Exhibit 10.5
[ * ] = 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.
COLLABORATION AGREEMENT
This Collaboration
Agreement (the “ Agreement ”) is
entered into and made effective as of August 31, 2007 (the
“ Effective Date ”) by and between Aradigm Corporation , a
California corporation having its principal place of business at
3929 Point Eden Way, Hayward, CA 94545 (
“Aradigm” ), and CyDex, Inc. , a Delaware
corporation having its principal place of business at 10513 W. 84th
Terrace, Lenexa, KS 66214 ( “CyDex” ). Aradigm
and CyDex are sometimes referred to herein individually as a
“Party” and collectively as the
“Parties.”
Recitals
Whereas, Aradigm possesses
proprietary rights related to the pulmonary delivery technology
known as AERx ® technology,
as well as expertise and know-how relating to the use and
manufacture of such technology; and
Whereas, CyDex possesses
proprietary rights related to certain solubilization and
formulation enabling technology known as Captisol, as well as
expertise and know-how relating to the use of and manufacture with
such technology; and
Whereas, CyDex and Aradigm
desire to collaborate on the development and commercialization of
certain pharmaceutical preparations for pulmonary delivery and to
share in the revenue from sales, and from licensing of such
pharmaceutical preparations to a third party for further
development and commercialization.
Now, Therefore , the
Parties agree as follows:
1.
Definitions
The following terms shall have the
following meanings as used in this Agreement:
1.1 “AERx
Technology” means the AERx ® Pulmonary
Drug Delivery System for pulmonary delivery of therapeutic
compounds.
1.2 “Affiliate”
means, with respect to a particular Party, a person, corporation,
partnership, or other entity that controls, is controlled by or is
under common control with such Party. For the purposes of the
definition in this Section 1.2, the word “control”
(including, with correlative meaning, the terms “controlled
by” or “under the common control with”) means the
actual power, either directly or indirectly through one or more
intermediaries, to direct the management and policies of such
entity, whether by the ownership of at least fifty percent (50%) of
the voting stock of such entity, or by contract or otherwise.
1.3 “Allocation
Ratio” means the ratio at which Aradigm and CyDex will
share Research Costs, Partnering Costs, and Licensing Revenue (all
as defined below), together with
patent-related costs to the extent applicable pursuant to
Section 8.3(c), which ratio is agreed to be as set forth in
Section 1.3 on the attached Schedule of commercial
terms.
1.4 “Aqueous
Formulation” means a formulation containing Compounds in
a vehicle consisting of [*]. For clarity, “Aqueous
Formulations” do not include [*].
1.5 “Aradigm Core
IP” means any and all inventions, developments, results,
know-how and other Information (including physical, chemical or
biological materials), and all Patents relating thereto, made,
conceived or reduced to practice by a Party, both Parties jointly,
or the Third Party Partner in the performance of the Research
Program (as defined below) that represent improvements or
modifications to the Aradigm Technology (as defined below) existing
as of the Effective Date.
1.6 “Aradigm Generic Third
Party Agreement” means an agreement between Aradigm and a
Third Party that relates to a particular Collaboration Product and
to other products as well.
1.7 “Aradigm
Information” means all raw data produced solely by
Aradigm in the course of performing its obligations under the
Research Program.
1.8 “Aradigm Specific Third
Party Agreement” means an agreement between Aradigm and a
Third Party that relates solely to a particular Collaboration
Product.
1.9 “Aradigm
Technology” means all Information and Patents under
Aradigm Control (as defined below) as of the Effective Date or
during the Term that relate directly to or claim a Collaboration
Product, or the manufacture or use of a Collaboration Product,
including AERx Technology, but excluding Program IP.
1.10
“Collaboration” means all activities performed by
or on behalf of Aradigm or CyDex or the Third Party Partner in the
course of performing the activities described in, or fulfilling of
their obligations pursuant to, this Agreement or the Partnering
Agreement.
1.11 “Collaboration
Product” means a pharmaceutical preparation, excluding
agents whose principle therapeutic effect is to control blood
glucose levels in humans, delivered via a portable, hand held
device, comprising one or more compounds selected by the JSC (or
otherwise described in the then-current Research Plan) that has
been formulated for use in AERx Technology using, or otherwise
incorporates, Formulation Technology.
