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CONFIDENTIAL TREATMENT REQUESTED
FOR PORTIONS OF THIS DOCUMENT
EXHIBIT 10.10
COOPERATION AND STRATEGIC
ALLIANCE AGREEMENT
This Cooperation and Strategic Alliance Agreement (this "Agreement) is
entered into as of September 3, 1997, by and between LRX Pharmaceuticals, Inc.,
a Delaware corporation ("LRX"), and MiniMed Inc., a Delaware corporation
("MiniMed").
RECITALS
A. LRX has rights to, and is further developing, a pharmaceutical compound
for the treatment of certain pulmonary hypertension and other vascular
conditions.
B. MiniMed is a leader in the design, development, manufacturing and
marketing of advanced microinfusion systems for delivery of a variety of drugs.
C. MiniMed and LRX wish to cooperate in the development, establishment and
worldwide delivery of therapies for the treatment of targeted medical conditions
by taking advantage of the respective technologies and other resources and
assets of MiniMed and LRX, on the terms and subject to the conditions of this
Agreement.
AGREEMENT
In consideration of the terms and conditions contained herein, and for
other valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties agree as follows.
1. DEFINITIONS.
(a) "Affiliate" means any person, directly or indirectly, controlling,
controlled by or under common control with any other person. "Control" shall
mean the direct or indirect ownership of 50% or more of the voting interest in,
or 50% or more of the interest in the income
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of, such other person, or the ability to appoint, elect or direct at least 50%
of the governing body of any such person.
(b) "Alliance Coordinator" means the person designated by a Party pursuant
to Section 3(e) of this Agreement, to be the primary contact person for such
Party for purposes of this Agreement.
(c) "FDA" means the United States Food and Drug Administration, and any
successor entity that may be established hereafter which has substantially the
same authority or responsibility currently vested in the United States Food and
Drug Administration.
(d) "15-AU" means that certain prostacyclin analog licensed exclusively to
LRX and being developed by LRX for treatment of targeted medical conditions,
particularly, primary pulmonary hypertension ("PPH"), secondary pulmonary
hypertension ("SPH"), and peripheral vascular disease ("PVD").
(e) "Governing Rules" means the general guidelines established by the
Managing Committee pursuant to Section 3(d) of this Agreement, which will be
used to guide generally the activities of the Managing Committee and the Parties
which are undertaken pursuant to this Agreement.
(f) "Joint Intellectual Property" means any intellectual property rights
which arise from the joint activities conducted pursuant to this Agreement, and
which shall be jointly owned as set forth in Section 7 of this Agreement.
(g) "Law" means any local, state or federal rule, regulation, statute or
law relevant to the activities undertaken pursuant to this Agreement or
applicable to either of the Parties with respect to any matters set forth
herein.
(h) "Losses" means any liabilities, damages, costs or expenses, including
without limitation, reasonable attorneys' fees (including the allocable cost of
in-house counsel), which arise from any claim, lawsuit, demand or other action
by any Party other than one of the Parties or an Affiliate of one of the
Parties.
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(i) "Managing Committee" means the committee established pursuant to
Section 3 which is responsible for the development and oversight of all
activities pursuant to this Agreement, in accordance with the terms of this
Agreement.
(j) "MiniMed Products" means any products, supplies or other goods which
are designed, developed, manufactured or marketed by MiniMed, whether existing
on the date of this Agreement or subsequently developed, acquired or otherwise
obtained by MiniMed.
(k) "Party" or "Parties" means MiniMed or LRX, or MiniMed and LRX,
collectively, as appropriate.
(1) "Senior Management Representative" means an executive officer of each
Party designated to facilitate the resolution of disputes hereunder, as
described in Section 3 of this Agreement.
(m) "Target Therapy" means a comprehensive health care therapy which
utilizes 15-AU and MiniMed Products and which is to be delivered through the
cooperative efforts of the Parties as contemplated by this Agreement.
2. GENERAL AGREEMENT.
MiniMed and LRX shall collaborate and cooperate in the design, development
and implementation of therapies for the treatment of PPH, SPH and PVD, utilizing
MiniMed Products and 15-AU, as set forth herein. The specific terms regarding
the scope and type of the collaborative efforts (including, without limitation,
the economic terms with respect to the parties), shall be determined from time
to time in accordance with Sections 3 and 4 of this Agreement. In addition to
PPH, SPH, and PVD, LRX and MiniMed may, in their discretion and subject to
mutual agreement, identify other medical conditions to be targeted by the
Parties hereunder.
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3. MANAGING COMMITTEE.
(a) MiniMed and LRX shall establish a Managing Committee hereunder, which
shall consist of two (2) representatives from each of MiniMed and LRX. The
initial designees are set forth in Schedule A hereto. MiniMed and LRX may each
from time to time replace its respective representatives on the Managing
Committee, in its sole and absolute discretion, by notice to the other Party.
