability based upon negligence, warranty, strict liability, violation
of government regulation or infringement of patent or other propriety rights,
arising from or occurring as a result of (a) any use of the Program Technology
by Spiros Corp. II or any sublicensee of Spiros Corp. II (other than the use of
such by DURA, DDSI or Spiros Corp. whether pursuant to the Agreements or
otherwise) or (b) subject to Section 5.3.2, any breach of the Agreements by
Spiros Corp. II, except, with respect to DURA Indemnitees, in cases in which
Claims are based upon the gross negligence or willful misconduct of a DURA
Indemnitee or, except with respect to DDSI Indemnitees, in cases in which Claims
are based upon the gross negligence or willful misconduct of a DDSI Indemnitee
or, except with respect to Spiros Corp. Indemnitees, in cases in which Claims
are based upon the gross negligence or willful misconduct of a Spiros Corp.
Indemnitee. An Indemnitee hereunder shall promptly notify Spiros Corp. II of
any Claim with respect to which such Indemnitee is seeking indemnification
hereunder, upon becoming aware thereof, and permit Spiros Corp. II at Spiros
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Corp. II's cost to defend against such Claim and shall cooperate in the
defense thereof.
6.3 DEFENSE OF CLAIMS. None of DURA, DDSI, Spiros Corp. or Spiros Corp.
II shall enter into, or permit, any settlement of any Claim for which
indemnification is being sought by such party hereunder without the express
written consent of each other party (or a DURA, DDSI, Spiros Corp. or Spiros
Corp. II Indemnitee, as the case may be), which consent shall not be
unreasonably withheld or delayed. Each party may, at its option and expense,
have its own counsel participate in any proceeding which is under the direction
of another party (the "Indemnifying Party") and will cooperate with the
Indemnifying Party and its insurer in the disposition of any such matter;
PROVIDED, HOWEVER, that if the Indemnifying Party shall not defend such Claim,
the other party shall have the right to defend such Claim itself and recover
from the Indemnifying Party all reasonable attorneys' fees and expenses incurred
by it during the course of such defense.
7. TECHNOLOGY ACCESS FEE.
7.1 FEE. In consideration of the license rights granted to Spiros
Corp. II herein and in recognition of DURA's, DDSI's and Spiros Corp.'s
expertise which they have developed over a period of years and individually,
Spiros Corp. II shall pay DURA, DDSI and Spiros Corp. an aggregate technology
access fee equal to the greater of (a) five percent (5%) of the Net Sales in
a calendar year for each Spiros Product, to be paid by Spiros Corp. II fifty
percent (50%) to DURA, twenty percent (20%) to DDSI and thirty percent
(30%) to Spiros Corp. or (b) Two Million Dollars for all Spiros Products in
any calendar year beginning in calendar 1998, to be paid by Spiros Corp. II
fifty percent (50%) to DURA, twenty percent (20%) to DDSI and thirty
percent (30%) to Spiros Corp.
7.2 TERM. Such technology access fee obligation shall terminate on a
country-to-country basis, on the following basis: (a) in those countries where
no patents covering such Spiros Product issue, ten (10) years following the
first commercial sale of such Spiros Product in such country; and (b) in those
countries where a patent(s) covering such Spiros Product issue, upon the
expiration of the last-to-expire patent covering the manufacture, use, import or
sale of a Spiros Product in such country.
7.3 PAYMENT OF TECHNOLOGY ACCESS FEES. Spiros Corp. II shall pay Five
Hundred Thousand Dollars ($500,000) on or before the forty-fifth (45th)
day following the end of each calendar quarter, fifty percent (50%) to
DURA, twenty percent (20%) to DDSI and thirty percent (30%) to Spiros
Corp. Within sixty (60) days following the end of each calendar year,
Spiros Corp. II shall provide to DURA, DDSI and Spiros Corp. a formal
accounting of the Net Sales of each Spiros Product in such calendar year
(the "Accounting"), and shall calculate the aggregate sum with respect to
sales of all Spiros Products which would be due if Spiros Corp. II were
to pay DURA five percent (5%) of the Net Sales in a calendar year for
each Spiros Product (the "Net Sales Amount"). In the event that the Net
Sales Amount is less than Two Million Dollars ($2,000,000), no additional
payments shall be due and payable from Spiros Corp. II with respect to
access to the Core Technology. In the event that the Net Sales Amount is
greater than Two Million Dollars ($2,000,000), Spiros Corp. II shall
promptly pay, but in no event later than five (5) business days following
delivery of the Accounting to DURA, DDSI and Spiros Corp., the difference
between the Net Sales Amount and Two Million Dollars ($2,000,000) with
respect to access to the Core Technology, fifty percent (50%) to DURA,
twenty percent (20%) to DDSI and thirty percent (30%) to Spiros Corp.
7.4 PRODUCT SALES. The Spiros Products for which such technology access
fees are payable shall be deemed to have been sold when shipped and billed to a
third party.
7.5 PAYEE. Such technology access fees shall be paid by Spiros Corp. II
directly to the party entitled thereto or to such party's designee as duly named
in a written notice to Spiros Corp. II.
