THIRD AMENDED AND RESTATED LICENSE AGREEMENT BETWEEN MEDISTEM LABORATORIES, INC. AND INSTITUTE FOR CELLULAR MEDICINE
THIRD
AMENDED AND RESTATED
BETWEEN
MEDISTEM
LABORATORIES, INC.
AND
INSTITUTE
FOR CELLULAR MEDICINE
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TABLE
OF CONTENTS
(continued)
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ii
TABLE
OF CONTENTS
(continued)
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iii
THIRD
AMENDED AND RESTATED LICENSE AGREEMENT
THIS
THIRD AMENDED AND RESTATED LICENSE AGREEMENT (this “Agreement”), dated as of
September 2, 2008, is entered into by and between Medistem Inc., a corporation
organized and existing under the laws of Nevada and formerly known as Medistem
Laboratories, Inc., having offices located at 0000 X. Xxxxx Xxxx, Xxxxx 0,
Xxxxxxxx, XX 00000 (“Medistem”), and Institute for Cellular Medicine, a company
organized and existing under the laws of Costa Rica, having offices located at
the Guimel Building, San Xxxx, Costa Rica (“Licensee”). This Agreement hereby
amends and restates and replaces in its entirety the Second Amended and Restated
License Agreement previously entered into between Licensee and Medistem, dated
December 31, 2007 (the “Second Amendment”).
PRELIMINARY
STATEMENTS
A. Medistem
owns the rights to the Patents and Know-How in existence as of the Effective
Date relating to the Invention.
B. Licensee
has the personnel, facilities and expertise necessary for the development and
commercialization of the Product in the Territory.
C. Licensee
wishes to perform all of the functions required to develop and commercialize the
Product in the Territory, and Medistem wishes to license Licensee do so, upon
the terms and subject to the conditions set forth in this
Agreement. In connection therewith, Licensee desires to obtain, and
Medistem desires to grant to Licensee, an exclusive license under the Licensed
Technology with respect to the commercialization of the Product in the Territory
for applications in the Field, subject to Medistem’s right to manufacture and
supply post-natal and adult stem cells for Licensee, all on the terms and
subject to the conditions set forth below.
D. Simultaneously
with the execution of the License Agreement previously entered into between
Licensee and Medistem, dated February 23, 2006 (the “Original Agreement,”) the
Parties entered into that certain Equipment Lease Agreement (the “Equipment
Lease Agreement”) and the documents ancillary thereto, all dated as of the date
of the Original Agreement, pursuant to which Licensee is leasing certain
equipment from Medistem for use in Licensee’s operations.
E. Parties
wish to amend and restate the License Agreement to adjust the licensing fees
from an ongoing royalty stream to a one-time payment and to expand the
Territory.
NOW,
THEREFORE, in consideration of the foregoing Preliminary Statements and the
mutual agreements and covenants set forth herein, the Parties hereby agree as
follows:
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1.
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DEFINITIONS.
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As used
in this Agreement, the following terms shall have the meanings set forth in this
Section 1
unless context dictates otherwise:
1
1.1 “Affiliate,” with respect to
any Party, shall mean any entity controlling, controlled by, or under common
control with, such Party. For these purposes, “control” shall refer
to: (i) the possession, directly or indirectly, of the power to direct the
management or policies of an entity, whether through the ownership of voting
securities, by contract or otherwise, or (ii) the ownership, directly or
indirectly, of at least 50% of the voting securities or other ownership interest
of an entity.
1.2 “Confidential Information”
shall have the meaning assigned to such term in Section 8.4.
1.3 “Development Program” shall
have the meaning assigned to such term in Section 3.1.
1.4 “Effective Date” shall mean
the date of this Agreement.
1.5 “Equipment Lease Agreement”
shall have the meaning assigned to such term in the Preliminary
Statements.
1.6 “Field” shall mean the
therapeutic treatment of various medical conditions in humans.
1.7 “First Amendment” shall mean
the First Amended and Restated License Agreement previously entered into between
Licensee and Medistem, dated October 12, 2006.
1.8 “IND” shall mean any filing
made with the Regulatory Authority in the Territory for initiating clinical
trials in such country with respect to the Product.
1.9 “Invention” shall mean any new
or useful process, manufacture, compound or composition of matter relating to
the Product (including, without limitation, the formulation, delivery or use
thereof), whether patentable or unpatentable, or any improvement thereof, that
is conceived or first reduced to practice or demonstrated to have utility during
the term of this Agreement.
