PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. SUCH PORTIONS ARE DESIGNATED "[***]."
RESEARCH COLLABORATION AND OPTION AGREEMENT
-------------------------------------------
Research Collaboration and Option Agreement (the "Agreement"), dated and
effective as of March 8, 2000 (the "Effective Date") between Emisphere
--------------
Technologies, Inc., 000 Xxx Xxx Xxxx Xxxxx Xxxx, Xxxxxxxxx, XX 00000 a Delaware
corporation ("Emisphere"), and Regeneron Pharmaceuticals Inc., 000 Xxx Xxx Xxxx
---------
Xxxxx Xxxx, Xxxxxxxxx, XX 00000, a New York corporation ("Regeneron").
---------
WHEREAS, Emisphere is engaged in the research and development of proprietary
synthetic chemical compounds that enable the improved systemic delivery of
therapeutic macromolecules and other compounds (including all related patents,
patent applications, trade secrets, Know-How (as defined below) and other
intellectual property rights presently owned by Emisphere and all patents,
patent applications, Know-How and other intellectual property rights relating to
inventions developed by Emisphere pursuant to the Program (as defined below),
collectively the "Emisphere Technology"); and
--------------------
WHEREAS, Regeneron produces, or is engaged in research to produce, therapeutic
macromolecules and other compounds, has significant expertise in identifying and
developing compounds that mediate a variety of disorders, and has proprietary
compounds and technology (including patents, patent applications, trade secrets,
Know-How and other intellectual property rights presently owned by Regeneron and
to be developed by Regeneron pursuant to the Program); and
WHEREAS, Emisphere and Regeneron desire to collaborate in research regarding the
applicability of the Emisphere Technology to Regeneron's compounds, and to
provide for certain rights and obligations of Emisphere and Regeneron in the
event such research produces commercially viable applications; and
WHEREAS, Emisphere desires to grant certain options and rights to Regeneron to
develop and market Regeneron's products using the Emisphere Technology.
NOW, THEREFORE, in consideration of the mutual promises and agreements contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, Emisphere and Regeneron (each a
"Party" and together "the Parties") agree as follows:
1
ARTICLE I
RESEARCH PROGRAM
1.1 Collaboration. Regeneron and Emisphere hereby agree to
-------------
collaborate on a research and development program (the "Program"), consisting
-------
of [***] (the "Stage(s)") as specified in Exhibit A of this Agreement, to
research the use of the Emisphere Technology for the oral delivery of a ciliary
neurotrophic factor, [***] (the "Compound"). As used herein, "a ciliary
neurotrophic factor, [***] includes but is not limited to [***]. Emisphere will
make available to Regeneron Emisphere Technology relevant to the Program, that
is used to facilitate transport of therapeutic compounds through membranes (the
"Carriers").
--------
1.2 Program Management.
------------------
(a) Regeneron and Emisphere shall establish a steering committee (the
"Steering Committee"). The function of the Steering Committee shall be to
------------------
plan, coordinate and manage the Program. The Steering Committee is not intended
to replace any internal management procedures of either Party. Rather, it is
intended to be a vehicle to ensure that the Program proceeds in a timely,
coordinated, and well-planned fashion. It shall be made up of a maximum of ten
members, with an equal number appointed by each of Regeneron and Emisphere and
with a central contact person appointed by each Party. Each Party hereto shall
name one member to be a co-chairperson of the Steering Committee. The first
responsibility of the Steering Committee shall be to establish and approve a
work plan to assure the timely completion of the Program. The second
responsibility of the Steering Committee shall be to [***] which will be
used to make the "go/no go" decision with respect to continued research into
and/or development of the use of the Carriers for oral delivery of the Compound
(the "Criteria") for Stages [***] only. Regeneron and Emisphere shall determine
--------
at the end of each Stage whether the Criteria have been met. On at least a
quarterly basis, the Steering Committee shall meet to review the results of the
Program and to modify the work plan as necessary. On a quarterly basis or time
frame agreed to by the parties, each party's respective patent counsel shall
meet to discuss patent filings and intellectual property matters.