7.6 PAYMENT IN DOLLARS. Such technology access fees shall
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be paid in United States currency. All technology access fees accrued in
currencies other than U.S. dollars shall be converted into U.S. dollars on
the basis of the rate of exchange applied by Citibank, N.A., New York, as of
the last banking day of each quarter for which such technology access fees
become due.
7.7 PROHIBITED PAYMENTS. Notwithstanding any other provision of the
Agreements, if Spiros Corp. II is prevented from paying any such technology
access fee by virtue of the statutes, laws, codes or governmental regulations of
the country from which the payment is to be made, then such technology access
fee shall be made by depositing funds in the currency in which accrued to the
other party's account in a bank acceptable to the other party in the country
whose currency is involved.
7.8 TAXES. If a law or governmental regulation requires withholding of
taxes on any payment due hereunder, such taxes shall be deducted from any amount
to be remitted hereunder and shall be paid to the proper taxing authority, and
proof of payment shall be provided to the party on whose behalf such taxes were
paid as evidence of such payment in such form as required by the tax authorities
having jurisdiction thereover.
7.9 REPORTS. Each payment of any such technology access fee shall be
accompanied by a written report, prepared and signed by a financial officer of
Spiros Corp. II, showing for the quarter for which payment is being made, the
gross sales and Net Sales of each Spiros Product sold and the technolgy access
fees which shall have accrued with respect thereto and currency conversion
calculations, if any. In the event that, for any quarter following the first
quarter in which a Spiros Product is sold for which such a technology access fee
would be payable, no such technology access fee is due, the party having
responsibility for sales of such Spiros Product shall report the same to the
other parties.
7.10 MAINTENANCE AND EXAMINATION OF RECORDS. At the request and expense
of DURA, Spiros Corp. II, or their respective Affiliates, the other parties
hereto and their Affiliates shall permit an independent certified public
accountant appointed by such party and reasonably acceptable to the other
party, at reasonable times and upon reasonable notice (but not exceeding once
in any twelve (12) month period), to examine those records as may be
necessary to: (a) determine, with respect to any calendar year ending not
more than three (3) years prior to such party's request, the correctness of
any report or payment under this Agreement; or (b) obtain information as to
the Spiros Product sales for any calendar year. Said independent certified
public accountant shall verify to the requesting party only the amount of
payment due or costs incurred hereunder and disclose no other information
revealed in its audit. Results of any such examination shall be made
available to the parties. Any amount of deficiency, or overcharge, shall be
paid or refunded promptly to Spiros Corp. II, plus interest at the commercial
prime lending rate of Citibank, N.A., New York (or equivalent banking
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institution) until the date paid. The party requesting the audit shall bear
the full cost of the performance of any such audit unless such audit
discloses a variance of more than five percent (5%) from the amount of the
original report, technology access fee or payment calculation, in which case
the party being audited shall bear the full cost of the performance of such
audit. DURA and Spiros Corp. II shall maintain and keep complete and
accurate records in sufficient detail to enable any examination concerning
technology access fees to be conducted pursuant to this Section 7.10.
8. TERM AND TERMINATION.
8.1 TERM. This Agreement shall be effective as of the date hereof and
shall continue in full force and effect indefinitely, unless terminated earlier
as provided in Sections 8.2, 8.3 and 8.4 hereof.
8.2 TERMINATION BY MUTUAL AGREEMENT. By mutual agreement, the parties
hereto may at any time terminate this Agreement and the Development on mutually
acceptable terms.
8.3 EFFECT OF PURCHASE OPTION EXERCISES.
8.3.1 PURCHASE OPTION. In the event the Purchase Option is
exercised by DURA, this Agreement shall terminate, effective upon the Purchase
Option Closing Date, without any obligation to make payments pursuant to Section
7 of this Agreement.
8.3.2 PARTIAL TERMINATION UPON EXERCISE OF ALBUTEROL OPTION. In the
event that the Albuterol Option is exercised, this Agreement shall terminate,
effective on the Albuterol Option Closing Date, with respect to the Albuterol
Program Assets and any obligation to make technology access fee payments with
respect to the Albuterol Product, but shall otherwise continue in full force and
effect until terminated pursuant to this Section 8.
8.3.3 PARTIAL TERMINATION UPON EXERCISE OF PRODUCT OPTION. In the
event that the Product Option is exercised, this Agreement shall terminate,
effective on the Product Option Closing Date, with respect to the Spiros Product
Program Assets and any obligation to make technology access fee payments with
respect to the Option Product, but shall otherwise continue in full force and
effect until terminated pursuant to this Section 8.
8.4 TERMINATION BY DURA, DDSI AND SPIROS. Either DURA, DDSI and Spiros
Corp., acting by unanimous action, or Spiros Corp. II shall have the right to
terminate this Agreement, effective as set forth in a written notice of the
occurrence of an Event of Default with respect to the other party.
8.5 RIGHTS IN BANKRUPTCY. All rights and licenses granted
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under or pursuant to this Agreement by DURA, DDSI, Spiros Corp. and Spiros
Corp. II are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the Bankruptcy Code, licenses of rights to "intellectual property"
as defined under Section 101 of the Bankruptcy Code. The parties agree that
DURA and Spiros Corp. II as licensees of such rights under this Agreement,
shall retain and may fully exercise all of their rights and elections under
the Bankruptcy Code. The parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against DURA, DDSI, Spiros
Corp. or Spiros Corp. II under the Bankruptcy Code, the parties hereto which
are not parties to such proceeding shall be entitled to a complete duplicate
of (or complete access to, as appropriate) any such intellectual property and
all embodiments of such intellectual property, and same, if not already in
their possession, shall be promptly delivered to them upon any such
commencement of a bankruptcy proceeding upon their written request therefor.