1.10 “Know-how” shall mean any and
all Inventions, improvements, discoveries, claims, formulae, processes, trade
secrets, technologies and know-how (including confidential data and Confidential
Information) that is generated, owned or controlled by Medistem at any time
before or during the term of this Agreement relating to, derived from or useful
for the use or sale of the Product, including, without limitation, synthesis,
preparation, recovery and purification processes and techniques, control methods
and assays, chemical data, toxicological and pharmacological data and
techniques, clinical data, medical uses, product forms and product formulations
and specifications.
1.11 “Licensed Claim” shall mean
any claim of any Patent that relates to and is necessary for the use and sale of
the Product, which claim has not been held invalid or unenforceable by decision
of a court or other governmental agency of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, and which is not admitted to
be invalid through disclaimer or otherwise not admitted by Medistem to be
invalid.
2
1.12 “Licensed Technology” shall
mean the Licensed Claims and Know-how, collectively.
1.13 “Original Agreement” shall
have the meaning assigned to such term in the Preliminary
Statements.
1.14
“Party” shall mean
Medistem or Licensee and, when used in the plural, shall mean Medistem and
Licensee.
1.15 “Patents” shall mean the
provisional patent application described on Exhibit
A attached hereto, and any other patents or patent applications owned or
controlled by Medistem during the term of this Agreement that relate to the
Product, together with any patents that may issue therefore, including any and
all extensions, renewals, continuations, continuations-in-part, divisions,
patents-of-additions, reissues, supplementary protection certificates or foreign
counterparts of any of the foregoing.
1.16 “Product” shall mean all
infusion quality adult stem cells for use in the Field, the manufacture, use or
sale of which either is: (i) based upon, derived from or related to any of the
Know-how; and/or (ii) covered by one or more Licensed Claims and, but for this
Agreement, would constitute an infringement (whether directly, contributorily or
by inducement) thereof, and such other ancillary services related to the
foregoing.
1.17 “Registration” shall mean,
with respect to any country in the Territory, approval of the Registration
Application for the Product filed in such country, including pricing or
reimbursement, where applicable, by the Regulatory Authority in such
country.
1.18 “Registration Application”
shall mean any filing(s) made with the Regulatory Authority in any country in
the Territory for regulatory approval of the manufacture and sale of the Product
in such country.
1.19 “Regulatory Authority” shall
mean the authority(ies) in any country in the Territory with responsibility for
granting regulatory approval for the manufacturing and sale of the Product in
such country, and any successor(s) thereto.
1.20 “Second Amendment” shall have
the meaning assigned to such term in the Preliminary Statements.
1.21 “Sublicensee” shall mean a
Third Party to which Licensee has granted a sublicense to develop, manufacture,
use or sell the Product in any country in the Territory, pursuant to Section 4.3.
1.22 “Territory” shall mean all of
Latin America and the Carribean; specifically the countries of Belize, Costa
Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Argentina, Bolivia,
Brazil, Chile, Colombia, Ecuador, French Guiana, Guyana, Paraguay, Peru,
Suriname, Uruguay, Venezuela, Mexico, Antigua & Barbuda, Aruba, Bahamas,
Barbados, Cayman Islands, Cuba, Dominica, Dominican Republic, Grenada,
Guadeloupe, Haiti, Jamaica, Martinique, Puerto Rico, St. Kitts & Nevis, St.
Lucia, St. Xxxxxxx and the Grenadines, Trinidad & Tobago, Turks & Caicos
Islands, Virgin Islands.
3
1.23
“Third Party” shall
mean any person who or which is neither a Party nor an Affiliate of a Party.
1.24 “Trademark” shall have the
meaning assigned thereto in Section 4.5.
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REPRESENTATIONS
AND WARRANTIES.
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2.1 Representations and Warranties of
Both Parties. Each Party represents and warrants to the other
Party, as of the Effective Date, that:
(a) such
Party is duly organized, validly existing and in good standing under the laws of
the jurisdiction of its organization and has full corporate power and authority
to enter into this Agreement and to carry out the provisions
hereof;
(b) such
Party is free to enter into this Agreement;
(c) in
so doing, such Party will not violate any other agreement to which it is a
party;
(d) such
Party has taken all corporate action necessary to authorize the execution and
delivery of this Agreement and the performance of its obligations under this
Agreement; and
(e) no
person or entity has or will have, as a result of the transactions contemplated
by this Agreement, any right, interest or valid claim against or upon such Party
for any commission, fee or other compensation as a finder or broker because of
any act or omission by such Party or any of its agents.
