Cooperation and Strategic Alliance Agreement - Trimeris Inc. and MiniMed Inc.
COOPERATION AND STRATEGIC
ALLIANCE AGREEMENT
This Cooperation and Strategic Alliance Agreement (this "Agreement") is
entered into as of April 21, 1997, by and between Trimeris, Inc., a Delaware
corporation ("Trimeris"), and MiniMed Inc., a Delaware corporation ("MiniMed").
RECITALS
A. Trimeris has developed a novel approach to the design and development of
drugs and other compounds which may have application for the treatment of a
variety of medical 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 Trimeris wish to cooperate in the development, establishment
and worldwide delivery of therapies for the treatment of various medical
conditions by taking advantage of the respective technologies and other
resources and assets of MiniMed and Trimeris, 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.
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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 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) "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.
(e) "Implementation Strategy" means the comprehensive approach and
strategy, which may be reduced to written form, which is developed by the
Managing Committee with respect to the development and implementation of
business activities hereunder. The Implementation Strategy shall generally
relate to the delivery of medical therapies to patients by MiniMed and Trimeris,
which therapies incorporate MiniMed Products and Trimeris Compounds, as
contemplated by this Agreement.
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(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 8 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 form 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.
(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" rereads MiniMed or Trimeris, or MiniMed and
Trimeris, 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.
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(m) "Target Therapy" means a comprehensive health care therapy which
utilizes Trimeris Compounds and MiniMed Products and which is to be delivered
through the cooperative efforts of the Parties as contemplated by this
Agreement.
(n) "Trimeris Compound" means any compound from time to time developed by
Trimeris for the treatment for venous medical conditions, which compound
utilizes Trimeris' cellular membrane anti-fusion technology.
2. General Agreement
MiniMed and Trimeris shall collaborate and cooperate in the design,
development and implementation of therapies for the treatment of medical
conditions, utilizing MiniMed Products and Trimeris Compounds, as set forth
herein. The identification of candidate Trimeris Compounds, and 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.
3. Managing Committee.
(a) MiniMed and Trimeris shall establish a Managing Committee hereunder,
which shall consist of two (2) representatives from each of MiniMed and
Trimeris. The initial designees are set forth in Schedule A hereto. MiniMed
and Trimeris 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 Therapies 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
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Committee shall be responsible for identifying Trimeris Compounds which are
appropriate candidates for consideration under this Agreement, and
establishing an Implementation Strategy for those Trimeris Compounds from time
to time designated and determined by the Managing Committee.
(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 a Target Therapy is commercialized or in a
pre-commercialized 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."
(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.
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(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 thirty (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 thirty (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 Trimeris and MiniMed. The Managing Committee shall establish Governing Rules,
which shall serve as guidelines for the general activities under this Agreement,
and Implementing Strategies relative to the activities for each Target Therapy,
all of which shall supplement the terms hereof, but which procedures and systems
shall satisfy and be consistent with the respective policies, procedures, and
systems of MiniMed and Trimeris. In that regard, the
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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 Trimeris with respect to the operation of
clinical trials and studies, regulatory affairs relating to development,
promotion, worldwide distribution and servicing of the delivery of Target
Therapies, 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. Target Therapies.
The Parties shall diligently pursue the design, development and ultimate
commercialization of Target Therapies from time to time designated by the
Managing Committee. For each Target Therapy designated as such by the Parties,
the Managing Committee shall develop an Implementation Strategy, which shall
consist of 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 Implementation
Strategies with respect to each Target Therapy may be developed in one or more
phases, and may include or address, without limitation, the following:
(a) Formulation of Trimeris Compounds for delivery via MiniMed Products,
including, without limitation, chemical stability and materials compatibility
issues. MiniMed shall be responsible generally for Investigating appropriate
modalities for drug deliver alternatives.
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(b) Clinical research, including the design, development, implementation
and analysis of joint clinical trials and protocols, feasibility studies and
similar activities from time to time agreed to by the Parties.
(c) Strategies and physical requirements for the manufacture, packaging and
storage of the Trimeris Compounds relative to the Target Therapies.