8.6 EFFECT OF TERMINATION.
8.6.1 TERMINATION BY DURA, DDSI AND SPIROS CORP.. If DURA, DDSI and
Spiros Corp. terminate this Agreement pursuant to Section 8.4 hereof, (a) the
licenses and sublicenses granted to Spiros Corp. II under Section 2.1 of this
Agreement shall terminate, (b) all rights to the DURA Core Technology shall
revert to DURA, all rights to the DDSI Core Technology shall revert to DDSI and
all rights to the Spiros Core Technology shall revert to Spiros Corp., (c) all
rights to the Program Technology except as set forth in (b) above shall revert
to DURA, (d) all rights to develop, make, have made, use, sell and import all
Spiros Products shall revert to DURA, DDSI and/or Spiros Corp. and (e) the
provisions of Sections 1, 3.2.6, 4.3, 4.4, 5.3, 6, 9.4 and 9.5 of this Agreement
shall survive. DURA will use reasonable efforts for a period of 120 days after
a termination by DURA, DDSI and Spiros Corp., pursuant to Section 8.4 hereof, to
negotiate royalties or any other compensation to be paid by DURA to Spiros Corp.
II with respect to the Developed Technology that will revert to DURA. In the
event the parties are unable to agree on the royalties or other compensation to
be paid by DURA with respect to the Developed Technology with the 120 day
period, such matter shall be submitted by DURA and Spiros Corp. II to binding
arbitration in accordance with the rules of the American Arbitration
Association.
8.6.2 TERMINATION BY SPIROS CORP. II. If Spiros Corp. II terminates
this Agreement pursuant to Section 8.4 hereof, the provisions of Sections 1,
2.1, 2.3.3 (if the Albuterol Option has been exercised), 2.3.4 (if the Product
Option has been exercised), 2.3.5, 3.2.6, 4.2.2, 4.3, 4.4, 5.3, 6, 7, 9.4 and
9.5 of this Agreement shall survive; PROVIDED, HOWEVER, if Spiros Corp. II fails
to perform or observe or otherwise breaches its Material Obligations under
Section 7 of this Agreement, which failure or breach is unremedied for a period
of sixty (60) days after receipt by Spiros Corp. II of written notice thereof
from DURA, or in the event such failure or breach
- 17 -
is not capable of cure within sixty (60) days, for such longer period of time
as Spiros Corp. II is vigorously pursuing such cure in good faith, DURA, DDSI
and Spiros Corp. shall have the right to terminate this Agreement with the
same effect as if DURA, DDSI and Spiros Corp. were to terminate this
Agreement pursuant to Section 8.4 hereof.
8.6.3 TERMINATION OF PURCHASE OPTION UNEXERCISED. If the Purchase
Option terminates unexercised, the licenses and sublicenses granted under
Sections 2.3.1 and 2.3.2 of this Agreement shall terminate.
8.6.4 CONTINUING OBLIGATION TO MAKE PAYMENTS. Notwithstanding
anything contained herein to the contrary, upon termination of this Agreement,
the obligation to pay any amounts payable by any party to another party which
accrued prior to such termination shall survive.
9. MISCELLANEOUS.
9.1 NO IMPLIED WAIVERS; RIGHTS CUMULATIVE. No failure on the part of
DURA, DDSI, Spiros Corp. or Spiros Corp. II to exercise and no delay in
exercising any right, power, remedy or privilege under this Agreement or
provided by statute or at law or in equity or otherwise, including, without
limitation, the right or power to terminate this Agreement, shall impair,
prejudice or constitute a waiver of any such right, power, remedy or privilege
or be construed as a waiver of any breach of this Agreement or as an
acquiescence therein, nor shall any single or partial exercise of any such
right, power, remedy or privilege preclude any other or further exercise thereof
or the exercise of any other right, power, remedy or privilege.
9.2 FORCE MAJEURE. DURA, DDSI, Spiros Corp. and Spiros Corp. II shall
each be excused for any failure or delay in performing any of their respective
obligations under this Agreement, if such failure or delay is caused by Force
Majeure.
9.3 RELATIONSHIP OF THE PARTIES. Nothing contained in this Agreement is
intended or is to be construed to constitute DURA, DDSI, Spiros Corp. and Spiros
Corp. II as partners or joint venturers or one party as an employee of any other
party. Except as expressly provided herein, no party hereto shall have any
express or implied right or authority to assume or create any obligations on
behalf of or in the name of any other party or to bind any other party to any
contract, agreement or undertaking with any third party.
9.4 NOTICES. All notices, requests and other communications to DURA,
DDSI, Spiros Corp. or Spiros Corp. II hereunder shall be in writing (including
telecopy or similar electronic transmissions), shall refer specifically to this
Agreement and shall be personally delivered or sent by telecopy or other
electronic facsimile transmission or by registered mail or certified mail,
return receipt requested and postage prepaid, or
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by reliable overnight courier service, in each case to the respective address
specified below (or to such address as may be specified in writing to the
other party hereto):
If to DURA, addressed to:
Dura Pharmaceuticals, Inc.