2.2 Representations and Warranties of
Medistem. Medistem represents and warrants to Licensee, as of
the Effective Date, that:
(a) Medistem
is the owner of, or has exclusive rights to, all of the Patents in existence on
the Effective Date, and has the exclusive right to grant the licenses granted
under this Agreement therefor;
(b) to
the best of Medistem’s knowledge, Medistem has exclusive rights to all of the
Know-how in existence on the Effective Date and the exclusive right to grant
licenses with respect thereto;
(c) to
the best of Medistem’s knowledge, Licensee’s use of the Product in the Field, in
accordance with the terms of this Agreement, does not infringe upon or conflict
with any patent or other proprietary rights in the Territory of any Third Party;
and
(d) Medistem
has not entered into any agreement with any Third Party that is in conflict with
the rights granted to Licensee pursuant to this Agreement.
2.3 Representations and Warranties of
Licensee. Licensee represents and warrants to Medistem, as of
the Effective Date, that:
4
(a) Licensee
has the facilities, personnel and experience sufficient in quantity and quality
to perform its obligations under this Agreement or will have such resources
within a reasonable period of time following the Effective Date;
(b) All
of the personnel assigned to perform such obligations shall be qualified and
properly trained and shall do so in accordance with applicable law;
and
(c) Licensee
shall perform such obligations in a manner commensurate with professional
standards generally applicable in its industry.
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GRANT
OF RIGHTS; MARKETING.
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3.1 Development
License. Medistem hereby grants to Licensee, during the term
of this Agreement, the exclusive (except as to Medistem as necessary for the
purposes of this Agreement), paid-up license, with the right to grant
sublicenses in accordance with the terms of this Agreement, under the Licensed
Technology, to perform the activities described herein.
3.2 Commercialization
License. Medistem hereby grants to Licensee an exclusive
license throughout the Territory, with the right to grant sublicenses in
accordance with the terms of this Agreement, under the Licensed Technology, to
develop, use, manufacture, register, market and sell Products in the
Field. With respect to any Patents that may issue in any country in
the Territory during the term of this Agreement, a statement referencing the
exclusive license granted to Licensee pursuant to this Section 4.2
shall be registered with the Patent Office (or similar authority) of such
country at Licensee’s cost, as soon as is practically possible after the
issuance of the respective Patents.
3.3 Sublicensing.
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FEES.
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4.1 Fees. As full
consideration to Medistem for the license and other rights granted to Licensee
under this Agreement, Licensee shall pay to Medistem cash totaling $1,000,000
and 560,000 shares of Medistem’s outstanding common stock, with such shares
coming from entities controlled by the majority owner of ICM. The
payment of 560,000 shares is due and payable within five (5) days following the
Effective Date of this Agreement. The cash payment of $1,000,000 is
due and payable as follows: $600,000 due on the date of this
Agreement, and $400,000 payable in eight equal monthly installments of $50,000
each over the eight month period that follows the Effective Date of this
Agreement. Medistem and Licensee agree that such fees are intended to
and shall satisfy all monetary obligations owed as of the Effective Date under
the Original Agreement, the First Amendment, and the Second Amendment, as well
as all principal and accrued interest as of the Effective Date with respect to
any and all loans made by Medistem to Licensee prior to the Effective
Date.
5
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REPORTS.
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5.1 Mode of
Payment. Licensee shall make all payments required under this
Agreement as directed by Medistem from time to time, net of any out-of-pocket
transfer costs or fees, in U.S. Dollars. All payments due shall be
translated at the current applicable foreign exchange rate quoted by a
commercial bank acceptable to Medistem, on the day and time of
remittance.
5.2 Taxes. In the
event that Licensee is required to withhold any tax to the tax or revenue
authorities in the Territory regarding any payment to Medistem due to the laws
of such country, such amount shall be deducted from the payment to be made by
Licensee, and Licensee shall promptly notify Medistem of such withholding and,
within a reasonable amount of time after making such deduction, furnish Medistem
with copies of any tax certificate or other documentation evidencing such
withholding. Each Party agrees to cooperate with the other Party in
claiming exemptions from such deductions or withholdings under any agreement or
treaty from time to time in effect.
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OWNERSHIP;
PATENTS.
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6.1 Ownership.
(a) Except
as otherwise provided in Section 7.1(b)
or Section 7.1(c),
Medistem shall retain all right, title and interest in and to the Patents and
Know-how, regardless of which Party prepares and prosecutes the applications
associated therewith, or maintains the patents, copyrights or other intellectual
property rights related thereto. Rights to Inventions made solely by
employees of Medistem shall belong to Medistem.
(b) Rights
to Inventions made solely by employees of Licensee shall belong to
Medistem.
(c) Rights
to Inventions which were made jointly by employees of Medistem and by employees
of Licensee shall belong to Medistem. Such joint Inventions shall be
subject to the Field and territorial restrictions of this Agreement with respect
to manufacture, use and sale of such Inventions.