(b) It is among the objectives of the Parties to design, develop and
implement the Target Therapy in a reasonably practicable fashion, subject,
however, to the respective corporate regulatory, financial and other obligations
and considerations of each of the Parties from time to time determined. To
achieve this objective, the Managing Committee shall be responsible for
establishing an implementation strategy to carry out the intent of this
Agreement, and ultimately to commercialize the Target Therapy.
(c) The Managing Committee shall meet at such times and places as it shall
determine appropriate to carry out its responsibilities hereunder. Such meetings
may be in person or by means of telephonic communication. Either Party may
designate an alternate member of the Managing Committee to act on behalf of a
member on a temporary or interim basis, in the reasonable discretion of such
Party. Either Party, through its Managing Committee members, may call a meeting
of the Managing Committee by giving written notice thereof to the members of the
other Party.
(d) The Managing Committee shall establish guidelines to govern the
strategic activities, co-development and related activities of the Parties; the
Managing Committee shall also establish such guidelines with respect to
operational matters at such time as the Target Therapy is commercialized or in a
pre-commercial phase, as contemplated by this Agreement. All such guidelines
shall be subject to the qualification of Section 3(g) hereof. The Managing
Committee shall be responsible for taking such other actions as may be provided
for or contemplated by this Agreement, subject at all times to the requirements
of Section 3(g), including the establishment and implementation of the
"Governing Rules."
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(e) The Parties shall each name one (1) of its Managing Committee members
as its Alliance Coordinator, who shall be the primary contact for purposes of
this Agreement, except to the extent the parties may otherwise agree. Either
Party may change its designation of Alliance Coordinator, in its sole and
absolute discretion, upon written notice to the other Party.
(f) If a disagreement arises between the Parties as to any matters within
the scope of this Agreement, either Party may give written notice to the other.
If the Alliance Coordinators are unable to resolve the dispute satisfactorily,
despite their good faith efforts, within (30) days of receipt of such notice,
either Alliance Coordinator may request a meeting of the Managing Committee,
which will, in good faith, diligently seek to resolve the dispute. If the
Managing Committee is unable to resolve the dispute, notwithstanding the
exercise of good faith efforts, within (30) days after such meeting, then,
unless otherwise agreed by the Alliance Coordinators, the matter shall
thereafter formally be referred to a Senior Management Representative of each of
the Parties, the initial designations of which are set forth in Schedule A.
Either Party may, in its sole discretion, change its designee of the Senior
Management Representative by written notice to the other. Except as expressly
provided in the immediately following sentence, neither Party shall initiate any
formal action against the other including, without limitation, the formal
commencement of arbitration proceedings or the formal filing of legal action,
until at least thirty (30) days have elapsed since the first communication
between the Senior Management Representatives hereunder. Notwithstanding the
foregoing, either Party may initiate proceedings to seek injunctive relief
before the time period otherwise required hereunder shall elapse, if such Party
in good faith believes that it will suffer irreparable harm without the
initiation of such proceedings.
(g) Notwithstanding anything to the contrary contained in this Agreement,
the authority of the Managing Committee shall at all times be subject to the
respective requirements and obligations of the quality systems and regulatory
policies and procedures, and internal corporate governance requirements, of each
of LRX and MiniMed. The Managing Committee shall establish Governing Rules,
which shall serve as guidelines for the general activities under this Agreement,
which Governing Rules shall supplement the terms hereof, but which procedures
and systems shall satisfy and be consistent with the respective policies,
procedures, and systems
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of MiniMed and LRX. In that regard, the Parties shall reasonably cooperate in an
attempt to assure their respective systems do not unduly impede the carrying out
of the intent of this Agreement. Without limiting the generality of the
foregoing, the operations and authority of the Managing Committee shall be
consistent with the underlying corporate policies of each of MiniMed and LRX
with respect to the operation of clinical trials and studies, regulatory studies
relating to development, promotion, worldwide distribution and servicing of the
delivery of the Target Therapy, quality assurance activities, medical device and
adverse event reporting requirements, patent strategies, and the like. The
Managing Committee shall establish a proposed approach for the Governing Rules
within ninety (90) days of the execution of this Agreement that shall consider
the relevant respective obligations of the parties.
4. JOINT ACTIVITIES
The Parties shall diligently pursue the design, development and ultimate
commercialization of the Target Therapy as from time to time determined by
Managing Committee, and the Managing Committee shall develop a comprehensive
plan with respect to such activities. It is the intention of the Parties that
they will cooperate jointly in such activities, as from time to time mutually
determined by the Managing Committee and agreed to by the Parties. The Parties
currently contemplate that the joint pursuit of the Target Therapy may be
developed in one or more phases. The Parties further contemplate preliminarily
that the respective responsibilities of the Parties will be as described in
Schedule B hereto, it being understood by the Parties, however, that such
schedule reflects only the initial understanding of the Parties, and the
Managing Committee shall be responsible for finalizing such strategy in a
definitive manner.