(b) The Steering Committee shall keep minutes of its meetings, and
shall be responsible only for the development and implementation of the work
plan. If the members of the Steering Committee cannot agree jointly on a task in
the work plan, it will be up to the Co-Chairmen to reach a decision. If the Co-
Chairmen cannot reach agreement, the matter shall be brought to the CEO of
Emisphere and CEO of Regeneron. In the event that the CEOs cannot resolve the
issues within [***] days, the CEOs of the Parties shall mutually agree upon and
appoint to the Steering Committee an additional member. If the CEOs cannot
mutually agree upon the identity of such additional member within [***], the
Parties shall request an arbitration panel, pursuant to section 4.19, to appoint
to the Steering Committee an additional member, knowledgeable in the research-
based pharmaceutical industry, possessing senior
2
executive experience and skills, and not associated with either Party, an
Affiliate of either Party or a competitor of either Party. Thereafter, all
decisions will be by majority vote of the Steering Committee. Such additional
member shall be appointed to the Steering Committee until such time as the CEOs
mutually agree that such disputes have been resolved. Such additional member
shall be instructed to render his/her votes consistent with the stated
responsibilities of the Steering Committee, as set forth in section 1.2(a)
above. Finally, meetings of the Steering Committee will alternate between
Emisphere's designated facility and Regeneron's designated facility.
1.3 Term; Termination; Damages.
--------------------------
(a) The Agreement is in effect as of the Effective Date. Subject to
articles 1.3(b), (c), (d), (e), and (f), the Program shall proceed as outlined
in Exhibit A. The Companies will determine at the end of each Stage whether the
Criteria have been met. If the Criteria have been met, then the Program shall
continue to the next Stage provided that the profile of the Compound itself does
not preclude its further development [***].
(b) If preclinical or clinical findings prevent initiation or
completion of a Stage of the Program with respect to the Emisphere Technology
and/or the Compound, Regeneron or Emisphere, as the case may be, will have the
option of immediately terminating the Program.
(c) Either Party may terminate this Agreement upon written notice to
the other Party that such Party has committed a material breach of this
Agreement if, within 60 days of receipt of such notice, such breach has not been
cured, or the Parties have not agreed in writing to amend the Agreement to waive
such breach.
(d) Should Emisphere have a bona fide written offer (the
"Offer") during [***] of this Agreement from a third party to in-license
Emisphere's Technology for use with the Compound or establish an exclusive
research collaboration for the Compound at terms more favorable to Emisphere
than herein, Emisphere shall be obligated, [***]. Regeneron shall have [***]
upon notification by Emisphere of the Offer or to [***], whichever is later (the
"Decision Period"), to determine whether or not to exercise its Option (as
defined below) to a license agreement (the "License Agreement"). If the Decision
Period expires and Regeneron has not exercised its Option, Emisphere may
immediately terminate the Program and this Agreement.
(e) Termination or expiration of this Agreement shall not affect the
rights and obligations of the Parties accrued hereunder prior to termination or
expiration. To avoid doubt, it is hereby confirmed that termination of this
Agreement by Regeneron because of a breach solely by Emisphere shall not affect
Regeneron's options and rights as set forth in Article II. To further avoid
doubt, if Emisphere terminates this Agreement because of a breach solely by
Regeneron, Regeneron's options and rights under Article II shall be terminated.
However, termination of this Agreement shall not affect any license entered into
pursuant to such options (whether Regeneron or Emisphere is the terminating
Party).
3
(f) If the Steering Committee cannot agree on the scope, Criteria and
tentative timelines for the Program within 45 days of the Effective Date, then
the dispute resolution process outlined in section 1.2 (b) shall be initiated.
1.4 Payments.
--------
(a) As part of the work plan established by the Steering Committee,
the Parties shall jointly define the number of Emisphere Full Time Equivalent
personnel ("FTE's") required to complete each Stage of the Program in a timely
-----
manner. Regeneron shall pay to Emisphere [***] for each Emisphere FTE who works
on the Program pursuant to the work plan as supported by appropriate
documentation. Regeneron shall be required to fund Emisphere FTE's required by
the work plan. All payments shall be paid by wire transfer within [***]
following receipt of Emisphere's invoice by Regeneron.
(b) "FTE" means a full-time equivalent scientific person year
---
directly related to the Program wherein said scientific person year refers to
chemical, biological or engineering research scientists and [***]. Scientific
work on or directly related to the Program to be performed by Emisphere can
include, but is not limited to, experimental laboratory work, recording and
writing up results, reviewing literature and references, holding scientific
discussions, managing and leading scientific staff, and carrying out Program
management duties or such other activities as may be appropriate to the conduct
of the Program.
(c) If Regeneron desires to expand research beyond the scope of the
Program, if acceptable to Emisphere in its sole discretion, the Parties hereto
will mutually agree in writing upon the research programs to be added and the
number of Emisphere FTE's necessary to achieve the objectives of the expanded
research. The additional cost for each Emisphere FTE shall be [***] to be paid
as follows: (i) an initial payment shall be made on the next date a payment is
due, pro-rated for the period between such day the Emisphere FTE is added and
the next quarterly payment due pursuant to Section 1.4(a), above, and (ii) all
subsequent payments shall be made at the same time as the payments for the
Program.
