[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
DEVELOPMENT AND LICENSE
AGREEMENT
This Agreement
is made this 2nd day of June, 1998 (“the Effective
Date”) by and between
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ARADIGM
CORPORATION
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26219 Eden
Landing Road
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Hayward,
California 94545
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(hereinafter
referred to as ARADIGM)
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NOVO NORDISK
A/S
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Novo
Alle
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DK-2880
Bagsvaerd
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Denmark
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(hereinafter
referred to as NOVO NORDISK)
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ARADIGM is the
owner of, and is beneficially entitled to, a number of patents and
patent applications and Know-How related to the production and
delivery of drugs, including proteins/peptides, via the pulmonary
route using a breath controlled delivery device;
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NOVO NORDISK is
the owner of, and is beneficially entitled to, a number of patents
and patent applications and Know-How relating to the development
and production of recombinant human insulin, as well as insulin
analogues and other compounds useful in the control of blood
glucose levels in humans;
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NOVO NORDISK
and ARADIGM wish to enter into a Development and License Agreement
to develop a system for pulmonary delivery of insulin (and
potentially other compounds) and ARADIGM is willing to use its
Patent Rights and Know-How in such a development
programme;
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NOVO NORDISK
and ARADIGM, in addition to the above mentioned development work,
wish to enter into a licensing arrangement under which ARADIGM will
grant to NOVO NORDISK an exclusive, world-wide license under
ARADIGM’s Patent Rights and ARADIGM’s Know-How, to use,
market, distribute, sell and sublicense products resulting from
such development programme in the Field;
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NOW, THEREFORE,
it is hereby agreed as follows:
In the present
Agreement the following definitions shall prevail:
1.1
“Affiliates” of a party hereto shall mean an entity
which controls, is controlled by or is under common control with
such party (by majority ownership or otherwise). For the purposes
hereof “control” shall mean the power to direct or
cause the direction of the management and the policies of an
entity, whether through the ownership of a majority of the
outstanding voting securities or by contract or
otherwise.
1.2
“ARADIGM” shall mean ARADIGM CORPORATION of 26219 Eden
Landing Road, Hayward, California 94545, and any of its
Affiliates.
1.3 “ARADIGM
Know-How” shall mean all knowledge, information and expertise
possessed by ARADIGM prior to or at any time during the term of
this Agreement related to the development and production of the
Device, Packaged Products, Formulated Compounds and Programme
Compounds, whether or not covered by ARADIGM Patent Rights or any
other industrial or intellectual property right of ARADIGM,
including but not limited to technical data, experimental results,
specifications, techniques, methods, processes and written
materials.
1.4 “ARADIGM
Patent Rights” shall mean any and all of ARADIGM’s
patents and patent applications related to the Device, Packaged
Products, Formulated Compounds and Programme Compounds, including
those that relate to the development, production and use of same,
possessed by ARADIGM at any time during the term of this Agreement.
A current and complete list of such rights, entitled “ARADIGM
Patents” and certified by an officer of ARADIGM, has been
delivered to NOVO NORDISK. ARADIGM Patent Rights shall also include
all continuations, continuations-in-part, divisionals or re-issues
of such patents and patent applications and any patents issuing
thereon or extensions thereof or any foreign counterparts thereof.
Extensions of patents shall include: a) extensions under the U.S.
Patent Term Restoration Act, b) extensions of patents under the
Japanese Patent Law, c) Supplementary Protection Certificates for
members of the European Patent Convention and other countries in
the European Economic Area and d) similar extensions under any
applicable law in the Territory.
1.5
“Development Costs” shall mean the fully burdened costs
of conducting development activities (including the supply by
ARADIGM of clinical trial quantities of Devices and Packaged
Products) pursuant to the Development Programme, including the
costs of labor (including all allocable benefits), materials,
outside consultants and research and development and corporate and
overhead amounts reasonably allocable to such development
activities [ * ].
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[ *
]
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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1.6
“Development Programme” shall mean the pharmaceutical
development of the Packaged Products (including Formulated
Compounds and the disposable unit dose packaging) and the Device,
including the pre-clinical and clinical development programmes
required for registration and approval of the Device and the
Packaged Products in the Territory as provided for in this
Agreement. The Development Programme shall initially consist of a
development plan addressing the development of the Device and a
Packaged Product containing the Initial Compound, but may be
enlarged to include the development of Packaged Products containing
one or more Other Compounds in accordance with
Article 2.1.