It is the intention of the Parties that they will participate in the
investment, contribution, commitment and risks associated with the design,
development and commercialization of the Target Therapy. Accordingly, the
parties intend generally to allocate the financial costs and profits of the
Target Therapy commercialized hereunder. It is currently contemplated, however,
that: (i) MiniMed shall be responsible generally for all development and
regulatory expenses relating to the MiniMed Products, and (ii) LRX shall be
responsible for all development and
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regulatory expenses relating to 15-AU. The Parties may from time to time agree
to allocate such costs and expenses differently in certain circumstances.
In furtherance of the foregoing, the Parties intend to establish an
appropriate strategy to carry out the intent of the cooperative relationship
contemplated hereby, and intend to consider appropriate provisions for revenue
sharing, which may include, without limitation, the following: (i) determination
of an appropriate transfer price for 15-AU (in circumstances in which the
Managing Committee determines that MiniMed is the appropriate party to undertake
distribution, and on such terms as the Parties may agree), (ii) allocation for
costs and expenses associated with formulation and packaging of 15-AU and, to
the extent required, the MiniMed Products, (iii) costs associated with the
delivery of the Target Therapy, (iv) costs associated with clinical and
technical support associated with the Target Therapy and (v) an appropriate
formula or basis to determine the profits derived from the delivery of the
Target Therapy.
Notwithstanding the foregoing, however, the parties recognize and agree
that an unanticipated disparity may occur or eventuate in the actual
contribution of each Party with respect to the design, development, distribution
and commercialization of the Target Therapy. With respect thereto, to the extent
a Party in good faith concludes that the financial return to such Party is
inconsistent with this Agreement and the reasonable expectations of such Party,
then it may give notice thereof to the other Party (which shall include
supporting documentation for its position), to be reviewed and considered by the
other Party. The Parties shall engage in good faith negotiations relative to the
financial arrangement then applicable as between the Parties with respect to the
Target Therapy to the extent a notice is given as contemplated by this
provision.
5. REPRESENTATIONS AND WARRANTIES.
(a) MiniMed Representations and Warranties. MiniMed represents and warrants
to LRX as follows:
(i) MiniMed is a corporation duly organized, validly existing and in
good standing under the laws of its jurisdiction of incorporation, is duly
qualified to do
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business as a foreign corporation and is in good standing in each
jurisdiction in which the nature of its business or the ownership of its
property makes such qualification necessary, except where the failure to so
qualify or be in good standing would not have a material adverse effect on
MiniMed or its ability to perform hereunder.
(ii) MiniMed has the full power and authority to execute and deliver
this Agreement and to consummate the transactions contemplated herein. The
execution, delivery and performance of this Agreement have been duly and
validly authorized and approved by all necessary corporate action on the
part of MiniMed. This Agreement has been duly executed and the provisions
hereof constitute the valid and legally binding obligations of MiniMed and
do not require the consent, approval or authorization of, or registration,
qualification, designation, declaration or filing with, any person, public
or governmental authority or other entity, except for any of the foregoing
which have been received or obtained or, either individually or in the
aggregate, do not and would not have a material adverse effect upon MiniMed
or its ability to perform its obligations hereunder.
(iii) The execution and delivery of this Agreement by MiniMed, and the
performance of its obligations hereunder, are not in violation or breach
of, and will not conflict with or constitute a default under, the
Certificate of Incorporation or Bylaws of MiniMed, or any material
agreement, contract, commitment or obligation to which MiniMed is a Party
or by which it is bound, and will not conflict with or violate any
applicable Law or any order or decree of any governmental agency or court
having jurisdiction over MiniMed or its assets or properties.
(iv) MiniMed has and, at the time the Targeted Therapy is
commercialized will have, all right, title and interest in and to the
MiniMed Products used in connection with the Targeted Therapy.
(b) LRX- Representations and Warranties. LRX represents and warrants to
MiniMed as follows:
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(i) LRX is a corporation duly organized, validly existing and in good
standing under the laws of its jurisdiction of incorporation, is duly
qualified to do business as a foreign corporation and is in good standing
in each jurisdiction in which the nature of its business or the ownership
of its property makes such qualification necessary, except where the
failure to so qualify or be in good standing would not have a material
adverse effect on LRX or its ability to perform hereunder.
(ii) LRX has full power and authority to execute and deliver this
Agreement and to consummate the transactions contemplated herein. The
execution, delivery and performance of this Agreement have been duly and
validly authorized and approved by all necessary corporate action on the
part of LRX. This Agreement has been duly executed and the provisions
hereof constitute the valid and legally binding obligations of LRX and do
not require consent, approval or authorization of, or registration,
qualification, designation, declaration or filing with, any person, public
or governmental authority or other entity, except for any of the foregoing
which have been received or obtained or, either individually or in the
aggregate, do not and would not have a material adverse effect upon LRX or
its ability to perform its obligations hereunder.