(d) All payments by Regeneron will be made following the receipt of
an invoice from Emisphere as per an invoicing structure to be provided by
Regeneron.
1.5 Ownership of Intellectual Property.
----------------------------------
(a) "Emisphere Know-How" means all trade secrets, confidential
------------------
scientific, technical and medical information, experimental results and
expertise from time to time developed, produced, created or acquired by or on
behalf of Emisphere either prior to the Effective Date and pertaining to the
Program or during the term and in the course of carrying out the Program,
including, but not limited to, unpatented inventions, discoveries, theories,
plans, ideas or designs (whether or not reduced to
4
practice) relating to the research and development, registration for marketing,
use, or sale of the Carriers, or products utilizing the Carriers, preclinical
toxicology and manufacturing for the Carriers, and toxicological,
pharmacological, analytical and clinical data, bioavailability studies and
formulations, control assays and specification, methods of preparation,
tableting techniques, salt and other physical forms, and stability data related
thereto. To the extent that any of the items listed above are acquired by
Emisphere, they shall only fall within the definition of Know-How hereunder to
the extent to which there are no obligations or restrictions in respect of such
items which would prohibit disclosure by Emisphere or free use by Regeneron or
Emisphere.
(b) " Regeneron Improvements of Emisphere Know-How" shall mean any
---------------------------------------------
improvement specifically relating to the Carriers and made solely by Regeneron
during the term and in the course of carrying out the Program.
(c) "Regeneron Know-How" means all trade secrets, confidential
------------------
scientific, technical and medical information, experimental results and
expertise from time to time developed, produced, created or acquired by or on
behalf of Regeneron either prior to the Effective Date and pertaining to the
Program or during the term and in the course of carrying out the Program,
including, but not limited to, unpatented inventions, discoveries, theories,
plans, ideas or designs (whether or not reduced to practice) relating to the
research and development, registration for marketing, use, or sale of the
Compound, preclinical toxicology and manufacturing for the Compounds, and
toxicological, pharmacological, analytical and clinical data, bioavailability
studies and formulations, control assays and specification, methods of
preparation, and stability data related thereto. To the extent that any of the
items listed above are acquired by Regeneron, they shall only fall within the
definition of Know-How hereunder to the extent to which there are no obligations
or restrictions in respect of such items which would prohibit disclosure by
Regeneron or free use by Emisphere or Regeneron.
(d) "Emisphere Improvements of Regeneron Know-How" shall mean any
--------------------------------------------
improvement specifically relating to the Compound and made solely by Emisphere
during the term and in the course of carrying out the Program.
(e) "Joint Improvements" shall mean any improvement made jointly by
------------------
Emisphere and Regeneron during the term and in the course of carrying out the
Program.
(f) Emisphere shall have the right to use any data including
preclinical and toxicology data, protocols and methods pertaining to the
Carriers and the Compound/Carrier combinations that are generated for the
Program, such use being subject to the confidentiality provisions of Article IV.
Regeneron shall have the right to use any data including preclinical and
toxicology data, protocols and methods that are generated for the Program
pertaining to Compound and the Compound/Carrier combinations, such use being
subject to the confidentiality provisions of Article IV.
5
(g) "Intellectual Property" shall mean all patents, patent
---------------------
applications, copyrights, Know-How, trade secrets, data generated during the
Program, and other intangible property rights relating to the inventions and/or
developments that pertain to the Program.
(h) With respect to Intellectual Property conceived and/or developed
by Emisphere, Regeneron or jointly as a result of activities carried-out
pursuant to this Agreement, the extent of ownership of such Intellectual
Property shall be as follows:
i) if the Intellectual Property relates to the Carriers alone or the
Carrier/Compound combination, Emisphere shall own such
Intellectual Property without regard to which party conceived or
developed the Intellectual Property;
ii) if the Intellectual Property relates to the Compound alone,
Regeneron shall own such Intellectual Property without regard to
which party conceived or developed the Intellectual Property;
iii) if the Intellectual Property is developed jointly by employees
of Regeneron and Emisphere, Regeneron and Emisphere shall each
own an undivided one-half interest in such Intellectual Property
except as provided in sections 1.5.h.i and 1.5.h.ii above;
iv) if the Intellectual Property is developed solely by Emisphere or
solely by Regeneron and the Intellectual property does not
relate to the Carrier alone, Carrier Compound combination, or
the Compound alone, then the respective party shall own the
Intellectual Property.
(i) Emisphere and Regeneron shall be granted a world-wide royalty-
free license on all Joint Improvements pertaining to section 1.5.h.iii.