6.2 Patent Maintenance.
(a) Medistem
shall have full responsibility for, and shall control the preparation and
prosecution of, all patent applications and the maintenance of all patents
relating to the Licensed Technology (including the Patents
(b) Medistem
shall select qualified independent patent counsel to file and prosecute all
patent applications pursuant to Section 7.2(a). Medistem
shall provide copies to Licensee of any filings made to, and written
communications received from, any patent office relating, in whole or in part,
to the Licensed Claims.
6
(c) Each
Party agrees promptly to provide to the other Party a complete written
disclosure of any Invention made by such Party. Medistem shall
determine whether any Invention is patentable and whether filing a patent
application is economically justifiable, and if so, shall proceed with the
preparation and prosecution of a patent application covering any such
Invention.
(d) Each
Party agrees to cooperate with the other Party to execute all lawful papers and
instruments, to make all rightful oaths and declarations and to provide
consultation and assistance as may be necessary in the preparation, prosecution,
maintenance and enforcement of all such patents and patent
applications.
6.3 Patent Enforcement.
(a) If
either Party learns of an infringement, unauthorized use,
misappropriation or ownership claim or threatened infringement or
other such claim (any of the foregoing, an “infringement”) by a Third Party with
respect to any Licensed Technology within the Territory, such Party shall
promptly notify the other Party and shall provide such other Party with
available evidence of such infringement.
(b) Medistem
shall have the first right, but not the duty, to institute patent infringement
actions against Third Parties based on any Licensed Technology in the
Territory. If Medistem (or its designee) does not secure actual
cessation of such infringement or institute an infringement proceeding against
an offending Third Party within 180 days of learning of such infringement,
Licensee shall have the right, but not the duty, to institute such an action
with respect to any infringement by such Third Party. The costs and
expenses of any such action (including fees of attorneys and other
professionals) shall be borne by the Party instituting the action, or, if the
Parties elect to cooperate in instituting and maintaining such action, such
costs and expenses shall be borne by the Parties in such proportions as they may
agree in writing. Each Party shall execute all necessary and proper
documents, take such actions as shall be appropriate to allow the other Party to
institute and prosecute such infringement actions and shall otherwise cooperate
in the institution and prosecution of such actions (including, without
limitation, consenting to being named as a nominal party
thereto). Any award paid by Third Parties as a result of such an
infringement action (whether by way of settlement or otherwise) shall be applied
first to reimburse both Parties for all costs and expenses incurred by the
Parties with respect to such action on a pro rata basis and, if after such
reimbursement any funds shall remain from such award, they shall be allocated as
follows: (i) if Medistem has instituted and maintained such action alone,
Medistem shall be entitled to retain such remaining funds; (ii) if Licensee has
instituted and maintained such action alone, Licensee shall be entitled to
retain such remaining funds; or (iii) if the Parties have cooperated in
instituting and maintaining such action, the Parties shall allocate such
remaining funds between themselves in the same proportion as they have agreed to
bear the expenses of instituting and maintaining such action.
7
6.4 Infringement Action by Third
Parties.
(a) In
the event of the institution or threatened institution of any suit by a Third
Party against Licensee for patent infringement involving the sale, distribution
or marketing of the Product in the Territory where such infringement claim is a
result of the use of the Licensed Technology, Licensee shall promptly notify
Medistem in writing of such suit. Unless otherwise covered by Section 9.3,
Licensee shall have the right to defend such suit at its own expense and shall
be responsible for all damages incurred as a result thereof. Medistem
hereby agrees to assist and cooperate with Licensee, at Licensee’s reasonable
request and expense, in the defense of such suit (including, without limitation,
consenting to being named as a nominal party thereto). During the
pendency of such action and thereafter, Licensee shall continue to make all
payments due under this Agreement.
(b) Any
award from such Third Party that arises as a result of such action described in
Section 7.4(a)
(whether by way of judgment, award, decree, settlement or otherwise) shall be
allocated as follows: (i) if Licensee finally prevails, such award shall be
applied first to reimburse Licensee for all costs and expenses incurred by it
with respect to such action and, if after such reimbursement any funds shall
remain from such award, Licensee shall be entitled to retain such excess funds;
(ii) if Medistem indemnifies Licensee with respect to any such action and
finally prevails, Medistem shall be entitled to retain such award; or (iii) if
the Parties cooperate in the defense of any such action, the expenses of such
defense shall be borne by the Parties in such proportions as they may agree in
writing, and the Parties shall allocate between themselves any part
of such award remaining after the reimbursement of such expenses, in the same
proportion as they have agreed to bear the expenses of such
defense.
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PUBLICATION;
CONFIDENTIALITY.