1.7
“Device” shall mean any pulmonary delivery device,
together with any accessories, used to administer any Formulated
Compounds contained in a disposable unit dose package, developed in
the course of the Development Programme based on the device
technology described in the ARADIGM Patent Rights or utilizing
ARADIGM Know-How.
1.8
“Diligent Efforts” shall mean no less than the efforts
that the applicable party applies to development, manufacture or
commercialization of its own compounds or products with similar
regulatory requirements and market potential.
1.9
“Field” shall mean pulmonary administration of insulin,
insulin analogs and any other compounds whose principal therapeutic
effect is to control blood glucose levels in humans, including but
not limited to glucagon-like peptide (“GLP”), GLP-1 and
analogs of GLP.
1.10 “First
Marketing” shall mean making available for sale the Device
and a Packaged Product in commercial quantities in any country in
the Territory.
1.11
“Formulated Compound” shall mean any formulation of any
Programme Compound developed in the course of the Development
Programme for use in a Packaged Product.
1.12 “Fully
Burdened Costs” shall mean the cost of raw materials
(excluding unless otherwise stated the Programme Compound),
components, labour (production), quality control (labour, material
and external analysis), third party royalties, freight, import
duties, taxes and reasonably allocated facilities, depreciation of
equipment and manufacturing overheads relating to the production of
the specified item.
1.13 “Gross
Profit” shall mean NOVO NORDISK’s Net Sales of Packaged
Products and Devices in the Territory minus the Fully Burdened
Costs of all Packaged Products and Devices (including finished
goods, components and raw materials such as Initial Compound that
become obsolete or outdated, whether due to inaccurate forecasting
or any other reason) supplied to NOVO NORDISK or produced by NOVO
NORDISK as contemplated by Article 4.7 [ * ] and
Article 4.9(a) (secondary packaging), including for this
purpose the Fully Burdened Costs of the applicable Programme
Compound, other than product that is so produced or provided as
samples (Article 4.9(f)).
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[ *
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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1.14
“Initial Compound” shall mean recombinant human
insulin.
1.15
“Minimum Product Profile” shall mean any and all of the
essential minimum product specifications and other criteria for the
Device and the Packaged Products, set forth in a separate document
entitled “Minimum Product Profile” signed by the
parties, which the parties have agreed must be met in the course of
the Development Programme to provide justification for commercial
launch and which may provide the basis for termination of this
Agreement as set forth in Article 9.2.
1.16 “Net
Sales” shall mean the invoiced gross revenue from sales of
product made by NOVO NORDISK and/or its sublicensees when invoiced
to any third party in an arm’s length transaction less: a)
Trade, cash and/or quantity discounts or rebates, if any; b)
Credits or allowances given for rejection or return of such
products previously sold; c) Any tax or governmental charge other
than income tax levied on the sale thereof or customs duties
associated therewith; d) Freight, insurance and other similar
expenses billed separately to the customer. Upon a request by NOVO
NORDISK supported by suitable documentation reflecting actual
operating experience, the parties will agree on a fixed percentage
of Net Sales to represent item (d).
1.17 “NOVO
NORDISK Know-How” shall mean knowledge, information and
expertise possessed by NOVO NORDISK prior to or at any time during
the term of this Agreement that relates to any Programme Compound
or any Formulated Compound or that NOVO NORDISK otherwise
contributes to the Development Programme, whether or not covered by
NOVO NORDISK Patent Rights or other industrial or intellectual
property right of NOVO NORDISK, including but not limited to
technical data, experimental results, specifications, techniques,
methods, processes and written materials.
1.18 “NOVO
NORDISK” shall mean NOVO NORDISK A/S, Novo Allé, DK-2880
Bagsvaerd, Denmark, and any of its Affiliates.
1.19 “NOVO
NORDISK Patent Rights” shall mean any and all of NOVO
NORDISK’s patents and patent applications related to any
Programme Compound or any Formulated Compound, including those that
relate to the production, development and use of same, possessed by
NOVO NORDISK at any time during the term of this Agreement. NOVO
NORDISK Patent Rights shall also include all continuations,
continuations-in-part, divisionals or re-issues of such patents and
patent applications and any patents issuing thereon or extensions
thereof or any foreign counterparts thereof. Extensions of patents
shall include: a) extensions under the U.S. Patent Term Restoration
Act, b) extensions under the Japanese Patent Law, c) Supplementary
Protection Certificates for members of the European Patent
Convention and other countries in the European Economic Area and d)
similar extensions under any applicable law in the
Territory.