ARTICLE II
RIGHTS AND OPTIONS
2.1 The Right. Regeneron is hereby granted a right during [***]
---------
(the "Right") to obtain an option (the "Option") to an exclusive worldwide (the
"Territory") license (the "License") to, in conjunction with Emisphere, develop,
---------
make, have made, use and sell products embodying the Emisphere Technology for
the Compound [***] for oral delivery thereof ("Product") as defined in the
-------
License, which would be executed at the end of the Option Period based upon the
terms set forth in the outline attached hereto as Exhibit B, an executable
version of which should be finalized within [***] after the Effective Date of
this Agreement and attached to this document in Exhibit C.
2.2 The Right Period. The Right shall expire at the [***] or upon
----------------
execution of a License (the "Right Period") whichever is sooner. Execution of a
License prior to the end of Stage B will eliminate and avoid the obligation to
pay the Option fee for Stage C.
6
2.3 The Option Fee. In order to exercise their Right to obtain the
--------------
Option, Regeneron shall send Emisphere a letter within the Right Period (the
"Rights Letter") indicating Regeneron's intent to exercise their Right, and
Regeneron will pay Emisphere [***] (the "Option Fee") by wire transfer within
[***] after receipt by Emisphere of the Rights Letter. The payment of this
Option fee will provide Regeneron a period of exclusivity (the "Option Period"),
whereby Emisphere will not be permitted to license the Emisphere Technology for
the oral delivery of the Compound to a third party.
2.4 Option Period. The Option shall begin upon receipt by Emisphere
-------------
of the Option Fee and [***]. The Option period may be extended by written
agreement signed by both Parties.
2.5 Exercising the Option. The Option shall be exercised by
---------------------
Regeneron, and solely at Regeneron's discretion, by delivery of a written notice
(the "Option Letter") to Emisphere during the Option Period. At such time the
License shall be executed and become effective after the exercise by Regeneron
of the Option and the payment of $[***] (the "License Fee") to Emisphere.
Each of the Parties hereto shall execute the License Agreement relating to the
Option within [***] working days of exercise thereof.
2.6 Responsibilities of the Parties during the Option period.
--------------------------------------------------------
During the Option Period as described in Exhibit A in Stage C, Emisphere shall
(i) provide Carrier Compound preparations for in vivo experiments, (ii) assist
in the formulation development (iii) assist in Product development (iv) assist
in planning for a first into man study, (vi) ensure a sufficient supply of
Carriers to support required preclinical and clinical studies, and (vii )
cooperate with Regeneron for future regulatory filings. Regeneron shall (i)
supply bulk Compounds for the Program, (ii) provide necessary physical or
chemical data on the Compounds, (iii) take all responsibility for the necessary
clinical studies, and (iv) take all responsibility for the regulatory filings
necessary for the Program. During the Program it is anticipated that Emisphere
will require [***] to manufacture the Carrier. Regeneron shall reimburse
Emisphere for the actual cost paid by Emisphere to the contract manufacturer of
the Carrier for all such material used in the Program. It is understood by the
Parties that the total number of kilograms of Carrier will have to be specified
in writing in the Program between the members of the Steering Committee of each
Party.
ARTICLE III
REPRESENTATIONS AND WARRANTIES
3.1 Due Incorporation. Each of the Parties represents and warrants
-----------------
to the other that it is duly incorporated under the relevant laws of
incorporation and each has full corporate authority to enter into and to perform
its obligations under this Agreement.
7
3.2 Due Authorization. Each of the Parties represents and warrants
-----------------
to the other that this Agreement has been fully authorized, executed and
delivered by it and it has full legal right, power and authority to enter into
and perform this Agreement, which constitutes a valid and binding agreement
between the Parties and that it does not conflict with or result in a breach of
the terms of such Party's organizational documents and applicable laws,
regulation or order or any agreement or other obligation to which such Party is
a party.
3.3 Litigation. Each of the Parties represents and warrants to the
----------
other that it is not engaged in any litigation or arbitration, or in any dispute
or controversy reasonably likely to lead to litigation, arbitration or other
proceeding, which would materially affect the validity of this Agreement or such
Party's ability to fulfill its respective obligations under this Agreement.