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7.1 Notification. Both
Parties recognize that each may wish to publish the results of their work
relating to the subject matter of this Agreement. However, both
Parties also recognize the importance of acquiring patent
protection. Consequently, subject to any applicable laws or
regulations obligating either Party to do otherwise, any proposed publication by
either Party shall comply with this Section 8.1. At
least 30 days before a manuscript is to be submitted to a publisher, the
publishing Party will provide the other party with a copy of the manuscript (or
an English translation thereof). If the publishing Party wishes to
make an oral presentation, it will provide the other party with a copy of the
abstract (if one is submitted) at least 30 days before it is to be
submitted. The publishing Party will also provide to the other party
a copy of the text of the presentation, including all slides, posters, and any
other visual aids, at least 30 days before the presentation is
made.
8
7.2 Review. The
non-disclosing party will review the manuscript, abstract, text or any other
material provided under Section 8.1 to
determine whether patentable subject matter is disclosed. The
non-disclosing party will notify the publishing Party within 30 days of receipt
of the proposed publication if the non-disclosing party, in good faith,
determines that patentable subject matter is or may be disclosed, or if the
non-disclosing party, in good faith, believes Confidential Information is or may
be disclosed. If it is determined by the non-disclosing party that
patent applications should be filed, the publishing Party shall delay its
publication or presentation for a period not to exceed 90 days from the
non-disclosing party’s receipt of the proposed publication or presentation to
allow time for the filing of patent applications covering patentable subject
matter. In the event that the delay needed to complete the filing of
any necessary patent application will exceed the 90-day period, the
non-disclosing party will discuss the need for obtaining an extension of the
publication delay beyond the 90-day period. If it is determined in
good faith by the non-disclosing party that Confidential Information or
proprietary information is being disclosed, the Parties will consult in good
faith to arrive at an agreement on mutually acceptable modifications to the
proposed publication or presentation to avoid such disclosure.
7.3 Exclusions. Nothing
in Section 8.1
and Section 8.2
shall prevent either Party: (i) in connection with efforts to secure financing
at any time during the term of this Agreement, from issuing statements as to
achievements made, and the status of the work being done by the Parties, under
this Agreement, so long as such statements do not jeopardize the ability to
obtain patent protection on Inventions or disclose non-public technical or
scientific Confidential Information; or (ii) from issuing statements that such
Party determines to be necessary to comply with applicable law (including the
disclosure requirements of the U.S. Securities and Exchange Commission, Nasdaq
or any other stock exchange on which securities issued by such Party are
traded); provided,
however, that, to the extent practicable under the circumstances, such
Party shall provide the other Party with a copy of the proposed text of such
statements sufficiently in advance of the scheduled release thereof to afford
such other Party a reasonable opportunity to review and comment upon the
proposed text. In addition, the provisions of Section 8.1 and Section 8.2 shall not
apply to Inventions solely owned by Licensee.
7.4 Confidentiality;
Exceptions. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that, during the
term of this Agreement and for 5 years thereafter, the receiving Party, its
Affiliates, its licensees and its Sublicensees shall, and shall ensure that
their respective employees, officers and directors shall, keep completely
confidential and not publish or otherwise disclose and not use for any purpose
any information furnished to it or them by the other Party, its Affiliates, its
licensees or its Sublicensees or developed under or in connection with this
Agreement, except to the extent that it can be established by the receiving
Party by competent proof that such information: (i) was already known to the
receiving Party, other than under an obligation of confidentiality, at the time
of disclosure by the other Party; (ii) was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
receiving Party; (iii) became generally available to the public or was otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement; or (iv) was
disclosed to the receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the disclosing Party
not to disclose such information to others (all such information to
which none of the foregoing exceptions applies, “Confidential
Information”).
9
7.5 Exceptions to
Obligation. The restrictions contained in Section 8.4
shall not apply to Confidential Information that: (i) is submitted by the
recipient to Regulatory Authorities to facilitate the issuance of Registrations
for the Product, provided that reasonable measures shall be taken to assure
confidential treatment of such information; (ii) is provided by the recipient to
Third Parties under confidentiality provisions at least as stringent as those in
this Agreement, for consulting, manufacturing development, manufacturing,
external testing, marketing trials and, with respect to Licensee, to Third
Parties who are Sublicensees or other development/marketing partners of Licensee
with respect to any of the subject matter of this Agreement; or (iii) is
otherwise required to be disclosed in compliance with applicable laws or
regulations or order by a court or other regulatory body having competent
jurisdiction; provided that if a Party is required to make any such disclosure
of the other Party’s Confidential Information such Party will, except where
impracticable for necessary disclosures (for example, to physicians conducting
studies or to health authorities), give reasonable advance notice to the other
Party of such disclosure requirement and, except to the extent inappropriate in
the case of patent applications, will use its best efforts to secure
confidential treatment of such Confidential Information required to be
disclosed.