1.20 “Other
Compounds” shall mean compounds in the Field other than the
Initial Compound.
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[ *
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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1.21
“Packaged Products” shall mean the disposable unit dose
packages developed in the course of the Development Programme
containing Formulated Compounds, packaged for use with the Device
for pulmonary delivery of such Formulated Compounds.
1.22
“Programme Compounds” shall mean the Initial Compound
and any Other Compounds that are added to the Development Programme
in accordance with Article 2.1.
1.23
“Regulatory Approval” shall mean the granting of a
commercial marketing authorization for the Packaged Product for
delivery of a Formulated Compound using the Device and for the
Device.
1.24
“Regulatory Submission” shall mean the filing of an
application for a commercial marketing authorization for a Packaged
Product for delivery of a Formulated Compound using the Device and
for the Device.
1.25
“Territory” shall include any and all countries of the
world.
ARTICLE
2 - DEVELOPMENT
ACTIVITIES AND RESPONSIBILITIES
2.1 NOVO NORDISK
and ARADIGM shall jointly conduct the Development Programme, which
shall initially consist of Diligent Efforts by the parties to carry
out a development plan addressing development of the Device and a
Packaged Product containing the Initial Compound for administration
using the Device. The preliminary details of such development plan
have been agreed upon by the parties and are set forth in a
separate document entitled “Milestone Plan.” The
details of this development plan shall be discussed and agreed on
in good faith between the parties and embodied in a document signed
by both parties, which shall thereafter be subject to further
modification from time to time as approved by the Steering
Committee. The product description for the Packaged Product and the
Device, including the Minimum Product Profile as well as desired
target profiles, shall be agreed by NOVO NORDISK and ARADIGM and
shall be included in the document defining the Development
Programme. It is understood between the parties that the
specifications for the Packaged Product and the Device may require
some changes during the course of the programme and that such
changes will be made when and as approved by the Steering
Committee. NOVO NORDISK shall specify within [ * ] after the
initiation of a Phase III trial of the initial Packaged Product one
or more Other Compounds for study by the Steering Committee as
candidates for the second Packaged Product to be added to the
Development Programme and may from time to time thereafter propose
additional Other Compounds for the Development Programme. Upon
agreement by the parties on a development plan to incorporate the
preliminary details for the development of such Other Compounds and
determination by the Steering Committee that such development is
feasible and should be undertaken, such Other Compounds will be
added to the Development Programme. Each time an Other Compound is
added to the Development Programme in this manner, the parties will
agree in good faith on the financial terms not otherwise specified
herein for such development and commercialization, which will
provide for a reasonable sharing of the
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[ *
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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potential value
of the Packaged Product containing such compound, as well as on
such other modifications of the other terms hereof as may be
reasonable under the circumstances.
2.2 A Steering
Committee will be established, consisting of an equal number of
people (at least three) from each party, whose responsibility will
be to ensure the Development Programme is carried out to the
satisfaction of both parties. The Steering Committee, [ * ] shall
have responsibility for approval of and release of funds, approving
budgets, approving any changes to the Development Programme, for
approving reimbursement of costs for pharmaceutical development as
described in Article 2.5, as well as plans for production
capacity and budgets for capital expenditures associated therewith,
and for the review and approval of product specifications as
contemplated by Article 4.9(d). The Steering Committee will
meet each quarter, during the first year of this Agreement, and
then as mutually agreed between the parties. In the event the
Steering Committee is unable to resolve any matter to the
satisfaction of the Steering Committee, the matter will be referred
to the senior managements of the two parties for resolution. While
in general the parties intend to act by mutual agreement, with
respect to issues concerning the design and implementation of
clinical trials and approval of specifications as provided in
Article 4.9(d), the senior management of NOVO NORDISK shall
have the right to make the final decision.
2.3 ARADIGM agrees
that it will use Diligent Efforts to develop, manufacture and
supply, to the deadlines included in the Development Programme
agreed between the parties, the Packaged Product and the Device
consistent with Good Manufacturing Practice and any other relevant
practices as required to obtain Regulatory Approval for the Device
and the Packaged Product in all major markets in the Territory.