ARTICLE IV
MISCELLANEOUS
4.1 Confidentiality.
----------------
4.1.1 Emisphere Information. Regeneron will maintain in confidence,
---------------------
and will ensure that its Affiliates and its and their consultants, employees,
agents and representatives maintain in confidence, all proprietary and
confidential information which has been or is provided by Emisphere to
Regeneron, including but not limited to, Emisphere's inventions, discoveries,
improvements, trade secrets, carriers (including structures and physical
properties), methods, scientific protocols, business plans, marketing techniques
or plans, manufacturing and other plant designs, location of operations, and any
other information affecting the business operations of Emisphere ("Emisphere
Information"), and will not use for any purpose other than the completion of the
Agreement and will not publish, disseminate, or disclose, in any manner, to any
person any Emisphere Information unless: (i) Regeneron is legally required to do
so, (ii) the Emisphere Information has entered or enters the public domain
through no fault of Regeneron, (iii) the Emisphere information was already known
by Regeneron before receipt from Emisphere, or is developed independently by
Regeneron without breach of this Agreement, in either case as shown by
contemporaneous written records, or (iv) the Emisphere Information is received
by Regeneron from a third party under no confidentiality obligation.
4.1.2 Regeneron Information. Emisphere will maintain in confidence,
----------------------
and will ensure that its Affiliates and its and their consultants, employees,
agents and representatives maintain in confidence, all proprietary and
confidential information which has been or is provided by Regeneron to
Emisphere, including but not limited to, Regeneron's inventions, discoveries,
improvements and methods, business plans, marketing techniques or plans,
manufacturing and other plant designs, location of operations, and any other
information affecting the business operations of Regeneron ("Regeneron
Information"), and will not use for any purpose other than the completion
8
of the Agreement Agreement, and will not publish, disseminate, or disclose, in
any manner, to any person any Regeneron Information unless: (i) Emisphere is
legally required to do so, (ii) the Regeneron Information has entered or enters
the public domain through no fault of Emisphere, (iii) the Regeneron Information
was already known by Emisphere before receipt from Regeneron, or is developed
independently by Emisphere without breach of this Agreement, in either case as
shown by contemporaneous written records, or (iv) the Regeneron Information is
received by Emisphere from a third party under no confidentiality obligation.
4.1.3 Required Disclosure. In the event that either Party is
-------------------
requested or required (by oral questions, interrogatories, requests for
information or documents in legal proceedings, subpoena civil investigative
demand or other similar process) to disclose any of the confidential information
of the other Party, the Party requested or required to make the disclosure shall
provide the other Party with prompt notice of any such request or requirement so
that the other Party may seek a protective order or other appropriate remedy
and/or waive compliance with the provisions of this Agreement. If in the absence
of a protective order or other remedy or the receipt of a waiver by such other
Party, the Party requested or required to make the disclosure are nonetheless,
in the opinion of counsel, legally compelled to disclose the other Party's
Confidential Information to any tribunal, the Party requested or required the
disclosure may without liability hereunder, disclose to such tribunal only that
portion of the other Party's Confidential Information which such counsel advises
is legally required to be disclosed, provided that the Party requested or
required to make the disclosure exercises its reasonable efforts to preserve the
confidentiality of the other Party's Confidential Information, including without
limitation, by cooperating with the other Party to obtain an appropriate
protective order or other reliable assurance that confidential treatment will be
accorded the other Party's Confidential Information by such tribunal.
4.1.4 Survival. The provisions of this Article 4 will survive the
--------
termination or expiration of this Agreement for seven (7) years.
4.2 Indemnity.
---------
4.2.1 Regeneron shall indemnify, defend and hold harmless
Emisphere, its affiliates, agents, directors, officers and employees from and
against any loss, damage, action, proceeding, expense or liability (including
attorney's fees) ("Loss") arising from or in connection with any claim of a
----
third party with regard to the manufacture, importation, exportation,
distribution, sale, offer for sale possession or use of any Product prepared
pursuant to the Program, except for any Loss caused by Emisphere's gross
negligence or intentional misconduct.
4.2.2 Emisphere shall indemnify, defend and hold harmless Regeneron,
its affiliates, agents, directors, officers and employees from and against any
Loss arising from or in connection with any claim of a third party with regard
to the manufacture, importation, exportation distribution, storage possession or
use of any Carrier prepared and supplied by Emisphere or its third party
suppliers to Regeneron, except for any Loss caused by Regeneron's gross
negligence or intentional misconduct.
9
4.3 Public Disclosure. The Parties hereto agree to disclose
-----------------
publicly upon signing the Agreement, the nature and scope of the Agreement.
Thereafter, all press releases and other public disclosures shall be approved in
writing in advance by both Parties, except for such disclosures permitted
pursuant to Section 4.1 above, such approval not to be unreasonably withheld or
delayed. Upon the occurrence of other significant events in the Program,
Emisphere and Regeneron agree to make joint press releases.