7475 Lusk Boulevard
San Diego, CA 92121
Attention: President
with a copy to the attention of General Counsel
If to DDSI, addressed to:
Dura Delivery Systems, Inc.
7475 Lusk Boulevard
San Diego, CA 92121
Attention: President
If to SPIROS, addressed to:
Spiros Development Corporation
7475 Lusk Boulevard
San Diego, CA 92121
Attention: President
If to Spiros Corp. II, addressed to:
Spiros Development Corporation II, Inc.
7475 Lusk Boulevard
San Diego, CA 92121
Attention: President
Each party shall provide each other party with copies of any notices sent
hereunder, with such copies sent at the same time as the original notice. Any
notice or communication given in conformity with this Section 9.4 shall be
deemed to be effective when received by the addressee, if delivered by hand,
telecopy or electronic transmission, three (3) days after mailing, if mailed,
and one (1) business day after delivery to a reliable overnight courier service.
9.5 FURTHER ASSURANCES. Each of DURA, DDSI, Spiros Corp. and Spiros Corp.
II hereby agrees to duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and do and cause to be done such further
acts and things, including, without limitation, the filing of such additional
assignments, agreements, documents and instruments, that may be necessary or as
the other party hereto may at any time and from time to time reasonably request
in connection with this Agreement or to carry out more effectively the
provisions and purposes of, or to better assure and confirm unto such other
party its rights and remedies under, this Agreement.
9.6 SUCCESSORS AND ASSIGNS. The terms and provisions of
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this Agreement shall inure to the benefit of, and be binding upon, DURA,
DDSI, Spiros Corp., Spiros Corp. II and their respective successors and
assigns; PROVIDED, HOWEVER, that DURA, DDSI, Spiros Corp. and Spiros Corp. II
may not assign or otherwise transfer any of their respective rights and
interests, nor delegate any of their respective obligations, hereunder,
including, without limitation, pursuant to a merger or consolidation, without
the prior written consent of the other party hereto; PROVIDED FURTHER,
HOWEVER, that DURA, DDSI or Spiros Corp. may fully assign their respective
rights and interests, and delegate their respective obligations, hereunder,
effective upon written notice thereof (a) to an Affiliate if such Affiliate
assumes all of the obligations of DURA, DDSI or Spiros Corp., as the case may
be, hereunder and this Agreement remains binding upon Dura, DDSI or Spiros
Corp., as the case may be; or (b) to any Person that acquires all or
substantially all of the assets of Dura, DDSI or Spiros Corp. as the case may
be, or which is the surviving Person in a merger or consolidation with Dura,
DDSI or Spiros Corp. if such Person assumes all the obligations of DURA, DDSI
or Spiros Corp., as the case may be, hereunder. Notwithstanding the
foregoing, Spiros Corp. II shall have the right to assign its rights and
delegate its obligations hereunder following expiration or termination (other
than by exercise) of the Purchase Option. Any attempt to assign or delegate
any portion of this Agreement in violation of this Section 9.6 shall be null
and void. Subject to the foregoing any reference to DURA, DDSI, Spiros Corp.
or Spiros Corp. II hereunder shall be deemed to include the successors
thereto and assigns thereof.
9.7 AMENDMENTS. No amendment, modification, waiver, termination or
discharge of any provision of this Agreement, nor consent by DURA, DDSI, Spiros
Corp. or Spiros Corp. II to any departure therefrom, shall in any event be
effective unless the same shall be in writing specifically identifying this
Agreement and the provision intended to be amended, modified, waived, terminated
or discharged and signed by DURA, DDSI, Spiros Corp. and Spiros Corp. II, and
each amendment, modification, waiver, termination or discharge shall be
effective only in the specific instance and for the specific purpose for which
given. No provision of this Agreement shall be varied, contradicted or
explained by any other agreement, course of dealing or performance or any other
matter not set forth in an agreement in writing and signed by DURA, DDSI, Spiros
Corp. and Spiros Corp. II.
9.8 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, as applied to contracts
made and performed entirely within the State of California. Except as otherwise
provided herein, any claim or controversy arising out of or related to this
contract or any breach hereof shall be submitted to a court of competent
jurisdiction in the State of California, and the parties hereby consent to the
jurisdiction and venue of such court.
9.9 SEVERABILITY. If any provision hereof should be held
- 20 -
invalid, illegal or unenforceable in any respect in any jurisdiction, then,
to the fullest extent permitted by law, (a) all other provisions hereof shall
remain in full force and effect in such jurisdiction and shall be liberally
construed in order to carry out the intentions of the parties hereto as
nearly as may be possible and (b) such invalidity, illegality or
unenforceability shall not affect the validity, legality or enforceability of
such provision in any other jurisdiction. To the extent permitted by
applicable law, DURA, DDSI, Spiros Corp. and Spiros Corp. II hereby waive any
provision of law that would render any provision hereof prohibited or
unenforceable in any respect.
9.10 HEADINGS. Headings used herein are for convenience only and shall not
in any way affect the construction of, or be taken into consideration in
interpreting, this Agreement.