(iii) The execution and delivery of this Agreement by LRX, and the
performance of its obligations hereunder, are not in violation or breach
of, and will not conflict with or constitute a default under, the Articles
or Certificate of Incorporation or Bylaws of LRX, or any material
agreement, contract, commitment or obligation to which LRX is a Party or by
which it is bound, and will not conflict with or violate any applicable Law
or any order or decree of any governmental agency or court having
jurisdiction over LRX or its assets or properties.
(iv) LRX has and, at the time the Targeted Therapy is commercialized
will have, the sole and exclusive right to exploit 15-AU for the Targeted
Therapy, which right is not subject to any restrictions or encumbrances
whatsoever.
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6. COMPLIANCE WITH LAWS.
In performing their obligations hereunder, MiniMed and LRX shall comply in
all material respects with all Laws regarding or relevant to the performance of
their respective obligations hereunder, except for any noncompliance which,
individually or in the aggregate, do not and would not have a material adverse
affect upon either Party hereto, or the agreements contemplated hereby. Without
limiting the generality of the foregoing, each Party shall comply in all
respects with all of the rules, regulations, statutes and laws under the
jurisdiction of the FDA, comparable regulatory bodies of any state or any
foreign jurisdiction, or such other regulatory authority which may from time to
time exercise jurisdiction over the activities of either MiniMed or LRX, or
which affect, impact or otherwise relate to this Agreement or the activities
conducted hereunder or contemplated hereby. MiniMed and LRX shall cooperate with
each other during any inspection, investigation or other inquiry by any
governmental agency exercising any such jurisdiction or authority, including
providing appropriate information and/or documentation, as may be lawfully
requested by such governmental entity. Notwithstanding the foregoing, each Party
expressly reserves its rights to in good faith challenge the activities of any
such governmental agency, to the extent such Party deems appropriate. Further
notwithstanding the foregoing, neither MiniMed nor LRX shall be under any
obligation to disclose information hereunder if, and to the extent, such Party
in good faith is seeking to protect the attorney-client privilege with respect
to any such activity or event.
7. INTELLECTUAL PROPERTY.
(a) Joint Developments. Each Party shall disclose to the other any and all
useful ideas, concepts, methods, procedures, processes, improvements, invention,
discoveries, and the like which arise from the joint activities conducted by the
Parties hereunder ("Discoveries") of any nature, made, conceived or first
reduced to practice as result of the Parties' activities hereunder relating to
the delivery of the Target Therapy. The Parties shall jointly own any and all
rights, title and interest in and to all Discoveries that are a result of this
Agreement, and such property shall constitute Joint Intellectual Property
hereunder. The parties contracting for any work performed under this Agreement
by a subcontractor or contract employee shall ensure all
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Discoveries vest with LRX and MiniMed. The Parties shall in good faith consider
the inclusion of procedures relative to patent filings and related matters with
respect to Discoveries which constitute Joint Intellectual Property, which
procedures would be considered for inclusion in the Governing Rules.
(b) Sole Property. All existing LRX intellectual property (including all
aspects of 15-AU), and all intellectual property developed solely by or on
behalf of LRX independent from activities pursuant to this Agreement (which must
be independently verifiable), shall be and remain the sole and exclusive
property of LRX. All existing MiniMed intellectual property (including all
aspects of the MiniMed Products), and all intellectual property developed solely
by or on behalf of MiniMed independent from activities undertaken pursuant to
this Agreement (which must be independently verifiable), shall be and remain the
sole and exclusive property of MiniMed.
8. COVENANT NOT TO COMPETE; EXCLUSIVITY.
(a) Except as provided for herein, during the term of this Agreement, the
Parties shall deal exclusively with one another with respect to the delivery of
the Target Therapy, subject to the inclusion of additional collaborative parties
as the Parties may from time to time agree.
(b) Except as provided in subsection (d) below, during the term of this
Agreement and for a period of one (1) year thereafter, LRX shall not, without
the prior written consent of MiniMed, enter into any agreement or arrangement
with any person or entity with respect to the design, development or
distribution of 15-AU for administration in a comprehensive subcutaneous,
intravenous or transdermal medication delivery system.
(c) Except as provided in subsection (d) below, during the term of this
Agreement and for a period of one (1) year thereafter, MiniMed shall not,
without the prior written consent of LRX, enter into any agreement or
arrangement with any person or entity with respect to the infusion of a
medicinal compound for the treatment of PPH or SPH.