4.4 (a) Standstill. For [***], or unless Regeneron shall have been
----------
specifically invited in writing by Emisphere (it being understood that
Regeneron's acknowledgment of this Agreement does not constitute such an
invitation), and unless and until a third party does such, Regeneron will not,
and will cause each of its Affiliates (as defined in the License Agreement
attachment) not to, directly or indirectly, solicit, seek or offer to effect,
negotiate with, encourage or support (including by providing financing for
another person) any person with respect to, or make any statement or proposal,
whether written or oral, either alone or in concert with others, to Emisphere or
any of its Affiliates (whether to the Board of Directors of Emisphere, to any
director or officer of Emisphere or otherwise) or to any security holder of
Emisphere, or otherwise make any public announcement or proposal or offer
whatsoever, with respect to (i) any form of business combination or transaction
involving Emisphere or any Affiliate thereof, including, without limitation, a
merger, consolidation, tender or exchange offer, sale or purchase of assets or
securities, or dissolution or liquidation of Emisphere or any direct or indirect
subsidiary thereof, (ii) any form of restructuring, recapitalization or similar
transaction with respect to Emisphere or any affiliate thereof, (iii) any
proposal or other statement inconsistent with the terms of this Agreement, (iv)
any demand or proposal to amend waive or terminate any provision of this section
4.4; or (v) instigate, encourage or assist any person to do any of the
foregoing.
As of the date hereof, neither Regeneron nor any Affiliate of Regeneron
beneficially owns any securities of Emisphere. Regeneron agrees that without the
express prior written consent of Emisphere unless and until a third party does
such that Regeneron will not, and will cause each of its Affiliates not to,
singly or as part of a "partnership, limited partnership, syndicate or other
group" (as those terms are used within the meaning of Section 13(d)(3) of the
Exchange Act, which meanings shall apply for all purposes of this Agreement),
directly or indirectly, through one or more intermediaries or otherwise;
i) acquire, offer or propose to acquire, or agree to acquire, by
purchase or otherwise, any securities entitled to, or that may be
entitled to, vote generally in the election of Emisphere's Board of
Directors (collectively, "Voting Securities") or any direct or indirect
rights or options to acquire (through purchase, exchange, conversion or
otherwise) any Voting Securities;
ii) make, or in any way participate in, any "solicitation" of "proxies"
(as such terms are defined or used in Regulation 14A of the Exchange Act)
with respect to the Voting Securities (including by the execution of
action by
10
written consent), seek to advise, encourage or influence any person or
entity with respect to the voting of any Voting Securities or demand a
copy of Emisphere's stock ledger, list of its stockholders, or other
books and record;
iii) participate in, encourage or support any person (or the formation
of any group) which owns or seeks or offers to acquire beneficial
ownership of securities of Emisphere or rights to acquire such
securities or which seeks or offers to affect control of Emisphere or
for the purpose of circumventing any provision of this Agreement
iv) otherwise act, alone or in concert with others (including by
providing financing for another person), to seek or offer to control
or influence, in any manner, the management, Board of Directors or
policies of Emisphere; or seek, alone or in concert with others,
representation on the board of Directors of Emisphere or seek the
removal of any member of the Board of Directors.
(b) Standstill. For [***], or unless Emisphere shall have been
----------
specifically invited in writing by Regeneron (it being understood that
Emisphere's acknowledgment of this Agreement does not constitute such an
invitation), and unless and until a third party does such, Emisphere will not,
and will cause each of its Affiliates (as defined in the License Agreement
attachment) not to, directly or indirectly, solicit, seek or offer to effect,
negotiate with, encourage or support (including by providing financing for
another person) any person with respect to, or make any statement or proposal,
whether written or oral, either alone or in concert with others, to Regeneron or
any of its Affiliates (whether to the Board of Directors of Regeneron, to any
director or officer of Regeneron or otherwise) or to any security holder of
Regeneron, or otherwise make any public announcement or proposal or offer
whatsoever, with respect to (i) any form of business combination or transaction
involving Regeneron or any Affiliate thereof, including, without limitation, a
merger, consolidation, tender or exchange offer, sale or purchase of assets or
securities, or dissolution or liquidation of Regeneron or any direct or indirect
subsidiary thereof, (ii) any form of restructuring, recapitalization or similar
transaction with respect to Regeneron or any affiliate thereof, (iii) any
proposal or other statement inconsistent with the terms of this Agreement, (iv)
any demand or proposal to amend waive or terminate any provision of this section
4.4; or (v) instigate, encourage or assist any person to do any of the
foregoing.