9.11 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
9.12 ENTIRE AGREEMENT. This Agreement, together with any agreements
referenced herein, constitute, on and as of the date hereof, the entire
agreement of DURA, DDSI, Spiros Corp. and Spiros Corp. II with respect to the
subject matter hereof, and all prior or contemporaneous understandings or
agreements, whether written or oral, between DURA, DDSI, Spiros Corp. and Spiros
Corp. II with respect to such subject matter are hereby superseded in their
entirety.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF the parties have executed this Agreement as of the date
first above written.
SPIROS DEVELOPMENT CORPORATION II, INC.
By: /s/ David S. Kabakoff
-------------------------------------------
David S. Kabakoff
President and Chief Executive Officer
DURA PHARMACEUTICALS, INC.
By: /s/ Cam L. Garner
-------------------------------------------
Cam L. Garner
President and Chief Executive Officer
DURA DELIVERY SYSTEMS, INC.
By: /s/ Mitchell R. Woodbury
-------------------------------------------
Mitchell R. Woodbury
Secretary
SPIROS DEVELOPMENT CORPORATION
By: /s/ Mitchell R. Woodbury
-------------------------------------------
Mitchell R. Woodbury
Secretary
[SIGNATURE PAGE TO TECHNOLOGY LICENSE AGREEMENT]
SCHEDULE 1.1
GLOSSARY
SCHEDULE 1.1
SCHEDULE 1.1
GLOSSARY
"AFFILIATE" of a person shall mean a Person that directly, or indirectly
through one or more intermediaries, controls, is controlled by or is under
common control with such Person. "Control" (and, with correlative meanings, the
terms "controlled by" and "under common control with") shall mean the possession
of the power to direct or cause the direction of the management and policies of
such Person, whether through the ownership of voting stock, by contract or
otherwise. In the case of a corporations, "control" shall mean, among other
things, the direct or indirect ownership of more than fifty percent (50%) of its
outstanding voting stock.
"AGREEMENTS" shall mean the Manufacturing and Marketing Agreement, the
Technology Agreement and the Development Agreement.
"ALBUTEROL OPTION" shall have the meaning assigned to it in Section 1.1 of
the Albuterol and Product Option Agreement.
"ALBUTEROL AND PRODUCT OPTION AGREEMENT" shall mean the Albuterol and
Product Option Agreement dated as of December 22, 1997, between DURA and Spiros
Corp. II, as amended, modified or supplemented from time to time.
"ALBUTEROL OPTION CLOSING DATE" shall have the meaning assigned to it in
Section 1.5 of the Albuterol and Product Option Agreement.
"ALBUTEROL PROGRAM ASSETS" shall have the meaning assigned to it in Section
1.1 of the Albuterol and Product Option Agreement.
"ALBUTEROL PRODUCT" shall have the meaning assigned to it in Section 1.1 of
the Albuterol and Product Option Agreement.
"AVAILABLE FUNDS" shall mean the sum of (a) the net proceeds to Spiros
Corp. II from the sale of the Units in the Offering and the Contribution, (b)
all royalties remitted to Spiros Corp. II by DURA (or its Affiliates) from the
Sale of Spiros Products pursuant to the Agreements, (c) the Option Proceeds, if
any, (d) any other amounts provided by DURA to Spiros Corp. II, if any and (e)
interest or other income earned through temporary investment of the amounts
described in clauses (a), (b), (c) or (d).
"BANKRUPTCY CODE" shall mean the United States Bankruptcy Code, as amended
from time to time.
"CLAIM" shall mean any and all liabilities, damages, losses, settlements,
claims, actions, suits, penalties, fines, costs or expenses (including, without
limitation, reasonable attorneys' fees).
SCHEDULE 1.1
"CONFIDENTIAL INFORMATION" shall mean all Program Technology disclosed by
DURA (and its Affiliates) to Spiros Corp. II or by Spiros Corp. II to DURA
pursuant to the Agreements or the Services Agreement.
"CONTRIBUTION" shall have the meaning assigned in Section 5.2 of the
Development Agreement.
"CORE TECHNOLOGY" shall mean the DURA Core Technology, the DDSI Core
Technology and the Spiros Core Technology.
"DDSI CORE TECHNOLOGY" shall mean (a) Technology owned or controlled by
DDSI as of the date of the closing of the Offering necessary or useful to the
development of the Spiros Products, and (b) the DDSI Patent Rights; PROVIDED,
HOWEVER, that DDSI Core Technology shall also include Technology acquired by
DDSI from a third party after the date of the closing of the Offering necessary
or useful to the development of the Spiros Products, except to the extent that
there are any limitations or restrictions on DDSI's ability to license or
sublicense such Technology. "Owned or controlled" shall include Technology that
DDSI owns, or under which DDSI is licensed and has the right to grant
sublicenses and/or grant immunity from suit.
"DDSI INDEMNITEE" shall mean DDSI, its successors and assigns, and the
directors, officers, employees, agents and counsel thereof.
"DDSI PATENT RIGHTS" shall mean those certain inventions described in
claims of (a) the patent applications pending, filed by DDSI (or the rights to
which have been assigned to DDSI) as of the date of the Technology Agreement
relating to dry powder inhalers, powder storage systems and/or formulation
methods for dry powder inhalation, (b) any patent application constituting an
equivalent, counterpart, reissue, extension or continuation (including, without
limitation, a continuation in part or a subdivision) of any of the foregoing
patent applications and (c) any patent issued or issuing upon any of the
foregoing.