ARADIGM shall use Diligent Efforts to obtain all the required
Regulatory Approvals in the Territory required for NOVO NORDISK
commercialization of the Device with the Packaged Products.
However, in such cases where the Device Regulatory Submission is an
integrated part of the Regulatory Submission, then ARADIGM shall
only timely submit to NOVO NORDISK all the sections of the
Regulatory Submission which are required for obtaining Regulatory
Approval of the Device with the Packaged Products. For countries
other than the United States, NOVO NORDISK shall provide reasonable
non-monetary assistance in structuring such Device Regulatory
Submission, provided NOVO NORDISK has the necessary experience to
provide such assistance. The personnel of NOVO NORDISK having
relevant expertise in technical areas affecting ARADIGM’s
activities directed to product development, production process
development and manufacturing scale-up and cost reduction,
including those pertaining to the Device as well as the Packaged
Product, shall participate or advise in the Development Programme
in such manner as is approved by the Steering Committee.
2.4 The
Development Costs necessary for activities after the Effective Date
required to develop the Packaged Product and the Device as
specified in the Development Programme referred to in
Article 2.1 shall be allocated and paid as described
below:
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[ *
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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Pre-clinical,
clinical and regulatory Development
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[ *
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Programme
Compound and Formulated Compound
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[ *
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Packaged
Product development work specific to Development
Programme
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[ *
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Packaged
Product supply for clinical development
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[ *
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Device
development and Device regulatory work specific to Development
Programme
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[ *
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Device supply
for clinical development (subject to Article 4.6)
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[ *
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Production
validation and process qualification specific to Development
Programme
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[ *
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All other
production process development
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[ *
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All other
Device and Packaged Product Development
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[ *
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In addition to
the foregoing, and in consideration of ARADIGM’s past and
future development activities, NOVO NORDISK agrees to make the
following milestone payments to ARADIGM at first occurrence of each
of the following events:
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(a)
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Twenty (20) days after the
Effective Date: USD two million (USD 2,000,000).
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(b)
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Upon initiation of the Phase IIb
clinical study (first patient, first dose) (see development plan):
[ * ]
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(c)
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Upon initiation of the Phase III
clinical study (first patient, first dose) (see development plan):
[ * ]
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(d)
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At
NOVO NORDISK’s first Regulatory Submission in the United
States, the EEC or Japan: [ * ]
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(e)
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Upon first Regulatory Approval in
the United States: [ * ]
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(f)
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Upon first Regulatory Approval in
the EEC: [ * ]
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(g)
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Upon first Regulatory Approval in
Japan: [ * ]
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[ *
]
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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Notwithstanding
any other provision of this Agreement, and for the avoidance of
doubt, each of the amounts referred to in [ * ] shall be payable
only once with respect to the development of the initial Packaged
Product and shall be non-refundable. Consequently, maximum total
milestone payments to be paid by NOVO NORDISK to ARADIGM under this
Agreement in respect of such milestones shall amount to [ *
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(h)
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Upon initiation (first patient,
first dose) of a Phase IIb clinical trial of a Packaged Product
containing the second Programme Compound: [ * ]
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(i)
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Upon initiation (first patient,
first dose) of a pivotal Phase III clinical trial of such second
Packaged Product: [ * ]
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(j)
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When cumulative Net Sales of Devices
and Packaged Products reach [ * ]
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(k)
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When cumulative Net Sales of Devices
and Packaged Products reach [ * ]
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(l)
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When cumulative Net Sales of Devices
and Packaged Products reach [ * ]
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For the
avoidance of doubt, each of the amounts referred to in [(h)-(l) of
this Article 2.4] shall be payable only once. Moreover, no
further payments in respect of such milestones will become due once
NOVO NORDISK has paid ARADIGM a total of [ * ]. Consequently,
maximum total milestone payments to be paid by NOVO NORDISK to
ARADIGM under this Agreement in respect of such milestones shall
amount to [ * ].
Thus, the total
milestone payments in respect of the Packaged Product containing
the second Programme Compound will be [ * ], plus milestone amounts
in respect of regulatory submission and approvals thereof to be
agreed upon at the time it is added to the Development Programme.
Upon request by NOVO NORDISK to develop a third Programme Compound
in the Development Programme pursuant to Article 2.1, the
parties will agree in good faith on the milestone payments to apply
to the clinical development of Packaged Products containing such
Other Compound.
Furthermore,
NOVO NORDISK shall invest up to a total of USD ten million (USD
10,000,000) equity in ARADIGM at times and under terms as specified
in a separate agreement between the parties.