As of the date hereof, neither Emisphere nor any Affiliate of Emisphere
beneficially owns any securities of Regeneron. Emisphere agrees that without the
express prior written consent of Regeneron unless and until a third party does
such that Emisphere will not, and will cause each of its Affiliates not to,
singly or as part of a "partnership, limited partnership, syndicate or other
group" directly or indirectly, through one or more intermediaries or otherwise;
i) acquire, offer or propose to acquire, or agree to acquire, by purchase
or otherwise, any securities entitled to, or that may be entitled to,
vote generally in the election of Regeneron's Board of Directors
(collectively, "Voting
11
Securities") or any direct or indirect rights or
options to acquire (through purchase, exchange, conversion or otherwise)
any Voting Securities;
ii) make, or in any way participate in, any "solicitation" of "proxies"
(as such terms are defined or used in Regulation 14A of the Exchange Act)
with respect to the Voting Securities (including by the execution of
action by written consent), seek to advise, encourage or influence any
person or entity with respect to the voting of any Voting Securities or
demand a copy of Regeneron's stock ledger, list of its stockholders, or
other books and record;
iii) participate in, encourage or support any person (or the formation of
any group) which owns or seeks or offers to acquire beneficial ownership
of securities of Regeneron or rights to acquire such securities or which
seeks or offers to affect control of Regeneron or for the purpose of
circumventing any provision of this Agreement
iv) otherwise act, alone or in concert with others (including by
providing financing for another person), to seek or offer to control or
influence, in any manner, the management, Board of Directors or policies
of Regeneron; or seek, alone or in concert with others, representation on
the board of Directors of Regeneron or seek the removal of any member of
the Board of Directors.
4.5 Change of Control. Upon any occurrence of a change in control of
-----------------
Emisphere or Regeneron prior to commercial introduction of the Product, the
other Party shall have the right to terminate this Agreement; however, all
provisions of Article 4, herein shall survive said termination, and specifically
the provisions of 4.1.
For purposes of this Section 4.5 a "change of control" shall mean that (A) in
any three-year period, a majority of the members of the Board of Directors
elected during such three-year period shall have been so elected against the
recommendation of the management of the company or the Board of Directors in
office immediately prior to such election; and (B) a person, singly or as a part
of a partnership, syndicate or other group, owns 50% or more of the company's
capital or business assets, has the power to exercise 50% or more of the voting
rights or to appoint 50% or more of the Board of Directors of the company, or
otherwise has the right to control the company's affairs.
4.6 Amendment. No amendment, waiver or consent to this Agreement
---------
shall be effective unless signed in writing by both Parties hereto.
4.7 Assignment. Neither Party may assign its rights or obligations
----------
under this Agreement without the prior written consent of the other Party,
except that a Party hereto may, without such prior written consent, assign any
of its rights or obligations to an Affiliate in the pharmaceutical business.
4.8 Entire Agreement. This Agreement constitutes the entire
----------------
agreement of the Parties with respect to the subject matter hereof and
supersedes any
12
and all prior negotiations, correspondence and understandings between the
Parties with respect to the subject matter hereof, whether oral or in writing.
4.9 GOVERNING LAW. THIS AGREEMENT SHALL BE GOVERNED BY AND
-------------
CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD
TO THE CONFLICTS OF LAWS PRINCIPLES THEREOF.
4.10 Notices. All notices and other communications pursuant to this
-------
Agreement shall be in writing, shall be effective when received, and shall be
deemed to have been received on the date of delivery if delivered personally; or
on the second business day after the business day of deposit with Federal
Express or other similar courier for overnight delivery, freight prepaid; in
each such case, addressed as follows (until any such address is changed by
notice duly given):
to Emisphere: Emisphere Technologies, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: Xxxxx X. Xxxxxx
Telecopy: (000) 000-0000
with copy to: Xxxx, Weiss, Rifkind, Xxxxxxx & Xxxxxxxx
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, XX 00000-0000
Attention: Xxxxx X. Xxxxxxx
Telecopy: (000) 000-0000
to Regeneron: Regeneron Pharmaceutical, Inc.
Finance Department
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: Xx. Xxxxxx Xxxxxxxx
with copy to: Skadden, Arps, Slate, Meagher, Xxxx LLP
Xxxx Xxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telephone: 000-000-0000
Fax: 000-000-0000
4.11 Counterparts. This Agreement may be executed in two or more
------------
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
4.12 Diligence. Each Party will use diligent efforts to conduct the
---------
tasks assigned to it hereunder. Each Party, further, agrees to conduct such
tasks at least as
13
diligently as the Party conducts research and development for other projects of
similar commercial potential and at similar stages of development. Neither Party
will be responsible for delays due to factors beyond its control.