"DESIGNATED COMPOUND(S)" shall mean any compounds for delivery using the
System selected by Spiros Corp. II, and agreed to be developed by DURA.
"DEVELOPED TECHNOLOGY" shall mean any Technology including, without
limitation, any enhancements, substitutions or improvements to the Core
Technology that is (a) discovered, developed or otherwise acquired by DURA
pursuant to the terms of the Development Agreement or (b) otherwise acquired by
or on behalf of Spiros Corp. II during the term of the Development Agreement.
"DEVELOPMENT" shall mean the further development of the Program Technology
for the purpose of identifying, developing, manufacturing, marketing and
commercializing Spiros Products and
SCHEDULE 1.1
the making of the Other Expenditures.
"DEVELOPMENT AGREEMENT" shall mean the Development Agreement dated as of
December 22, 1997, between DURA and Spiros Corp., as amended, modified or
supplemented from time to time.
"DEVELOPMENT COSTS" shall mean the Direct Development Costs, the Indirect
Development Costs and the Other Expenditures.
"DEVELOPMENT TERM" shall mean the period commencing on the Closing Date and
ending on the earlier of (a) the Option Closing Date or (b) the date the Option
terminates or expires other than by exercise.
"DIRECT DEVELOPMENT COSTS" shall mean all costs incurred by DURA or its
Affiliates in respect of the Development, other than Indirect Development
Costs, determined in accordance with generally accepted accounting principles
consistent with DURA's internal accounting system, allocated on a reasonable
and consistent basis. Direct Development Costs shall consist primarily of
fully-burdened payroll costs (burdened to include benefits, payroll taxes and
an allocation of facilities and overhead costs) and any other such costs
generated internally by DURA in respect of the Development.
"DPI" shall mean the motor-driven dry powder inhaler (other than an inahler
designed to deliver a single dose of a drug) developed by DURA, DDSI and/or
Spiros Corp. and to be developed by DURA and/or Spiros Corp. II.
"DURA COMMON STOCK" shall mean the Common Stock of DURA, par value $.001
per share.
"DURA CORE TECHNOLOGY" shall mean (a) Technology owned or controlled by
DURA as of the date of the closing of the Offering necessary or useful to the
development of the Spiros Products, and (b) the DURA Patent Rights and DURA
Trademarks; PROVIDED, HOWEVER, that DURA Core Technology shall also include
Technology acquired by DURA from a third party after the date of the closing of
the Offering necessary or useful to the development of the Spiros Products,
except to the extent that there are any limitations or restrictions on DURA's
ability to license or sublicense such Technology. "Owned or controlled" shall
include Technology that DURA owns, or under which DURA is licensed and has the
right to grant sublicenses and/or grant immunity from suit.
"DURA INDEMNITEE" shall mean DURA, its successors and assigns, and the
directors, officers, employees, agents and counsel thereof.
"DURA PATENT RIGHTS" shall mean those certain inventions described in
claims of (a) the patent applications pending, filed by DURA (or the rights to
which have been assigned to DURA) as of the date of the Technology Agreement
relating to DPIs, PSSs and/or formulation methods for dry powder inhalation, (b)
any
SCHEDULE 1.1
patent application constituting an equivalent, counterpart, reissue,
extension or continuation (including, without limitation, a continuation in part
or a subdivision) of any of the foregoing patent applications and (c) any patent
issued or issuing upon any of the foregoing.
"DURA TRADEMARKS" shall mean Spiros-TM-.
"EVENT OF DEFAULT" shall mean any of the following events: (a) at any
time, if DURA or Spiros Corp. II fails to perform or observe or otherwise
breaches any of its Material Obligations, and such failure or breach continues
unremedied for a period of sixty (60) days after receipt by of written notice
thereof from the other party; (b) at any time, effective as set forth in a
written notice from the other party if DURA or Spiros Corp. II shall (i) seek
the liquidation, reorganization, dissolution or winding-up of itself or the
composition or readjustment of its debts (other than pursuant to a merger with
an Affiliate), (ii) apply for or consent to the appointment of, or the taking
possession by, a receiver, custodian, trustee or liquidator for itself or of all
or a substantial part of its assets, (iii) make a general assignment for the
benefit of its creditors, (iv) commence a voluntary case under the Bankruptcy
Code, (v) file a petition seeking to take advantage of any other law relating to
bankruptcy, insolvency, reorganization, winding-up or composition or
readjustment of debts (other than pursuant to a merger with an Affiliate) or
(vi) adopt any resolution of its Board of Directors or shareholders for the
purpose of effecting any of the foregoing (other than pursuant to a merger with
an Affiliate); or (c) at any time, effective as set forth in a written notice
from the other party, if a proceeding or case shall be commenced without the
application or consent of DURA or Spiros Corp. II as applicable, and such
proceeding or case shall continue undismissed, or an order, judgment or decrees
approving or ordering any of the following shall be entered and continued
unstayed and in effect, for a period of sixty (60) days from and after the date
service of process is effected, seeking (i) DURA's or Spiros Corp. II's, as
applicable, liquidation, reorganization, dissolution or winding-up, or the
composition or readjustment of its debts, (ii) the appointment of a trustee,
receiver, custodian, liquidator or the like of DURA or Spiros Corp. II or for
all or any substantial part of its assets or (iii) similar relief in respect of
DURA or Spiros Corp. II under any law relating to bankruptcy, insolvency,
reorganization, winding-up or the composition or readjustment of debts.