1.12 “Compound”
means a compound that has been selected by the JSC (or is otherwise
described in the then-current Research Plan) as a potential active
ingredient in a Collaboration Product. Compounds are expected to
include, without limitation, inhalation corticosteroids, beta
adrenergic agonists, and cholinergic antagonists.
1.13 “Confidential
Information” has the meaning assigned to it in
Section 9.1.
1.14 “Control”
means, with respect to an item of Information or an intellectual
property right, that a Party owns or has a license to such item or
right and has the ability to
[ * ]
= 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.
2
disclose
and grant a license or sublicense as provided for in this Agreement
under such item or right without violating the terms of any
agreement or other arrangement with any Third Party.
1.15 “CyDex Core
IP” means any and all inventions, developments, results,
know-how and other information (including physical, chemical or
biological materials), and all Patents relating thereto, made,
conceived or reduced to practice by a Party, both Parties jointly,
or the Third Party Partner in the performance of the Research
Program (as defined below) that represent improvements or
modifications to CyDex Technology (as defined below) existing as of
the Effective Date.
1.16 “CyDex Generic Third
Party Agreement” means an agreement between CyDex and a
Third Party that relates to a particular Collaboration Product and
to other products as well.
1.17 “CyDex
Information” means all raw data produced solely by CyDex
in the course of performing its obligations under the Research
Program.
1.18 “CyDex Specific Third
Party Agreement” means an agreement between CyDex and a
Third Party that relates solely to a particular Collaboration
Product.
1.19 “CyDex
Technology” means all Information and Patents under CyDex
Control as of the Effective Date or during the Term that relate
directly to or claim the Collaboration Product, or the manufacture
or use of the Collaboration Product, including Formulation
Technology, but excluding Program IP.
1.20 “Diligent
Efforts” means the carrying out of obligations or tasks
in a sustained manner consistent with the efforts a Party devotes
to a research project for a pharmaceutical product or products of
similar market potential, profit potential or strategic value
resulting from its own research efforts, based on conditions then
prevailing. Diligent Efforts requires that the Party:
(a) promptly assign responsibility for such obligations to
specific employee(s) who are held accountable for progress and
monitor such progress on an on-going basis, (b) set and
consistently seek to achieve specific and meaningful objectives for
carrying out such obligations, and (c) consistently make and
implement decisions and allocate resources designed to advance
progress with respect to such objectives.
1.21 “Directly Competitive
Product” means a pharmaceutical preparation that is not a
Collaboration Product but comprises as an active ingredient
(a) the same Compound as a Collaboration Product (in the case
of a Collaboration Product that contains a single Compound); or
(b) one or more of the same Compounds as in a Collaboration
Product (in the case of a Collaboration Product that contains
multiple Compounds).
1.22 “Field”
means pulmonary delivery via a portable, hand held device of
pharmaceutical agents, other than agents whose principle
therapeutic effect is to control blood glucose levels in humans,
using [*] delivery of liquid formulations containing Formulation
Technology whereby [*] delivery here means pulmonary delivery of
the medication in which a dose is administered in [*].
[ * ]
= 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.
3
1.23 “Formulation
Technology” means CyDex’s solubilization and
stabilization technology, including its Captisol ®
(sulfobutylether-7-beta-cyclodextrin) technology.
1.24
“Information” means information, results and data
of any type whatsoever, in any tangible or intangible form
whatsoever, including without limitation, databases, inventions,
practices, methods, techniques, specifications, formulations,
formulae, knowledge, know-how, skill, experience, test data
including pharmacological, biological, chemical, biochemical,
toxicological and clinical test data, analytical and quality
control data, stability data, studies and procedures, and patent
and other legal information or descriptions.
1.25 “JSC,” or
“Joint Steering Committee,” has the meaning set forth
in Section 2.1.
1.26 “Liaison
Party” means the Party identified by the JSC for
partnering purposes as provided for in Article 4.
1.27 “Licensing
Revenues” means any and all forms of consideration that
either Party receives from a Third Party Partner in connection with
a Partnering Agreement, which may include upfront license fees,
annual license or maintenance payments, milestone payments,
royalties, imputed income on interest-free loans received from such
Third Party and other similar payments. Subject to the provisions
of Section 4.3(b) Licensing Revenues do not include payments
made by any third party licensee to either Party for manufacture
and supply agreements for Aradigm Technology and/or Cydex
Technology, licenses for the right to manufacture Aradigm
Technology or CyDex Technology or costs associated with the
transfer of manufacturing technology.