4.13 No Agency. It is understood and agreed that Emisphere and
---------
Regeneron each shall have the status of independent contractors under this
Agreement and that nothing in this Agreement shall be construed as authorization
for either Party to act as agent for the other. Members of the Steering
Committee who are employees of Emisphere shall be and shall remain employees of
Emisphere and Regeneron shall not incur any liability for any act or failure to
act by such employees. Members of the Steering Committee who are employees of
Regeneron shall be and shall remain employees of Regeneron and Emisphere shall
not incur any liability for any act or failure to act by such employees.
4.14 Force Majeure. Each Party hereto shall be relieved of its
-------------
obligations hereunder to the extent that fulfillment of such obligations shall
be prevented by acts beyond its reasonable control.
4.15 Titles. The titles of the Articles and Sections of this
------
Agreement are for general information and reference only, and this Agreement
shall not be construed by reference to such titles.
4.16 Severability. Each Party agrees that, should any provision of
------------
this Agreement be determined by a court of competent jurisdiction to violate or
contravene any applicable law or policy, such provision will be severed or
modified by the court to the extent necessary to comply with the applicable law
or policy, and such modified provision and the remainder of the provisions
hereof will continue in full force and effect.
4.17 Waiver. Failure by either Party to enforce any rights under
------
this Agreement shall not be construed as a waiver of such rights nor shall a
waiver by either Party in one or more instances be construed as constituting a
continuing waiver or as a waiver in other instances.
4.18 No Strict Construction. This Agreement has been prepared
----------------------
jointly and shall not be strictly construed against either Party.
14
4.19 Dispute Resolution. Any dispute regarding this Agreement or
------------------
the enforcement of a Party's rights or obligations hereunder shall be submitted
in the first instance to the Chief Executive Officers of Emisphere and of
Regeneron. If the dispute cannot be resolved by the designated individuals
within thirty (30) days after such submission, then the matter may be submitted
to binding arbitration pursuant to the rules of the International Chamber of
Commerce, such arbitration to take place in New York, NY.
4.20 Disclosure of evaluation results. Each party recognizes that
--------------------------------
the other may wish to publish a scientific article or make any other public
disclosure based upon the results of the Program (the "Disclosure"). Each party
agrees that as a condition of any Disclosure, the disclosing party must (i)
provide the other party with a copy of the proposed Disclosure prior to its
submission to any public forum, (ii) receive from the other party its approval
of the form and content of the proposed Disclosure, which approval shall not be
unreasonably withheld, and Emisphere and Regeneron agree that no Disclosure will
be submitted to any third party without the prior written consent of the other.
Both Parties hereby agree that either party shall have the right to withhold its
approval of any Disclosure if such Disclosure (a) contains the chemical
structure of the Carrier (b) otherwise contains any of the Confidential
Information of the non-disclosing party as defined in the Confidential
Disclosure Agreement or (c) would require the filing of a patent application.
15
IN WITNESS WHEREOF, the undersigned have executed this Agreement on the day and
year first above written.
EMISPHERE TECHNOLOGIES, INC.
By: ___________________________
Name:
Title:
Date:
REGENERON PHARMACEUTICALS
By: ___________________________
Name:
Title:
Date:
16
Exhibit A
---------
Collaboration Program
---------------------
Stage Title FTEs Costs
---- -----
[***]
17
Exhibit B Outline of License Terms
The following is the basis for a license agreement.
Product: Oral forms the Compound and a Carrier.
-------
Field: All human therapeutic uses of the Product administered by
----- oral means
Territory: [***]
---------
License: Exclusive use of Emisphere's oral delivery technology
------- (patents and know-how) for the Product in the Territory in
the Field.
Manufacturing: Regeneron or Emisphere would manufacture the Product(s).
-------------- Emisphere would supply the Carrier [***].
Marketing: Regeneron would have worldwide rights to market Product(s).
--------- Regeneron would have the option of declining the rights for
various countries. Regeneron could find sublicensees in
various countries provided the Emisphere royalty rate on net
sales of the Product is unchanged.
Research &
Development Regeneron would be responsible for full funding all
----------- research efforts agreed upon by the two Parties for [***]
to identify a delivery agent suitable for a commercial
product. Regeneron would be responsible for funding of all
development efforts agreed upon by the two Parties including
clinical and non-clinical testing during the research period
and after a delivery agent is identified.
License fee: Upon execution of a license agreement for the oral product,
------------ Emisphere would receive a payment of [***].
Milestones: [***]
-----------
Royalty Rate to
be paid to
Emisphere: [***]
---------
18
Exhibit C
---------
FORM OF LICENSE AGREEMENT
[to be attached within 90 days of the execution of this Agreement]
19