(d) Notwithstanding the foregoing, the Parties acknowledge that unforeseen
circumstances may eventuate wherein a Party is materially and adversely affected
because of the
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exclusivity and noncompetition provisions contained herein. In the event such
were to occur, the Parties so affected may terminate its obligations hereunder
with respect to therapy delivery relative to PPH and/or SPH, in which case the
terminating party shall be obligated to pay the other party royalties of [ ] of
the net proceeds. For purposes herein, "Net Proceeds" shall mean the gross
revenue derived from sales of 15-AU for the treatment of PPH or SPH (in the
event LRX is the terminating party) or sales of the MiniMed Products (relative
to delivery of therapy to treat PPH or SPH), less (i) applicable taxes and other
governmental charges, (ii) allowances for credits, returns, discounts, rebates,
cancellations, and (iii) actual freight costs. The obligation to pay such
royalties shall terminate on the sixth (6th) anniversary of the date the FDA
grants a new drug approval. The non-terminating party shall have reasonable
audit rights to verify such royalty payments, which shall be paid quarterly
(within 60 days of the end of each calendar quarter), and all be accompanied by
a royalty report setting forth the basis for the royalty calculation.
9. TERM, EXTENSION AND TERMINATION.
(a) Term. The term of this Agreement shall commence as of the date hereof
and continue until the date seven (7) years after the FDA grants a New Drug
Approval for 15-AU to be used in the Target Therapy hereunder ("Initial Term"),
unless sooner terminated as set forth herein. Unless sooner terminated in
accordance with the terms of this Agreement, the term of this Agreement shall
automatically be extended for additional successive 12-month periods, unless a
Party gives notice of nonrenewal at least six (6) months prior to the end of the
Initial Term or any renewal term.
(b) Termination.
(i) Breach. If a Party materially defaults in its performance of any
of its material obligations under this Agreement, and such default is not
cured or resolution of a disputed breach pursuant to Subsection 3(f) is not
demanded within sixty (60) days of written notice of such default by the
other Party, this Agreement may be terminated at the end of such 60-day
period by the Party not in default by written notice of termination to
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the defaulting Party, such written notice to be given not later than
seventy-five (75) days after the first written notice.
(ii) Bankruptcy. In the event of the institution by or against either
Party of insolvency, receivership or bankruptcy proceedings or any other
proceedings for the settlement of a Party's debts which are not dismissed
within sixty (60) days, or upon a Party's making an assignment for the
benefit of creditors, or upon a Party's dissolution or ceasing to do
business, the other Party may terminate this Agreement upon written notice.
(c) Effect of Termination. The provisions of Section 8 (Covenant Not to
Compete), Section 10 (Confidentiality), Section 11 (Indemnification), and
Section 12 (General), shall survive the termination of this Agreement.
10. CONFIDENTIALITY
(a) Disclosure of Confidential Information. Except as otherwise expressly
provided in this Agreement or as may be agreed to by the Managing Committee in
writing, both MiniMed and LRX shall retain in confidence and not use for its own
benefit (other than as expressly contemplated by this Agreement) all
confidential and proprietary information received from the other as a result of
this Agreement during the term of this Agreement and continuing thereafter for a
period of five (5) years after termination. Such information may, however, be
disclosed insofar as such disclosure is necessary (where possible, with adequate
safeguards for confidentiality) to allow either Party to defend against
litigation, to file and prosecute patent applications or to comply with
governmental regulations, or rules or regulations of applicable self-regulatory
organizations (including, without limitation, any exchange or stock market on
which the securities of a Party are listed or traded, or qualified for trading),
or otherwise as required by Law. Such obligation of confidentiality and non-use
shall also not apply to information which: (i) is in the public domain as of the
date of receipt, (ii) comes into the public domain through no fault of the Party
claiming waiver, (iii) was known by the Party claiming waiver prior to
disclosure, as shown by such Party's written records, (iv) is disclosed to the
Party claiming waiver by a third party having a lawful right to make such
disclosure, (v) is independently developed by the Party claiming waiver, or (vi)
disclosed to a third party that has
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agreed in writing to be bound by obligations of confidentiality similar to those
set forth herein. Nothing contained herein shall prevent either Party from
disclosing information to its Affiliates or to the FDA or other regulatory
authorities where necessary.
(b) Press Release and Public Announcements. MiniMed and LRX shall not issue
any press release or public announcement with respect to this Agreement without
the prior consent of the other Party as to the form and content of such release,
except for any such release or announcement that may be required by Law or the
rules or regulations of any exchange on which the securities of a Party are
listed, traded or qualified for trading. To the extent practical, the parties
shall consult with each other in advance as to the form, content and timing of
all releases or announcements. It is the present intention of the parties to
issue a joint press release announcing the execution of this Agreement.