1.28 “Partnering
Agreement” means an executed and in-force written
agreement between, on the one hand, one or both of the Parties,
and, on the other hand, a Third Party, wherein such Third Party
obtains a license granting a Third Party the right to develop
and/or commercialize a Collaboration Product for its own account or
in collaboration with one or both of the Parties.
1.29 “Partnering
Costs” means the out-of-pocket legal and consultant fees
and travel costs incurred by the Parties in connection with
identifying and negotiating with potential Third Party Partners and
preparing, negotiating, and executing a Partnering Agreement for a
Collaboration Product.
1.30 “Patent”
means (a) unexpired letters patent (including inventor’s
certificates) which have not been held invalid or unenforceable by
a court of competent jurisdiction from which no appeal can be taken
or has been taken within the required time period, including
without limitation any substitution, extension, registration,
confirmation, reissue, re- examination, renewal or any like filing
thereof and (b) pending applications for letters patent,
including without limitation any continuation, division or
continuation-in-part thereof and any provisional
applications.
1.31 “Program IP”
means any and all inventions, developments, results, know-how and
other Information (including physical, chemical or biological
materials), and all intellectual
[ * ]
= 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.
4
property
relating thereto, that is (a) made, conceived or reduced to
practice by employee(s) or agent(s) of one or both Parties in the
performance of the Research Program and that is (b) neither
(i) Aradigm Core IP nor (ii) CyDex Core IP.
1.32 “Program
Patents” has the meaning set forth in
Section 8.3(c).
1.33 “Research
Budget” has the meaning set forth in
Section 3.2.
1.34 “Research
Costs” means the unreimbursed expenses incurred by a
Party or for its account in connection with the Research Program
that are specified in the Research Plan and Research Budget.
Notwithstanding the foregoing, Research Costs shall exclude any
overhead expenses of a Party, except to the extent such overhead
expenses are included in the FTE rate set forth in
Section 3.2(a).
1.35 “Research
Plan” has the meaning set forth in
Section 3.2.
1.36 “Research
Program” has the meaning set forth in
Section 2.1.
1.37 “Term” has
the meaning assigned to it in Section 10.1.
1.38 “Territory”
means the world.
1.39 “Third Party
Partner” means a Third Party that has entered into a
Partnering Agreement.
1.40 “Third
Party” means any entity other than (i) Aradigm,
(ii) CyDex or (iii) an Affiliate of either of them.
2.
Management of the Collaboration
2.1 Overall Management
Structure . The overall management of the Collaboration shall
be vested in a Joint Steering Committee (the “ JSC
”), with responsibility, as further discussed in
Section 2.2, for establishing the strategic direction of the
Collaboration and for managing and directing the overall research
program to be jointly established by the Parties (the “
Research Program ”) and the Parties’ efforts to
commercialize and to out-license the technology developed
thereunder. The JSC may further establish one or more subcommittees
as it deems appropriate and delegate one or more of its
responsibilities to such subcommittee, provided that the
subcommittee’s actions will be subject to review and approval
by the JSC.
2.2 Joint Steering Committee
.
(a) Membership. The JSC shall be composed of two
(2) representatives from each Party. Promptly following the
Effective Date, the Parties shall appoint their initial
representatives to the JSC. Each Party may replace its JSC
representatives at any time upon written notice to the other Party.
Each Party will designate one of its representatives as a co-
chairperson of the JSC. The co-chairpersons shall be responsible
for scheduling meetings,
[ * ]
= 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.
5
preparing and circulating an agenda in advance of each meeting, and
preparing and issuing minutes of each meeting within thirty
(30) days thereafter.
(b) Responsibilities. During the term of this
Agreement, the JSC shall meet a minimum of four (4) times per
year at a location mutually agreeable to the Parties or by
telephonic or other electronic means. The JSC will make its
decisions by unanimous vote, with each Party’s
representatives collectively having one vote. The JSC shall
determine the overall strategy for the Collaboration, including the
Research Program. Without limiting the generality of the foregoing,
the JSC shall be responsible for (i) selecting the
Collaboration Products, (ii) creating the Research Plan and
Research Budget for each Collaboration Product,
(iii) evaluating the Parties’ performance under the
Research Plan, and (iv) upon completion of a Research Program
for a Collaboration Product, making a recommendation to the senior
management of each Party regarding the potential for further
development and commercialization of such Collaboration
Product.