7.6 Limitations on
Use. Each Party shall use, and cause each of its Affiliates,
its licensees and its Sublicensees to use, any Confidential Information obtained
by such Party from the other Party, its Affiliates, its licensees or its
Sublicensees, pursuant to this Agreement or otherwise, solely in connection with
the activities or transactions contemplated hereby.
7.7 Remedies. Each
Party shall be entitled, in addition to any other right or remedy it may have,
at law or in equity, to an injunction, without the posting of any bond or other
security, enjoining or restraining the other Party, its Affiliates, its
licensees and/or its Sublicensees from any violation or threatened violation of
this Section 8.
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INDEMNIFICATION.
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8.1 Indemnification by
Licensee. Except for items covered by Medistem’s indemnity in
Section 9.2,
Licensee shall indemnify, defend and hold harmless Medistem and its Affiliates,
and their respective directors, officers, employees and agents, from and against
any and all liabilities, damages, losses, costs and expenses (including the
reasonable fees of attorneys and other professionals) arising out of or
resulting from:
(a) negligence,
recklessness or wrongful intentional acts or omissions of Licensee, its
Affiliates or its Sublicensees, if any, and their respective directors,
officers, employees and agents, in connection with the work performed by
Licensee under this Agreement and the Development Program;
(b) any
tort claims of personal injury (including death) or property damage relating to
or arising out of any manufacture, use or sale of the Product by Licensee, its
Affiliates or its Sublicensees due to any negligence, recklessness or wrongful
intentional acts or omissions by, or strict liability of, Licensee, its
Affiliates or its Sublicensees, and their respective directors, officers,
employees and agents, except, in each case, to the comparative extent such claim
arose out of or resulted from the negligence, recklessness or wrongful
intentional acts or omissions of Medistem and its Affiliates, and their
respective directors, officers, employees and agents; or
10
(c) any
breach, or any claim which if true would constitute a breach, of any
representation or warranty made by Licensee under Section 2.
8.2 Indemnification by
Medistem. Medistem shall indemnify, defend and hold harmless
Licensee, its Affiliates, Sublicensees and distributors, and their respective
directors, officers, employees and agents, from and against any and all
liabilities, damages, losses, costs and expenses (including the reasonable fees
of attorneys and other professionals) arising out of or resulting
from:
(a) negligence,
recklessness or wrongful intentional acts or omissions of Medistem or its
Affiliates, and their respective directors, officers, employees and agents, in
connection with Medistem’s fulfillment of its obligations under Section 3;
(b) any
tort claims of personal injury (including death) or property damage relating to
or arising out of any manufacture, use or sale of the Product by Medistem or its
Affiliates due to any negligence, recklessness or wrongful intentional acts or
omissions by, or strict liability of, Medistem or its Affiliates, and their
respective directors, officers, employees and agents, except, in each case, to
the comparative extent such claim arose out of or resulted from the negligence,
recklessness or wrongful intentional acts or omissions of Licensee, its
Affiliates or its Sublicensees, and their respective directors, officers,
employees and agents; or
(c) any
breach, or any claim which if true would constitute a breach, of any
representation or warranty made by Medistem under Section 2.
8.3 Notice of
Indemnification. In the event that any person (an
“indemnitee”) entitled to indemnification under Section 9.1 or
Section 9.2 is
seeking such indemnification, such indemnitee shall inform the indemnifying
Party of the claim as soon as reasonably practicable after such indemnitee
receives notice of such claim, shall permit the indemnifying Party to assume
direction and control of the defense of the claim (including the sole right to
settle it at the sole discretion of the indemnifying Party, provided that such
settlement does not impose any obligation on, or otherwise adversely affect, the
indemnitee or the other Party) and shall cooperate as requested (at the expense
of the indemnifying Party) in the defense of the claim.
8.4 Complete
Indemnification. As the Parties intend complete
indemnification, all costs and expenses incurred by an indemnitee in connection
with enforcement of Section 9.1 or
Section
9.2 shall also be reimbursed by the indemnifying
Party.
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TERM;
TERMINATION.
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9.1 Term. This Agreement shall become
effective as of the Effective Date and, unless earlier terminated pursuant to
the other provisions of this Section 10, shall remain in force.