(c) Existing Mutual Nondisclosure Agreement. The Mutual Nondisclosure
Agreement entered into by the Parties and effective as of March 18, 1997 is
superseded by Section 10 of this Agreement; provided, however, that any
confidential information disclosed by one Party to the other pursuant to such
Mutual Nondisclosure Agreement shall be treated as if it had been disclosed
after the Effective Date of this Agreement shall therefore be subject to the
terms of this Section.
11. INDEMNIFICATION.
(a) Indemnification by MiniMed. MiniMed shall indemnify, defend and hold
LRX harmless from and against any and all Losses resulting from or arising out
of the negligence or willful misconduct of MiniMed in the performance of its
obligations under this Agreement. Without limiting the generality of the
foregoing, MiniMed shall indemnify, defend and hold LRX harmless from and
against Losses relating to product liability claims solely with respect to
MiniMed Products which are designed, developed and manufactured solely and
independently by MiniMed.
(b) Indemnification by LRX. LRX shall indemnify, defend and hold MiniMed
harmless from and against any Losses resulting from or arising out of negligence
or willful
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misconduct of LRX in performing its obligations under Agreement. Without
limiting the generality of the foregoing, LRX shall indemnify, defend and hold
MiniMed harmless from and against any Losses resulting solely from any design
defect or other claim with respect to AU-15.
(c) Indemnification Procedures. A Party seeking indemnification (the
"Indemnified Party") pursuant to this Section 11 shall notify, in writing, the
other Party (the "Indemnifying Party") within fifteen (15) days of the assertion
of any claim or discovery of any fact upon which the Indemnified Party intends
to base a claim for indemnification. An Indemnified Party's failure to so notify
the Indemnifying Party shall not, however, relieve the Indemnifying Party from
any liability under this Agreement to the Indemnified Party with respect to such
claim except to the extent that such Indemnifying Party is actually denied,
during the period of delay in notice, or materially prejudiced with respect to,
the opportunity to remedy or otherwise mitigate the event or activity(ies)
giving rise to the claim for indemnification and thereby suffers or otherwise
incurs additional quantifiable damages as a result of such failure. The
Indemnifying Party, while reserving the right to contest its obligations to
indemnify hereunder, shall be responsible for the defense of any claim, demand,
lawsuit or other proceeding in connection with which the Indemnified Party
claims indemnification hereunder. The Indemnified Party shall have the right at
its own expense to participate jointly with the Indemnifying Party in the
defense of any such claim, demand, lawsuit or other proceeding, but with respect
to any issue involved in such claim, demand, lawsuit or other proceeding with
respect to which the Indemnifying Party has acknowledged its obligation to
indemnify the Indemnified Party hereunder, the Indemnifying Party shall have the
right to select counsel, settle, or otherwise dispose of or handle such claim,
demand, lawsuit or other proceeding on such terms as the Identifying Party shall
deem appropriate, subject to any reasonable objection of the Indemnified Party.
(d) Insurance. The Parties, through the Managing Committee, shall pursue
purchase of appropriate liability insurance which would jointly insure both of
the Parties for the activities undertaken pursuant to this Agreement, to the
extent such insurance is available to the Parties on commercially reasonable
terms. The Managing Committee shall in good faith determine the most efficient
and effective way to obtain such insurance and shall in good faith negotiate an
appropriate allocation of the cost of acquiring any such insurance.
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12. GENERAL.
(a) Entire Agreement. This Agreement, including any Schedules, Exhibits and
Appendices, constitutes the entire agreement and understanding relating to the
subject matter of this Agreement and supersedes all previous communications,
proposals, representations and agreements, whether oral or written, including
that certain Letter Agreement between the parties dated May 20, 1997 relating to
the subject matter of this Agreement.
(b) Counterparts and Headings. This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original and all of which
together shall constitute one instrument. Headings of sections and subsections
of this Agreement are for convenience only and the construction of this
Agreement shall not be affected by reference to such headings.
(c) Notices. Any notice required or permitted to be given under this
Agreement shall be in writing and shall be deemed to have been sufficiently
given for all purposes if personally delivered or mailed by first class
certified or registered mail, postage prepaid, hand delivered, or sent by
telecopy or by reputable courier. Notices sent by U.S. mail shall be deemed
delivered three (3) days after deposit with postal authorities or upon confirmed
delivery if personally delivered, sent by confirmed fax or courier service.
Unless otherwise specified in writing, the mailing addresses of the parties
shall be as described below:
For LRX: LRX Pharmaceuticals, Inc.
0 Xxxxx Xxxxx
Xxxxxxxx Xxxxxxxx Xxxx, Xxxxx Xxxxxxxx 00000
Attention: President
Fax Number: (000) 000-0000
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For MiniMed: MiniMed Inc.