2.3 Obligations of Parties.
Aradigm and CyDex shall provide the JSC and all subcommittees
thereof that are formed, and their authorized representatives, with
reasonable access during regular business hours to all records,
documents, and Information relating to the Research Program that
any such committee may reasonably require in order to perform its
obligations hereunder, provided that if such records, documents or
Information are under a bona fide obligation of confidentiality to
a Third Party, then Aradigm or CyDex, as the case may be, may
withhold access thereto to the extent necessary to satisfy such
obligation.
2.4 Collaboration
Guidelines.
(a) General. In all matters related to the
Collaboration, the Parties shall be guided by standards of
reasonableness in economic terms and fairness to each of the
Parties, striving to balance the legitimate interests and concerns
of the Parties, to further the Research Program, and to realize the
economic potential of the Collaboration Products.
(b) Independence. Subject to the terms of this
Agreement, the activities and resources of each Party shall be
managed by such Party, acting independently and in its individual
capacity. The relationship between Aradigm and CyDex is that of
independent contractors and neither Party shall have the power to
bind or obligate the other Party in any manner, other than as is
expressly set forth in this Agreement.
3.
Research Program
3.1 Scope. The goal of the
Research Program will be to identify and select, via the JSC,
potential Collaboration Products that are of interest to the
Parties and to obtain in vitro proof-of-concept data regarding such
Collaboration Products. It is anticipated that the Collaboration
Products will either comprise two or more off-patent compounds.
Notwithstanding the foregoing, the JSC may agree, on a case-by-case
basis, to include Collaboration Products that do not fall within
these categories. The JSC shall determine from time to time whether
clinical testing of Collaboration Products will be conducted under
this Agreement; provided, however, such clinical testing shall not
be conducted unless and until the
[ * ]
= 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.
6
Parties
have amended this Agreement to provide for the terms and conditions
relating to such clinical testing.
3.2 Selection of Compounds;
Research Plan.
(a) The work performed by the Parties under the Research
Program with respect to a particular Collaboration Product will be
governed by a written research plan (each, a “ Research
Plan” ). Each Research Plan shall specifically identify
the Collaboration Product (and the relevant Compounds) to which it
pertains and shall include a budget (each, a “ Research
Budget ”) describing each Party’s funding
obligations with respect to the work specified in the Research
Plan. Such funding obligations may consist of cash payments or
in-kind contributions of materials, equipment, or labor, and the
Research Budget shall indicate the dollar value associated with any
in-kind contributions. For the purpose of establishing a Research
Budget, the dollar value of any in-kind contribution of labor by
the employees of a Party shall be calculated on an average fully
burdened FTE basis that includes estimated overheads using a rate
of $[*]/hour per FTE. The JSC will review such reimbursement rate
on an annual basis and, if necessary, may elect to change such
reimbursement rate to reflect changes in costs. Each Research Plan
shall allocate between the Parties responsibility for each of the
Research Program activities described therein in a manner
consistent with this Agreement. In each Research Plan, it is
anticipated that Aradigm shall be primarily responsible for the
supply of the AERx Technology, optimizing the formulation for use
in the AERx Technology, including adjusting the [*] parameters, in
vitro and in vivo preclinical studies, and that CyDex shall be
primarily responsible for developing the formulations and
analytical methods, and for supplying Captisol or other substituted
cyclodextrins, for the bulk formulations.
(b) A specimen Research Plan (and Research Budget) covering
expected in vitro activities for the initial Collaboration Product
is attached to this Agreement and incorporated by this reference
and is intended to be used by the JSC in developing specific
Research Plans (and Research Budgets). The JSC shall be responsible
for drafting additional Research Plans for additional Collaboration
Products, as required. During the Research Term, the JSC shall
review each then-existing Research Plan at least semiannually and
may generate and approve revised versions of each Research Plan
(including revisions to the list of Collaboration Products, as
required) that are consistent with the terms of this Agreement and
the goals of the Research Program. Once approved by the JSC, such
revised Research Plan shall replace the prior Research Plan.