9.2 Termination
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(a) Termination
for Cause. Either Party (the “non-breaching Party”) may, without prejudice to
any other remedies available to it at law or in equity, terminate this Agreement
in the event the other Party (the “breaching Party”) shall have materially
breached or defaulted in the performance of any of its material obligations
hereunder, and such default shall have continued for 30 days after written
notice thereof was provided to the breaching party by the non-breaching party
(or, if such default cannot be cured within such 30-day period, if the breaching
party does not commence and diligently continue actions to cure such default
during such 30-day period). Any such termination shall become
effective at the end of such 30-day period unless the breaching party has cured
any such breach or default prior to the expiration of such 30-day period (or, if
such default cannot be cured within such 30-day period, if the breaching party
has commenced and diligently continued actions to cure such
default). The right of either Party to terminate this Agreement as
provided in this Section 10.2
shall not be affected in any way by such Party’s waiver or failure to take
action with respect to any previous default.
(b) Termination
by Mutual Agreement. This Agreement may be terminated by mutual written
agreement of the parties at any time. Expiration or termination of this
Agreement shall not relieve the parties of any obligation that accrued prior to
such expiration or termination.
9.3 Effect of Termination.
Following the termination of this Agreement: (a) Licensee shall
promptly pay all amounts remaining owed to Medistem, if any, pursuant to this
Agreement; (e) all sublicenses granted by Licensee under this Agreement with
respect to the Territory shall terminate.
9.4 Accrued Rights; Surviving
Obligations.
(a) Termination
or relinquishment of this Agreement for any reason shall be without prejudice to
any rights that shall have accrued to the benefit of either Party prior to such
termination, relinquishment or expiration. Such termination,
relinquishment or expiration shall not relieve either Party from obligations
which are expressly indicated to survive termination or expiration of this
Agreement.
(b) All
of the Parties’ rights and obligations under this Agreement to be performed
during the terms of this Agreement shall survive termination or relinquishment
of this Agreement.
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FORCE
MAJEURE.
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10.1 Events of Force
Majeure. Neither Party shall be held liable or responsible to
the other Party nor be deemed to be in default under, or in breach of any
provision of, this Agreement for failure or delay in fulfilling or performing
any obligation of this Agreement when such failure or delay is due to force majeure, and without
the fault or negligence of the Party so failing or delaying. For
purposes of this Agreement, force majeure is defined as
causes beyond the control of the Party, including, without limitation, acts of
God; acts, regulations, or laws of any government; war; civil commotion;
destruction of production facilities or materials by fire, flood, earthquake,
explosion or storm; labor disturbances; epidemic; and failure of public
utilities or common carriers. In such event Medistem or Licensee, as
the case may be, shall immediately notify the other Party of such inability and
of the period for which such inability is expected to continue. The
Party giving such notice shall thereupon be excused from such of its obligations
under this Agreement as it is thereby disabled from performing for so long as it
is so disabled and the 30 days thereafter. To the extent possible,
each Party shall use reasonable efforts to minimize the duration of any force majeure.
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MISCELLANEOUS.
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11.1 Relationship of
Parties. Nothing in this Agreement is intended or shall be
deemed to constitute a partnership, agency, employer-employee or joint venture
relationship between the Parties. No Party shall incur any debts or
make any commitments for the other, except to the extent, if at all,
specifically provided herein.
11.2 Assignment. ICM
shall be entitled to assign its rights hereunder without the consent of the
other Party hereto.
11.3 Books and
Records. Any books and records to be maintained under this
Agreement by a Party or its Affiliates or Sublicensees shall be maintained in
accordance with generally accepted accounting principles, consistently
applied.
11.4 Further
Actions. Each Party shall execute, acknowledge and deliver
such further instruments, and do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this
Agreement.
11.5 Notice.
(a) Any
notice or request required or permitted to be given under or in connection with
this Agreement shall be deemed to have been sufficiently given if in writing and
personally delivered or sent by certified mail (return receipt requested),
facsimile transmission (receipt verified), or overnight express courier service
(signature required), prepaid, to the Party for which such notice is intended,
at the address set forth for such Party below:
(i) In
the case of Medistem, to:
0000 X.
Xxxxx Xxxx
Xxxxx
0
Xxxxxxxx,
XX 00000
(ii) In
the case of Licensee, to:
Institute
for Cellular Medicine
Guimel
Building
San Xxxx,
Costa Rica
or to
such other address for such Party as it shall have specified by like notice to
the other Party, provided that notices of a change of address shall be effective
only upon receipt thereof. If delivered personally or by facsimile
transmission, the date of delivery shall be deemed to be the date on which such
notice or request was given. If sent by overnight express courier
service, the date of delivery shall be deemed to be the next business day (two
business days if sent via international express courier service) after such
notice or request was deposited with such service. If sent by
certified mail, the date of delivery shall be deemed to be the third business
day after such notice or request was deposited with the postal service of the
country in which the sender is located (the fifth business day if mailed
internationally), as the case may be.
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(b) All
correspondence, notices and other communications of any kind whatsoever given
between the Parties, including, without limitation, all data, information and
reports relating to the Development Program and all regulatory filings, shall be
promptly provided to the other Party in English, or as an English translation
thereof, as the case may be.