2.5 Development
Costs of ARADIGM to be borne by NOVO NORDISK will be paid quarterly
[ * ] by NOVO NORDISK based on budgeted expenses approved by the
Steering Committee, subject to a reconciliation to actual costs
incurred at the end of each year (based on a presentation to the
Steering Committee no later than sixty (60) days after the end
of such year) approved by the Steering Committee (such approval not
to be unreasonably withheld or delayed) or more frequently if
requested by either party. NOVO NORDISK shall pay or ARADIGM shall
refund, as applicable, any difference between amounts advanced and
actual costs incurred within thirty (30) days after such
reconciliation is approved. Any anticipated material deviations
from established budgets will be reported as promptly as
practicable to the Steering Committee.
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[ *
]
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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2.6 NOVO NORDISK
and ARADIGM shall use their Diligent Efforts to obtain all
necessary regulatory approvals for pre-clinical and clinical
development work. All regulatory submissions required for clinical
development work in the USA to be filed initially by ARADIGM that
are needed by NOVO NORDISK to continue development will be
transferred to NOVO NORDISK as soon as practicable but in any event
prior to the commencement of Phase III trials, and NOVO NORDISK
will thereafter be the holder thereof and will have responsibility
for all further regulatory filings worldwide unless otherwise
approved by the Steering Committee.
2.7 NOVO NORDISK
agrees that it will use its Diligent Efforts to clinically develop
and register, to the deadlines included in the Development
Programme agreed between the Parties, and market the Packaged
Products for administration using the Device in the Territory. [ *
]
2.8 All supplies
of Programme Compounds (including certificates of analysis and
safety handling data) required for the Development Programme, shall
be supplied by NOVO NORDISK to ARADIGM, [ * ] and in a timely
manner, so as not to adversely affect the expected duration of the
Development Programme.
2.9 All supplies
of Packaged Product and the Device plus safety and handling
information and training required for the Development Programme,
shall be supplied by ARADIGM to NOVO NORDISK, [ * ] and in a timely
manner, so as not to adversely affect the expected duration of the
Development Programme.
2.10 NOVO NORDISK
shall furnish ARADIGM with such data and information as ARADIGM
shall reasonably require regarding each Programme Compound to
enable ARADIGM to carry out the work under the Development
Programme.
2.11 ARADIGM shall
furnish NOVO NORDISK with such data and information as NOVO NORDISK
shall reasonably require regarding the Packaged Products, the
Devices and components thereof, as well as the manufacturing
processes therefor, to enable NOVO NORDISK to carry out the work
under the Development Programme.
2.12 ARADIGM shall
only use Programme Compounds supplied by NOVO NORDISK and the NOVO
NORDISK Know-How as provided for in this Agreement. NOVO NORDISK
shall only use the ARADIGM Know-How as provided for in this
Agreement. Upon termination of this Agreement, ARADIGM undertakes
to return, upon NOVO NORDISK’s written request, all written
documentation embodying NOVO NORDISK Know-How and any and all
remaining Programme Compound to NOVO NORDISK, except and to the
extent retention thereof is reasonably necessary during any post
termination period in which NOVO NORDISK continues to supply
insulin to ARADIGM. Upon termination of this Agreement, NOVO
NORDISK undertakes to return, upon Aradigm’s written request,
all written documentation embodying ARADIGM Know-How to
ARADIGM.
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[ *
]
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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2.13 ARADIGM
hereby acknowledges that NOVO NORDISK may be simultaneously
conducting exploratory research and development on alternative
pulmonary delivery technologies that may be applicable in the Field
and that NOVO NORDISK is free to develop and commercialise such
technology outside the Field. NOVO NORDISK may also supply insulin
to third parties free of charge for use in such third party’s
clinical studies using such third party’s pulmonary delivery
technology in exchange for rights in such technology in the Field.
However, NOVO NORDISK [ * ] and [ * ] provided that NOVO NORDISK
has given written notice (the “Alternative Technology
Notice”) to ARADIGM of its intention to commence such
commercialization at least one year prior to such commencement.
Notwithstanding the foregoing, in the event NOVO NORDISK proposes
to add an Other Compound to the Development Programme pursuant to
Article 2.1, and ARADIGM is unwilling or unable to do so, NOVO
NORDISK may thereafter develop and commercialize such Other
Compound with an alternative pulmonary delivery technology without
being in breach of this Agreement and such Other Compound, together
with equivalent compounds, will thereafter be excluded from the
Field.