(d) Market research activities.
(e) Patent strategies with respect to Joint Intellectual Property.
(f) Strategies and activities relative to the requisite regulatory
approvals of and post-market regulatory compliance for the components of the
Target Therapies. (Notwithstanding the foregoing, its is recognized and agreed
that Trimeris will generally be responsible for the regulatory approval of the
Trimeris Compounds, and MiniMed will generally be responsible for the regulatory
approval of the MiniMed Products; provided, however, that the Managing Committee
may from time to time determine appropriate joint regulatory strategies which
may include joint or coordinated 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 party
payoffs.
(h) Marketing activities, which may include, without limitation, activities
directed to patients, health care professionals and third party payors.
(i) Clinical and technical services to provide support relative to the
delivery systems for the Target Therapies, which may be based upon the current
MiniMed model of providing technical services for MiniMed Products and 24-hour
clinical services.
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(j) Sales and related worldwide distribution activities relating to the
Target Therapies, including the composition and structure of the sales force or
distribution network, or other method of distribution (which may involve third
parties with which the Parties may collaborate hereunder), all of which will be
determined in the exercise of the Managing Committee's responsibilities.
(k) Warranty, product service (including technical service and clinical
service) and similar matters.
(1) The right of a Party to terminate the Party's commitments with respect
to a particular Target Therapy in accordance with subsection 9(e) or in the
event milestones established by the Managing Committee arc not achieved.
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 Therapies. Accordingly, the
parties intend generally to allocate the financial costs and profits of the
Target Therapies 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, (ii) Trimeris shall be
responsible for all development and regulatory expenses relating to the Trimeris
Compounds, (iii) the Parties shall share expenses for clinical trials, and
marketing and selling expenses relative to the Target Therapies. The Parties may
from time to time agree to allocate such costs and expenses differently in
certain circumstances, which would be incorporated into an Implementation
Strategy for a specified Target Therapy.
In furtherance of the foregoing, the Implementation Strategy may include
appropriate provisions for revenue sharing, which may vary depending upon the
requirements of a particular Target Therapy, but which may include, without
limitation, the following. (i) determination of an appropriate transfer price
for the Trimeris
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Compounds (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 the Trimeris Compounds 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 a particular Target Therapy. With respect to each
Target Therapy, 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 applicable as between the
Parties with respect to any Target Therapy to the extent a notice is given as
contemplated by this provision.
With respect to any particular Target Therapy, the Parties acknowledge and
agree that they may need to further collaborate with additional unrelated third
parties. In such event, the Parties shall cooperate hereunder to devise an
appropriate strategy with respect to pursuing such third parties. Without
limiting the generality of the foregoing, the Parties acknowledge and agree that
the treatment of diseases caused by enveloped viruses (which are the general
targets of the Trimeris Compounds), particularly HIV/AIDS, may be best
accomplished by a variety of anti-retroviral therapies, including "drug
cocktails" containing multiple therapeutic agents. and that many of the
components of such cocktails are best delivered by continuous infusion such as
is accomplished by MiniMed Products. To the extent determined to be
scientifically appropriate, the Parties,
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collectively and/or individually, shall investigate the use of the Trimeris
Compounds in such cocktails for use as a Target Therapy hereunder. To the extent
such cocktails containing anti-viral compounds (e.g., protease inhibitors,
reverse transcriptase inhibitors and the like) other than the Trimeris Compounds
are identified hereunder, the Managing Committee shall in good faith cooperate
to determine an appropriate business strategy (which may include, without
limitation, financial allocations based upon the relative contributions of the
Parties and one or more third parties) which will be recommended to the Parties
for approval.
5. Pentafuside (T-20). The Parties acknowledge that they have been
collaborating with respect to the development of Pentafuside, a Trimeris
Compound for the treatment of HIV/AIDS, the delivery of which, with MiniMed
Products, the Parties have designated as a Target Therapy hereunder. The
Managing Committee shall undertake to establish the first phase of an
Implementation Strategy for such Target Therapy within ninety (90) days from the
date of this Agreement.