11.6 Use of
Name. Except as otherwise provided herein, neither Party shall
have any right, express or implied, to use in any manner the name or other
designation of the other Party or any other trade name or trademark of the other
Party (including, without limitation, the Trademark) for any purpose in
connection with the performance of this Agreement.
11.7 Public
Announcements. Except as permitted by Section 8.3 or
required by law, neither Party shall make any public announcement concerning
this Agreement or the subject matter hereof without the prior written consent of
the other Party, which shall not be unreasonably withheld, provided that it
shall not be unreasonable for a Party to withhold consent with respect to any
public announcement containing any of such Party’s Confidential
Information.
11.8 Waiver. A waiver
by either Party of any of the terms and conditions of this Agreement in any
instance shall not be deemed or construed to be a waiver of such term or
condition for the future, or of any subsequent breach hereof. All
rights, remedies, undertakings, obligations and agreements contained in this
Agreement shall be cumulative and none of them shall be in limitation of any
other remedy, right, undertaking, obligation or agreement of either
Party.
11.9 Compliance with
Law. Nothing in this Agreement shall be deemed to permit a
Party to export, re-export or otherwise transfer any Product sold under this
Agreement without compliance with applicable laws.
11.10 Severability. When
possible, each provision of this Agreement will be interpreted in such manner as
to be effective and valid under applicable law, but if any provision of this
Agreement is held to be prohibited by or invalid under applicable law, such
provision will be ineffective only to the extent of such prohibition or
invalidity, without invalidating the remainder of this Agreement.
11.11 Amendment. No
amendment, modification or supplement of any provisions of this Agreement shall
be valid or effective unless made in writing and signed by a duly authorized
officer of each Party.
11.12 Governing Law. This Agreement
shall be governed by and interpreted in accordance with the laws of the State of
Arizona without regard to conflicts of law principles; provided, however, that any
arbitration proceeding conducted pursuant to Section 12.13
shall be governed by the American Arbitration Association.
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11.13 Arbitration.
(a) Except
as expressly otherwise provided in this Agreement, any dispute arising out of or
relating to any provisions of this Agreement shall be finally settled by
arbitration to be held in Phoenix, Arizona, under the commercial arbitration
rules of the America Arbitration Association. Such arbitration shall
be conducted by 3 arbitrators appointed according to said rules and in the
English language. The Parties shall instruct such arbitrators to
render a determination of any such dispute within 4 months after their
appointment.
(b) Any
award rendered by the arbitrator shall be final and binding upon the
Parties. Judgment upon any award rendered may be entered in any court
having jurisdiction, or application may be made to such court for a judicial
acceptance of the award and an order of enforcement, as the case may
be. Each Party shall pay its own expenses of arbitration, and the
expenses of the arbitrators shall be equally shared unless the arbitrators
assess as part of their award all or any part of the arbitration expenses of one
Party (including reasonable attorneys’ fees) against the other
Party.
(c) This
Section 12.13
shall not prohibit a Party from seeking injunctive relief from a court of
competent jurisdiction in the event of a breach or prospective breach of this
Agreement by the other Party which would cause irreparable harm to the first
Party.
11.14 Entire
Agreement. This Agreement and the other documents and
agreements executed in connection herewith and therewith, together with the
schedules and exhibits to any of the foregoing, sets forth the entire agreement
and understanding between the Parties as to the subject matter hereof and merges
all prior discussions and negotiations between them, and neither of the Parties
shall be bound by any conditions, definitions, warranties, understandings or
representations with respect to such subject matter other than as expressly
provided herein or as duly set forth on or subsequent to the date hereof in
writing and signed by a proper and duly authorized officer or representative of
the Party to be bound thereby.
11.15 Parties in
Interest. All of the terms and provisions of this Agreement
shall be binding upon, inure to the benefit of and be enforceable by the Parties
hereto and their respective permitted successors and assigns.
11.16 Descriptive
Headings. The descriptive headings of this Agreement are for
convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.
11.17 Counterparts. This
Agreement may be executed simultaneously in any number of counterparts, any one
of which need not contain the signature of more than one Party but all such
counterparts taken together shall constitute one and the same
agreement.
* *
*
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IN
WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by
its duly authorized representative as of the day and year first above
written.
MEDISTEM
By: /s/ Xxxxxx
Xxxxx
Name: Xxxxxx
Xxxxx
Title: Chief
Executive Officer
LICENSEE
By: /s/
Xxxx X. Xxxxxxx
Name:
Xxxx X. Xxxxxxx, Ph.D
Title: President
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EXHIBIT
A
PATENTS
A-1