Significant changes in the scope or direction of the work and, any
increase or decrease in either Party’s funding requirements
in excess of fifteen percent (15%), or any changes to the funding
requirements that would cause the allocation of budgeted Research
Costs to deviate from the Allocation Ratio must be approved in
writing by a member of the senior management of each Party. In the
absence of approval of a Research Plan by the JSC or the senior
management of each Party (as the case may be), the most recently
approved Research Plan shall remain in effect.
(c) The Parties acknowledge that such Research Plan and
Research Budget allocate the budgeted Research Costs between the
Parties in accordance with the Allocation Ratio. For the avoidance
of doubt, it is the intent of the Parties (a) to ensure that
additional or revised Research Plans and/or Research Budgets also
allocate the budgeted Research Costs
[ * ]
= 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.
7
between
the Parties in accordance with the Allocation Ratio and (b) to
make adjustments over time as may be necessary and appropriate to
align actual Research Costs with budgeted Research Costs in
accordance with the Allocation Ratio. To the extent that the JSC
decides that it is not possible or in the best interests of the
Collaboration Product to allocate budgeted Research Costs between
the Parties according to the Allocation Ratio, then the Party
contributing less than its portion under the Allocation Ratio will
make cash payments on a quarterly basis to the party contributing
more than its portion under the Allocation Ration to bring the sum
contribution of resources plus cash in line with the Allocation
Ratio.
3.3 Research Term. The
Research Term shall commence on the Effective Date and shall
continue for a period of two (2) years unless both parties
agree in writing to extend the Research Term. Each Party’s
obligations under the Research Plan and each Party’s research
funding commitments set forth in Section 3.8 shall remain in
force during the Research Term and shall terminate at the end of
the Research Term.
3.4 Conduct of Research
Program. The Parties shall use Diligent Efforts to conduct
their respective tasks assigned pursuant to the Research Plan and
to attempt to achieve the objectives of the Research Program
efficiently and expeditiously. Each Party shall conduct its portion
of the Research Program in good scientific manner, and in
compliance in all material respects with the requirements of
applicable laws, rules and regulations and all applicable good
laboratory practices.
3.5 Reports to JSC. At each
meeting of the JSC during the Research Term and the six-month
period following the end of the Research Term, each Party shall
submit to the JSC a written progress report summarizing the work
performed under the Research Plan since the last meeting.
3.6 Use of Subcontractors.
Either Party may subcontract portions of the activities allocated
to it under the Research Plan to any of its Affiliates, or to a
Third Party, provided that such Third Party is approved by the JSC
prior to commencing any work. Notwithstanding the foregoing, the
JSC may expressly waive this requirement with respect to the
subcontracting of certain Research Program activities that the
Parties mutually agree should be within the sole discretion of a
Party.
3.7 Records . Each Party
shall maintain complete and accurate records of all work conducted
under the Research Program and all results, data and developments
made pursuant to its efforts under the Research Program. Such
records shall be complete and accurate and shall fully and properly
reflect all work done and results achieved in the performance of
the Research Program in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes. Each Party
shall have the right to review and copy such records of the other
Party at reasonable times to the extent necessary for such Party to
conduct its obligations under the Agreement.
3.8 Research Costs. Each
Party shall bear all costs and expenses incurred by such Party in
the course of performing Research Program activities. For clarity,
Partnering Costs, even if incurred during the Research Term, will
be shared in accordance with Section 4.3.
[ * ]
= 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.
8
3.9 Materials Transfer. In
order to facilitate the Research Program, either Party may provide
to the other Party, at no charge, certain biological materials,
chemical compounds, devices, equipment, or other research materials
owned or controlled by the supplying Party (collectively, the
“ Materials ”) for use by the other Party in
furtherance of the Research Program. Each Party shall use the other
Party’s Materials solely for the purposes of performing under
the Research Program and in compliance with all applicable legal
requirements. Neither Party shall use the other Party’s
Materials for any other purposes. Neither Party shall sell,
transfer, disclose or otherwise provide access to the other
Party’s Materials, without the prior express written consent
of the other Party. However, each Party may allow access, on a
need-to-know basis, to the other Party’s Materials to such
first Party’s employees and agents for purposes of
performance of the Research Program in accordance with the Research
Plan, provided that such employees and agents are made aware
of the restrictions on the use of such Materials that are set forth
in this Agreement. Upon expiration or early termination of the
Research Term, each Party will return any remaining quantities of
the other Party’s Materials to such other Party, or otherwise
dispose of such Materials as directed by such other Party. Each
Party acknowledges and agrees that the Materials of the other Party
may have biological and/or chemical properties that are
unpredictable and unknown as the time of transfer, that they are to
be used with caution and prudence, and that they are not to be used
for testing in or treatment of humans. Except as expressly set
forth herein, THE MATERIALS ARE PROVIDED “AS IS” AND
WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR EXCEPT
AS OTHERWISE PROVIDED IN THIS AGREEMENT ANY WARRANTY THAT THE USE
OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER
PROPRIETARY RIGHTS OF ANY THIRD PARTY.