6. Representations and Warranties.
(a) MiniMed Representations and Warranties. MiniMed represents and warrants
to Trimeris 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 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.
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(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.
(b) Trimeris Representations and Warranties. Trimeris represents and
warrants to MiniMed as follows:
(i) Trimeris 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
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qualification necessary, except where the failure to so qualify or be in
good standing would not have a material adverse effect on Trimeris or its
ability to perform hereunder.
(ii) Trimeris 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 Trimeris. This Agreement has been duly executed and the provisions
hereof constitute the valid and legally binding obligations of Trimeris 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
Trimeris or its ability to perform its obligations hereunder.
(iii) The execution and delivery of this Agreement by Trimeris, 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 Trimeris, or any
material agreement, contract, commitment or obligation to which Trimeris 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 Trimeris or its assets or properties.
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7. Compliance With Laws.
In performing their obligations hereunder, MiniMed and Trimeris 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
Trimeris, or which affect, impact or otherwise relate to this Agreement or the
activities conducted hereunder or contemplated hereby. MiniMed and Trimeris
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 Trimeris
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.
8. Intellectual Property.
(a) Joint Developments. Each Party shall disclose to the other any and all
useful ideas, concepts, methods, procedures, processes, improvements,
inventions, 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 a result of the Parties' activities
hereunder. The Parties shall jointly own any and all rights,
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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 Discoveries vest with
Trimeris 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 Trimeris intellectual property (including
all aspects of the Trimeris Compounds), and all intellectual property developed
solely by Trimeris independent from activities pursuant to this Agreement (which
must be independently verifiable), shall be and remain the sole and exclusive
property of Trimeris. All existing MiniMed intellectual property (including all
aspects of the MiniMed Products), and all intellectual property developed solely
by 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.
9. 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
Target Therapies, subject to the inclusion of additional collaborative parties
as contemplated by Section 4.
(b) During the term of this Agreement and for a period of one (1) year
thereafter, MiniMed shall not, without the prior written consent of Trimeris,
enter into any agreement or arrangement with any other person or entity with
respect to the continuous or continual microdose infusion of any pharmaceutical
product which is predicated on anti-viral agents which block virus to cell
membrane fusion.
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(c) During the term of this Agreement and for a period of one (1) year
thereafter, Trimeris 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 any of the Trimeris Compounds used
in a Target Therapy hereunder for administration via a continuous or continual
microdose infusion delivery system.
(d) The Parties acknowledge and agree that, except as may be mutually
determined with respect to an Implementation Strategy, or otherwise agreed to in
writing (i) Trimeris may collaborate, independent of this Agreement, with other
parties for the development and distribution of Trimeris Compounds used in a
Target Therapy hereunder for delivery otherwise than via continuous or continual
microdose infusion and (ii) except as expressly provided for in subsection (b)
above, MiniMed may collaborate, independent of this Agreement, with other
parties for the delivery of drugs, drug "cocktails" and compounds other than the
Trimeris Compounds, some of which may be deemed to be competitive with one or
more of the Trimeris Compounds.
(e) Notwithstanding the foregoing, the Parties recognize that circumstances
may eventuate wherein the capability of Trimeris to efficiently and effectively
distribute a Trimeris compound identified for use in a Target Therapy hereunder
is materially and adversely affected because of the exclusivity and
noncompetition provisions contained herein ("Materially Adverse Circumstances").
In recognition of such possibility, the Management Committee may include in an
Implementation Strategy the right of Trimeris to terminate its obligations with
respect to the subject Trimeris Compound, subject to the terms and conditions
herein and in the Implementation Strategy. In any such case, Trimeris must in
good faith conclude that Materially Adverse Circumstances exist and Trimeris
shall be obligated to pay MiniMed a termination fee in the form of a one-time
payment and/or royalty payments for the balance of the exclusivity period.