00000 Xxx Xxxxxxxx Xxxx
Xxxxxx, Xxxxxxxxxx 00000
Attention: President
Fax Number: (000) 000-0000
Copy to: General Counsel at same address
Fax Number (000) 000-0000
(d) Amendment and Waiver. This Agreement may be modified, amended and
supplemented only by written agreement signed by the Parties. The waiver by any
Party to this Agreement of any breach or violation of any provision of this
Agreement by the other Party shall not operate or be construed to be a waiver of
any subsequent breach or violation of the same or any other provision of this
Agreement.
(e) Assignment. Neither Party may assign its rights and obligations under
this Agreement without the prior written consent of the other Party. This
Agreement shall be binding upon, and inure to the benefit of, the legal
successors to the Parties hereto.
(f) Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California.
(g) Partial Invalidity. If any provision of this Agreement is held to be
invalid, then the remaining provisions shall nevertheless remain in full force
and effect. The Parties agree to renegotiate in good faith any term held invalid
and be bound by the mutually agreed substitute provision.
(h) Construction. The Parties have participated jointly in the negotiation
and drafting of this Agreement. In the event an ambiguity or question of intent
or interpretation arises, this Agreement shall be construed as if drafted
jointly by the Parties and no presumption or burden of proof shall arise
favoring or disfavoring any Party by virtue of the authorship of any of the
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provisions of this Agreement. When this Agreement uses the word "including" such
word shall be deemed to be followed by the words "without limitation."
(i) Force Majeure. Both Parties to this Agreement shall be excused from the
performance of their obligations hereunder if such performance is prevented by
force majeure and the nonperforming Party promptly provides notice of the
prevention to the other Party. Such excuse shall be continued so long as the
condition constituting force majeure continues and the nonperforming Party takes
reasonable efforts to remove the condition. For purposes of this Agreement,
"force majeure" shall include conditions beyond the control of the Parties and
not resulting from the negligence of the Party seeking excuse, including an act
of God, war, civil commotion, epidemic, failure or default of public utilities
or common carriers, destruction of production facilities or materials by fire,
earthquake, storm or like catastrophe.
(j) Independent Contractors. The relationship of LRX and MiniMed
established by this Agreement is that of independent contractors, and nothing
contained in this Agreement shall be construed to give either Party the power to
direct and control the day-to-day activities of the other or allow one Party to
create or assume any obligation on behalf of the other of any purpose
whatsoever.
(k) Limitation of Liability. Except as may be elsewhere herein specifically
provided for, neither Party shall be liable to the other for indirect, special,
incidental, consequential or punitive damages, or for any lost profits of the
other Party, however caused and on any theory of liability, arising out of the
performance or failure to perform any obligations set forth herein.
IN WITNESS WHEREOF, this Agreement is executed and effective as of the date
first above written.
LRX PHARMACEUTICALS, INC. MINIMED INC.
/s/ XXXXXX XXXXXXXX /s/ XXXX X. XXXXXX
-------------------------- -------------------
Xxxxxx Xxxxxxxx, Ph.D. Xxxx X. Xxxxxx
Executive Vice President Senior Vice President
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SCHEDULE B
The following sets forth the allocation of responsibilities between the Parties
with respect to the development and ultimate commercialization of the delivery
of the Target Therapy. While the following sets forth the current intention of
the Parties, the Parties further recognize and agree that the actual development
of the Target Therapy, and, assuming such developmental efforts are successful,
the ultimate commercialization thereof, remains subject to a number of
contingencies and considerations, some of which are not at this time
predictable. Accordingly, the following only expresses the present intention of
the Parties, and it is anticipated to be subject to further refinement,
clarification, modification and other considerations prior to definitive
implementation. In this regard, the Management Committee should recognize that,
with regard to this 15-AU pulmonary hypertension project, the expertise of LRX
is in the fields of CMC and clinical development of pharmaceuticals while the
expertise of MiniMed is in the field of drug delivery.
Subject to the foregoing, the Parties currently contemplate that the Target
Therapy may be developed in one or more phases, which may include or address,
without limitation, the following:
(a) Cooperative efforts between the Parties relating to the formulation of
15-AU for delivery via the MiniMed Products, including, without limitation,
chemical stability, concentration, preservative, and materials compatibility
issues.
(b) Clinical research, including the design, development, implementation
and analysis of clinical trials and protocols, feasibility studies and similar
studies from time to time agreed to by the Parties. It is currently contemplated
that MiniMed will be responsible for distribution of the Target Therapy system
in clinical trials conducted in North America and Europe. The parties will
evaluate the appropriate mechanism for the compounding and distribution vehicle
for 15-AU in connection with such clinical activities. The Parties will evaluate
personnel and other resources necessary to conduct clinical trials, including
consideration of utilizing MiniMed
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SCHEDULE B (CONTINUED)
personnel in Europe and/or the United States or, alternatively, contracting with
an independent clinical research organization to conduct the trials; the
ultimate structure of such trials, and financial responsibility, shall be
determined by the Managing Committee.