2.14 During the
term of this Agreement, in the event NOVO NORDISK becomes aware of
[ * ] it agrees subject to the rights and demands of the potential
licensor, to inform ARADIGM of such opportunity and, [ * ] then the
parties will jointly consider in good faith terms under which
ARADIGM would license such rights for application within pulmonary
delivery, further develop the applicable technology and make it
available to a collaboration between the two parties.
2.15 For so long
as the license to NOVO NORDISK under Article 3 is exclusive,
and subject to Article 2.13 above, ARADIGM shall not be
entitled to enter into any other agreement with any third party
within the Field, and shall not conduct any work programme with
Initial Compound or any Other Compound from any third party
supplier without the written consent of NOVO NORDISK.
2.16 NOVO NORDISK
agrees that, in the event it cannot produce sufficient quantities
of the Initial Compound to satisfy all customer demand on its
capacity, [ * ] form.
ARTICLE 3
– GRANT OF LICENSE; OPTION
3.1 ARADIGM hereby
grants NOVO NORDISK a world-wide sole and exclusive license under
the ARADIGM Patent Rights and ARADIGM Know-How a) to use, market,
distribute, sell, offer for sale, import and export the Packaged
Products and the Device in and from the Territory for use within
the Field, with the right to sublicense, and b) to otherwise
exercise and perform its rights and obligations under this
Agreement.
3.2 ARADIGM hereby
grants NOVO NORDISK the right to sublicense its customers to a) use
the Packaged Products and the Device, and b) sell, offer to sell,
import or export the Packaged Products and the Device, so long as
said items were bought from NOVO NORDISK.
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[ *
]
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= Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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11
3.3
Notwithstanding the foregoing and except as set forth herein,
effective one year after NOVO NORDISK gives ARADIGM the Alternative
Technology Notice pursuant to Article 2.13, the licences
granted to NOVO NORDISK under Article 3.1 and 3.2 will become
nonexclusive, and ARADIGM shall be entitled from and after receipt
of the Alternative Technology Notice to engage marketing partners
and other distributors and otherwise prepare itself to commence
commercial marketing of Devices and Packaged Products on the
effective date of such conversion. If at the time of delivery of
the Alternative Technology Notice, NOVO NORDISK is engaged in
clinical development of one or more Packaged Products containing
one or more Other Compounds, or intends to promptly commence
clinical development of one or more such Packaged Products, it may
at its option elect to [ * ] with respect to such Other Compounds
by specifying such Other Compounds in the Alternative Technology
Notice. In this case, (a) the parties will proceed promptly
under Article 2.1 to add any of such specified Other Compounds to
the Development Programme (if they are not already in development),
(b) the parties will thereafter meet their respective
obligations to diligently develop and commercialize such specified
Other Compounds and (c) the terms and conditions of this
Agreement, including but not limited to Articles 2.13 (with NOVO
NORDISK’s obligation not to conduct or fund clinical studies
to apply until the first Regulatory Approval of a specified Other
Compound), 2.15 and 3.1, shall remain in full force and effect but
only with respect to Packaged Products containing such specified
Other Compounds until NOVO NORDISK provides a supplemental
Alternative Technology Notice at least one year in advance of its
commencement of commercialization of any of such specified Other
Compounds using an [ * ], provided that such supplemental notice
may not be given prior to the end of the fifth year after First
Marketing of a Packaged Product containing a specified Other
Compound. ARADIGM shall be granted access to, and be given
sufficient rights under, relevant [ * ], NOVO NORDISK Patents and
NOVO NORDISK Know-How to the extent reasonably necessary to enable
it to commercialise Devices and Packaged Products directly or
through marketing partners. The foregoing notwithstanding, it is
expressly understood that neither ARADIGM nor any marketing partner
of ARADIGM shall be granted access to [ * ] Moreover, NOVO NORDISK
will continue to supply the Initial Compound in bulk to ARADIGM for
use in Packaged Products to be marketed by ARADIGM during the term
of this Agreement at the price specified in
Article 9.5.
3.4 In
consideration of NOVO NORDISK undertaking the development and
marketing activities hereunder, ARADIGM hereby grants to NOVO
NORDISK an exclusive option to enter into a development and license
agreement addressing the development of a product for
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