With respect to Pentafuside, if Materially Adverse Circumstances occur,
Trimeris may terminate its obligations hereunder with respect to Pentafuside, in
which case
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Trimeris shall be obligated to pay MiniMed royalties equal to seven percent (7%)
of the Net Proceeds. For purposes of this Agreement "Net Proceeds" shall mean
the gross revenue derived from sales of Pentafuside formulated for delivery via
continuous or continual microdose infusion, less (i) applicable taxes and other
governmental charges, (ii) allowances for credits, returns, discounts, rebates
and cancellations, and (iii) actual freight cost. The obligation of Trimeris to
pay such royalties shall terminate on the sixth (6") anniversary of the date the
FDA grants a New Drug Approval for Pentafuside. MiniMed shall have reasonable
audit rights to verify such royalty payments, which shall be paid quarterly
(within sixty days of the end of each calendar quarter), and shall be
accompanied by a royalty report setting forth the basis for the royalty
calculation.
10. Term. Extension and Termination.
(a) Term. The term of this Agreement shall commence as of the date hereof
and continue until the date six (6) years after the FDA grants a New Drug
Approval for a Trimeris Compound used in a Target Therapy hereunder ("Initial
Term"), unless sooner terminated as set forth herein. Unless sooner terminated
in accordance with the terms of this Agreements 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 the
defaulting Party, such written notice to be given not later than
seventy-five (75) days after the first written notice.
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(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 9 (Covenant Not to
Compete), Section 11 (Confidentiality), Section 12 (Indemnification), and
Section 13 (General), shall survive the termination of this Agreement.
11. 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 Trimeris 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)
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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) is disclosed to a third party that has 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 Trimeris 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 catered into by the Parties and effective as of August 21, 1996 is
superseded by Section 11 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 and shall therefore be subject to the
terms of this Section.
12. Indemnification.
(a) Indemnification by MiniMed. MiniMed shall indemnify, defend and hold
Trimeris 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
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indemnify, defend and hold Trimeris harmless from and against any 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 Trimeris. Trimeris shall indemnify, defend and hold
MiniMed harmless from and against any Losses resulting from or arising out of
the negligence of willful misconduct of Trimeris in performing is obligations
under this Agreement. Without limiting the generality of the foregoing, Trimeris
shall indemnify, defend and hold MiniMed harmless from and against any Losses
resulting from any design defect with respect to any Trimeris Compound which is
the subject of the cooperative efforts pursuant to this Agreement.
(c) Indemnification Procedures. A Party seeking indemnification (the
"Indemnified Party") pursuant to this Section 12 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
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obligation to indemnify the Indemnified Party hereunder, the Indemnifying Party
shall have the right to select counsel, settle, try or otherwise dispose of or
handle such claim, demand, lawsuit or other proceeding on such terms as the
Indemnifying Party shall deem appropriate, subject to any reasonable objection
of the Indemnified Party.
(d) Insurance. The Parties, through the Managing Committee, shall pursue
the 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.
13. 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 December 10, 1996 (as
amended) 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) Notice. 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
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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 Trimeris: Trimeris, Inc.
4727 University Drive
Durham, North Carolina 27707
Attention. President
Fax Number: (919)419-1816
Copy to: General Counsel at same address
Fax Number: (919)419-1816
For MiniMed: MiniMed Inc.
12744 San Fernando Road
Sylmar, California 91342
Attention: President
Fax Number: (818) 362-6928
Copy to: General Counsel at same address
Fax Number (818) 367-1460
(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
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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
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 file 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
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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 Trimeris 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.
TRIMERIS, INC.
/s/ Max N. Wallace
-------------------------
Max N. Wallace
Vice President, Operations and General Counsel
MINIMED INC.
/s/ Terrance H. Gregg
-------------------------
Terrance H. Gregg
President & Chief Operating Officer
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Schedule A
Managing Committee
Trimeris, Inc. MiniMed Inc.
TO BE DETERMlNED Eric S. Kentor
Senior Vice President and General
Counsel
TO BE DETERMINED William Van Antwerp
Chief Scientist
Alliance Coordinator: Alliance Coordinator:
TO BE DETERMINED TO BE DETERMINED
Senior Management Representative
Trimeris, Inc. MiniMed Inc.
TO BE DETERMINED Terrance H. Gregg
President & Chief Operating Officer
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