(c) Strategies and physical requirements for the manufacture, packaging,
storage, and shipment of 15-AU relative to the Target Therapy, and related
activities constituting pharmacy services.
(d) Market research activities.
(e) Patent strategies with respect to any Joint Intellectual Property.
(f) Strategies and activities relative to the requisite regulatory
approvals and post-market regulatory compliance for the components of the Target
Therapy. Currently, the Parties generally anticipate that LRX will be
responsible for the regulatory approval of 15-AU and MiniMed will generally be
responsible for the regulatory approval of the MiniMed Products relative to the
Target Therapy. Notwithstanding the foregoing, however, the Managing Committee
may from time to time determine joint regulatory strategies which may include
joint or coordinated meetings and/or submissions to the FDA and other
appropriate regulatory authorities.
(g) Market development activities, which may include, without limitation,
educational and other programs for health care professionals and third
parties-payors, and related marketing activities which may include, without
limitation, activities directed to patients, health care professionals and third
party payors. It is currently anticipated that MiniMed will assume primary
responsibility for this function.
(h) Clinical and technical services to provide support relative to the
delivery systems for the Target Therapy, which may be based upon the current
MiniMed model of providing 24-hour clinical services and technical services for
the MiniMed products. The Parties currently
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SCHEDULE B (CONTINUED)
anticipate that a system will be developed whereby adverse drug events relative
to 15-AU will generally be the responsibility of LRX, and the need for a system
whereby such adverse events which come to the attention of MiniMed shall be
reported to LRX; similarly, to the extent LRX becomes aware of any adverse
events involving the MiniMed Products, a companion communication system may be
developed.
(i) Sales and related worldwide distribution activities relating to the
Target Therapy. Currently, the Parties envision that it is in their mutual best
interest to package and commercialize the Target Therapy as a comprehensive
product. Accordingly, it is anticipated that MiniMed shall generally assume
primary responsibility for the sales, marketing and related activities with
respect to the distribution and commercial activities of the Target Therapy,
which is anticipated to include component elements of each of the Party's
products.
(j) Warranty, product service and similar matters relative to the component
elements of the Target Therapy.
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September 3, 1997
LRX Pharmaceuticals, Inc.
0000 X Xxxxxx, X.X,
Xxxxxxxxxx X.X. 00000
Re: Letter Agreement
Ladies and Gentlemen:
Reference is made to that certain Cooperation and Strategic Alliance Agreement
(the "Agreement") of even date between LRX Pharmaceuticals, Inc., a Delaware
corporation ("LRX") and MiniMed Inc., a Delaware corporation ("MiniMed").
Capitalized terms used but not otherwise described herein have the meanings set
forth in the Agreement. The purpose of this Letter Agreement is to memorialize
certain agreements and understandings between LRX and MiniMed which relate to
the Agreement but which supplement the terms thereof.
Pursuant to the Agreement, it is anticipated that the Parties will participate
in the economic costs and returns/profits of the Target Therapy commercialized
under the Agreement, pursuant to an allocation to be agreed upon through the
developmental process and ultimate commercialization of the Target Therapy. In
the event that the Parties are not able to agree on provisions for revenue
sharing for PPH and SPH, then the Parties shall allocate revenues such that
MiniMed shall receive the greater of (a) [ ] of revenues derived from
commercialization of the Target Therapy or (b) $5,000 per patient per year.
The Parties recognize and agree that the flexibility of economic terms
contemplated by the Agreement are appropriate, and the Parties shall endeavor to
cooperate in good faith to allocate revenues on the basis of the criteria set
forth in the Agreement. The allocation set forth in this Letter Agreement
provides a mechanism by which the Parties shall allocate revenues if,-despite
good faith efforts, the Parties are unable to so agree.
The Parties further agree that the Managing Committee shall establish a mutually
agreeable, reasonable criteria whereby the Agreement shall be subject to
termination in the event the Target Therapy (a) is determined not to be
clinically feasible, (b) does not receive regulatory approval or (c) otherwise
is not commercially viable. Such provisions shall be deemed to be an amendment
to the Agreement.
If this letter is in agreement with your understanding of our discussions on the
subject, please so indicate by countersigning below where your name appears.
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Thank you for your continued cooperation in connection with this matter. We look
forward to a long and mutually rewarding business arrangement.
Sincerely,
MINIMED INC.
By: /s/ Xxxx X. Xxxxxx Date: 9/3/97
---------------------------------- -------------------
Xxxx X. Xxxxxx
Senior Vice President
ACCEPTED AND AGREED TO:
LRX Pharmaceuticals, Inc.
By: /s/ Xxxxxx Xxxxxxxx Date: 9/4/97
---------------------------------- -------------------
Xxxxxx Xxxxxxxx, Ph.D.
Executive Vice President for
Business Development
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