"FDA" shall mean the United States Food and Drug Administration or any
successor agency or authority, the approval of which is required to market
health care products in the United States.
"FDA APPROVAL" shall mean the final regulatory approval of the FDA required
to commence commercial marketing of a health product.
SCHEDULE 1.1
"FORCE MAJEURE" shall mean any act of God, any accident explosion, fire,
storm, earthquake, flood, drought, peril of the sea, riot, embargo, war or
foreign, federal, state or municipal order of general application, seizure,
requisition or allocation, any failure or delay of transportation, shortage of
or inability to obtain supplies, equipment, fuel or labor or any other
circumstance or event beyond the reasonable control of the party relying upon
such circumstance or event.
"INDIRECT DEVELOPMENT COSTS" shall mean all costs, fees and out-of-pocket
or other expenses, including the purchase of any capital equipment related to
the Development, incurred or paid by DURA to a third party, other than an
Affiliate of DURA, in respect of the Development, determined in accordance with
generally accepted accounting principles consistent with DURA's internal
accounting system, allocated on a reasonable and consistent basis.
"MANUFACTURING AND MARKETING AGREEMENT" shall mean the Manufacturing and
Marketing Agreement dated as of December 22, 1997 between DURA and Spiros
Corp. II, as amended, modified or supplemented from time to time.
"MANUFACTURE" shall mean the manufacture and assembly of the Spiros
Products.
"MATERIAL OBLIGATION" shall mean the material obligations of a party under
the Technology Agreement, the Development Agreement or the Manufacturing and
Marketing Agreement.
"NET SALES" shall mean the gross amount invoiced for sales of Spiros
Products by DURA or its sublicensees, if any, to third parties less (i)
discounts actually allowed, (ii) credits for claims, allowances, retroactive
price reductions or returned Spiros Products, (iii) prepaid freight charges
incurred in transporting Spiros Products to customers, (iv) sales taxes and
other governmental charges actually paid in connection with the sales (but
excluding what is commonly known as income taxes) and (v) any royalty
obligations under the 1993 Royalty Agreement. Net Sales shall not include sales
between or among DURA, its Affiliates and its sublicensees unless such sales are
for end use rather than for purposes of resale.
"OFFERING" shall mean the underwritten public offering of the Units
pursuant to the Registration Statement.
"OPTION PROCEEDS" shall have the meaning assigned to it in Section 3 of the
Albuterol and Product Option Agreement.
"OPTION PRODUCT" shall have the meaning assigned to it in Section 2.1 of
the Albuterol and Product Option Agreement.
"OTHER EXPENDITURES" shall mean funds spent by Spiros Corp. II to acquire
capital equipment, develop a next generation inhaler system or to enhance the
System.
SCHEDULE 1.1
"PATENT RIGHTS" shall mean any patents or patent applications within the
Spiros Corp. II Patent Rights, the DURA Patent Rights, the DDSI Patent Rights
and the Spiros Corp. Patent Rights.
"PERSON" shall mean any individual, partnership, corporation, firm,
association, unincorporated organization, joint venture, trust or other entity.
"PRODUCT OPTION" shall have the meaning assigned to it in Section 2.1 of
the Albuterol and Product Option Agreement.
"PRODUCT OPTION CLOSING DATE" shall have the meaning assigned to it in
Section 2.5 of the Albuterol and Product Option Agreement.
"PROGRAM TECHNOLOGY" shall mean the Core Technology and the Developed
Technology.
"PSS" shall mean the powder storage system developed and to be developed by
DURA for use with the DPI.
"PURCHASE AGREEMENT" shall mean the Purchase Agreement dated as of
December 16, 1997, among DURA, Spiros Corp. II, Merrill Lynch & Co., and
Donaldson, Lufkin & Jenrette.
"PURCHASE OPTION" shall mean the option granted to the holder of Spiros
Corp. II's Special Common Stock to purchase all of the Spiros Corp. II Common
Stock as set forth in Article V of the Spiros Corp. II Charter.
"PURCHASE OPTION CLOSING DATE" shall have the meaning assigned to it in
Article V of the Spiros Corp. II Charter.
"PURCHASE OPTION EXERCISE PRICE" shall have the meaning assigned to it in
Article V of the Spiros Corp. II Charter
"REGISTRATION STATEMENT" shall mean the Registration Statement on Form
S-1/S-3 filed by Spiros Corp. II and DURA dated October 10, 1997 (No.
333-37673/333-37673-01), including all exhibits and any amendments thereof
and supplements thereto.
"RESEARCH FUNDS" shall mean the Available Funds, less (i) all general and
administrative expenses including, without limitation, those paid or payable
pursuant to the Development Agreement or the Services Agreement, and the
reasonable out-of-pocket expenses of Spiros Corp. II directors and reasonable
compensation for Spiros Corp. II's independent directors, less (ii) any amounts
paid to DURA under the Development Agreement or the Services Agreement, less
(iii) any costs and expenses incurred in the defense or settlement of any action
or claim or in respect of a judgment thereon, and less (iv) One Million Dollars
($1,000,000) to be retained by Spiros Corp. II as working capital in the event
DURA does not exercise the Purchase Option.