4.
Partnering
4.1 General. The Parties
shall cooperate, via the JSC, to identify potential Third Party
Partners for further development and commercialization of
Collaboration Products in the Field in the Territory.
4.2 Partnering Agreement .
The Liaison Party shall have direct responsibility for identifying
and negotiating with potential Third Party Partners for development
and commercialization of Collaboration Products in the Field in the
Territory. The Liaison Party shall keep the other Party informed
regarding such negotiations and shall provide the other Party with
an opportunity to comment thereon. The ultimate form of the
Partnering Agreement shall be presented to both Parties for review
and approval. It is anticipated that, under the Partnering
Agreement, (a) each Party will grant the relevant Third Party
Partner an exclusive license to research, develop, use, register,
make, have made, sell, have sold, and distribute Collaboration
Products in the Field in the Territory; (b) CyDex would be
responsible for manufacturing (or having manufactured) Formulation
Technology and (c) Aradigm would be responsible for
manufacturing (or having manufactured) AERx Strips ® dosage
packets and AERX Essence ®
devices.
[ * ]
= 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.
9
4.3 Sharing of Licensing
Revenue .
(a) Except as provided in Section 4.3(b), the Parties
will share all Licensing Revenues realized and Partnering Costs
incurred in respect to the Collaboration Product in accordance with
Allocation Ratio.
(b) Any payments or other compensation provided by a Third
Party Partner to either Aradigm or CyDex in consideration for such
Party undertaking contract services relating to the development,
manufacture, or commercialization of a Collaboration Product
(whether or not made pursuant to a Partnering Agreement) shall not
be considered Licensing Revenues hereunder, provided that the other
Party is given the opportunity to review the financial and
non-financial terms under which such services will be provided and
(ii) such compensation does not exceed the normal rates
charged by the contracting Party in other, unrelated arms-length
transactions.
4.4 Reporting and
Reconciliation. Within fifteen (15) days after the end of
each calendar quarter during negotiation of, or following the
execution of, a Partnering Agreement, each Party shall provide a
written report to the JSC (with a copy to the other Party)
specifying and documenting, both in reasonable detail, the
Licensing Revenues it received, and Partnering Costs that it
incurred, during such quarter with respect to such Partnering
Agreement. Within thirty (30) days after the end of each such
calendar quarter, the JSC shall provide each Party with an
accounting in reasonable detail of the Parties’ Partnering
Costs and Licensing Revenues for such quarter, and the JSC shall
promptly direct by written notice the remittance between the
Parties of a payment that will result in the sharing of Licensing
Revenues and Partnering Costs as set forth in Section 4.3. All
payments required by this Section 4.4 shall be made within
thirty (30) days after receipt of a written notice. Each Party
shall keep detailed records of the Partnering Costs it incurs, and
all Licensing Revenues it receives, including all supporting
documentation for such costs and revenues. Each Party shall keep
such records for at least three (3) years after the date that
such expense was incurred or revenue received. Either Party may
audit, in accordance with the procedures set forth in
Section 7.4, such records for the sole purpose of verifying
the accuracy of the other Party’s reports pursuant to this
Section 4.4.
5.
Development and Commercialization
5.1 In General. Subject to
Section 5.2 and subject to Section 10.3 (as appropriate),
all development of Collaboration Products beyond the activities
that are part of the Research Program and all commercialization of
Collaboration Products shall be governed by a separate development
and commercialization agreement between the Parties, which will be
negotiated in good faith by the Parties at a mutually agreeable
time and shall include commercially reasonable terms.
5.2 Partnering Agreement . To
the extent that a Partnering Agreement covers a Collaboration
Product, the development and commercialization of such
Collaboration Product in the Field in the Territory shall be
governed by the terms and conditions of such Partnering
Agreement.
[ * ]
= 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.
10
6.
Licenses and Related Rig
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