SCHEDULE 1.1
"SALE(S)" or "SELL" shall mean the activity undertaken by a sales
representative during a sales call on physicians, physician assistants, nurses,
hospitals, clinics, health maintenance organizations, preferred provider
organizations and managed care companies (including all forms of communication
not involving face to face contact by such sales representatives), describing
the FDA-approved indicated uses, safety, effectiveness, contraindications, side
effects, warnings and other relevant characteristics of the Spiros Product, in a
fair and balanced manner consistent with the requirements of the Federal Food,
Drug, and Cosmetic Act, as amended (and the regulations thereunder).
"SPIROS CASSETTE SYSTEM" shall mean a DPI in which the PSS is in the form
of a cassette.
"SPIROS CORE TECHNOLOGY" shall mean (a) Technology owned or controlled by
Spiros Corp. as of the date of the closing of the Offering necessary or useful
to the development of the Spiros Products, and (b) the Spiros Corp. Patent
Rights; PROVIDED, HOWEVER, that Spiros Core Technology shall also include
Technology acquired by Spiros Corp. from a third party after the date of the
closing of the Offering necessary or useful to the development of the Spiros
Products, except to the extent that there are any limitations or restrictions on
Spiros Corp.'s ability to license or sublicense such Technology. "Owned or
controlled" shall include Technology that Spiros Corp. owns, or under which
Spiros Corp. is licensed and has the right to grant sublicenses and/or grant
immunity from suit.
"SPIROS CORP. INDEMNITEE" shall mean Spiros Corp., its successors and
assigns, and the directors, officers, employees, agents and counsel thereof.
"SPIROS CORP. PATENT RIGHTS" shall mean those certain inventions described
in claims of (a) the patent applications pending, filed by Spiros Corp. (or the
rights to which have been assigned to Spiros Corp.) as of the date of the
Technology Agreement relating to dry powder inhalers, powder storage systems
and/or formulation methods for dry powder inhalation, (b) any patent application
constituting an equivalent, counterpart, reissue, extension or continuation
(including, without limitation, a continuation in part or a subdivision) of any
of the foregoing patent applications and (c) any patent issued or issuing upon
any of the foregoing.
"SPIROS CORP. II CHARTER" shall mean Amended and Restated Certificate of
Spiros Development Corporation II, Inc. in effect as of the closing of the
Offering, as amended from time to time.
"SPIROS CORP. II COMMON STOCK" shall mean the Callable Common Stock of
Spiros Corp. II, $.001 par value.
"SPIROS CORP. II INDEMNITEE" shall mean Spiros Corp. II, its
SCHEDULE 1.1
successors and assigns, and the directors, officers, employees, agents and
counsel thereof.
"SPIROS CORP. II PATENT RIGHTS" shall mean those certain inventions
described in claims of (a) any patent application having one or more claims
covering Developed Technology, (b) any patent application constituting an
equivalent, counterpart, reissue, extension or continuation (including, without
limitation, a continuation in part or a subdivision) of any of the foregoing
applications or (c) any patent issued or issuing upon any of the foregoing
applications.
"SPIROS PRODUCT(S)" shall mean (a) any System used with a formulation of
albuterol, beclomethasone, ipratropium, an albuterol-ipratropium combination,
budesonide or a Designated Compound developed, produced, manufactured or
marketed by DURA on behalf of Spiros Corp. II using the Program Technology.
"SPIROS PRODUCT PROGRAM ASSETS" shall have the meaning assigned to it in
Section 2.1 of the Albuterol and Product Option Agreement.
"SYSTEM" shall mean the DPI and the PSS when used together.
"TECHNOLOGY" shall mean, solely with respect to motor-driven dry powder
inhalers and powder storage systems for drugs for delivery through such
inhalers, the manufacture thereof, and formulations of drugs to be delivered
through such inhalers, public and nonpublic technical or other information,
trade secrets, know-how, processes, formulations, concepts, ideas, preclinical,
clinical, pharmacological or other data and testing results, experimental
methods, or results, assays, descriptions, business or scientific plans,
depictions, customer lists and any other written, printed or electronically
stored materials, pharmaceutical compounds or any other natural or man-made
pharmaceutical materials and any and all other intellectual property, including
patents and patent applications, of any nature whatsoever. The term
"Technology" shall include, without limitation, any of the foregoing as it
relates to enhancements of, substitutions for or improvements to the Core
Technology.
"TECHNOLOGY AGREEMENT" shall mean the Technology License Agreement dated
as of December 22, 1997, among DURA, DDSI, Spiros Corp. and Spiros Corp. II,
as amended, modified or supplemented from time to time.
"TERRITORY" shall mean the entire world.
"UNDERWRITERS" shall have the meaning assigned to it in the Registration
Statement.
"UNITS" shall mean units, each consisting of one share of Spiros Corp. II
Common Stock and one warrant to purchase one-fourth of one share of DURA Common
Stock, all as described in the Registration Statement.
SCHEDULE 1.1
"1993 ROYALTY AGREEMENT" shall have the meaning assigned to it in the
Registration Statement.
SCHEDULE 1.1